Heart and Circulation Tonic
Generic Name: crataegus fruit, arnica montana, potassium phosphate, dibasic and calcium fluoride granule
Dosage Form: FOR ANIMAL USE ONLYHEART AND CIRCULATION TONIC
Improves circulation and strengthens heart and arteries
Indications: Homeopathic heart and circulation tonic.
Dosage: Sprinkle into the mouth and administer 3 times daily. Cats and dogs under 20 lbs: 1 large pinch. Dogs 20-50 lbs: 2 pinches. Dogs over 50 lbs: 1/4 cap.
Caution: Consult your vet if symptoms persist or worsen. Keep this and all medicines from the reach of children.
Ingredients: Each dose contains equal parts of Crataegus (3X) (HPUS), Arnica (3X) (HPUS), Kali phos (6C) (HPUS), Calc flour (6C) (HPUS)
Sucrose (inactive ingredient).
Contains no gluten, artificial flavors, colors or preservatives.
Insulin Lispro Protamine/Insulin Lispro Pens
Pronunciation: IN-su-lin LIS-proGeneric Name: Insulin Lispro Protamine/Insulin LisproBrand Name: Examples include Humalog Mix 75/25 and Humalog Mix 50/50
KOGENATE Bayer 250 IU Powder and solvent for solution for injection (Medimop)
1. Name Of The Medicinal Product
KOGENATE Bayer 250 IU powder and solvent for solution for injection.
2. Qualitative And Quantitative Composition2.1 General description
Each vial contains nominally 250 IU human coagulation factor VIII (octocog alfa).
Human coagulation factor VIII is produced by recombinant DNA technology (rDNA) in baby hamster kidney cells containing the human factor VIII gene.
2.2 Qualitative and quantitative composition
One ml of KOGENATE Bayer 250 IU contains approximately 100 IU (250 IU / 2.5 ml) of human coagulation factor VIII (octocog alfa) after reconstitution.
The potency (IU) is determined using the one-stage clotting assay against the FDA Mega standard which was calibrated against WHO standard in International Units (IU).
The specific activity of KOGENATE Bayer is approximately 4000 IU/mg protein.
Solvent: water for injections.
For a full list of excipients, see section 6.1.
3. Pharmaceutical FormPowder and solvent for solution for injection.
Powder: dry white to slightly yellow powder or cake.
Solvent: water for injection, a clear, colourless solution.
The reconstituted medicinal product is a clear and colourless solution.
4. Clinical Particulars 4.1 Therapeutic IndicationsTreatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.
4.2 Posology And Method Of AdministrationTreatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.
Posology
The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to the International Standard for factor VIII in plasma). One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma. The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1.5% to 2.5% of normal activity. The required dose is determined using the following formulae:
I. Required IU = body weight (kg) ? desired factor VIII rise (% of normal) ? 0.5
II. Expected factor VIII rise (% of normal) =
2 ? administered IU
body weight (kg)
On demand treatment
The dose, frequency and duration of the substitution therapy must be individualised according to the patient's needs (weight, severity of disorder of the haemostatic function, the site and extent of the bleeding, the presence of inhibitors, and the factor VIII level desired).
The following table provides a guide for factor VIII minimum blood levels. In the case of the haemorrhagic events listed, the factor VIII activity should not fall below the given level (in % of normal) in the corresponding period:
Degree of haemorrhage/ Type of surgical procedure
Factor VIII level required (%) (IU/dl)
Frequency of doses (hours)/ Duration of therapy (days)
Haemorrhage
Early haemarthrosis, muscle bleed or oral bleed
20 - 40
Repeat every 12 to 24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
More extensive haemarthrosis, muscle bleed or haematoma
30 - 60
Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and disability are resolved.
Life threatening bleeds such as intracranial bleed, throat bleed, severe abdominal bleed
60 - 100
Repeat infusion every 8 to 24 hours until threat is resolved
Surgery
Minor
including tooth extraction
30 - 60
Every 24 hours, at least 1 day, until healing is achieved.
Major
80 - 100
(pre- and postoperative)
a) By bolus infusions
Repeat infusion every 8 - 24 hours until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60%
b) By continuous infusion
Raise factor VIII activity pre-surgery with an initial bolus infusion and immediately follow with continuous infusion (in IU/Kg/h) adjusting according to patient's daily clearance and desired factor VIII levels for at least 7 days.
The amount to be administered and the frequency of administration should always be adapted according to the clinical effectiveness in the individual case. Under certain circumstances larger amounts than those calculated may be required, especially in the case of the initial dose.
During the course of treatment, appropriate determination of factor VIII levels is advised in order to guide the dose to be administered and the frequency at which to repeat the infusions. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable. Individual patients may vary in their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Continuous Infusion
It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that KOGENATE Bayer can be used for continuous infusion in surgeries (pre-, during and postoperative). In this study heparin was used to prevent thrombophlebitis at the infusion site as with any other long term intravenous infusions. For the calculation of the initial infusion rate, clearance can be obtained by performing a pre-surgery decay curve, or by starting from an average population value (3.0-3.5 ml/h/kg) and then adjust accordingly.
Infusion rate (in IU/kg/h) = Clearance (in ml/h/kg) ? desired factor VIII level (in IU/ml)
For continuous infusion, clinical and in vitro stability has been demonstrated using ambulatory pumps with a PVC reservoir. KOGENATE Bayer contains low level of polysorbate-80 as an excipient, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC) materials. This should be considered for a continuous infusion administration.
Prophylaxis
For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of KOGENATE Bayer per kg body weight at intervals of 2 to 3 days.
In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.
Paediatric population
Data have been obtained from clinical studies in 61 children under 6 years of age and non-interventional studies in children of all ages.
Patients with inhibitors
Patients should be monitored for the development of factor VIII inhibitors. If the expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present. If the inhibitor is present at levels less than 10 Bethesda Units (BU) per ml, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with KOGENATE Bayer. However, in the presence of an inhibitor the doses required are variable and must be adjusted according to clinical response and monitoring of plasma factor VIII activity. In patients with inhibitor titres above 10 BU or with high anamnestic response, the use of (activated) prothrombin complex concentrate (PCC) or recombinant activated factor VII (rFVIIa) preparations has to be considered. These therapies should be directed by physicians with experience in the care of patients with haemophilia.
Method of administration
For intravenous use.
KOGENATE Bayer should be injected intravenously over several minutes. The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 ml/min).
Continuous infusion
KOGENATE Bayer can be infused by continuous infusion. The infusion rate should be calculated based on the clearance and the desired FVIII level.
Example: for a 75 kg patient with a clearance of 3 ml/h/kg, the initial infusion rate would be 3 IU/h/kg to achieve a FVIII level of 100%. For calculation of ml/hour, multiply infusion rate in IU/h/kg by kg bw/concentration of solution (IU/ml).
Example for calculation of infusion rate for continuous infusion after initial bolus injection
Desired plasma FVIII level
Infusion rate
IU/h/kg
Infusion rate for 75 kg patient
ml/h
Clearance: 3 ml/h/kg
Concentrations of rFVIII solution
100 IU/ml
200 IU/ml
400 IU/ml
100 % (1 IU/ml)
3.0
2.25
1.125
0.56
60 % (0.6 IU/ml)
1.8
1.35
0.68
0.34
40 % (0.4 IU/ml)
1.2
0.9
0.45
0.225
Higher infusion rates may be required in conditions with accelerated clearance during major bleedings or extensive tissue damage during surgical interventions.
After the initial 24 hours of continuous infusion, the clearance should be recalculated every day using the steady state equation with the measured FVIII level and the rate of infusion using the following equation:
clearance = infusion rate/actual FVIII level.
During continuous infusion, infusion bags should be changed every 24 hours.
For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the package leaflet.
4.3 Contraindications- Known hypersensitivity to the active substance or to any of the excipients.
- Known allergic reactions to mouse or hamster protein.
4.4 Special Warnings And Precautions For UseHypersensitivity reactions
As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Patients should be made aware that the potential occurrence of chest tightness, dizziness, mild hypotension and nausea during infusion can constitute an early warning for hypersensitivity and anaphylactic reactions. Symptomatic treatment and therapy for hypersensitivity should be instituted as appropriate. If allergic or anaphylactic reactions occur, the injection/infusion should be stopped immediately and patient should contact their physician. In case of shock, the current medical standards for shock treatment should be observed.
Antibodies (inhibitors)
The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Modified Bethesda Units (BU) per ml of plasma. The risk of developing inhibitors is correlated to the exposure to anti-haemophilic factor VIII and to genetic factors among others, this risk being highest within the first 20 exposure days. Rarely, inhibitors may develop after the first 100 exposure days.
Cases of recurrence of inhibitors (low titre) have been observed after switching from one recombinant factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development.
Patients treated with recombinant coagulation factor VIII should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. (See also section 4.8)
Continuous infusion
In a clinical study about the use of continuous infusion in surgeries, heparin was used to prevent thrombophlebitis at the infusion site as with any other long term intravenous infusions.
Registration
In the interest of the patients, it is recommended that, whenever possible, every time that KOGENATE Bayer is administered to them, the name and the batch number of the product is registered.
Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium free”.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionNo interactions of KOGENATE Bayer with other medicinal products are known.
4.6 Pregnancy And LactationAnimal reproduction studies have not been conducted with KOGENATE Bayer.
Based on the rare occurrence of haemophilia A in women, experience regarding the use of KOGENATE Bayer during pregnancy and breast-feeding is not available. Therefore, KOGENATE Bayer should be used during pregnancy and breast-feeding only if clearly indicated.
There are no fertility data available.
4.7 Effects On Ability To Drive And Use MachinesKOGENATE Bayer has no influence on the ability to drive or to use machines.
4.8 Undesirable EffectsThe most commonly reported adverse drug reaction occurring is the formation of neutralising antibodies (prevalent in previously untreated or minimally treated patients).
The frequencies of adverse reactions reported with KOGENATE Bayer are summarized in the table below. Within each frequency group, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as common (
MedDRA Standard
System Organ Class
Common
Uncommon
Rare
Blood and the Lymphatic System Disorders
Inhibitor Formation to FVIII
(Reported in PUP and minimally treated patients in clinical trials)*
Inhibitor Formation to FVIII
(Reported in PTP in clinical trials and Post Marketing Studies)*
General Disorders and Administration Site Conditions
Infusion site reaction
Infusion related febrile reaction (pyrexia)
Immune System Disorders
Skin associated hypersensitivity reactions, (pruritus, urticaria and rash)
Systemic Hypersensitivity reactions (including one anaphylactic reaction, nausea, blood pressure abnormal and, dizziness)
* see section below
Description of selected adverse reactions
The formation of neutralising antibodies to factor VIII (inhibitors) is a known complication in the management of individuals with haemophilia A. In studies with recombinant factor VIII preparations, development of inhibitors is predominantly observed in previously untreated haemophiliacs. Patients should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
In clinical studies, KOGENATE Bayer has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated pediatric patients (MTPs, defined as having equal to or less than 4 exposure days). Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with KOGENATE Bayer developed inhibitors: Overall, 9 out of 60 (15%) developed inhibitors, 6 out of 60 (10%) with a titre above 10 BU and 3 out of 60 (5%) with a titre below 10 BU. The median number of exposure days at the time of inhibitor detection in these patients was 9 days (range 3 - 18 days).
