Ifa Acxion may be available in the countries listed below.
Ingredient matches for Ifa Acxion PhenterminePhentermine hydrochloride (a derivative of Phentermine) is reported as an ingredient of Ifa Acxion in the following countries:
MexicoInternational Drug Name Search
Humulin R (Concentrated)
Pronunciation: IN-su-linGeneric Name: Insulin RegularBrand Name: Humulin R (Concentrated)
Laryngesic Lozenges
Pronunciation: BEN-zoe-kaneGeneric Name: BenzocaineBrand Name: Examples include Trocaine Throat and Laryngesic
Cromolyn Solution
Pronunciation: KROE-moe-linGeneric Name: CromolynBrand Name: Examples include Nasal Allergy Control and NasalCrom
Boots Dual Action Athlete's Foot Powder
Boots Dual Action Athlete's Foot Powder
(Chlorhexidine Hydrochloride, Tolnaftate)
Effectively treats athlete's foot
Relieves skin irritation
75 g e
Please read this label carefully. It contains important information for you. Keep this label you may need to read it again Ask your pharmacist if you need more information or advice What this medicine is forAn anti-fungal and antibacterial powder for the treatment and prevention of athlete's foot. Also effective for other skin conditions where tenderness and sweating cause skin irritation, such as dhobie itch (groin ringworm).
Before you use this medicine Do not use: If you are allergic to any of the ingredientsYou can use this medicine if you are pregnant or breastfeeding.
How to use this medicine Wash and thoroughly dry the affected area Apply the powder liberally to the affected area If suffering from athlete's foot, apply the powder between the toes and also dust socks and inside of shoes with powder Adults and children:Apply morning and night.
Continue treatment for at least one week after the condition has cleared up, to stop it coming back.
If you are treating athlete's foot it is recommended that an athlete's foot cream is used together with this product.
For use on the skin only.
Possible side effectsMost people will not have problems, but some may get some of these:
Allergic reactions (red, itchy skin) Skin irritation Contact dermatitis (redness and swelling of the skin)If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.
What is in this medicineThis powder contains Chlorhexidine Hydrochloride 0.25% w/w, Tolnaftate 1% w/w.
Also contains: purified talc, maize starch, colloidal silicon dioxide.
This pack contains 75 g powder
Who makes this medicineManufactured by the Marketing Authorisation Holder
The Boots Company PLC Nottingham NG2 3AALeaflet prepared July 2007
If you would like any further information about this medicine please contact
The Boots Company PLC Nottingham NG2 3AAKeep all medicines out of the sight and reach of children.
Use by the date on the label edge.
PL 00014/0456
The Boots Company PLC Nottingham NG2 3AAIf you need more advice ask your pharmacist.
BTC13414 vC 03-12-07
perflutren lipid microsphere Intravenous
per-FLOO-tren LIP-id MYE-kroe-sfeers
Commonly used brand name(s)In the U.S.
DefinityAvailable Dosage Forms:
SuspensionTherapeutic Class: Radiological Non-Ionic Contrast Media
Uses For perflutren lipid microspherePerflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound. Ultrasound is a special kind of diagnostic procedure. It uses high-frequency sound waves to create images or “pictures” of certain areas inside the body. The sound waves produced by the ultrasound equipment can be reflected (bounced off) by different parts of the body, like for example, the heart. As the sound waves return they are electronically converted into images on a television screen. Unlike x-rays, ultrasound does not involve ionizing radiation.
The perflutren lipid microspheres preparation contains very small gas-filled lipid microspheres that reflect the sound waves and help create a better picture. The lipid microsphere preparation is given by injection into a vein before ultrasound to help diagnose problems of the heart.
perflutren lipid microsphere is to be given only by or under the direct supervision of a doctor with specialized training in ultrasound procedures.
Before Using perflutren lipid microsphereIn deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:
AllergiesTell your doctor if you have ever had any unusual or allergic reaction to perflutren lipid microsphere 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 perflutren lipid microsphere injection in the pediatric population. Safety and efficacy have not been established.
GeriatricAppropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of perflutren lipid microsphere injection 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 receiving this diagnostic test, 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.
Receiving this diagnostic test with any of the following medicines is not recommended. Your doctor may decide not to use this diagnostic test or change some of the other medicines you take.
Cisapride Dronedarone Mesoridazine Pimozide Sparfloxacin ThioridazineReceiving this diagnostic test 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.
Alfuzosin Amiodarone Amitriptyline Amoxapine Apomorphine Arsenic Trioxide Asenapine Astemizole Azithromycin Chloroquine Chlorpromazine Ciprofloxacin Citalopram Clarithromycin Clomipramine Clozapine Crizotinib Dasatinib Desipramine Disopyramide Dofetilide Dolasetron Droperidol Erythromycin Flecainide Fluconazole Gatifloxacin Gemifloxacin Granisetron Halofantrine Haloperidol Ibutilide Iloperidone Imipramine Lapatinib Levofloxacin Lopinavir Lumefantrine Mefloquine Methadone Moxifloxacin Nilotinib Norfloxacin Nortriptyline Octreotide Ofloxacin Ondansetron Paliperidone Pazopanib Posaconazole Procainamide Prochlorperazine Promethazine Propafenone Protriptyline Quetiapine Quinidine Quinine Ranolazine Salmeterol Saquinavir Sodium Phosphate Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Solifenacin Sorafenib Sotalol Sunitinib Telavancin Telithromycin Terfenadine Tetrabenazine Toremifene Trazodone Trifluoperazine Trimipramine Vandetanib Vardenafil Vemurafenib Voriconazole Ziprasidone 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 diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:
Congestive heart failure or Heart attack or Heart disease (e.g., coronary artery syndrome) or Heart rhythm problems (e.g., ventricular arrhythmia) or Respiratory distress syndrome—May increase risk for more serious side effects. Heart rhythm problems (e.g., QT prolongation)—Use with caution. May make this condition worse. Heart shunt, right-to-left, bi-directional, or transient right-to-left—Should not be used in patients with this condition. Proper Use of perflutren lipid microsphereA doctor or other trained health professional will give you perflutren lipid microsphere. perflutren lipid microsphere is given through a needle placed in one of your veins before ultrasound.
Your doctor may have special instructions for you in preparation for your test. If you do not understand the instructions you receive or if you have not received such instructions, check with your doctor in advance.
Precautions While Using perflutren lipid microsphereIt is very important that your doctor check your progress very closely while you are receiving perflutren lipid microsphere. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.
perflutren lipid microsphere may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after receiving perflutren lipid microsphere.
Tell your doctor right away if you have a chest pain; fast, slow, pounding, or irregular heartbeat; lightheadedness, dizziness, or fainting; shortness of breath; or troubled breathing. These may be symptoms of heart or lung problems.
perflutren lipid microsphere 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 or nurse immediately if any of the following side effects occur:
Rare Black, tarry stools blurred vision chest pain chills difficulty with breathing dizziness, severe or continuing fast, pounding, or irregular heartbeat or pulse hives itching lightheadedness when getting up from a lying or sitting position shortness of breath skin rash slow or irregular heartbeat swollen glands unusual bleeding or bruising Incidence not known Cough difficulty swallowing dizziness puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue tightness in the chest unusual tiredness or weakness wheezingSome 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:
Less common Back pain feeling of warmth on the skin headache nausea redness of the face, neck, arms, and occasionally, upper chest Rare Acid or sour stomach bruising diarrhea difficulty with moving dizziness dryness of the mouth feeling of constant movement of self or surroundings fever heartburn indigestion leg cramps muscle stiffness or tension pain at the injection site pain or swelling in the joints prickly or tingling sensation sneezing or runny nose stomach upset or painOther 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.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
More perflutren lipid microsphere Intravenous resources Perflutren lipid microsphere Intravenous Use in Pregnancy & BreastfeedingPerflutren lipid microsphere Intravenous Drug InteractionsPerflutren lipid microsphere Intravenous Support Group0 Reviews · Be the first to review/rate this drugAristocort A Cream
Pronunciation: TRY-am-SIN-oh-lone ah-SEE-toe-nideGeneric Name: TriamcinoloneBrand Name: Examples include Aristocort A and Kenalog
Xigris 20mg powder for solution for infusion, 5mg powder for solution for infusion
1. Name Of The Medicinal Product
Xigris* 5mg powder for solution for infusion.
Xigris 20mg powder for solution for infusion.
2. Qualitative And Quantitative CompositionXigris 5mg: Each vial contains 5mg of Drotrecogin alfa (activated).
After reconstitution with 2.5ml of Water for Injection each ml contains 2mg of Drotrecogin alfa (activated).
Excipient: Each vial contains approximately 17mg sodium.
Xigris 20mg: Each vial contains 20mg of drotrecogin alfa (activated).
After reconstitution with 10ml of Water for Injection, each ml contains 2mg of Drotrecogin alfa (activated).
Excipient: Each vial contains approximately 68mg sodium.
Drotrecogin alfa (activated) is a recombinant version of the endogenous activated Protein C and is produced by genetic engineering from an established human cell line.
For a full list of excipients, see section 6.1.
3. Pharmaceutical FormPowder for solution for infusion. Xigris is supplied as a lyophilised, white to off-white powder.
4. Clinical Particulars 4.1 Therapeutic IndicationsXigris is indicated for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. The use of Xigris should be considered mainly in situations when therapy can be started within 24 hours after the onset of organ failure (for further information see section 5.1).
4.2 Posology And Method Of AdministrationXigris should be used by experienced doctors in institutions skilled in the care of patients with severe sepsis.
Treatment should be started within 48 hours, and preferably within 24 hours, of onset of the first documented sepsis-induced organ dysfunction (see section 5.1).
The recommended dose of Xigris is 24?g/kg/hr (based on actual body weight) given as a continuous intravenous infusion for a total duration of 96 hours. It is recommended that Xigris be infused with an infusion pump to accurately control the infusion rate. If the infusion is interrupted for any reason, Xigris should be restarted at the 24?g/kg/hr infusion rate and continued to complete the full recommended 96 hours of dosing administration. Dose escalation or bolus doses of Xigris are not necessary to account for the interruption in the infusion.
No dose adjustments are required in adult patients with severe sepsis with regard to age, gender, hepatic function (as measured by transaminase levels), renal function, obesity or co-administration of prophylactic heparin. The pharmacokinetics of drotrecogin alfa (activated) have not been studied in patients with severe sepsis and pre-existing end-stage renal disease and chronic hepatic disease.
Paediatrics: Data from a placebo-controlled clinical trial, which was stopped for futility after 477 patients 0 to 17 years old had received the study treatment, did not establish efficacy of Xigris in paediatric patients and showed a higher rate of central nervous system bleeding in the Xigris versus placebo group. Xigris is contraindicated in children below the age of 18 (see sections 4.3 and 5.1).
4.3 ContraindicationsHypersensitivity to the active substance, to any of the excipients, or to bovine thrombin (a trace residue from the manufacturing process).
Drotrecogin alfa (activated) is contraindicated in children below the age of 18 years (see section 5.1).
Because drotrecogin alfa (activated) may increase the risk of bleeding, Xigris is contraindicated in the following situations:
• Active internal bleeding.
• Patients with intracranial pathology; neoplasm or evidence of cerebral herniation.
• Concurrent heparin therapy
• Known bleeding diathesis except for acute coagulopathy related to sepsis.
• Chronic severe hepatic disease.
• Platelet count <30,000 x 106 /l, even if the platelet count is increased after transfusions.
• Patients at increased risk for bleeding (for example):
a) Any major surgery, defined as surgery that requires general or spinal anaesthesia, performed within the 12-hour period immediately preceding drug infusion, or any postoperative patient who demonstrates evidence of active bleeding, or any patient with planned or anticipated surgery during the drug infusion period.
b) History of severe head trauma that required hospitalisation, intracranial or intraspinal surgery, or haemorrhagic stroke within the previous 3 months, or any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesion; patients with an epidural catheter or who are anticipated to receive an epidural catheter during drug infusion.
c) History of congenital bleeding diatheses.
d) Gastro-intestinal bleeding within the last 6 weeks that has required medical intervention unless definitive surgery has been performed.
e) Trauma patients at increased risk of bleeding.
4.4 Special Warnings And Precautions For Use
No further study has confirmed the efficacy results of the single pivotal trial.
Patients With Single Organ Dysfunction and Recent Surgery
Xigris is not approved for the treatment of patients with single organ dysfunction and should not be used in this particular subgroup of patients, especially if they had recent surgery (within 30 days). In each of two randomised, placebo-controlled trials, PROWESS and ADDRESS (see section 5.1), 28-day and in-hospital mortality were higher in patients treated with drotrecogin alfa (activated) compared to placebo for the sub-population of patients with single organ dysfunction and recent surgery (n = 98 in PROWESS and n = 636 in ADDRESS).
Bleeding
Drotrecogin alfa (activated) increases the risk of bleeding. In the following conditions, the risks of the administration of Xigris should be weighed against the anticipated benefits:
• Recent administration (within 3 days) of thrombolytic therapy.
• Recent administration (within 7 days) of oral anticoagulants.
• Recent administration (within 7 days) of aspirin or other platelet inhibitors.
• Recent (within 3 months) ischaemic stroke.
• Any other condition in which the physician considers significant bleeding is likely.
For procedures with an inherent bleeding risk, discontinue Xigris for 2 hours prior to the start of the procedure. Xigris may be restarted 12 hours after major invasive procedures or surgery if adequate haemostasis has been achieved. The incidence of serious bleeding events with Xigris was higher in patients with recent (within 30 days) surgery than in “medical” patients without surgery (see section 4.8). Bleeding risk should be taken into account when considering the risk benefit for individual patients. Xigris may be restarted immediately after uncomplicated less invasive procedures if adequate haemostasis has been achieved.
As a component of routine care, measures of haemostasis (e.g., activated partial thromboplastin time [APTT], prothrombin time [PT], and platelet count) should be obtained during the infusion of Xigris. If sequential tests of haemostasis indicate an uncontrolled or worsening coagulopathy that significantly increases the risk of bleeding, the benefits of continuing the infusion must be weighed against the potential increased risk of bleeding for that patient.
Laboratory Tests
Drotrecogin alfa (activated) has minimal effect on the PT. Prolongation of the APTT in patients with severe sepsis receiving Xigris may be due to the underlying coagulopathy, the pharmacodynamic effect of drotrecogin alfa (activated), and/or the effect of other concurrent medicinal products. The pharmacodynamic effect of drotrecogin alfa (activated) on the APTT assay is dependent on the reagent and instrument used to perform the assay and the time that elapses between sample acquisition and assay performance. Drotrecogin alfa (activated) that is present in a blood or plasma sample drawn from a patient who is being infused with the drug will be gradually neutralised by endogenous plasma protease inhibitors present in the sample. Virtually no measurable activity of drotrecogin alfa (activated) is present 2 hours after obtaining the blood sample. Due to these biological and analytical variables, the APTT should not be used to assess the pharmacodynamic effect of drotrecogin alfa (activated). In addition, approximately 2 hours after terminating the infusion of the drug, there is virtually no measurable activity of drotrecogin alfa (activated) remaining in the circulation of the patient; blood samples drawn for APTT determination after this point are no longer affected by the drug. The interpretation of sequential determinations of the PT and/or APTT should take these variables into consideration.
Because drotrecogin alfa (activated) may affect the APTT assays, drotrecogin alfa (activated) present in plasma samples may interfere with one-stage coagulation assays based on the APTT (such as Factor VIII, IX, and XI assays). Drotrecogin alfa (activated) present in plasma samples does not interfere with one-stage factor assays based on the PT (such as Factor II, V, VII and X assays).
If sequential measures of coagulopathy (including platelet count) indicate severe or worsening coagulopathy, the risk of continuing the infusion should be weighed against the expected benefit.
Immunogenicity
In adult patients in severe sepsis clinical studies, the frequency of anti-human Activated Protein C IgA/IgG/IgM antibodies or neutralising antibodies is low and is similar between drotrecogin alfa (activated) and placebo-treated patients tested. In patients developing antibodies, adverse events were not more frequent in drotrecogin alfa (activated) than in placebo patients. There was no evidence that the antibodies detected represented a specific immune response to drotrecogin alfa (activated) therapy.
There have been no clinical trials in severe sepsis specifically studying drotrecogin alfa (activated) re-administration. However, a small number of patients in severe sepsis controlled clinical trials received a prior course of drotrecogin alfa (activated). No hypersensitivity reactions were reported in these patients. Samples available were subsequently tested and all were negative for anti-human Activated Protein C antibody.
No anti-activated Protein C antibody formation was detected in healthy subjects, even after repeat administration.
However, the possibility of allergic reactions to constituents of the preparation cannot be completely excluded in certain predisposed patients. If allergic or anaphylactic reactions occur, treatment should be discontinued immediately and appropriate therapy initiated. If Xigris is readministered to patients, caution should be employed.
Xigris 5mg: This medicinal product contains approximately 17mg sodium per vial. To be taken into consideration by patients on a controlled sodium diet.
Xigris 20mg: This medicinal product contains approximately 68mg sodium per vial. To be taken into consideration by patients on a controlled sodium diet.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionCaution should be employed when Xigris is used with other drugs that affect haemostasis (see sections 4.3 and 4.4), including Protein C, thrombolytics (e.g., streptokinase, tPA, rPA and urokinase), oral anticoagulants (e.g., warfarin), hirudins, antithrombin, aspirin and other anti-platelets agents, e.g., non-steroidal anti-inflammatory drugs, ticlopidine and clopidogrel, glycoprotein IIb/IIIa antagonists (such as abciximab, eptifibatide, tirofiban) and prostacyclins, such as iloprost.
Co-administration of Low-dose Heparin for Prophylaxis of Venous Thrombotic Events (VTE)
Low-dose heparin for VTE prophylaxis may be co-administered with drotrecogin alfa (activated). In a randomised study of heparin versus placebo (XPRESS) in 1,935 adult severe sepsis patients, all treated with drotrecogin alfa (activated), prophylactic heparin did not adversely affect mortality (heparin 28.3% versus placebo 31.9% in the overall ITT population, and heparin 30.3% versus placebo 26.9% in patients with multiple organ dysfunction treated within 24 hours of their first sepsis-induced organ dysfunction (n=890)). In the subgroup of 885 patients who were already receiving prophylactic heparin at study entry, mortality was 26.9% in the group randomised to continue heparin versus 35.6% in the group whose randomisation (to placebo) led to the discontinuation of heparin. However, the reasons for this difference are unknown and could be related to other factors. Additionally, there was no increased risk of serious bleeding, including central nervous system (CNS) bleeding. Prophylactic heparin increased the risk of non-serious bleeding (see section 4.8). There was no statistical difference in the rates of VTE between study arms.
4.6 Pregnancy And LactationAnimal studies with respect to effects on pregnancy, embryonal/foetal development, parturition, and post-natal development have not been conducted with Xigris. Therefore, the potential risk for humans is unknown. Xigris should not be used during pregnancy unless clearly necessary.
It is not known whether Xigris is excreted in human milk or if there is a potential effect on the breast-fed infant. Therefore, the patient should not breast-feed whilst treated with Xigris.
4.7 Effects On Ability To Drive And Use MachinesNot relevant.
4.8 Undesirable EffectsXigris increases the risk of bleeding.
The Phase 3 international, multi-centre, randomised, double-blind, placebo-controlled clinical trial (PROWESS) involved 850 drotrecogin alfa (activated)-treated and 840 placebo-treated patients. The percentage of patients experiencing at least one bleeding event in the two treatment groups was 24.9% and 17.7%, respectively. In both treatment groups, the majority of bleeding events were ecchymosis or gastro-intestinal tract bleeding. The difference in the incidence of serious bleeding events between the two treatment groups occurred primarily during study drug administration.
A total of 2,378 adult patients with severe sepsis received drotrecogin alfa (activated) in a Phase 3b, international, single-arm, open-label clinical trial (ENHANCE).