The median number of exposure days in the clinical studies was 114 (range: 4-478). Four of the five patients, who had not achieved 20 exposure days at the end of the study, ultimately achieved more than 20 exposure days in post-study follow-up and one of them developed a low titre inhibitor. The fifth patient was lost to follow-up.
In clinical studies with 73 previously treated patients (PTP, defined as having more than 100 exposure days), followed over four years, no de-novo inhibitors were observed.
In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed: Less than 0.2% PTP developed de-novo inhibitors. In a subset defined as having less than 20 exposure days at study entry, less than 11% developed de-novo inhibitors.
During studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation. However, the possibility of allergic reactions to constituents, e.g. trace amounts of mouse and hamster protein in the preparation exists in certain predisposed patients (see sections 4.3 and 4.4).
4.9 OverdoseNo case of overdose with recombinant coagulation factor VIII has been reported.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesPharmacotherapeutic group: antihemorrhagics: blood coagulation factor VIII, ATC code B02BD02.
The factor VIII/von Willebrand factor (vWF) complex consists of two molecules (factor VIII and vWF) with different physiological functions. When infused into a haemophilic patient, factor VIII binds to vWF in the patient's circulation. Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Determination of activated partial thromboplastin time (aPTT) is a conventional in vitro assay method for biological activity of factor VIII. The aPTT is prolonged in all haemophiliacs. The degree and duration of aPTT normalisation observed after administration of KOGENATE Bayer is similar to that achieved with plasma-derived factor VIII.
5.2 Pharmacokinetic PropertiesThe analysis of all recorded in vivo recoveries in previously treated patients demonstrated a mean rise of 2 % per IU/kg body weight for KOGENATE Bayer. This result is similar to the reported values for factor VIII derived from human plasma.
After administration of KOGENATE Bayer, peak factor VIII activity decreased by a two-phase exponential decay with a mean terminal half-life of about 15 hours. This is similar to that of plasma-derived factor VIII which has a mean terminal half-life of approx. 13 hours. Additional pharmacokinetic parameters for KOGENATE Bayer for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 ml/h. Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 ml/h corresponding to 3.0 ml/h/kg (range 1.6-4.6 ml/h/kg).
5.3 Preclinical Safety DataEven doses several fold higher than the recommended clinical dose (related to body weight) failed to demonstrate any acute or subacute toxic effects for KOGENATE Bayer in laboratory animals (mouse, rat, rabbit, and dog).
Specific studies with repeated administration such as reproduction toxicity, chronic toxicity, and carcinogenicity were not performed with octocog alfa due to the immune response to heterologous proteins in all non-human mammalian species.
No studies were performed on the mutagenic potential of KOGENATE Bayer, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of KOGENATE Bayer.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsPowder
Glycine
Sodium chloride
Calcium chloride
Histidine
Polysorbate 80
Sucrose
Solvent
Water for injections
6.2 IncompatibilitiesThis medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6..
Only the provided components (powder vial, pre-filled syringe containing solvent, vial adapter and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
6.3 Shelf Life30 months.
After reconstitution, the product should be used immediately.
However, during in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 30°C in PVC bags for continuous infusion.
Do not refrigerate after reconstitution.
6.4 Special Precautions For StorageStore in a refrigerator (2°C – 8°C). Do not freeze. Keep the vial and the pre-filled syringe in the outer carton in order to protect from light.
The product when kept in its outer carton may be stored at ambient room temperature (up to 25°C) for a limited period of 12 months. In this case, the product expires at the end of this 12-month period; the new expiry date must be noted on the outer carton.
For storage conditions of the reconstituted medicinal product, see section 6.3.
6.5 Nature And Contents Of ContainerEach package of KOGENATE Bayer contains:
• one vial with powder (10 ml clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper and aluminium seal)
• one pre-filled syringe with 2.5 ml solvent (clear glass cylinder type 1 with latex-free grey bromobutyl rubber blend stopper)
• syringe plunger rod
• vial adapter
• one venipuncture set
• two sterile alcohol swabs for single use
• two dry swabs
• two plasters
6.6 Special Precautions For Disposal And Other HandlingDetailed instructions for preparation and administration are contained in the package leaflet provided with KOGENATE Bayer.
KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) in the prefilled syringe and the vial adapter. Reconstitution should be performed in accordance with good practices rules, particularly with attention to asepsis. Gently rotate the vial until all powder is dissolved. After reconstitution the solution is clear. Do not use KOGENATE Bayer if you notice visible particulate matter or turbidity.
After reconstitution, the solution is drawn back into the syringe.
Use the provided venipuncture set for intravenous injection.
For continuous infusion, the product must be prepared under aseptic conditions.
For single use only. Any unused solution must be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing Authorisation HolderBayer Pharma AG
13342 Berlin
Germany
8. Marketing Authorisation Number(S)EU/1/00/143/007
9. Date Of First Authorisation/Renewal Of The AuthorisationDate of first authorisation: 04 August 2000
Date of latest renewal: 06 August 2010
10. Date Of Revision Of The Text1 July 2011
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Oruvail I.M. Injection
1. Name Of The Medicinal Product
Oruvail IM Injection
2. Qualitative And Quantitative CompositionIn terms of the active ingredient
Ketoprofen BP 100mg in 2 ml.
3. Pharmaceutical FormSolution for IM injection
4. Clinical Particulars 4.1 Therapeutic IndicationsOruvail injection is recommended in the management of acute exacerbations of:
• Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.
• Periarticular conditions such as fibrositis, bursitis, capsulitis, tendinitis and tenosynovitis.
• Low back pain of musculoskeletal origin and sciatica.
• Other painful musculoskeletal conditions.
• Acute gout.
• Control of pain and inflammation following orthopaedic surgery.
4.2 Posology And Method Of AdministrationAdults: 50 to 100 mg every four hours, repeated up to a maximum of 200 mg in twenty-four hours. Following a satisfactory response, oral therapy should be instituted with ketoprofen capsules. It is recommended that the injection should not normally be continued for longer than three days.
Elderly: The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
Paediatric dosage: not established.
Oruvail IM Injection is for intramuscular injection only.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4
4.3 ContraindicationsKetoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as bronchospasm, asthmatic attacks, rhinitis, angioedema, urticaria or other allergic-type reactions to ketoprofen, any other ingredients in this medicine, ASA or other NSAIDs.
Ketoprofen is contraindicated in patients with hypersensitivity to any of the excipients of the drug.
Ketoprofen is also contraindicated in the third trimester of pregnancy.
Ketoprofen is contraindicated in the following cases:
-severe heart failure
-active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
-haemorrhagic diathesis
-severe hepatic insufficiency
-severe renal insufficiency
-third trimester of pregnancy
Ketoprofen is contraindicated in cases of cerebrovascular bleeding or any other active bleeding.
Ketoprofen is contraindicated in patients with haemostatic disorders or ongoing anticoagulant therapy.
4.4 Special Warnings And Precautions For UseOruvail injection is for intramuscular use only.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 Posology and method of administration, and GI and cardiovascular risks below).
The use of ketoprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5 Interactions).
Elderly:
The elderly have an increased risk of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal (see Section 4.2 Posology and method of administration).
Cardiovascular, Renal and Hepatic impairment:
At the start of treatment, renal function must be carefully monitored in patients with heart impairment, heart failure, liver dysfunction, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly. In these patients, administration of ketoprofen may induce a reduction in renal blood flow caused by prostaglandin inhibition and lead to renal decomposition (see Section 4.3 Contra-indications).
Cardiovascular and cerebrovascular effects
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for ketoprofen.
Respiratory disorders:
Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to aspirin and/or NSAIDs than the rest of the population. Administration of this medicinal product can cause asthma attacks or bronchospasm, particularly in subjects allergic to aspirin or NSAIDs (see section 4.3).
Gastrointestinal bleeding, ulceration and perforation:
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
Some epidemiological evidence suggests that ketoprofen may be associated with a high risk of serious gastrointestinal toxicity, relative to some other NSAIDs, especially at high doses (see also section 4.2 and 4.3).
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAlD doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).
NSAIDs should only be given with care to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see Section 4.8 Undesirable effects).
Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding), particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).
When GI bleeding or ulceration occurs in patients receiving ketoprofen, the treatment should be withdrawn.
SLE and mixed connective tissue disease:
In patients with systemic lupus erythematosis (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8 Undesirable effects).
Impaired female fertility:
The use of ketoprofen, as with other NSAIDs, may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of ketoprofen should be considered.
Skin reactions:
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAlDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Infectious disease:
As with other NSAIDs, in the presence of an infectious disease, it should be noted that the anti-inflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.
Risk of gastrointestinal bleeding: the relative risk increases in subjects who have a low body weight. If gastrointestinal bleeding or ulcer occur, treatment must be discontinued immediately.
Blood counts and liver and kidney function tests should be carried out during long-term treatment.
Hyperkalaemia:
Hyperkalaemia promoted by diabetes or concomitant treatment with potassium-sparing agents (see section 4.5 Interactions).
Potassium levels must be monitored regularly under these circumstances.
In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy.
Patients with active or a past history of peptic ulcer.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionAnticoagulants (heparin and warfarin) and platelet aggregation inhibitors (i.e. ticlopidine, clopidogrel):
Increased risk of bleeding (see section 4.4).
If co-administration is unavoidable, patient should be closely monitored
Lithium:
Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAIDs therapy.
Other analgesics/NSAIDs (including cyclooxygenase-2 selective inhibitors) and high dose salicylates:
Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects, particularly gastrointestinal ulceration and bleeding (see section 4.4 Special warnings and precautions for use).
Methotrexate:
Serious interactions have been recorded after the use of high dose methotrexate with NSAIDs, including ketoprofen, due to decreased elimination of methotrexate. At doses greater than 15mg/week: Increased risk of haematologic toxicity of methotrexate, particularly if administered at high doses (> 15mg/week), possibly related to displacement of protein-bound methotrexate and to its decreased renal clearance.
Allow at least 12 hours between the discontinuation or initiation of ketoprofen treatment and the administration of methotrexate.
At doses lower than 15mg/week: During the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function or if the patient is elderly, monitoring should be done more frequently.
Mifepristone:
NSAlDs should not be used for 8-12 days after mifepristone administration as NSAlDs can reduce the effect of mifepristone.
Antihypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics):
Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs).
Diuretics:
Risk of reduced diuretic effect. Patients and particularly dehydrated patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating co-administration therapy and renal function monitored when the treatment is started (see section 4.4 Special warnings and precautions for use).
Cardiac glycosides:
NSAlDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
Ciclosporin: Increased risk of nephrotoxicity, particularly in elderly subjects.
Quinolone antibiotics:
Animal data indicate that NSAlDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAlDs and quinolones may have an increased risk of developing convulsions.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus, particularly in elderly subjects.
Thrombolytics:
Increased risk of bleeding.
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4 Special warnings and precautions for use).
ACE inhibitors and Angiotensin II Antagonists:
In patients with compromised renal function (e.g. dehydrated patients or elderly patients the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure.
Zidovudine:
Increased risk of haematological toxicity when NSAlDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
Risks related to hyperkalaemia:
Certain medicinal products or therapeutic categories can promote hyperkalaemia, i.e. potassium salts, potassium-sparing diuretics, converting enzyme inhibitors, angiotensin II receptor blockers, NSAIDs, heparins (low molecular-weight or unfractioned), ciclosporin, tacrolimus and trimethoprim. The occurrence of hyperkalaemia can depend on the presence of co-factors. This risk is enhanced when the drugs mentioned above are administered concomitantly.
Risks related to antiplatelet effect:
Several substances are involved in interactions due to their antiplatelet effects: tirofiban, eptifibarid, abcixiab, and iloprost. The use of several antiplatelet drugs enhances the risk of bleeding.
4.6 Pregnancy And LactationPregnancy
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, ketoprofen should not be given unless clearly necessary. If ketoprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of the pregnancy, to:
- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
- Inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, ketoprofen is contraindicated during the third trimester of pregnancy.
Lactation
No data are available on excretion of ketoprofen in human milk. Ketoprofen is not recommended in nursing mothers.
4.7 Effects On Ability To Drive And Use MachinesPatients should be warned about the potential for somnolence, dizziness or convulsions and be advised not to drive or operate machinery if these symptoms occur.
Patients should be warned of possible visual disturbances. If patients experience this, they should not drive or use machines.
4.8 Undesirable EffectsGastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4) have been r3eported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.
Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Local reactions can occur and may include pain or a burning sensation. In all cases of major adverse effects Oruvail should be withdrawn at once.
Cardiovascular and cerebrovascular:
Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Other adverse reactions reported less commonly include:
Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephritic syndrome and renal failure.
Hepatic: abnormal liver function, hepatitis and jaundice.
Neurological and special senses: Visual disturbances, optic neuritis, headaches, paraesthesia, reports of aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (See section 4.4) , depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.
Haematological: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
Dermatological: Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.
4.9 OverdoseSymptoms
In adults, the principal signs of overdose are headache, dizziness, drowsiness, nausea, vomiting, diarrhoea and abdominal pain. Disorientation, excitation, coma, tinnitus, fainting, occasionally convulsions may also occur. During severe intoxication, hypotension, respiratory depression and gastrointestinal bleeding have been observed.
Adverse effects seen after overdose with propionic acid derivatives such as hypotension, bronchospasm and gastro-intestinal haemorrhage should be anticipated.
In cases of significant poisoning, acute renal failure and liver damage are possible.
Therapeutic measures:
The patient must be transferred immediately to a specialised hospital setting where symptomatic treatment can begin.
There is no specific antidote.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Frequent or prolonged convulsions should be treated with intravenous diazepam.
Other measures may be indicated by the patient's clinical condition.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesKetoprofen is a pharmacopoeial non-steroidal anti-inflammatory drug (NSAID). It is a strong inhibitor of prostaglandin synthetase and potent analgesic agent. Studies in vitro and in vivo show that ketoprofen possesses powerful anti-inflammatory, antipyretic, antibradykinin and lysosomal membrane stabilising properties.
5.2 Pharmacokinetic PropertiesPeak concentrations of approximately 10 mg/L are reached at about 0.5-0.75 H after a 100 mg dose. The elimination half life is approximately 1.88 H. Apart from earlier Tmax values, there are no significant differences between the pharmacokinetics of Oruvail IM injection and conventional release capsules (Orudis).
5.3 Preclinical Safety DataNo additional data of relevance to the prescriber.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsArginine
BP
Benzyl Alcohol
BP
Citric Acid anhydrous (E330)
BP
Water For Injections
BP
6.2 IncompatibilitiesNone stated
6.3 Shelf Life36 months
6.4 Special Precautions For StorageStore below 30°C. Protect from light.
6.5 Nature And Contents Of ContainerCartons containing 10 ampoules each having 2 ml. of injection.
6.6 Special Precautions For Disposal And Other HandlingNone stated
7. Marketing Authorisation HolderSanofi-aventis
One Onslow Street
Guildford
Surrey, GU1 4YS, UK
8. Marketing Authorisation Number(S)PL 04425/0377
9. Date Of First Authorisation/Renewal Of The Authorisation15 November 2005
10. Date Of Revision Of The Text11 May 2011
LEGAL CATEGORYPOM
Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc
Pronunciation: VYE-ta-min B/VYE-ta-min C/VYE-ta-min D/BYE-oh-tin/FOE-lik AS-id/zinkGeneric Name: Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/ZincBrand Name: Vital-D Rx
Lorabid Suspension
Generic Name: Loracarbef (lor-a-KAR-bef)Brand Name: Lorabid
Lorabid Suspension is used for:
Treating mild to moderate infections caused by certain bacteria.
Lorabid Suspension is a carbacephem antibiotic. It kills sensitive bacteria by interfering with formation of the bacteria's cell wall while it is growing. This weakens the cell wall and it ruptures, resulting in the death of the bacteria.
Do NOT use Lorabid Suspension if: you are allergic to any ingredient in Lorabid Suspension or to cephalosporins (eg, cephalexin)Contact your doctor or health care provider right away if any of these apply to you.
Before using Lorabid Suspension:Some medical conditions may interact with Lorabid Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a penicillin antibiotic (eg, amoxicillin) or other beta-lactam antibiotic (eg, imipenem) if you have stomach or bowel problems (eg, inflammation), blood clotting problems, kidney or liver problems, or poor nutritionSome MEDICINES MAY INTERACT with Lorabid Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:
Diuretics (eg, furosemide) because the risk of kidney side effects may be increased Anticoagulants (eg, warfarin) or heparin because the risk of bleeding may be increasedThis may not be a complete list of all interactions that may occur. Ask your health care provider if Lorabid Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Lorabid Suspension:Use Lorabid Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Lorabid Suspension on an empty stomach at least 1 hour before or 2 hours after eating. Shake well before each use. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. To clear up your infection completely, continue using Lorabid Suspension for the full course of treatment even if you feel better in a few days. If you miss a dose of Lorabid Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.Ask your health care provider any questions you may have about how to use Lorabid Suspension.
Important safety information: Lorabid Suspension may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Lorabid Suspension. Using Lorabid Suspension alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. Lorabid Suspension is effective only against bacteria. It is not effective for treating viral infections (eg, the common cold). It is important to use Lorabid Suspension for the full course of treatment. Failure to do so may decrease the effectiveness of Lorabid Suspension and may increase the risk that the bacteria will no longer be sensitive to Lorabid Suspension and will not be able to be treated by this or certain other antibiotics in the future. Long-term or repeated use of Lorabid Suspension may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur. If severe diarrhea, stomach pain/cramps, or bloody stools occur, contact your doctor immediately. This could be a symptom of a serious side effect requiring immediate medical attention. Do not treat diarrhea without consulting your doctor. Diabetes patients - Lorabid Suspension may cause incorrect test results with some urine glucose tests. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet. Lorabid Suspension may affect certain LAB TEST results. Make sure your doctor and laboratory personnel know that you are using Lorabid Suspension. Use Lorabid Suspension with caution in the ELDERLY because they may be more sensitive to its effects. Use Lorabid Suspension with extreme caution in CHILDREN younger than 6 months of age. Safety and effectiveness in this age group have not been confirmed. Use Lorabid Suspension with extreme caution in CHILDREN younger than 10 years of age who have diarrhea or a stomach or bowel infection. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Lorabid Suspension, discuss with your doctor the benefits and risks of using Lorabid Suspension during pregnancy. It is unknown if Lorabid Suspension is excreted in breast milk. If you are or will be breast-feeding while you are using Lorabid Suspension, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Lorabid Suspension:All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; dizziness; drowsiness; headache; loss of appetite; nausea; stomach pain; stuffy nose; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; decreased urination; fever; hoarseness; red, swollen, or blistered skin; seizures; severe diarrhea; severe nausea or vomiting; severe stomach pain or cramps; unusual bruising or bleeding; unusual tiredness; vaginal irritation or discharge; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.
See also: Lorabid side effects (in more detail)
If OVERDOSE is suspected:Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/DNN/), or emergency room immediately. Symptoms may include severe diarrhea, nausea, stomach upset, or vomiting.
Proper storage of Lorabid Suspension:Store Lorabid Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Throw away any unused medicine after 14 days. Do not store in the bathroom. Keep Lorabid Suspension out of the reach of children and away from pets.
General information: If you have any questions about Lorabid Suspension, please talk with your doctor, pharmacist, or other health care provider. Lorabid Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor.This information is a summary only. It does not contain all information about Lorabid Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Lorabid resources Lorabid Side Effects (in more detail)Lorabid Use in Pregnancy & BreastfeedingLorabid Drug InteractionsLorabid Support Group1 Review for Lorabid - Add your own review/rating Compare Lorabid with other medications Bladder InfectionBronchitisImpetigoKidney InfectionsOtitis MediaPneumoniaSinusitisSkin InfectionStrep ThroatTonsillitis/PharyngitisUpper Respiratory Tract InfectionPenbritin 250 mg Capsules
1. Name Of The Medicinal Product
Penbritin 250mg Capsules
2. Qualitative And Quantitative Composition(Ampicillin Capsules): 250mg ampicillin as Ampicillin Trihydrate
3. Pharmaceutical FormBlack and red capsules overprinted Penbritin 250
4. Clinical Particulars 4.1 Therapeutic IndicationsAmpicillin is a broad-spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin-sensitive organisms. Typical indications include: ear, nose and throat infections, bronchitis, pneumonia, urinary tract infections, gonorrhoea, gynaecological infections, septicaemia, peritonitis, endocarditis, meningitis, enteric fever, gastro-intestinal infections.
Parenteral usage is indicated where oral dosage is inappropriate.
4.2 Posology And Method Of AdministrationUsual adult dosage (including elderly patients):
Ear, nose and throat infections:
250mg four times a day.
Bronchitis:
Routine therapy:
250mg four times a day.
High-dosage therapy:
1 g four times a day.
Pneumonia:
500 mg four times a day.
Urinary tract infections:
500 mg three times a day.
Gonorrhoea:
2 g orally with 1 g probenecid as a single dose.
Repeated doses are recommended for the treatment of females.
Gastro-intestinal infections:
500-750 mg three to four times daily.
Enteric:
Acute:
1-2 g four times a day for two weeks.
Carriers:
1-2 g four times a day for four to twelve weeks
Usual children's dosage (under 10 years):
Half adult routine dosage.
All recommended dosages are a guide only. In severe infections the above dosages may be increased, or ampicillin given by injection. Oral doses of ampicillin should be taken half to one hour before meals.
Renal Impairment
In the presence of severe renal impairment (creatinine clearance <10ml/min) a reduction in dose or extension of dose interval should be considered. In cases of dialysis, an additional dose should be administered after the procedure.
4.3 ContraindicationsAmpicillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. ampicillin, penicillins, cephalosporins) or excipients.
4.4 Special Warnings And Precautions For UseBefore initiating therapy with ampicillin, careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity.
Ampicillin should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
Dosage should be adjusted in patients with renal impairment (see section 4.2).
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionBacteriostatic drugs may interfere with the bactericidal action of ampicillin.
In common with other oral broad-spectrum antibiotics, ampicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
Probenecid decreases the renal tubular secretion of ampicillin. Concurrent use with ampicillin may result in increased and prolonged blood levels of ampicillin.
Concurrent administration of allopurinol during treatment with ampicillin can increase the likelihood of allergic skin reactions.
It is recommended that when testing for the presence of glucose in urine during ampicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of ampicillin, false positive readings are common with chemical methods.
4.6 Pregnancy And LactationPregnancy:
Animal studies with Ampicillin have shown no teratogenic effects. The product has been in extensive clinical use since 1961 and its use in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, Ampicillin may be considered appropriate.
Lactation:
During lactation, trace quantities of penicillins can be detected in breast milk. Adequate human and animal data on use of Ampicillin during lactation are not available.
4.7 Effects On Ability To Drive And Use MachinesAdverse effects on the ability to drive or operate machinery have not been observed.
4.8 Undesirable EffectsHypersensitivity reactions:
If any hypersensitivity reaction occurs, the treatment should be discontinued.
Skin rash, pruritis and urticaria have been reported occasionally. The incidence is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura has also been reported. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.
As with other antibiotics, anaphylaxis (see Item 4.4 – Warnings) has been reported rarely.
Renal effects:
Interstitial nephritis can occur rarely.
Gastrointestinal reactions:
Effects include nausea, vomiting and diarrhoea. Pseudomembraneous colitis and haemorrhagic colitis have been reported rarely.
Hepatic effects:
As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely. As with most other antibiotics, a moderate and transient increase in transaminases has been reported.
Haematological effects:
As with other beta-lactams, haematological effects including transient leucopenia, transient thrombocytopenia and haemolytic anaemia have been reported rarely. Prolongation of bleeding time and prothrombin have also been reported rarely.
4.9 OverdoseGastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.
Ampicillin may be removed from the circulation by haemodialysis.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesAmpicillin is a broad spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin sensitive organisms.
5.2 Pharmacokinetic PropertiesAmpicillin is excreted mainly in the bile and urine with a plasma half life of 1-2 hours.
5.3 Preclinical Safety DataNo further information of relevance to add.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsMagnesium stearate, gelatin, black and red iron oxides (E172), titanium dioxide (E171) and erythrosine (E127).
6.2 IncompatibilitiesNone.
6.3 Shelf LifeBlister packs:
five years
Others:
three years
6.4 Special Precautions For StorageContainers: Do not store above 25°C. Keep the container tightly closed.
Blisters: Do not store above 25°C. Store in the original package.
6.5 Nature And Contents Of ContainerAluminium canister
Glass bottle fitted with a screw cap
Polypropylene tube with a polyethylene closure
Aluminium foil pack - 4, 16, 50, 100, 500
Aluminium/PVC tray foil blister pack - 28
Aluminium/PVC/PVdC blister pack - 28
6.6 Special Precautions For Disposal And Other HandlingNone.
7. Marketing Authorisation HolderChemidex Pharma Ltd
Chemidex House
Egham Business Village
Crabtree Road
Egham
Surrey
TW20 8RB
United Kingdom
8. Marketing Authorisation Number(S)PL 17736/0071
9. Date Of First Authorisation/Renewal Of The Authorisation4th March 2005
10. Date Of Revision Of The Text26/09/2007
Jayacin may be available in the countries listed below.
Ingredient matches for Jayacin CiprofloxacinCiprofloxacin is reported as an ingredient of Jayacin in the following countries:
IndonesiaInternational Drug Name Search
Histex CT Extended-Release Capsules
Pronunciation: kar-bi-NOX-a-meenGeneric Name: Carbinoxamine MaleateBrand Name: Examples include Histex CT and Histex I/E
AmBisome
Pronunciation: am-foe-TER-ih-sin BGeneric Name: Amphotericin B LiposomeBrand Name: AmBisome
Boots Epsom Salts B.P.
1. Name Of The Medicinal Product
Epsom Salts (Magnesium Sulphate BP)
Boots Epsom Salts B.P.
2. Qualitative And Quantitative CompositionMagnesium Sulphate 100%
3. Pharmaceutical FormPowder for oral solution
4. Clinical Particulars 4.1 Therapeutic IndicationsFor the symptomatic relief of occasional constipation.
4.2 Posology And Method Of AdministrationAdults and children over 12 years: 1 to 4g to be taken in warm water, once daily.
Children under 12 years. Not recommended.
4.3 ContraindicationsIntestinal obstruction.
4.4 Special Warnings And Precautions For UseTo be used with caution in elderly or debilitated patients and in those with renal insufficiency.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionThis product may interact with tetracyclines, digoxin, vitamins and iron and may potentiate tubocurarine during anaesthesia.
4.6 Pregnancy And LactationThe use of magnesium containing salts in the first trimester of pregnancy should be avoided.
They should only be used after medical advice if the benefits exceed potentially unknown risks of foetal exposure to magnesium. No adverse effects are anticipated in breast fed infants.
4.7 Effects On Ability To Drive And Use MachinesNone known.
4.8 Undesirable EffectsProlonged excessive use of this product may cause alkalosis and hypermagnesaemia.
4.9 OverdoseExcessive amounts of this medicine may cause diarrhoea and dehydration. Hypermagnesaemia and hypercalcaemia may also occur, particularly if there is impaired renal function. Treatment consists of supportive and symptomatic measures with appropriate correction of fluid and electrolyte balance.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesNot applicable.
5.2 Pharmacokinetic PropertiesNot applicable.
5.3 Preclinical Safety DataNever undertaken by Abdine Limited. This product was granted a 'Licence as of Right' some 25 years ago.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsNone.
6.2 IncompatibilitiesNone are recognised.
6.3 Shelf LifeAs packaged for sale: Three years
As reconstituted for use: One day
After first opening the container: One month
6.4 Special Precautions For StorageDo not store above 25°C
6.5 Nature And Contents Of ContainerA spirally wound, varnished, cardboard tub with a press-fit lid or polypropylene jar and cap containing 100g, 150g, 200g, 250g, 300g or 500g.
6.6 Special Precautions For Disposal And Other HandlingTake from 1 to 4g in warm water.
7. Marketing Authorisation HolderBell Sons & Co (Druggists) Ltd
Gifford House
Slaidburn Crescent
Southport
Merseyside PR9 9AL
8. Marketing Authorisation Number(S)PL 03105/0068
9. Date Of First Authorisation/Renewal Of The Authorisation12 February 1999
10. Date Of Revision Of The Text29th November 2010
11 DOSIMETRY(IF APPLICABLE)
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS(IF APPLICABLE)
Generic Name: phenytoin (oral) (FEN i toyn) Brand Names: Dilantin, Dilantin Infatabs, Dilantin-125, Phenytek
What is phenytoin?Phenytoin is an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures.
Phenytoin is used to control seizures. Phenytoin is not made to treat all types of seizures, and your doctor will determine if it is the right medication for you.
Phenytoin may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about phenytoin?You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself. What should I discuss with my healthcare provider before taking phenytoin?You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.
Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
Patients of Asian ancestry may have a higher risk of developing a rare but serious skin reaction to phenytoin. Your doctor may recommend a blood test before you start the medication to determine your risk of this skin reaction.
How should I take phenytoin?Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Do not crush, chew, break, or open an extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.To be sure this medication is helping your condition, your blood may need to be tested often. You may also need a blood test when switching from one form of phenytoin to another. Visit your doctor regularly.
If you are taking phenytoin to treat seizures, keep taking the medication even if you feel fine. You may have an increase in seizures if you stop taking phenytoin. Follow your doctor's instructions. Wear a medical alert tag or carry an ID card stating that you take phenytoin. Any medical care provider who treats you should know that you are taking a seizure medication. Store at room temperature away from moisture, light, and heat. What happens if I miss a dose?Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of phenytoin can be fatal. What should I avoid while taking phenytoin? Drinking alcohol can increase some of the side effects of phenytoin, and can also increase your risk of seizure.Avoid taking antacids at the same time you take phenytoin. Antacids can make it harder for your body to absorb the medication.
Phenytoin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Phenytoin side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.Less serious side effects may include:
headache, joint pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect phenytoin?Drugs that can increase phenytoin levels in your blood include:
stomach acid reducers such as cimetidine (Tagamet), ranitidine (Zantac), famotidine (Pepcid), or nizatidine (Axid);
certain sedatives (such as Librium or Valium) or antidepressants (such as Prozac);
estrogen hormone replacement;
This list is not complete and there are many other medicines that can interact with phenytoin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you. More Phenytoin Sodium, Prompt resources Phenytoin Sodium, Prompt Side Effects (in more detail)Phenytoin Sodium, Prompt Use in Pregnancy & BreastfeedingDrug ImagesPhenytoin Sodium, Prompt Drug InteractionsPhenytoin Sodium, Prompt Support Group0 Reviews for Phenytoin Sodium, Prompt - Add your own review/rating Phenytoin Professional Patient Advice (Wolters Kluwer) Phenytoin MedFacts Consumer Leaflet (Wolters Kluwer) Phenytoin Monograph (AHFS DI) Dilantin Prescribing Information (FDA) Dilantin Consumer Overview Dilantin Suspension MedFacts Consumer Leaflet (Wolters Kluwer) Dilantin Advanced Consumer (Micromedex) - Includes Dosage Information Dilantin Infatabs Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Dilantin Infatabs Prescribing Information (FDA) Dilantin Kapseals Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Dilantin Kapseals Prescribing Information (FDA) Dilantin-125 Prescribing Information (FDA) Phenytek Prescribing Information (FDA) Compare Phenytoin Sodium, Prompt with other medications AnxietyArrhythmiaEpilepsyNeurosurgeryPeripheral NeuropathySeizuresStatus EpilepticusTrigeminal Neuralgia Where can I get more information? Your pharmacist can provide more information about phenytoin.See also: Phenytoin Sodium, Prompt side effects (in more detail)
Generic Name: caffeine and ergotamine (oral/rectal) (KAF een and er GOT a meen) Brand Names: Cafergot, Migergot
What is caffeine and ergotamine?Caffeine is a stimulant that causes narrowing of blood vessels (vasoconstriction).