The incidence of serious bleeding events in the PROWESS and ENHANCE studies is provided below. In these studies, serious bleeding events included any intracranial haemorrhage, any life-threatening or fatal bleed, any bleeding event requiring the administration of
A Phase 3b, international, multi-centre, randomised, double-blind, placebo-controlled clinical trial (ADDRESS) of adult severe sepsis patients at low risk of death involved 1,317 drotrecogin alfa (activated)-treated and 1,293 placebo-treated patients. The percentage of patients experiencing at least one bleeding event in the two treatment groups was 10.9% and 6.4%, respectively (P <0.001). Bleeding events included serious bleeding events, bleeding events assessed as possibly study drug related by the investigator, bleeding events associated with the need for a red blood cell transfusion, and bleeding events that led to permanent discontinuation of the study drug. In the ADDRESS trial, serious bleeding events included any fatal bleed, any life-threatening bleed, any CNS bleed, or any bleeding event assessed as serious by the investigator.
Serious Bleeding Events During the Infusion Period
The following table lists the percentage of patients in PROWESS and ENHANCE experiencing serious bleeding events by site of haemorrhage during the study drug infusion period (defined as the duration of infusion plus the next full calendar day following the end of the infusion).
Site of Haemorrhage
Drotrecogin Alfa
(Activated)
[PROWESS]
n = 850
Placebo
[PROWESS]
n = 840
Drotrecogin Alfa
(Activated)
[ENHANCE]
n = 2,378
Gastro-intestinal
5 (0.6%)
4 (0.5%)
19 (0.8%)
Intra-abdominal
2 (0.2%)
3 (0.4%)
18 (0.8%)
Intra-thoracic
4 (0.5%)
0
11 (0.5%)
Retroperitoneal
3 (0.4%)
0
4 (0.2%)
Central nervous system (CNS)1
2 (0.2%)
0
15 (0.6%)
Genito-urinary
2 (0.2%)
0
0
Skin/soft tissue
1 (0.1%)
0
16 (0.7%)
Nasopharyngeal
0
0
4 (0.2%)
Joint/bone
0
0
1 (0.04%)
Site unknown2
1 (0.1%)
1 (0.1%)
6 (0.3%)
Total
20 (2.4%)
8 (1.0%)
853 (3.6%)
1 CNS bleeding is defined as any bleed in the central nervous system, including the following types of haemorrhage: petechial, parenchymal, subarachnoid, subdural, and stroke with haemorrhagic transformation.
2 Patients requiring the administration of
3 In ENHANCE, six patients experienced multiple serious bleeding events during the study drug infusion period (94 events observed in 85 patients).
During the infusion period in PROWESS and ENHANCE, the incidence of serious bleeding events with Xigris was numerically higher in patients with recent (within 30 days) surgery than in patients without surgery (PROWESS: 3.3% versus 2.0%; ENHANCE: 5.0% versus 3.1% respectively. Placebo rates in PROWESS 0.4% versus 1.2% respectively).
In ADDRESS, the percentage of treated patients experiencing a serious bleeding event by site of haemorrhage was similar to that observed in PROWESS. The incidence of serious bleeding events during infusion (defined as study day 0 through study day 6) was 31 (2.4%) and 15 (1.2%) in drotrecogin alfa (activated)-treated and placebo-treated patients, respectively (P = 0.02). The incidence of CNS bleeds during infusion was 4 (0.3%) and 3 (0.2%) for drotrecogin alfa (activated)-treated and placebo-treated patients, respectively. Recent surgery (within 30 days prior to study entry) was associated with a numerically higher risk of serious bleeding during infusion in both the Xigris-treated and the placebo-treated patients (Xigris: 3.6% in patients with recent surgery versus 1.6% in patients without recent surgery; placebo: 1.6% versus 0.9%, respectively).
In XPRESS, a randomised study of prophylactic heparin versus placebo in adult severe sepsis patients, all treated with drotrecogin alfa (activated), serious bleeding rates were consistent with those observed in previous studies over the treatment period of 0-6 days, and prophylactic heparin did not increase the risk of serious bleeding compared to placebo (2.3% versus 2.5%, respectively), including CNS bleeding (0.3% on both arms). However, prophylactic heparin increased the risk of non-serious bleeding compared with placebo (8.7% versus 5.7%, respectively; P = 0.0116).
Serious Bleeding Events During the 28-Day Study Period
In PROWESS, the incidence of serious bleeding events during the 28-day study period was 3.5% and 2.0% in drotrecogin alfa (activated)-treated and placebo-treated patients, respectively. The incidence of CNS bleeds during the 28-day study period was 0.2% and 0.1% for drotrecogin alfa (activated)-treated and placebo-treated patients, respectively. The risk of CNS bleeding may increase with severe coagulopathy and severe thrombocytopenia (see sections 4.3 and 4.4).
In the open-label ENHANCE study, the incidence of serious bleeding events during the 28-day study period was 6.5%, and the incidence of CNS bleeds during the 28-day study period was 1.5%.
In the placebo-controlled ADDRESS study, the incidence of serious bleeding events during the 28-day study period was 51 (3.9%) and 28 (2.2%) in drotrecogin alfa (activated)-treated and placebo-treated patients, respectively (P = 0.01). The incidence of CNS bleeds during the 28-day study period was 6 (0.5%) and 5 (0.4%) for drotrecogin alfa (activated)-treated and placebo-treated patients, respectively.
In XPRESS, serious bleeding rates were consistent with those observed in previous studies during the 28-day study period (days 0-28). Prophylactic heparin did not increase the risk of serious bleeding compared to placebo (3.9% versus 5.2%, respectively), including CNS bleeding (1.0% versus 0.7%, respectively).
In the Phase 1 studies, adverse events with a frequency of
4.9 OverdoseIn clinical trials and in post-marketing experience there have been reports of accidental overdosing. In the majority of cases, no reactions have been observed. For the other reports, the observed events were consistent with known undesirable effects of the drug (see section 4.8), effects of the drug on laboratory tests (see section 4.4), or consequences of the underlying condition of sepsis.
There is no known antidote for drotrecogin alfa (activated). In case of overdose, immediately stop the infusion (see section 5.2).
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesPharmacotherapeutic group: Antithrombotic agents, enzymes. ATC code: B01AD10.
This medicinal product has been authorised under “Exceptional Circumstances”. This means that for scientific reasons it has not been possible to obtain complete information on this medicinal product. The European Medicines Agency (EMEA) will review any new information which may become available every year, and this SPC will be updated as necessary.
Mechanism of Action
Xigris is a recombinant version of the natural plasma-derived Activated Protein C, from which it differs only by unique oligosaccharides in the carbohydrate portion of the molecule. Activated Protein C is a crucial coagulation regulator. It limits thrombin formation by inactivating Factors Va and VIIIa, thereby providing negative feedback regulation of coagulation. Excessive coagulation activation in the microcirculatory bed plays a significant part in the pathophysiology of severe sepsis. Furthermore, Activated Protein C is an important modulator of the systemic response to infection and has antithrombotic and profibrinolytic properties. Xigris has similar properties to those of endogenous human Activated Protein C.
Pharmacodynamic Effects
In placebo-controlled clinical trials in patients with severe sepsis, Xigris exerted an antithrombotic effect by limiting thrombin generation and improved sepsis-associated coagulopathy, as shown by a more rapid improvement in markers of coagulation and fibrinolysis. Xigris caused a more rapid decline in thrombotic markers, such as D-dimer, prothrombin F1.2, and thrombin-antithrombin levels, and a more rapid increase in Protein C and antithrombin levels. Xigris also restored endogenous fibrinolytic potential, as evidenced by a more rapid trend toward normalisation in plasminogen levels and a more rapid decline in plasminogen activator inhibitor-1 levels. Additionally, patients with severe sepsis treated with Xigris had a more rapid decline in interleukin-6 levels, a global marker of inflammation, consistent with a reduction in the inflammatory response.
Clinical Efficacy
Xigris was studied in one Phase 3, international, multi-centre, randomised, double-blind, placebo-controlled trial (PROWESS) in 1,690 patients with severe sepsis. Severe sepsis is defined as sepsis associated with acute organ dysfunction. Patients meeting the clinical diagnosis of severe sepsis had: a) known or suspected infection; b) clinical evidence of systemic response to infection, including fever or hypothermia, leucopenia or leucocytosis, tachycardia and tachypnoea; and c) acute organ dysfunction. Organ dysfunction was defined as shock, hypotension or the need for vasopressor support despite adequate fluid resuscitation, relative hypoxemia (ratio of partial pressure of oxygen in arterial blood in mmHg to the percentage of oxygen in the inspired air expressed as a decimal [PaO2/FiO2 ratio] <250), oliguria despite adequate fluid resuscitation, marked reduction in blood platelet counts, and/or elevated lactic acid concentrations.
Exclusion criteria encompassed patients at high risk of bleeding (see sections 4.3 and 4.4), patients who were not expected to survive for 28 days due to a pre-existing, non-sepsis related medical condition, HIV positive patients whose most recent CD4 count was 3, patients on chronic dialysis, and patients who had undergone bone marrow, lung, liver, pancreas, or small bowel transplantation, and patients with acute clinical pancreatitis without a proven source of infection.
In the PROWESS trial, treatment was initiated within 48 hours of onset of the first sepsis-induced organ dysfunction. The median duration of organ dysfunction prior to treatment was 18 hours. Patients were given a 96-hour constant rate infusion of Xigris at 24?g/kg/hr (n = 850) or placebo (n = 840). Xigris was added to best standard care. Best standard care includes adequate antibiotics, source control and supportive treatment (fluids, inotropes, vasopressors and support of failing organs, as required).
Patients treated with Xigris experienced improved 28-day survival compared to those treated with placebo. At 28 days, the overall mortality rates were 24.7% for the Xigris-treated group and 30.8% for the placebo-treated group (P = 0.005).
Significant absolute death reduction was limited to the subgroup of patients with greater disease severity, i.e., baseline APACHE II score
A consistent treatment effect on mortality with Xigris administration was observed across patient subgroups defined by age, gender, and infection type.