Ergotamine is in a group of drugs called ergot alkaloids (ER-got AL-ka-loids). It works by narrowing the blood vessels around the brain. Ergotamine also affects blood flow patterns that are associated with certain types of headaches.
The combination of caffeine and ergotamine is used to treat or prevent a migraine type headache.
This medication will only treat a headache that has already begun. It will not prevent migraine headaches or reduce the number of attacks.
Caffeine and ergotamine should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches.Caffeine and ergotamine may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about caffeine and ergotamine? This medication can harm an unborn baby or a nursing baby. Do not use caffeine and ergotamine if you are pregnant or breast-feeding. Do not use this medication if you are allergic to caffeine and ergotamine or other ergot medicines, or if you have a history of heart disease, angina (chest pain), blood circulation problems, history of a heart attack or stroke, coronary artery disease, uncontrolled high blood pressure, severe liver or kidney disease, or a serious infection. Using certain medications together with caffeine and ergotamine can cause even greater decreases in blood flow than caffeine and ergotamine used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Tell your doctor about all other medications you are using, especially antibiotics, antidepressants, heart or blood pressure medications, or medicines to treat HIV or AIDS.Also tell your doctor about all of your medical conditions, especially breathing problems, high blood pressure, liver or kidney disease, or risk factors for coronary artery disease (diabetes, high blood pressure or cholesterol, menopause or hysterectomy, smoking, taking birth control pills, being overweight, having a family history of coronary artery disease, or being a man older than 40).
This medication will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.
Never use more than your prescribed dose of caffeine and ergotamine. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. An overdose of caffeine and ergotamine can be fatal. What should I discuss with my healthcare provider before using caffeine and ergotamine ? Do not use this medication if you are allergic to caffeine or ergotamine, or other ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), methylergonovine (Methergine), or methysergide (Sansert).Do not use caffeine and ergotamine if you are pregnant or breast-feeding, or if you have:
a history of heart disease, angina (chest pain), blood circulation problems, or history of a heart attack or stroke;
coronary artery disease or "hardening of the arteries";
uncontrolled high blood pressure;
severe liver disease; severe kidney disease; ora serious infection called sepsis.
Using certain medications together with caffeine and ergotamine can cause even greater decreases in blood flow than caffeine and ergotamine used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Do not use caffeine and ergotamine if you are also using any of the following medications:conivaptan (Vaprisol);
diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);
imatinib (Gleevec);
isoniazid (for treating tuberculosis);
an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), telithromycin (Ketek), or troleandomycin (Tao);
an antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
an antidepressant such as nefazodone;
heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quinaglute, Quinidex, Quin-Release), or verapamil (Calan, Covera, Isoptin, Verelan); or
HIV/AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir).
Caffeine and ergotamine can cause rare but serious side effects on the heart, including heart attack or stroke. If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using caffeine and ergotamine, tell your doctor if you have:
breathing problems;
high blood pressure;
liver disease;
kidney disease; or
coronary artery disease (or risk factors that include diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).
FDA pregnancy category X. This medication can cause birth defects. Do not use caffeine and ergotamine if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using caffeine and ergotamine. Caffeine and ergotamine passes into breast milk and may be harmful to a nursing infant. Do not use caffeine and ergotamine without telling your doctor if you are breast-feeding a baby. How should I use caffeine and ergotamine?Use this medication exactly as prescribed by your doctor. Never use more than your prescribed dose of caffeine and ergotamine. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. Caffeine and ergotamine is not for daily use.
To use caffeine and ergotamine tablets: Take 2 tablets of caffeine and ergotamine as soon as you notice headache symptoms, or after an attack has already begun.
If your headache does not completely go away, you may take 1 more tablet after at least 30 minutes have passed. If additional medication is needed, you may take 1 tablet every 30 minutes up to a total of 6 tablets for one migraine attack.
If you still have migraine symptoms after taking a total of 6 tablets, call your doctor. Do not take more than a total of 6 tablets in any 24-hour period. Do not take more than a total of 10 tablets over a period of 7 days.To use caffeine and ergotamine rectal suppositories: Insert 1 suppository at the first sign of migraine headache symptoms, or after an attack has already begun. If your headache does not completely go away, use 1 more suppository after at least 1 hour has passed.
Do not take a rectal suppository by mouth. It is for use only in your rectum.Try to empty your bladder just before using the suppository. Remove the outer wrapper from the suppository and insert it gently into the rectum, pointed tip first. Avoid handling the suppository too long or it will melt in your hands.
For best results, lie down after inserting the suppository and hold it in for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after you have inserted the suppository.
If you still have migraine symptoms after using a total of 2 rectal suppositories, call your doctor. Do not use more than a total of 2 suppositories per headache. Do not use more than a total of 5 suppositories over a period of 7 days. Do not give this medication to anyone else, even if they have the same headache symptoms you have. Caffeine and ergotamine can be dangerous if it is used to treat headache in a person who has not been diagnosed by a doctor as having true migraine headaches. Store caffeine and ergotamine at room temperature away from moisture, heat, and light. Do not use any stored caffeine and ergotamine if the expiration date on the label has passed. What happens if I miss a dose?Since caffeine and ergotamine is used only when needed, you are not likely to miss a dose.
Do not take more than 6 caffeine and ergotamine tablets per day or more than 10 tablets per week. Do not use more than 2 suppositories per headache or 5 suppositories per week. What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. An overdose of caffeine and ergotamine can be fatal.Overdose can cause vomiting, confusion, drowsiness, weak pulses in your arms and legs, numbness and tingling or pain in your hands or feet, blue-colored fingers or toes, fainting, and seizure (convulsions).
What should I avoid while using caffeine and ergotamine? Do not use caffeine and ergotamine within 24 hours before or after using another migraine headache medicine, including:dihydroergotamine (D.H.E. 45, Migranal), caffeine and ergotamine (Cafergot, Ercaf, Wigraine), ergonovine (Ergotrate), methylergonovine (Methergine), methysergide (Sansert); or
almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), sumatriptan (Imitrex), rizatriptan (Maxalt, Maxalt-MLT), or zolmitriptan (Zomig).
Grapefruit and grapefruit juice may interact with caffeine and ergotamine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
Caffeine and ergotamine side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using caffeine and ergotamine and call your doctor at once if you have a serious side effect such as:sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
fast or slow heart rate;
muscle pain in your arms or legs;
leg weakness;
numbness or tingling and a pale or blue-colored appearance in your fingers or toes;
severe pain in your stomach or lower back;
urinating less than usual or not at all;
painful sores on your rectum after using the rectal suppositories;
swelling or itching in any part of your body;
cough with stabbing chest pain and trouble breathing; or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
dizziness, spinning sensation;
weakness;
nausea, vomiting; or
mild itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect caffeine and ergotamine?Many drugs can interact with caffeine and ergotamine. Below is just a partial list. Talk with your doctor before using caffeine and ergotamine if you are also taking:
birth control pills;
zileuton (Zyflo);
cold or allergy medications;
nicotine (Nicoderm, Nicorette);
diet pills, stimulants, or medication to treat ADHD (such as Ritalin or Adderall);
an antidepressant such fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), nefazodone (Serzone), paroxetine (Paxil), sertraline (Zoloft), and others;
nitroglycerin or other nitrate medicines such as isosorbide (Isordil, Dilatrate, Imdur, Monoket); or
heart or blood pressure medication such as atenolol (Tenormin), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.
This list is not complete and there may be other drugs that can interact with caffeine and ergotamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
More Migergot resources Migergot Side Effects (in more detail)Migergot Use in Pregnancy & BreastfeedingMigergot Drug InteractionsMigergot Support Group6 Reviews for Migergot - Add your own review/rating Compare Migergot with other medications Cluster HeadachesMigraine Where can I get more information? Your pharmacist can provide more information about caffeine and ergotamine.See also: Migergot side effects (in more detail)
Generic Name: ascorbic acid (Oral route)
as-KORE-bik AS-id
Commonly used brand name(s)In the U.S.
Ascocid C-500 Cecon Cemill 1000 Cemill 500 Cevi-Bid C-Time w/Rose Hips Mega-C One-Gram C Protexin Sunkist Vitamin CIn Canada
Ce-Vi-Sol Revitalose-C-1000 Revitonus C-1000 Yellow Ampule Vitamin C PowderAvailable Dosage Forms:
Tablet Powder Powder for Solution Capsule, Liquid Filled Tablet, Chewable Granule Capsule Syrup Powder for Suspension Liquid Solution Tablet, Extended Release Lozenge/Troche Capsule, Extended Release WaferTherapeutic Class: Nutritive Agent
Pharmacologic Class: Vitamin C
Uses For C-Time w/Rose HipsVitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Ascorbic acid, also known as vitamin C, is necessary for wound healing. It is needed for many functions in the body, including helping the body use carbohydrates, fats, and protein. Vitamin C also strengthens blood vessel walls.
Lack of vitamin C can lead to a condition called scurvy, which causes muscle weakness, swollen and bleeding gums, loss of teeth, and bleeding under the skin, as well as tiredness and depression. Wounds also do not heal easily. Your health care professional may treat scurvy by prescribing vitamin C for you.
Some conditions may increase your need for vitamin C. These include:
AIDS (acquired immune deficiency syndrome) Alcoholism Burns Cancer Diarrhea (prolonged) Fever (prolonged) Infection (prolonged) Intestinal diseases Overactive thyroid (hyperthyroidism) Stomach ulcer Stress (continuing) Surgical removal of stomach TuberculosisAlso, the following groups of people may have a deficiency of vitamin C:
Infants receiving unfortified formulas Smokers Patients using an artificial kidney (on hemodialysis) Patients who undergo surgery Individuals who are exposed to long periods of cold temperaturesIncreased need for vitamin C should be determined by your health care professional.
Vitamin C may be used for other conditions as determined by your health care professional.
Claims that vitamin C is effective for preventing senility and the common cold, and for treating asthma, some mental problems, cancer, hardening of the arteries, allergies, eye ulcers, blood clots, gum disease, and pressure sores have not been proven. Although vitamin C is being used to reduce the risk of cardiovascular disease and certain types of cancer, there is not enough information to show that these uses are effective.
Injectable vitamin C is given by or under the supervision of a health care professional. Other forms of vitamin C are available without a prescription.
Once a medicine or dietary supplement has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, vitamin C is used in certain patients with the following medical conditions:
Overdose of iron (to help another drug in decreasing iron levels in the body) Methemoglobinemia (a blood disease) Importance of DietFor good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.
Vitamin C is found in various foods, including citrus fruits (oranges, lemons, grapefruit), green vegetables (peppers, broccoli, cabbage), tomatoes, and potatoes. It is best to eat fresh fruits and vegetables whenever possible since they contain the most vitamins. Food processing may destroy some of the vitamins. For example, exposure to air, drying, salting, or cooking (especially in copper pots), mincing of fresh vegetables, or mashing potatoes may reduce the amount of vitamin C in foods. Freezing does not usually cause loss of vitamin C unless foods are stored for a very long time.
Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.
The daily amount of vitamin C needed is defined in several different ways.
For U.S.— Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy). Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs). For Canada— Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.Normal daily recommended intakes for vitamin C are generally defined as follows:
Persons U.S. (mg) Canada (mg) Infants and childrenGeneric Name: ondansetron (Oral route, Oromucosal route)
on-DAN-se-tron
Commonly used brand name(s)In the U.S.
Zofran Zofran ODT ZuplenzAvailable Dosage Forms:
Film Tablet, Disintegrating Tablet SolutionTherapeutic Class: Antiemetic
Pharmacologic Class: Serotonin Receptor Antagonist, 5-HT3
Uses For Zofran ODTOndansetron is used to prevent nausea and vomiting that is caused by cancer medicines (chemotherapy) or radiation. It is also used to prevent nausea and vomiting that may occur after surgery. Ondansetron works in the stomach to block the signals to the brain that cause nausea and vomiting.
This medicine is available only with your doctor's prescription.
Before Using Zofran ODTIn deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
AllergiesTell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
PediatricAppropriate studies have not been performed on the relationship of age to the effects of ondansetron in children under 4 years of age. Safety and efficacy have not been established.
GeriatricAppropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ondansetron in the elderly.
Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast FeedingThere are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with MedicinesAlthough certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Apomorphine Cisapride Dronedarone Fluconazole Mesoridazine Pimozide Posaconazole Sparfloxacin ThioridazineUsing this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Acecainide Alfuzosin Amiodarone Amitriptyline Amoxapine Arsenic Trioxide Asenapine Astemizole Azimilide Azithromycin Bretylium Chloroquine Chlorpromazine Ciprofloxacin Citalopram Clarithromycin Clomipramine Clozapine Crizotinib Dasatinib Desipramine Disopyramide Dofetilide Dolasetron Droperidol Enflurane Erythromycin Flecainide Gatifloxacin Gemifloxacin Granisetron Halofantrine Haloperidol Halothane Ibutilide Iloperidone Isoflurane Isradipine Lapatinib Lopinavir Lumefantrine Mefloquine Methadone Moxifloxacin Nilotinib Norfloxacin Nortriptyline Octreotide Ofloxacin Paliperidone Pazopanib Perflutren Lipid Microsphere Procainamide Prochlorperazine Promethazine Propafenone Protriptyline Quetiapine Quinidine Quinine Salmeterol Saquinavir Sematilide Sodium Phosphate Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Solifenacin Sorafenib Sotalol Sunitinib Tedisamil Telavancin Telithromycin Terfenadine Tetrabenazine Toremifene Trazodone Trifluoperazine Trimipramine Vandetanib Vardenafil Vemurafenib Voriconazole ZiprasidoneUsing this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Cyclophosphamide Interactions with Food/Tobacco/AlcoholCertain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical ProblemsThe presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Allergy to other selective 5-HT3 receptor antagonists (alosetron Lotronex], dolasetron [Anzemet], granisetron [Kytril], palonosetron [Aloxi])—Use with caution. It is likely you will also be allergic to ondansetron. Bowel blockage or Gastric distension (enlarged abdomen)—May cover up symptoms of these stomach or intestinal problems. Heart rhythm problems (e.g., prolonged QT interval)—Use with caution. May make this condition worse. Liver disease—May have an increased chance of side effects. Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make your condition worse. Proper Use of ondansetronThis section provides information on the proper use of a number of products that contain ondansetron. It may not be specific to Zofran ODT. Please read with care.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
To use the oral disintegrating tablet:
Make sure your hands are dry. Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet. Immediately place the tablet on top of the tongue. The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet.To use the oral soluble film:
Make sure your hands are clean and dry before and after using this medicine. Fold the pouch along the dotted line to expose the tear notch. While still folded, tear the pouch carefully along the edge and remove the film out from the pouch. Put the soluble film immediately on top of your tongue where it will dissolve in 4 to 20 seconds. Do not chew or swallow the film whole. Once the film is dissolved, you may swallow with or without water.If you vomit within 30 minutes after using this medicine, take the same amount of medicine again. If vomiting continues, check with your doctor.
This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
DosingThe dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage forms (oral disintegrating tablets, solution, or tablets): For prevention of moderate nausea and vomiting after treatment with cancer medicines: Adults, teenagers, and children 12 years of age—At first, 8 milligrams (mg) taken 30 minutes before starting cancer treatment. The 8-mg dose is taken again 8 hours after the first dose. Then, the dose is 8 mg every 12 hours for 1 to 2 days. Children 4 to 11 years of age—At first, 4 mg taken 30 minutes before starting cancer treatment. The 4-mg dose is taken again 4 and 8 hours after the first dose. Then, the dose is 4 mg every 8 hours for 1 to 2 days. Children younger than 4 years of age—Use and dose must be determined by your doctor. For prevention of more severe nausea and vomiting after treatment with cancer medicines: Adults, teenagers, and children 12 years of age—One 24-milligram (mg) tablet taken 30 minutes before starting cancer treatment. Children younger than 12 years of age—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after radiation treatment: Adults—At first, 8 milligrams (mg) taken 1 to 2 hours before radiation treatment. Then, the dose is 8 mg every 8 hours. Children—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after surgery: Adults—16 milligrams (mg) one hour before anesthesia is given. Children—Use and dose must be determined by your doctor. For oral dosage form (soluble film): For prevention of moderate nausea and vomiting after treatment with cancer medicines: Adults, teenagers, and children 12 years of age—At first, one 8-milligram (mg) film taken 30 minutes before starting cancer treatment. The second 8-mg film is taken 8 hours after the first dose. Then, one 8-mg film is taken two times a day (every 12 hours) for 1 to 2 days. Children 4 to 11 years of age—At first, one 4-milligram (mg) film taken 30 minutes before starting cancer treatment. The second and third 4-mg films are taken 4 and 8 hours after the first dose. Then, one 4-mg film is taken three times a day (every 8 hours) for 1 to 2 days. Children younger than 4 years of age—Use and dose must be determined by your doctor. For prevention of more severe nausea and vomiting after treatment with cancer medicines: Adults—24 milligrams (mg) or three 8-mg films taken 30 minutes before starting cancer treatment. Each film should be dissolved in the tongue before taking the next film. Children—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after radiation treatment: Adults—One 8-milligram (mg) film three times a day. Children—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after surgery: Adults—16 milligrams (mg) or two 8-mg films taken 1 hour before anesthesia is given. Each film should be dissolved in the tongue before taking the next film. Children—Use and dose must be determined by your doctor. Missed DoseIf you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose of this medicine, and you feel nauseated or you vomit, take the missed dose as soon as possible.
StorageStore the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Zofran ODTCheck with your doctor if severe nausea and vomiting continue after leaving the hospital or cancer treatment center.
Do not use this medicine if you are receiving apomorphine (Apokyn®). Using these medicines together may increase risk for more serious problems.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
Check with your doctor right away if you start to have pain or swelling in your stomach area. These may be signs of a serious stomach or bowel problem.
Zofran ODT Side EffectsAlong with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common Confusion dizziness fast heartbeat fever headache shortness of breath weakness Less common Decrease in the frequency of urination decrease in urine volume difficulty with passing urine (dribbling) painful urination Rare Arm, back, or jaw pain chest pain or discomfort chest tightness or heaviness convulsions cough decreased urine difficulty with breathing difficulty with swallowing dry mouth fast, pounding, or irregular heartbeat or pulse hives increased thirst itching loss of appetite loss of bladder control loss of consciousness mood changes muscle pain or cramps nausea or vomiting noisy breathing numbness or tingling in the hands, feet, or lips puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue skin rash sweating tightness in the chest total body jerking unusual tiredness or weakness wheezing Incidence not known Blurred vision dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position fixed position of the eye heart stops hoarseness inability to move the eyes increased blinking or spasms of the eyelid large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs no breathing no pulse or blood pressure noisy breathing pounding heartbeat slow or irregular breathing sticking out of the tongue sweating trouble with breathing, speaking, or swallowing unconscious uncontrolled twisting movements of the neck, trunk, arms, or legs unusual facial expressionsSome side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common Anxiety difficulty having a bowel movement (stool) dry mouth general feeling of discomfort or illness hyperventilation irritability restlessness shaking trouble sleeping Rare Difficulty with speaking drooling loss of balance control muscle trembling, jerking, or stiffness shuffling walk stiffness of the limbs twisting movements of the body uncontrolled movements, especially of the face, neck, and back Incidence not known Feeling of warmth hiccups hives or welts redness of the face, neck, arms, and occasionally, upper chest redness of the skinOther side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Zofran ODT Oral, Oromucosal side effects (in more detail)
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More Zofran ODT Oral, Oromucosal resources Zofran ODT Oral, Oromucosal Side Effects (in more detail)Zofran ODT Oral, Oromucosal Use in Pregnancy & BreastfeedingDrug ImagesZofran ODT Oral, Oromucosal Drug InteractionsZofran ODT Oral, Oromucosal Support Group9 Reviews for Zofran ODT Oral, Oromucosal - Add your own review/rating Compare Zofran ODT Oral, Oromucosal with other medications Alcohol DependenceGastroenteritisNausea/VomitingNausea/Vomiting, Chemotherapy InducedNausea/Vomiting, PostoperativeNausea/Vomiting, Radiation InducedObsessive Compulsive DisorderPostanesthetic ShiveringPruritusTums Plus Chewable Tablets
Pronunciation: KAL-see-uhm/si-METH-i-koneGeneric Name: Calcium/SimethiconeBrand Name: Examples include Titralac Plus and Tums Plus
Generic Name: phenylpropanolamine (fen ill proe pa NOLE a meen) Brand Names: Acutrim 16 Hour, Acutrim II, Maximum Strength, Acutrim Late Day, Control, Dexatrim, Empro, Mega-Trim, Phenyldrine, Propagest, Propan, Rhindecon, Westrim, Westrim LA
What is Westrim (phenylpropanolamine)?Phenylpropanolamine is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in your body. Constriction of blood vessels in your sinuses, nose, and chest allows drainage of those areas, which decreases congestion.