PROWESS Follow-Up Study
Survival status was assessed in a follow-up study of PROWESS survivors. In-hospital and 3-month survival status was reported for 98% and 94% of the 1,690 PROWESS subjects, respectively. In the overall population, the in-hospital mortality was significantly lower in patients on Xigris than in patients on placebo (29.4% versus 34.6%; P = 0.023). Survival through 3 months was also better in the Xigris group compared to placebo (log rank P = 0.048). These data confirmed that the benefit of Xigris is limited to the more severely affected sepsis patients, such as patients with multiple organ failure and shock.
Further Clinical Experience
In a Phase 3b, international, single-arm, open-label clinical trial (ENHANCE), 2,378 adult patients with severe sepsis received drotrecogin alfa (activated). The entry criteria were similar to those employed in PROWESS. Patients received drotrecogin alfa (activated) within 48 hours of onset of the first sepsis-induced organ dysfunction. The median duration of organ dysfunction prior to treatment was 25 hours. At 28 days, the mortality rate in the Phase 3b study was 25.3%. The mortality rate was lower for patients treated within 24 hours of organ dysfunction compared to those treated after 24 hours, even after adjustment for differences in disease severity.
A total of 2,640 adult patients with severe sepsis who were at low risk of death (e.g., patients with APACHE II <25 or with only one sepsis-induced organ failure) were enrolled in a randomised, double-blind, placebo-controlled trial (ADDRESS). The trial was stopped for futility after an interim analysis.
No benefit of drotrecogin alfa (activated) was observed in the subgroup of 872 patients at low risk of death with multiple organ dysfunction, so ADDRESS did not confirm the efficacy results of the PROWESS study.
In the multiple organ dysfunction subgroup of ADDRESS the 28-day placebo mortality was 21.9%, similar to the single organ dysfunction subgroup of PROWESS (21.2%), confirming the lack of efficacy in patients with severe sepsis who are at low risk of death.
Paediatric Patients
Xigris is contraindicated in children below the age of 18 years (see also sections 4.2 and 4.3).
Data from a placebo-controlled clinical trial (RESOLVE) did not establish efficacy of Xigris in paediatric patients suffering from severe sepsis, acute infection, systemic inflammation and respiratory and cardiovascular organ dysfunction. This trial was stopped for futility after 477 patients had received the study drug (out of 600 patients intended). A planned interim analysis (with 400 patients enrolled) showed a low likelihood of demonstrating a significant difference in the primary endpoint of “Composite Time to Complete Organ Failure Resolution” (CTCOFR score of 9.8 versus 9.7 mean days over 14 days). There was also no difference in 28-day mortality (17.1% versus 17.3% in the Xigris and placebo groups, respectively).
Investigators attributed 2 deaths in the Xigris group and 5 deaths in the placebo group to bleeding events. There was a higher rate of central nervous system (CNS) bleeding in the drotrecogin alfa (activated) versus the placebo group. Over the infusion period (study days 0-6) the number of patients experiencing CNS bleeding was 5 versus 1 (2.1% versus 0.4%) for the overall population (drotrecogin alfa (activated) versus placebo), with 4 of the 5 events in the drotrecogin alfa (activated) group occurring in patients
In placebo controlled clinical trials, the treatment effect was most evident at sites enrolling larger numbers of patients.
5.2 Pharmacokinetic PropertiesDrotrecogin alfa (activated) and endogenous human Activated Protein C are inactivated in plasma by endogenous protease inhibitors, but the mechanism by which they are cleared from plasma is unknown. Plasma concentrations of endogenous Activated Protein C in healthy subjects and patients with severe sepsis are usually below detection limits (<5ng/ml) and do not significantly influence the pharmacokinetic properties of drotrecogin alfa (activated).
In healthy subjects, greater than 90% of the steady-state condition is attained within 2 hours following the start of a constant-rate intravenous infusion of Xigris. Following the completion of an infusion, the decline in plasma drotrecogin alfa (activated) concentrations is biphasic and is comprised of a rapid initial phase (t?? = 13 minutes) and a slower second phase (t?? = 1.6 hours). The short half-life of 13 minutes accounts for approximately 80% of the area under the plasma concentration curve and governs the initial rapid accrual of plasma drotrecogin alfa (activated) concentrations towards the steady-state. Plasma drotrecogin alfa (activated) steady-state concentrations are proportional to the infusion rate over a range of infusion rates from 12?g/kg/hr to 48?g/kg/hr. The mean steady-state plasma concentration of drotrecogin alfa (activated) in healthy subjects receiving 24?g/kg/hr is 72ng/ml.
In patients with severe sepsis, infusion of drotrecogin alfa (activated) from 12?g/kg/hr to 30?g/kg/hr rapidly produced steady-state plasma concentrations that were proportional to infusion rates. In the Phase 3 trial, the pharmacokinetics of drotrecogin alfa (activated) were evaluated in 342 patients with severe sepsis administered a 96-hour continuous infusion at 24µg/kg/hr. The pharmacokinetics of drotrecogin alfa (activated) were characterised by attainment of steady-state plasma concentration within 2 hours following the start of the infusion. In the majority of patients, measurements of Activated Protein C beyond 2 hours after termination of the infusion were below the quantifiable limit, suggesting rapid elimination of drotrecogin alfa (activated) from the systemic circulation. The plasma clearance of drotrecogin alfa (activated) is approximately 41.8 l/hr in sepsis patients as compared with 28.1 l/hr in healthy subjects.
In patients with severe sepsis, the plasma clearance of drotrecogin alfa (activated) was significantly decreased by renal impairment and hepatic dysfunction, but the magnitude of the differences in clearance (<30%) does not warrant any dosage adjustment.
5.3 Preclinical Safety DataChanges observed in monkeys at, or in small excess of, the maximum human exposure during repeated dose studies were all related to the pharmacological effect of Xigris and include, beside the expected prolongation of APTT, decreases in haemoglobin, erythrocytes and haematocrit and increases in reticulocyte count and PT.
Drotrecogin alfa (activated) was not mutagenic in an in vivo micronucleus study in mice or in an in vitro chromosomal aberration study in human peripheral blood lymphocytes with or without rat liver metabolic activation.
Carcinogenicity studies and animal reproduction studies have not been conducted with Xigris. However, with respect to the latter, the potential risk for humans being unknown, Xigris should not be used during pregnancy unless clearly necessary (see section 4.6).
6. Pharmaceutical Particulars 6.1 List Of ExcipientsSucrose
Sodium chloride
Sodium citrate
Citric acid
Hydrochloric acid
Sodium hydroxide
6.2 IncompatibilitiesThis medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf Life3 years.
After reconstitution, immediate use is recommended. However, the reconstituted solution in the vial may be held for up to 3 hours at room temperature (15?C- 30?C). After preparation, the intravenous infusion solution can be used at room temperature (15?C- 30?C) for a period up to 14 hours.
6.4 Special Precautions For StorageStore in a refrigerator (2°C-8°C). Keep the vial in the outer carton in order to protect it from light.
6.5 Nature And Contents Of ContainerPowder in Type I glass vial. Pack of 1 vial.
6.6 Special Precautions For Disposal And Other Handling1.
Use appropriate aseptic technique during the preparation of Xigris for intravenous administration.
2.
Calculate the dose and the number of Xigris vials needed.
Xigris 5mg: Each Xigris vial contains 5mg of drotrecogin alfa (activated).
Xigris 20mg: Each Xigris vial contains 20mg of drotrecogin alfa (activated).
The vial contains an excess of drotrecogin alfa (activated) to facilitate delivery of the label amount.
3.
Xigris 5mg: Prior to administration, 5mg vials of Xigris must be reconstituted with 2.5ml of sterile water for injection, resulting in a solution with a concentration of approximately 2mg/ml drotrecogin alfa (activated).
Xigris 20mg: Prior to administration, 20mg vials of Xigris must be reconstituted with 10ml of sterile water for injection, resulting in a solution with a concentration of approximately 2mg/ml drotrecogin alfa (activated).
Slowly add the sterile water for injection to the vial and avoid inverting or shaking the vial. Gently swirl each vial until the powder is completely dissolved.
4.
The solution of reconstituted Xigris must be further diluted with sterile 0.9% sodium chloride injection to a final concentration of between 100?g/ml and 200?g/ml. Slowly withdraw the appropriate amount of reconstituted drotrecogin alfa (activated) solution from the vial. Add the reconstituted drotrecogin alfa (activated) into a prepared infusion bag of sterile 0.9% sodium chloride injection. When adding the reconstituted drotrecogin alfa (activated) into the infusion bag, direct the stream to the side of the bag to minimise the agitation of the solution. Gently invert the infusion bag to obtain a homogeneous solution. Do not transport the infusion bag between locations using mechanical delivery systems.
5.
After reconstitution, immediate use is recommended. However, the reconstituted solution in the vial may be held for up to 3 hours at room temperature (15 to 30?C).
After preparation, the intravenous infusion solution can be used at room temperature (15 to 30?C) for a period up to 14 hours.
6.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
7.
It is recommended that Xigris be infused with an infusion pump to accurately control the infusion rate. The solution of reconstituted Xigris should be diluted into an infusion bag containing sterile 0.9% sodium chloride injection to a final concentration of between 100µg/ml and 200µg/ml.
8.
When administering drotrecogin alfa (activated) at low flow rates (less than approximately 5ml/hr), the infusion set must be primed for approximately 15 minutes at a flow rate of approximately 5ml/hr.
9.
Xigris should be administered via a dedicated intravenous line or a dedicated lumen of a multi-lumen central venous catheter. The ONLY other solutions that can be administered through the same line are 0.9% sodium chloride injection, lactated Ringer's injection, dextrose, or dextrose and saline mixtures.
10.
Avoid exposing drotrecogin alfa (activated) solutions to heat and/or direct sunlight. No incompatibilities have been observed between drotrecogin alfa (activated) and glass infusion bottles or infusion bags made of polyvinylchloride, polyethylene, polypropylene, or polyolefin. The use of other types of infusion sets could have a negative impact on the amount and potency of drotrecogin alfa (activated) administered.