Phenylpropanolamine is used to treat the congestion associated with allergies, hay fever, sinus irritation, and the common cold. Phenylpropanolamine also causes a decrease in appetite and is used in some over-the-counter diet aids.
Phenylpropanolamine has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.
Phenylpropanolamine may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Westrim (phenylpropanolamine)?Phenylpropanolamine has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.
Do not take phenylpropanolamine for longer than 7 days if your condition does not improve or if your symptoms are accompanied by a high fever.
Do not take more of this medication than is recommended on the package or by your doctor. Use caution when driving, operating machinery, or performing other hazardous activities. Phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Who should not take Westrim (phenylpropanolamine)?Do not take phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.
Before taking this medication, tell your doctor if you have
high blood pressure;
any type of heart disease, hardening of the arteries, or irregular heartbeat;
thyroid problems;
diabetes;
glaucoma or increased pressure in your eye;
an enlarged prostate or difficulty urinating; or
liver or kidney disease.
You may not be able to take phenylpropanolamine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.
It is not known whether phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of phenylpropanolamine. Do not take this drug if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from phenylpropanolamine. You may require a lower dose of this medication. Using a short-acting formulation of phenylpropanolamine (not a long-acting or a controlled-release formulation) may be safer if you are over 60 years of age. How should I take Westrim (phenylpropanolamine)?Take phenylpropanolamine exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water. Never take this medication in larger doses or more often than is recommended. Too much phenylpropanolamine could be very harmful.If your symptoms are accompanied by a high fever, or if they do not improve in 7 days, see your doctor.
Store phenylpropanolamine at room temperature away from moisture and heat. What happens if I miss a dose?Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.
What happens if I overdose? Seek emergency medical attention.Symptoms of a phenylpropanolamine overdose include extreme tiredness, sweating, dizziness, a slow heart beat, and a coma.
What should I avoid while taking Westrim (phenylpropanolamine)? Use caution when driving, operating machinery, or performing other hazardous activities. Phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Never take this medication in larger doses or more often than is recommended. Too much phenylpropanolamine could be very harmful. Westrim (phenylpropanolamine) side effectsIf you experience any of the following serious side effects from this medication, stop taking phenylpropanolamine and seek emergency medical attention:
an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
seizures;
unusual behavior or hallucinations; or
an irregular or fast heartbeat.
Other, less serious side effects may be more likely to occur. Continue to take phenylpropanolamine and talk to your doctor if you experience
dizziness, lightheadedness, or drowsiness;
headache;
insomnia;
anxiety;
tremor (shaking) or restlessness;
nausea or vomiting; or
sweating.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Westrim (phenylpropanolamine)?Do not take phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.
Phenylpropanolamine may also interact with the following medicines:
furazolidone (Furoxone);
guanethidine (Ismelin);
indomethacin (Indocin);
methyldopa (Aldomet);
bromocriptine (Parlodel);
caffeine in cola, tea, coffee, chocolate, and other products;
theophylline (Theo-Dur, Theochron, Theolair, others);
tricyclic antidepressants such as amitriptyline (Elavil, Endep), doxepin (Sinequan), and nortriptyline (Pamelor); other commonly used tricyclic antidepressants, including amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), protriptyline (Vivactil), and trimipramine (Surmontil); phenothiazines such as chlorpromazine (Thorazine), thioridazine (Mellaril), and prochlorperazine (Compazine); and other commonly used phenothiazines, including fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), and trifluoperazine (Stelazine).Drugs other than those listed here may also interact with phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
More Westrim resources Westrim Side Effects (in more detail)Westrim Use in Pregnancy & BreastfeedingWestrim Drug InteractionsWestrim Support Group0 Reviews for Westrim - Add your own review/rating Propantheline Bromide Monograph (AHFS DI) Compare Westrim with other medications Nasal CongestionWeight Loss Where can I get more information? Your pharmacist has more information about phenylpropanolamine written for health professionals that you may read. What does my medication look like?Phenylpropanolamine is available over the counter under the brand name Propagest, and with a prescription under the brand name Rhindecon. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Propagest 25 mg--oval, white, scored tablets
Rhindecon 75 mg--timed-release capsules
See also: Westrim side effects (in more detail)
Erythromycin 250mg Tablets
1. Name Of The Medicinal Product
Erythromycin Tablets BP 250mg
2. Qualitative And Quantitative CompositionErythromycin 250mg
For a full list of excipients, see section 6.1.
3. Pharmaceutical FormGastro-resistant tablets;
Reddish orange coloured round biconvex tablets, plain on both sides. They are made Gastro-resistant by enteric coating.
4. Clinical Particulars 4.1 Therapeutic IndicationsFor the prophylaxis and treatment of infections caused by Erythromycin-sensitive organisms.
Erythromycin is highly effective in the treatment of a great variety of clinical infections such as:
1. Upper respiratory tract infections: Tonsillitis, peritonsillar abscess, pharyngitis, laryngitis, sinusitis, secondary infections in influenza and common colds.
2. Lower respiratory tract infections: Tracheitis, acute and chronic bronchitis, pneumonia (lobar pneumonia, bronchopneumonia, primary atypical pneumonia), bronchiectasis, Legionnaire's disease
3. Ear infections: Otitis media and otitis externa, mastoiditis.
4. Eye infections: Blepharitis
5. Oral infections: Gingivitis, Vincent's angina
6. Skin and soft tissue infections: Boils and carbuncles, paronychia, abscesses, pustular acne, impetigo, cellulitis, erysipelas
7. Gastro-intestinal infections: cholecystitis, staphylococcal enterocolitis
8. Prophylaxis: pre- and post- operative trauma, burns, rheumatic fever
9. Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis, lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever
Note: Erythromycin has also proved to be of value in endocarditis and septicaemia, but in these conditions initial administration of erythromycin lactobionate by the intravenous route is advisable.
4.2 Posology And Method Of AdministrationAdults and older children: Usual dosage is one tablet every four to six hours. This may be increased to 4g per day unusually severe infection.
4.3 ContraindicationsKnown hypersensitivity to erythromycin. Erythromycin is contraindicated in patients taking simvastatin, tolterodine, mizolastine, amisulpride, astemizole, terfenadine, and cisapride or pimozide.
Erythromycin is contraindicated with ergotamine and dihydroergotamine.
4.4 Special Warnings And Precautions For UseErythromycin is excreted principally by the liver, so caution should be exercised in administering the antibiotic to patients with impaired hepatic function or concomitantly receiving potentially hepatotoxic agents. Hepatic dysfunction including increased liver enzymes and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with erythromycin.
There have been reports suggesting erythromycin does not reach the foetus in adequate concentrations to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen.
There have been reports that erythromycin may aggravate the weakness of patients with myasthenia gravis.
Erythromycin interferes with the fluorometric determination of urinary catecholamines.
As with other broad-spectrum antibiotics, pseudomembranous colitis has been reported rarely with erythromycin.
Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionConcomitant use of erythromycin with simvastatin, tolterodine, mizolastine, amisulpride, terfenadine or astemizole is likely to result in an enhanced risk of cardio toxicity with these drugs. The concomitant use of erythromycin with either simvastatin, tolterodine, mizolastine, amisulpride, astemizole or terfenadine is therefore contra-indicated.
The metabolism of terfenadine and astemizole is significantly altered when either are taken concomitantly with erythromycin. Rare cases of serious cardio-vascular events have been observed, including torsades de pointes, other ventricular arrhythmias and cardiac arrest. Death has been reported with the terfenadine/erythromycin combination.
Elevated cisapride levels have been reported in patients receiving erythromycin and cisapride concomitantly. This may result in QT prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades de pointes.
Similar effects have been observed with concomitant administration of pimozide and clarithromycin, another macrolide antibiotic.
Concurrent use of erythromycin and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity, characterised by the rapid development of severe peripheral vasospasm and dysaesthesia.
Increases in serum concentrations of the following drugs metabolised by the cytochrome P450 system may occur when administered concurrently with erythromycin: alfentanil, astemizole, bromocriptine, carbamazepine, cyclosporin, digoxin, dihydroergotamine, disopyramide, ergotamine, hexobarbitone, midazolam, phenytoin, quinidine, tacrolimus, terfenadine, theophylline, triazolam, valproate, and warfarin. Appropriate monitoring should be undertaken and dosage should be adjusted as necessary.
Erythromycin has been reported to decrease the clearance of zopiclone and thus may increase the pharmacodynamic effects of this drug.
When oral erythromycin is given concurrently with theophylline, there is also a significant decrease in erythromycin serum concentrations. The decrease could result in subtherapeutic concentrations of erythromycin.
4.6 Pregnancy And LactationErythromycin has been in widespread use for a number of years without apparent ill consequence. Animal studies have shown no hazard.
Erythromycin has been reported to cross the placental barrier in humans, but foetal plasma levels are generally low.
Erythromycin is excreted in breast milk, therefore, caution should be exercised when erythromycin is administered to a nursing mother.
4.7 Effects On Ability To Drive And Use MachinesNone stated.
4.8 Undesirable EffectsOccasional side effects such as nausea, abdominal discomfort, vomiting and diarrhoea may be experienced. Reversible hearing loss associated with doses of erythromycin usually greater than 4g per day has been reported. Allergic reactions are rare and mild, although anaphylaxis has occurred. Skin reactions ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis have rarely been reported. There are no reports implicating erythromycin products with abnormal tooth development, and only rare reports of damage to the blood, kidneys or central nervous system.
Cardiac arrhythmias have been very rarely reported in patients receiving erythromycin therapy. There have been isolated reports of chest pain, dizziness and palpitations; however, a cause and effect relationship has not been established.
Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur.
4.9 OverdoseSymptoms: hearing loss, severe nausea, vomiting and diarrhoea.
Treatment: gastric lavage, general supportive measures.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesPharmacotherapeutic Group: Macrolides- ATC Code: J01FA01
Erythromycin exerts its antimicrobial action by binding to the 50S ribosomal sub-unit of susceptible microorganisms and suppresses protein synthesis. Erythromycin is usually active against most strains of the following organisms both in vitro and in clinical infections:
Gram-positive bacteria - Listeria monocytogenes, Corynebacterium diphtheriae (as an adjunct to antitoxin), Staphylococci spp, Streptococci spp (including Enterococci).
Gram-negative bacteria - Haemophilus influenzae, Neisseria meningitidis, Neisseria gonorrhoeae, Legionella pneumophila, Moraxella (Branhamella) catarrhalis, Bordetella pertussis, Campylobacter spp.
Mycoplasma - Mycoplasma pneumoniae, Ureaplasma urealyticum
Other organisms - Treponema pallidum, Chlamydia spp, Clostridia spp, L-forms, the agents causing trachoma and lymphogranuloma venereum
Note: The majority of strains of Haemophilus influenzae are susceptible to the concentrations reached after ordinary doses.