11.
Care should be taken to administer Xigris at the appropriate rate, calculated based on kg of bodyweight and infused for the correct duration. It is recommended that the bag be labelled accordingly.
7. Marketing Authorisation HolderEli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, The Netherlands.
8. Marketing Authorisation Number(S)5mg vial:
EU/1/02/225/001
20mg vial:
EU/1/02/225/002
9. Date Of First Authorisation/Renewal Of The AuthorisationDate of first authorisation:
22 August 2002
Date of latest renewal:
Luveris
lutropin alfa
Dosage Form: injectionLuveris® (lutropin alfa for injection)
Tritace Tablet Titration Pack
1. Name Of The Medicinal Product
Tritace Tablet Titration Pack 2.5 mg, 5 mg, 10 mg tablets
2. Qualitative And Quantitative CompositionTablets
Each 2.5 mg tablet contains ramipril 2.5 mg
Each 5 mg tablet contains ramipril 5 mg
Each 10 mg tablet contain ramipril 10 mg
For a full list of excipients, see section 6.1.
3. Pharmaceutical FormTablets 2.5 mg
Yellowish to yellow oblong tablets with score-line.
Upper stamp: 2.5 & logo (
Lower stamp: HMR & 2.5
The tablet can be divided into equal halves.
Tablets 5 mg
Pale red oblong tablets with score-line.
Upper stamp: 5 & logo (
Lower stamp: HMP & 5
The tablet can be divided into equal halves
Tablets 10 mg
White to almost white oblong tablets with score-line.
Upper stamp: HMO/HMO
The tablet can be divided into equal halves.
4. Clinical Particulars 4.1 Therapeutic Indications- Treatment of hypertension.
- Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:
• manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or
• diabetes with at least one cardiovascular risk factor (see section 5.1).
- Treatment of renal disease:
• Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria,
• Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1),
• Manifest glomerular non diabetic nephropathy as defined by macroproteinuria
- Treatment of symptomatic heart failure.
- Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction.
4.2 Posology And Method Of AdministrationOral use.
It is recommended that TRITACE is taken each day at the same time of the day.
TRITACE can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2).
TRITACE has to be swallowed with liquid. It must not be chewed or crushed.
Adults
Diuretic-Treated patients
Hypotension may occur following initiation of therapy with TRITACE; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted. If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with TRITACE (see section 4.4).
In hypertensive patients in whom the diuretic is not discontinued, therapy with TRITACE should be initiated with a 1.25 mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of TRITACE should be adjusted according to blood pressure target.
Hypertension
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
TRITACE may be used in monotherapy or in combination with other classes of antihypertensive medicinal products.
Starting dose
TRITACE should be started gradually with an initial recommended dose of 2.5 mg daily.
Patients with a strongly activated renin-angiotensin-aldosterone system may experience an excessive drop in blood pressure following the initial dose. A starting dose of 1.25 mg is recommended in such patients and the initiation of treatment should take place under medical supervision (see section 4.4).
Titration and maintenance dose
The dose can be doubled at interval of two to four weeks to progressively achieve target blood pressure; the maximum permitted dose of TRITACE is 10 mg daily. Usually the dose is administered once daily.
Cardiovascular prevention
Starting dose
The recommended initial dose is 2.5 mg of TRITACE once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose should be gradually increased. It is recommended to double the dose after one or two weeks of treatment and - after another two to three weeks - to increase it up to the target maintenance dose of 10 mg TRITACE once daily.
See also posology on diuretic treated patients above.
Treatment of renal disease
In patients with diabetes and microalbuminuria:
Starting dose:
The recommended initial dose is 1.25 mg of TRITACE once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the once daily dose to 2.5 mg after two weeks and then to 5 mg after a further two weeks is recommended.
In patients with diabetes and at least one cardiovascular risk
Starting dose:
The recommended initial dose is 2.5 mg of TRITACE once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the daily dose to 5 mg TRITACE after one or two weeks and then to 10 mg TRITACE after a further two or three weeks is recommended. The target daily dose is 10 mg.
In patients with non- diabetic nephropathy as defined by macroproteinuria
Starting dose:
The recommended initial dose is 1.25 mg of TRITACE once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the once daily dose to 2.5 mg after two weeks and then to 5 mg after a further two weeks is recommended.
Symptomatic heart failure
Starting dose
In patients stabilized on diuretic therapy, the recommended initial dose is 1.25 mg daily.
Titration and maintenance dose
TRITACE should be titrated by doubling the dose every one to two weeks up to a maximum daily dose of 10 mg. Two administrations per day are preferable.
Secondary prevention after acute myocardial infarction and with heart failure
Starting dose
After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5 mg twice daily for three days. If the initial 2.5 mg dose is not tolerated a dose of 1.25 mg twice a day should be given for two days before increasing to 2.5 mg and 5 mg twice a day. If the dose cannot be increased to 2.5 mg twice a day the treatment should be withdrawn.
See also posology on diuretic treated patients above.
Titration and maintenance dose
The daily dose is subsequently increased by doubling the dose at intervals of one to three days up to the target maintenance dose of 5 mg twice daily.
The maintenance dose is divided in 2 administrations per day where possible.
If the dose cannot be increased to 2.5 mg twice a day treatment should be withdrawn. Sufficient experience is still lacking in the treatment of patients with severe (NYHA IV) heart failure immediately after myocardial infarction. Should the decision be taken to treat these patients, it is recommended that therapy be started at 1.25 mg once daily and that particular caution be exercised in any dose increase.
Special populations
Patients with renal impairment
Daily dose in patients with renal impairment should be based on creatinine clearance (see section 5.2):
- if creatinine clearance is
- if creatinine clearance is between 30-60 ml/min, it is not necessary to adjust the initial dose (2.5 mg/day); the maximal daily dose is 5 mg;
- if creatinine clearance is between 10-30 ml/min, the initial dose is 1.25 mg/day and the maximal daily dose is 5 mg;
- in haemodialysed hypertensive patients: ramipril is slightly dialysable; the initial dose is 1.25 mg/day and the maximal daily dose is 5 mg; the medicinal product should be administered few hours after haemodialysis is performed.
Patients with hepatic impairment (see section 5.2)
In patients with hepatic impairment, treatment with TRITACE must be initiated only under close medical supervision and the maximum daily dose is 2.5 mg TRITACE.
Elderly
Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects especially in very old and frail patients. A reduced initial dose of 1.25 mg ramipril should be considered.
Paediatric population
The safety and efficacy of ramipril in children has not yet been established. Currently available data for TRITACE are described in sections 4.8, 5.1, 5.2 and 5.3 but no specific recommendation on posology can be made.
4.3 Contraindications- Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin Converting Enzyme) inhibitors (see section 6.1)
- History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or AIIRAs)
- Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5)
- Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
- Second and third trimesters of pregnancy (see sections 4.4 and 4.6)
- Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.
4.4 Special Warnings And Precautions For UseSpecial populations
Pregnancy: ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
- Patients at particular risk of hypotension
- Patients with strongly activated renin-angiotensin-aldosterone system
Patients with strongly activated renin-angiotensin-aldosterone system are at risk of an acute pronounced fall in blood pressure and deterioration of renal function due to ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is given for the first time or at first dose increase.
Significant activation of renin-angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in:
- patients with severe hypertension
- patients with decompensated congestive heart failure
- patients with haemodynamically relevant left ventricular inflow or outflow impediment (e.g. stenosis of the aortic or mitral valve)
- patients with unilateral renal artery stenosis with a second functional kidney
- patients in whom fluid or salt depletion exists or may develop (including patients with diuretics)
- patients with liver cirrhosis and/or ascites
- patients undergoing major surgery or during anaesthesia with agents that produce hypotension.
Generally, it is recommended to correct dehydration, hypovolaemia or salt depletion before initiating treatment (in patients with heart failure, however, such corrective action must be carefully weighed out against the risk of volume overload).
- Transient or persistent heart failure post MI
- Patients at risk of cardiac or cerebral ischemia in case of acute hypotension
The initial phase of treatment requires special medical supervision.
- Elderly patients
See section 4.2.
Surgery
It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery.
Monitoring of renal function
Renal function should be assessed before and during treatment and dosage adjusted especially in the initial weeks of treatment. Particularly careful monitoring is required in patients with renal impairment (see section 4.2). There is a risk of impairment of renal function, particularly in patients with congestive heart failure or after a renal transplant.
Angioedema
Angioedema has been reported in patients treated with ACE inhibitors including ramipril (see section 4.8).
In case of angioedema, TRITACE must be discontinued.
Emergency therapy should be instituted promptly. Patient should be kept under observation for at least 12 to 24 hours and discharged after complete resolution of the symptoms.
Intestinal angioedema has been reported in patients treated with ACE inhibitors including TRITACE (see section 4.8). These patients presented with abdominal pain (with or without nausea or vomiting).
Anaphylactic reactions during desensitization
The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens are increased under ACE inhibition. A temporary discontinuation of TRITACE should be considered prior to desensitization.
Hyperkalaemia
Hyperkalaemia has been observed in some patients treated with ACE inhibitors including TRITACE. Patients at risk for development of hyperkalaemia include those with renal insufficiency, age (> 70 years), uncontrolled diabetes mellitus, or those using potassium salts, potassium retaining diuretics and other plasma potassium increasing active substances, or conditions such as dehydration, acute cardiac decompensation, metabolic acidosis. If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended (see section 4.5).
Neutropenia/agranulocytosis
Neutropenia/agranulocytosis, as well as thrombocytopenia and anaemia, have been rarely seen and bone marrow depression has also been reported. It is recommended to monitor the white blood cell count to permit detection of a possible leucopoenia. More frequent monitoring is advised in the initial phase of treatment and in patients with impaired renal function, those with concomitant collagen disease (e.g. lupus erythematosus or scleroderma), and all those treated with other medicinal products that can cause changes in the blood picture (see sections 4.5 and 4.8).
Ethnic differences
ACE inhibitors cause higher rate of angioedema in black patients than in non black patients. As with other ACE inhibitors, ramipril may be less effective in lowering blood pressure in black people than in non black patients, possibly because of a higher prevalence of hypertension with low renin level in the black hypertensive population.