5.2 Pharmacokinetic PropertiesAbsorption and Fate
Erythromycin is adversely affected by gastric acid. For this reason erythromycin tablets are enteric coated.
It is absorbed from the small intestine. It is widely distributed throughout body tissues. Little metabolism occurs and only about 5% is eliminated in the urine. It is excreted principally by the liver.
5.3 Preclinical Safety DataThere are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsMaize Starch
Croscarmellose Sodium Type A
Povidone
Talc
Magnesium Stearate (E572)
Sub coat:
Hypromellose (E464)
Macrogol 6000
Erythrosine (E127)
Talc
Enteric coat:
Methacrylic Acid ethylacrylate Copolymer (1:1) dispersion 30%
Macrogol 6000
Talc
Polysorbate 80 (E433)
Erythrosine (E127)
6.2 IncompatibilitiesNot applicable.
6.3 Shelf Life24 months
6.4 Special Precautions For StorageDo not store above 25°C.
(a) Tablet container: Keep the container tightly closed. Store in the original container.
(b) Blister: Store in the original container.
(c) Bag: Keep container in the outer carton.
6.5 Nature And Contents Of ContainerTablet container:
Nature: Polypropylene tamper evident tablet container with polyethylene cap.
Contents: 21, 100, 250, 500 and 1000 tablets
Blister:
Nature: 250 um PVC/20 um aluminium blister packs
Contents: 28, 56, 84 and 100 tablets.
Bag:
Nature: Polyethylene sealed bag
Contents: 5,000 and 10,000 tablets.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other HandlingNothing stated.
7. Marketing Authorisation HolderMilpharm Limited,
Ares,
Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD,
United Kingdom
8. Marketing Authorisation Number(S)PL 16363/0019
9. Date Of First Authorisation/Renewal Of The Authorisation05/02/2009
10. Date Of Revision Of The Text19/03/2009
Generic Name: typhoid vaccine (live), oral (TYE foid vax EEN) Brand Names: Vivotif Berna
What is typhoid vaccine?Typhoid (also called "typhoid fever") is a serious disease caused by Salmonella typhi bacteria. Typhoid can be fatal if left untreated.
Typhoid can cause high fever, muscle aches, severe headache, weakness, confusion or agitation, loss of appetite, stomach pain, diarrhea or constipation, and rose-colored spots on the skin.
Untreated typhoid infection may lead to kidney failure, or intestinal bleeding caused by perforation (forming of a hole), which can be fatal. If the infection spreads to the gallbladder, the infected person may become a chronic carrier of the bacteria that causes typhoid. A carrier may have no symptoms but is capable of spreading the infection to others.
Typhoid is spread through contact with the stool (bowel movements) of a person infected with the bacteria. This usually occurs by eating food or drinking water that has become contaminated with feces from an infected person. Once in the digestive tract, typhoid infection can spread to the blood and other parts of the body.
Typhoid fever is most common in non-industrialized parts of the world, especially Asia, Africa, and Central or South America. People who travel to those regions are at risk of coming into contact with the disease.
The typhoid vaccine is used to help prevent this disease in adults and children who are at least 6 years old. Although not part of a routine immunization schedule in the U.S., typhoid vaccine is recommended for people who travel to areas where the disease is common.
This vaccine works by exposing you to a small amount of the bacteria, which causes your body to develop immunity to the disease.
Typhoid vaccine will not treat an active infection that has already developed in the body, and will not prevent any disease caused by bacteria other than Salmonella typhi.Like any vaccine, the typhoid vaccine may not provide protection from disease in every person.
What is the most important information I should know about typhoid vaccine? You should not receive this vaccine if you have ever had an allergic reaction to typhoid vaccine in the past, or if you have fever with any type of infection or illness, or a weak immune system caused by disease or by using certain medicines such as chemotherapy. Typhoid vaccine should not be used in a person who is a typhoid carrier.Before you receive this vaccine, tell the doctor if you have any illness with vomiting or diarrhea, if you are taking an antibiotic or sulfa drug (Azulfidine, Bactrim, Cotrim, Gantrisin, Septra, SMX-TMP, Sulfazine), or if you plan to start taking an anti-malaria medication within 10 days after receiving typhoid vaccine.
You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, the doctor may ask you to wait until you get better before you can receive the vaccine.
The typhoid oral vaccine is given in a series of 4 capsules that are taken 1 per day on alternating days (days 1, 3, 5, and 7). On this alternating-day schedule, you will take 1 capsule every 48 hours for 7 days. You must take each capsule according to the recommended schedule for this vaccine to be effective.
You should complete all doses at least 1 week before your scheduled travel or possible exposure to typhoid.
You must keep typhoid vaccine capsules cold when not in use. Once you receive the capsules from your doctor or pharmacy, take them directly home and place them in the refrigerator. Keep each capsule in the foil blister pack in the refrigerator until you are ready to take it. Do not allow the capsules to freeze.Like any vaccine, the typhoid vaccine may not provide protection from disease in every person.
In addition to receiving typhoid vaccine, take precautions while traveling such as avoiding raw fruits or vegetables that cannot be peeled, drinks that contain ice, flavored ices that may have been made with contaminated water, unbottled or unboiled water, or any food or beverage purchased from a street vendor.
What should I discuss with my healthcare provider before receiving typhoid vaccine? Typhoid vaccine should not be used in a person who is a typhoid carrier. You should not receive this vaccine if you have ever had an allergic reaction to typhoid vaccine in the past, or if you have:fever with any type of infection or illness;
a weak immune system caused by disease such as HIV/AIDS or cancer; or
a weak immune system caused by using certain medicines such as chemotherapy.
You may not be able to receive this vaccine if you have:
stomach flu or any illness with vomiting or diarrhea;
if you are taking an antibiotic, especially a sulfa drug such as sulfasalazine (Azulfidine, Sulfazine), sulfamethoxazole (Bactrim, Cotrim, Septra, SMX-TMP), or sulfisoxazole (Gantrisin); or
if you plan to start taking an anti-malaria medication within 10 days after receiving a typhoid oral vaccine.
You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, the doctor may ask you to wait until you get better before you can receive the vaccine.
Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with typhoid. It is not known whether typhoid vaccine passes into breast milk, or if it could harm a nursing baby. Do not receive this vaccine without telling your doctor if you are breast-feeding a baby. How is typhoid vaccine given?Typhoid vaccine is recommended for adults and children in the following situations:
people who travel to countries where typhoid fever is common;
people who will have long-term exposure to food or water that may be contaminated with typhoid;
people who live with someone who is a typhoid carrier; and
laboratory workers who may come into contact with Salmonella typhi in a work setting.
The typhoid oral vaccine is given in a series of 4 capsules that are taken 1 per day on alternating days (days 1, 3, 5, and 7). On this alternating-day schedule, you will take 1 capsule every 48 hours for 7 days. You must take each capsule according to the recommended schedule for this vaccine to be effective.
You should complete all doses at least 1 week before your scheduled travel or possible exposure to typhoid.
You must keep typhoid vaccine capsules cold when not in use. Once you receive the capsules from your doctor or pharmacy, take them directly home and place them in the refrigerator. Keep each capsule in the foil blister pack in the refrigerator until you are ready to take it. Do not allow the capsules to freeze. Take the capsule on an empty stomach, at least 1 hour before a meal.Swallow the capsule as quickly as possible after placing it in your mouth. Take with a full glass of cold or lukewarm water or other beverage. Do not use warm or hot drinks such as coffee, tea, or warm milk. The liquid you use to help swallow the typhoid vaccine capsule should not be warmer than your body temperature (98.6 degrees F).
Do not crush, chew, or break a typhoid vaccine capsule. Swallow the pill whole. The enteric-coated pill has a special coating to release the vaccine slowly into your body. Breaking the pill could damage this coating.The complete series of 4 vaccine capsules should provide protection against typhoid for up to 5 years. Another series of 4 capsules is then recommended every 5 years during possible exposure to typhoid. Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the Centers for Disease Control and Prevention (CDC).
Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of capsules every 5 years during continued exposure, you may not be fully protected against the disease.
Wash your hands often to help prevent typhoid when you are in an area where contamination is possible. What happens if I miss a dose?Contact your doctor if you forget to take a capsule on the scheduled day. You may need to start over to make sure you are fully protected against the disease.
Be sure to receive another series of 4 capsules every 5 years during continued exposure to typhoid.
What happens if I overdose?An overdose of this vaccine is unlikely to occur when taken as directed.
What should I avoid before or after getting typhoid vaccine?In addition to receiving typhoid vaccine, take precautions while traveling to further prevent coming into contact with bacteria that cause typhoid fever:
Avoid eating leafy vegetables such as spinach or lettuce, which are harder to wash properly.
Avoid eating raw fruits or vegetables that cannot be peeled, or that have been peeled by another person.
Avoid drinks that contain ice, or frozen treats and flavored ices that may have been made with contaminated water.
Avoid eating foods you have not cooked or prepared yourself. Use clean surfaces and utensils when preparing food.
Drink only bottled water (carbonated is best) or water that has been boiled for at least 1 minute.
Avoid any food or beverage purchased from a street vendor.
Typhoid vaccine side effects You should not receive a booster dose if you had a life-threatening allergic reaction after taking a typhoid vaccine capsule.Becoming infected with typhoid is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.Less serious side effects include:
low fever;
headache;
nausea, vomiting, diarrhea, stomach pain; or
mild skin rash.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Typhoid vaccine (live), oral Dosing InformationUsual Adult Dose for Typhoid Prophylaxis:
One capsule orally 1 hour before a meal with a cold or lukewarm drink [temperature not to exceed body temperature, e.g., 37 ?°C (98.6 ?°F)] on alternate days, e.g., days 1, 3, 5 and 7.Immunization with all 4 doses should be completed at least 1 week prior to potential exposure to Salmonella typhi.
Usual Pediatric Dose for Typhoid Prophylaxis:
>= 6 years: One capsule orally 1 hour before a meal with a cold or lukewarm drink [temperature not to exceed body temperature, e.g., 37 ?°C (98.6 ?°F)] on alternate days, e.g., days 1, 3, 5 and 7.
Definition of Mercury Poisoning: A disease usually caused by the ingestion of mercury or mercury compounds, which are toxic in relation to their ability to produce mercuric ions; usually acute mercury poisoning is associated with ulcerations of the stomach and intestine and toxic changes in the renal tubules; anuria and anaemia may occur; usually chronic mercury poisoning is a result of industrial poisoning and causes gastrointestinal or central nervous system manifestations including stomatitis, diarrhoea, ataxia, tremor, hyperreflexia, sensorineural impairment, and emotional instability
Drugs associated with Mercury PoisoningThe following drugs and medications are in some way related to, or used in the treatment of Mercury Poisoning. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
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