Cough
Cough has been reported with the use of ACE inhibitors. Characteristically, the cough is nonproductive, persistent and resolves after discontinuation of therapy. ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionContra-indicated combinations
Extracorporeal treatments leading to contact of blood with negatively charged surfaces such as dialysis or haemofiltration with certain high-flux membranes (e.g. polyacrylonitril membranes) and low density lipoprotein apheresis with dextran sulphate due to increased risk of severe anaphylactoid reactions (see section 4.3). If such treatment is required, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.
Precautions for use
Potassium salts, heparin, potassium-retaining diuretics and other plasma potassium increasing active substances (including Angiotensin II antagonists, trimethoprim, tacrolimus, ciclosporin): Hyperkalaemia may occur, therefore close monitoring of serum potassium is required.
Antihypertensive agents (e.g. diuretics) and other substances that may decrease blood pressure (e.g. nitrates, tricyclic antidepressants, anaesthetics, acute alcohol intake, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin): Potentiation of the risk of hypotension is to be anticipated (see section 4.2 for diuretics)
Vasopressor sympathomimetics and other substances (e.g. isoproterenol, dobutamine, dopamine, epinephrine) that may reduce the antihypertensive effect of TRITACE: Blood pressure monitoring is recommended.
Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count: Increased likelihood of haematological reactions (see section 4.4).
Lithium salts: Excretion of lithium may be reduced by ACE inhibitors and therefore lithium toxicity may be increased. Lithium level must be monitored.
Antidiabetic agents including insulin: Hypoglycaemic reactions may occur. Blood glucose monitoring is recommended.
Non-steroidal anti-inflammatory drugs and acetylsalicylic acid: Reduction of the antihypertensive effect of TRITACE is to be anticipated. Furthermore, concomitant treatment of ACE inhibitors and NSAIDs may lead to an increased risk of worsening of renal function and to an increase in kalaemia.
4.6 Pregnancy And LactationPregnancy
The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4). The use of ACE inhibitors is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
Exposure to ACE inhibitor therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3). Should exposure to ACE inhibitors have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension (see sections 4.3 and 4.4).
Lactation
Because insufficient information is available regarding the use of ramipril during breastfeeding (see section 5.2), Tritace is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
4.7 Effects On Ability To Drive And Use MachinesSome adverse effects (e.g. symptoms of a reduction in blood pressure such as dizziness) may impair the patient's ability to concentrate and react and, therefore, constitute a risk in situations where these abilities are of particular importance (e.g. operating a vehicle or machinery).
This can happen especially at the start of treatment, or when changing over from other preparations. After the first dose or subsequent increases in dose it is not advisable to drive or operate machinery for several hours.
4.8 Undesirable EffectsThe safety profile of ramipril includes persistent dry cough and reactions due to hypotension. Serious adverse reactions include angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis.
Adverse reactions frequency is defined using the following convention:
Very common (
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Common
Uncommon
Rare
Very rare
Not known
Cardiac disorders
Myocardial ischaemia including angina pectoris or myocardial infarction, tachycardia, arrhythmia, palpitations, oedema peripheral
Blood and lymphatic system disorders
Eosinophilia
White blood cell count decreased (including neutropenia or agranulocytosis), red blood cell count decreased, haemoglobin decreased, platelet count decreased
Bone marrow failure, pancytopenia, haemolytic anaemia
Nervous system disorders
Headache, dizziness
Vertigo, paraesthesia, ageusia, dysgeusia,
Tremor, balance disorder
Cerebral ischaemia including ischaemic stroke and transient ischaemic attack, psychomotor skills impaired, burning sensation, parosmia
Eye disorders
Visual disturbance including blurred vision
Conjunctivitis
Ear and labyrinth disorders
Hearing impaired, tinnitus
Respiratory, thoracic and mediastinal disorders
Non-productive tickling cough, bronchitis, sinusitis, dyspnoea
Bronchospasm including asthma aggravated, nasal congestion
Gastrointestinal disorders
Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting
Pancreatitis (cases of fatal outcome have been very exceptionally reported with ACE inhibitors), pancreatic enzymes increased, small bowel angioedema, abdominal pain upper including gastritis, constipation, dry mouth
Glossitis
Aphtous stomatitis
Renal and urinary disorders
Renal impairment including renal failure acute, urine output increased, worsening of a pre-existing proteinuria, blood urea increased, blood creatinine increased
Skin and subcutaneous tissue disorders
Rash in particular maculo-papular
Angioedema; very exceptionally, the airway obstruction resulting from angioedema may have a fatal outcome; pruritus, hyperhidrosis
Exfoliative dermatitis, urticaria, onycholysis,
Photosensitivity reaction
Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, psoriasis aggravated, dermatitis psoriasiform, pemphigoid or lichenoid exanthema or enanthema, alopecia
Musculoskeletal and connective tissue disorders
Muscle spasms, myalgia
Arthralgia
Metabolism and nutrition disorders
Blood potassium increased
Anorexia, decreased appetite,
Blood sodium decreased
Vascular disorders
Hypotension, orthostatic blood pressure decreased, syncope
Flushing
Vascular stenosis, hypoperfusion, vasculitis
Raynaud's phenomenon
General disorders and administration site conditions
Chest pain, fatigue
Pyrexia
Asthenia
Immune system disorders
Anaphylactic or anaphylactoid reactions, antinuclear antibody increased
Hepatobiliary disorders
Hepatic enzymes and/or bilirubin conjugated increased,
Jaundice cholestatic, hepatocellular damage
Acute hepatic failure, cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional).
Reproductive system and breast disorders
Transient erectile impotence, libido decreased
Gynaecomastia
Psychiatric disorders
Depressed mood, anxiety, nervousness, restlessness, sleep disorder including somnolence
Confusional state
Disturbance in attention
Paediatric Population
The safety of ramipril was monitored in 325 children and adolescents, aged 2-16 years old during 2 clinical trials. Whilst the nature and severity of the adverse events are similar to that of the adults, the frequency of the following is higher in the children:
Tachycardia, nasal congestion and rhinitis, “common” (i.e.
Conjunctivitis “common” (i.e.
Tremor and urticaria “uncommon” (i.e.
The overall safety profile for ramipril in paediatric patients dose not differ significantly from the safety profile in adults.
4.9 OverdoseSymptoms associated with overdosage of ACE inhibitors may include excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure. The patient should be closely monitored and the treatment should be symptomatic and supportive. Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including, administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration. Ramiprilat, the active metabolite of ramipril is poorly removed from the general circulation by haemodialysis.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesPharmacotherapeutic group: ACE Inhibitors, plain, ATC code C09AA05.
Mechanism of action
Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I (synonyms: angiotensin-converting enzyme; kininase II). In plasma and tissue this enzyme catalyses the conversion of angiotensin I to the active vasoconstrictor substance angiotensin II, as well as the breakdown of the active vasodilator bradykinin. Reduced angiotensin II formation and inhibition of bradykinin breakdown lead to vasodilatation.
Since angiotensin II also stimulates the release of aldosterone, ramiprilat causes a reduction in aldosterone secretion. The average response to ACE inhibitor monotherapy was lower in black (Afro-Caribbean) hypertensive patients (usually a low-renin hypertensive population) than in non-black patients.
Pharmacodynamic effects
Antihypertensive properties:
Administration of ramipril causes a marked reduction in peripheral arterial resistance. Generally, there are no major changes in renal plasma flow and glomerular filtration rate. Administration of ramipril to patients with hypertension leads to a reduction in supine and standing blood pressure without a compensatory rise in heart rate.
In most patients the onset of the antihypertensive effect of a single dose becomes apparent 1 to 2 hours after oral administration. The peak effect of a single dose is usually reached 3 to 6 hours after oral administration. The antihypertensive effect of a single dose usually lasts for 24 hours.
The maximum antihypertensive effect of continued treatment with ramipril is generally apparent after 3 to 4 weeks. It has been shown that the antihypertensive effect is sustained under long term therapy lasting 2 years.
Abrupt discontinuation of ramipril does not produce a rapid and excessive rebound increase in blood pressure.
Heart failure:
In addition to conventional therapy with diuretics and optional cardiac glycosides, ramipril has been shown to be effective in patients with functional classes II-IV of the New-York Heart Association. The drug had beneficial effects on cardiac haemodynamics (decreased left and right ventricular filling pressures, reduced total peripheral vascular resistance, increased cardiac output and improved cardiac index). It also reduced neuroendocrine activation.
Clinical efficacy and safety
Cardiovascular prevention/Nephroprotection;
A preventive placebo-controlled study (the HOPE-study), was carried out in which ramipril was added to standard therapy in more than 9,200 patients. Patients with increased risk of cardiovascular disease following either atherothrombotic cardiovascular disease (history of coronary heart disease, stroke or peripheral vascular disease) or diabetes mellitus with at least one additional risk factor (documented microalbuminuria, hypertension, elevated total cholesterol level, low high-density lipoprotein cholesterol level or cigarette smoking) were included in the study.
The study showed that ramipril statistically significantly decreases the incidence of myocardial infarction, death from cardiovascular causes and stroke, alone and combined (primary combined events).
The HOPE Study: Main Results;
Ramipril
Placebo
relative risk
(95% confidence interval)
p-value
%
%
All patients
n=4,645
N=4,652
Primary combined events
14.0
17.8
0.78 (0.70-0.86)
<0.001
Myocardial infarction
9.9
12.3
0.80 (0.70-0.90)
<0.001
Death from cardiovascular causes
6.1
8.1
0.74 (0.64-0.87)
<0.001
Stroke
3.4
4.9
0.68 (0.56-0.84)
<0.001
Secondary endpoints
Death from any cause
10.4
12.2
0.84 (0.75-0.95)
0.005
Need for Revascularisation
16.0
18.3
0.85 (0.77-0.94)
0.002
Hospitalisation for unstable angina
12.1
12.3
0.98 (0.87-1.10)
NS
Hospitalisation for heart failure
3.2
3.5
0.88 (0.70-1.10)
0.25
Complications related to diabetes
6.4
7.6
0.84 (0.72-0.98)
0.03
The MICRO-HOPE study, a predefined substudy from HOPE, investigated the effect of the addition of ramipril 10 mg to the current medical regimen versus placebo in 3,577 patients at least
The primary analysis showed that 117 (6.5 %) participants on ramipril and 149 (8.4 %) on placebo developed overt nephropathy, which corresponds to a RRR 24 %; 95 % CI [3-40], p = 0.027.
The REIN study, a multicenter randomized, double-blind parallel group, placebo-controlled study aimed at a
Generic Name: chlorpheniramine, hydrocodone, and phenylephrine (KLOR fe NEER a meen, HYE droe KOE done, FEN il EFF rin) Brand Names: B-Tuss, Coughtuss, Cytuss HC, De-Chlor HC, DroTuss-CP, Ed-TLC, Ed-Tuss HC, Endal-HD Plus, H-C Tussive, Histussin-HC, Hydro-PC II, Hydro-PC II Plus, Hydron CP, Liquicough HC, Maxi-Tuss HCX, Mintuss MS, Neo HC, Poly-Tussin, Poly-Tussin HD, Relacon-HC, Relacon-HC NR, Relasin-HC, Rindal HD Plus, Rindal-HD, Triant-HC, Tusana-D, Z-Cof HC
What is Hydro-PC II Plus (chlorpheniramine, hydrocodone, and phenylephrine)?Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Hydrocodone is a narcotic cough medicine.
Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of chlorpheniramine, hydrocodone, and phenylephrine is used to treat runny or stuffy nose, sinus congestion, and cough caused by the common cold or flu.
Chlorpheniramine, hydrocodone, and phenylephrine may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Hydro-PC II Plus (chlorpheniramine, hydrocodone, and phenylephrine)? Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use chlorpheniramine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body. Chlorpheniramine, hydrocodone, and phenylephrine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine, hydrocodone, and phenylephrine. Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, hydrocodone, and phenylephrine. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. What should I discuss with my healthcare provider before taking Hydro-PC II Plus (chlorpheniramine, hydrocodone, and phenylephrine)? Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use chlorpheniramine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body. You should not use chlorpheniramine, hydrocodone, and phenylephrine if you are allergic to it.To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:
asthma, COPD, sleep apnea, or other breathing disorder;
liver or kidney disease;heart disease or high blood pressure;
diabetes;
a thyroid disorder;
curvature of the spine;
a history of head injury or brain tumor;
epilepsy or other seizure disorder;
low blood pressure;
glaucoma;
gallbladder disease;
Addison's disease or other adrenal gland disorders;
enlarged prostate, urination problems;
mental illness; or
a history of drug or alcohol addiction.
Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether chlorpheniramine, hydrocodone, and phenylephrine will harm an unborn baby. Hydrocodone may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using chlorpheniramine, hydrocodone, and phenylephrine. It is not known whether chlorpheniramine, hydrocodone, and phenylephrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Hydro-PC II Plus (chlorpheniramine, hydrocodone, and phenylephrine)?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.
You may take this medication with or without food.
Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription. 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 hydrocodone can be fatal.Overdose symptoms may include extreme drowsiness, feeling restless or nervous, vomiting, stomach pain, warmth or tingly feeling, seizure (convulsions), pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.
What should I avoid while taking Hydro-PC II Plus (chlorpheniramine, hydrocodone, and phenylephrine)? Chlorpheniramine, hydrocodone, and phenylephrine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine, hydrocodone, and phenylephrine. Hydro-PC II Plus (chlorpheniramine, hydrocodone, and phenylephrine) 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 this medication and call your doctor at once if you have a serious side effect such as:severe dizziness, anxiety, restless feeling, or nervousness;
fast, pounding, or uneven heartbeats;
shallow breathing, slow heartbeat;
confusion, hallucinations, unusual thoughts or behavior;
feeling like you might pass out;
urinating less than usual or not at all;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, seizure); or
upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
nausea, vomiting, upset stomach, constipation;
dry mouth;
blurred vision;
dizziness, drowsiness;
problems with memory or concentration;
sleep problems (insomnia);
ringing in your ears;
warmth, tingling, or redness under your skin; or
skin rash or 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 Hydro-PC II Plus (chlorpheniramine, hydrocodone, and phenylephrine)? Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, hydrocodone, and phenylephrine.Tell your doctor about all other medications you use, especially:
blood pressure medication;
cimetidine (Tagamet);
rifampin (Rifadin, Rifater, Rifamate, Rimactane);
zidovudine (Retrovir, AZT);
an antidepressant;
a diuretic (water pill);
medication to treat irritable bowel syndrome;
bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);
aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);
seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or
medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril).
This list is not complete and other drugs may interact with chlorpheniramine, hydrocodone, and phenylephrine. 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.
More Hydro-PC II Plus resources Hydro-PC II Plus Side Effects (in more detail)Hydro-PC II Plus Use in Pregnancy & BreastfeedingHydro-PC II Plus Drug InteractionsHydro-PC II Plus Support Group0 Reviews for Hydro-PC II Plus - Add your own review/rating Chlorpheniramine/Hydrocodone/Phenylephrine Liquid MedFacts Consumer Leaflet (Wolters Kluwer) Compare Hydro-PC II Plus with other medications Cough and Nasal Congestion Where can I get more information? Your pharmacist can provide more information about chlorpheniramine, hydrocodone, and phenylephrine.See also: Hydro-PC II Plus side effects (in more detail)
Dispersible Aspirin Tablets 75mg (P) (Actavis UK Ltd)
Dispersible Aspirin Tablets 75mg
Please read this leaflet carefully before you start to take your medicine. It gives you important information about your medicine. If you want to know more, or you are not sure about anything, ask your pharmacist or doctor. Keep the leaflet until you have finished the medicine. What’S In Your MedicineDispersible Aspirin Tablets are white, uncoated tablets which contain 75mg of the active ingredient Aspirin.
The tablets also contain: citric acid, lactose, maize starch, saccharin sodium, calcium carbonate (E170).
Dispersible Aspirin Tablets are available in a pack size of 28.
Dispersible Aspirin Tablets is one of a group of medicines which have analgesic (pain relief ), anti-inflammatory (reduce swelling) and antipyretic (reduce temperature) properties. Aspirin also acts on the blood helping to prevent the formation of blood clots.
MA holder/Manufacturer: Actavis Barnstaple EX32 8NS UK About Your MedicineThe name of your medicine is Dispersible Aspirin Tablets which is the generic (common) name. Your doctor may have given you this medicine before from another company or you may have purchased it and it may have looked slightly different. Either brand will have the same effect.
Dispersible Aspirin may be used to help prevent heart attacks and stroke in patients who have previously suffered such events, in patients who have unstable angina and following by-pass surgery.
Before Taking Your MedicineThere is a possible association between aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which can be fatal. For this reason aspirin should not be given to children aged under 16 years, unless on the advice of a doctor.
Make sure you talk to your doctor before you start long-term treatment with aspirin. Also tell your doctor if you:
are pregnant, plan to become pregnant or are breast feeding. Aspirin should be avoided in the last three months of pregnancy and during breast feeding. are sensitive to aspirin, other ingredients in the product, salicylates or non-steroidal anti-inflammatory drugs (NSAIDs). You may have developed difficulty breathing, a runny nose, itchy skin or swelling after taking aspirin or a NSAID previously. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product, as it contains lactose. have a stomach ulcer or a history of stomach ulcers or indigestion. have haemophilia or other blood clotting disorder. are anaemic or suffer from a deficiency of the enzyme glucose-6-phosphate dehydrogenase, this can cause episodes of anaemia after eating certain foods such as fava beans (favism). have asthma, or suffer from allergies. have nasal polyps. have heart, liver or kidney problems. have an overactive thyroid gland. have gout. are dehydrated. have systemic lupus erythematosus (SLE) or other connective tissue disease. are taking other medicines such as anticoagulants (medicines to stop blood clotting eg warfarin and heparin), water tablets (diuretics eg spironolactone, frusemide, acetazolamide), medicines which make your urine more alkaline (eg antacids, citrates), medicines to treat gout (eg probenecid, sulphinpyrazone), methotrexate, antidiabetics, corticosteroids, metoclopramide, domperidone, mifepristone, dipyridamole, anti-epileptic medicines (eg phenytoin, sodium valproate), other non-steroidal anti-inflammatory medicines - NSAIDs (eg ibuprofen or naproxen), medicines which can cause hearing problems (eg vancomycin) and any that you may have bought without a prescription. alcohol may increase the risk of side effects. Avoid alcohol whilst taking aspirin.If you need to have an operation including having teeth removed tell your doctor or dentist that you are taking aspirin. Aspirin may interfere with some laboratory tests such as urine tests.
Taking Your MedicineThe usual dosage(s) are described below:
Your doctor’s advice should be sought before starting long-term aspirin treatment.
Adults: The usual dose for long-term use is 1-2 tablets (75-150mg) once daily. In some circumstances a higher dose may be appropriate, especially in the short-term, and up to 4 tablets (300mg) a day may be used on the advice of a doctor.
Children: Not recommended.
These tablets should be dissolved or mixed with water before taking with or after food. Swallow the tablets immediately after dispersing them in water. If symptoms persist you should consult your doctor.
If you forget to take a dose, take another as soon as you remember and then your next dose at the usual time. NEVER take two doses at the same time.
If you take more tablets than recommended above, contact your nearest hospital casualty department, or tell your doctor, immediately. Take any remaining tablets and the container with you.
After Taking Your MedicineLike many medicines, Dispersible Aspirin may occasionally cause side-effects in some patients, particularly when you first start taking it. Effects may include:
Allergic Reactions - runny nose, itchy skin, swelling and worsening of asthma.
Effects on the gastrointestinal system - stomach ulcers or bleeding which can be severe (you may develop bloody or black tarry stools, severe stomach pain and vomit blood), stomach irritation (mild stomach pain, heartburn and feeling sick) and inflammation of the liver.
Effects on the blood - anaemia, changes in numbers and types of blood cells. If you have an increase in number of nose bleeds or notice that you bruise more easily or have more infections talk to your doctor.
Effects on the ear - ringing or buzzing in the ear.
Salicylism - if you take large doses for a long time you may develop symptoms of salicylism, these include: dizziness, ringing or buzzing in the ear, deafness, sweating, feeling or being sick, headache and confusion.
If you are concerned about any side-effects or have any other unusual effects, tell your doctor immediately and seek advice.
Storing Your MedicineDo not use the tablets after the expiry date shown on the product packaging. Keep the tablets stored below 25°C in a dry place and in the original packaging. KEEP THEM IN A SECURE PLACE WHERE CHILDREN CANNOT GET AT OR SEE THEM. REMEMBER, this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours.
Give any medicines you no longer need to your pharmacist for safe disposal.
Date of last revision: March 2007.
Actavis Barnstaple EX32 8NS UK50106989
Generic Name: abacavir and lamivudine (a BAK a veer and la MIV yoo deen) Brand Names: Epzicom
What is abacavir and lamivudine?Abacavir and lamivudine is an antiviral medication. It is in a group of human immunodeficiency virus (HIV) medicines called reverse transcriptase inhibitors. Abacavir and lamivudine helps keep the HIV virus from reproducing in the body.
Abacavir and lamivudine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Abacavir and lamivudine is not a cure for HIV or AIDS.
Abacavir and lamivudine may also be used for purposes not listed in this medication guide.
What is the most important information I should know about abacavir and lamivudine? Stop using this medication and call your doctor at once if you have any of these signs of an allergic reaction: fever; rash; nausea, vomiting, diarrhea, stomach pain; general tiredness, body aches; shortness of breath, cough, sore throat. Once you have had an allergic reaction to abacavir and lamivudine, you must never use it again.Before taking abacavir and lamivudine, tell your doctor if you have kidney disease, heart disease, high blood pressure, or a risk factor for heart disease such as smoking, diabetes, or high cholesterol.
You may need a blood test before you start taking abacavir and lamivudine for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction.
Read the Warning Card that comes with this medication, and carry it with you at all times so you will know the symptoms of allergic reaction to watch for.
Some people develop lactic acidosis while taking abacavir and lamivudine. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired. Do not allow this medicine to run out completely before you get your prescription refilled. If you miss several doses, you could have a dangerous or even fatal allergic reaction when you start taking the medicine again. If you stop taking abacavir and lamivudine for any reason, talk to your doctor before you start taking the medication again. What should I discuss with my healthcare provider before taking abacavir and lamivudine? You should not take abacavir and lamivudine if you have liver disease. Do not take this medicine if you have ever had an allergic reaction to abacavir. Tell your doctor if you have had an allergic reaction to any medicine that contains abacavir, such as Trizivir or Ziagen. Once you have had an allergic reaction to abacavir and lamivudine, you must never use it again.You may need a blood test before you start taking abacavir and lamivudine for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction.
Some people develop a life-threatening condition called lactic acidosis while taking abacavir and lamivudine. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.To make sure you can safely take abacavir and lamivudine, tell your doctor if you have any of these other conditions:
kidney disease;
heart disease or high blood pressure; or
a risk factor for heart disease such as smoking, diabetes, or high cholesterol.
FDA pregnancy category C. It is not known whether abacavir and lamivudine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. This medication should not be given to children under 18 years old. How should I take abacavir and lamivudine?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.
You may take abacavir and lamivudine with or without food.
This medicine comes with a Medication Guide and a Warning Card that lists the symptoms of an allergic reaction. Read this information carefully and carry the Warning Card with you at all times so you will know what symptoms to watch for.HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.
If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using abacavir and lamivudine. Visit your doctor regularly.
Store at room temperature away from moisture and heat.See also: Abacavir and lamivudine dosage (in more detail)
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.
Do not allow this medicine to run out completely before you get your prescription refilled. It is important that you not stop taking the medicine once you have started. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking abacavir again. If you stop taking abacavir and lamivudine for any reason, talk to your doctor before you start taking the medication again. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking abacavir and lamivudine? Avoid taking other medications that contain abacavir or lamivudine, such as Combivir, Epivir, Trizivir, or Ziagen. Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person. Abacavir and lamivudine side effects Stop using this medication and call your doctor at once if you have any of these signs of an allergic reaction to abacavir:Group 1 - fever;
Group 2 - rash;
Group 3 - nausea, vomiting, diarrhea, stomach pain;
Group 4 - general tiredness, body aches;
Group 5 - shortness of breath, cough, sore throat.
Once you have had an allergic reaction to abacavir, you must never use it again. If you stop taking abacavir and lamivudine for any reason, talk to your doctor before you start taking the medication again. Other serious side effects that may not be signs of an allergic reaction include:stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired;
fever, chills, body aches, flu symptoms; or
white patches or sores inside your mouth or on your lips.
Less serious side effects include:
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk);
sleep problems or strange dreams;
headache, depression, anxiety; or
mild diarrhea.
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.
Abacavir and lamivudine Dosing InformationUsual Adult Dose for HIV Infection:
1 tablet orally once every 24 hours
Usual Adult Dose for Nonoccupational Exposure:
1 tablet orally once every 24 hoursDuration: Prophylaxis should be initiated as soon as possible, within 72 hours of exposure, and continued for 28 days.
Ipran may be available in the countries listed below.
Ingredient matches for Ipran EscitalopramEscitalopram is reported as an ingredient of Ipran in the following countries:
Chile EcuadorInternational Drug Name Search
CIP - Fenofibrate
Pronunciation: FEN-oh-FYE-brateGeneric Name: CIP - FenofibrateBrand Name: Lipofen
Maalox Concentrate
Pronunciation: a-LOO-min-uhm/mag-NEE-zee-uhmGeneric Name: Aluminum/MagnesiumBrand Name: Examples include Alamag and Maalox
Generic Name: mazindol (MA zin doll) Brand Names: Mazanor, Sanorex
What is Sanorex (mazindol)?Mazindol is a sympathomimetic amine, which is similar to an amphetamine. It is also known as an "anorectic" or an "anorexigenic" drug. Mazindol stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite.
Mazindol is used as a short-term supplement to diet and exercise in the treatment of obesity.
Mazindol may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Sanorex (mazindol)? Use caution when driving, operating machinery, or performing other hazardous activities. Mazindol may cause dizziness, blurred vision, or restlessness, and it may hide the symptoms of extreme tiredness. If you experience these effects, avoid hazardous activities. Mazindol is habit forming. You can become physically and psychologically dependent on this medication, and withdrawal effects may occur if you stop taking it suddenly after several weeks of continuous use. Talk to your doctor about stopping this medication gradually. Who should not take Sanorex (mazindol)? You cannot take mazindol if youhave heart disease or high blood pressure;
have arteriosclerosis (hardening of the arteries);
have glaucoma;
have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) in the last 14 days; or
have a history of drug or alcohol abuse.
Before taking this medication, tell your doctor if you have
problems with your thyroid;
an anxiety disorder;
epilepsy or another seizure disorder; or
diabetes.
You may not be able to take mazindol, 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 mazindol will harm an unborn baby. Do not take mazindol without first talking to your doctor if you are pregnant. It is also not known whether mazindol passes into breast milk. Do not take mazindol without first talking to your doctor if you are breast-feeding a baby. How should I take Sanorex (mazindol)?Take mazindol exactly as directed by your doctor. 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. Mazindol is usually taken one to three times a day before meals. Mazindol can be taken with food if it upsets your stomach. Follow your doctor's instructions. Never take more of this medication than is prescribed for you. Too much mazindol could be very dangerous to your health. Store mazindol 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 or if it is already evening, skip the missed dose and take only your next regularly scheduled dose. A dose taken too late in the day will cause insomnia. Do not take a double dose of this medication. What happens if I overdose? Seek emergency medical attention.Symptoms of a mazindol overdose include restlessness, tremor, rapid breathing, confusion, hallucinations, panic, aggressiveness, nausea, vomiting, diarrhea, an irregular heartbeat, and seizures.
What should I avoid while taking Sanorex (mazindol)? Use caution when driving, operating machinery, or performing other hazardous activities. Mazindol may cause dizziness, blurred vision, or restlessness, and it may hide the symptoms of extreme tiredness. If you experience these effects, avoid hazardous activities. Sanorex (mazindol) side effects If you experience any of the following serious side effects, stop taking mazindol and seek emergency medical attention:an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
an irregular heartbeat or very high blood pressure (severe headache, blurred vision); or
hallucinations, abnormal behavior, or confusion.
Other, less serious side effects may be more likely to occur. Continue to take mazindol and talk to your doctor if you experience
restlessness or tremor,
nervousness or anxiety,
headache or dizziness,
insomnia,
dry mouth or an unpleasant taste in your mouth,
diarrhea or constipation, or
impotence or changes in your sex drive.
Mazindol is habit forming. You can become physically and psychologically dependent on this medication, and withdrawal effects may occur if you stop taking it suddenly after several weeks of continuous use. Talk to your doctor about stopping this medication gradually.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 Sanorex (mazindol)? You cannot take mazindol if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) in the last 14 days.Changes in insulin and other diabetes drug therapies may be necessary during treatment with mazindol.
Mazindol may reduce the effects of guanethidine (Ismelin). This could lead to an increase in blood pressure. Tell your doctor if you are taking guanethidine.
Before taking this medication, tell your doctor if you are taking a tricyclic antidepressant such as amitriptyline (Elavil), amoxapine (Asendin), doxepin (Sinequan), nortriptyline (Pamelor), imipramine (Tofranil), clomipramine (Anafranil), protriptyline (Vivactil), or desipramine (Norpramin). These drugs may decrease the effects of mazindol.
Drugs other than those listed here may also interact with mazindol. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
More Sanorex resources Sanorex Drug InteractionsSanorex Support Group0 Reviews for Sanorex - Add your own review/rating Compare Sanorex with other medications ObesityWeight Loss Where can I get more information? Your pharmacist has more information about mazindol written for health professionals that you may read. What does my medication look like?Mazindol is available with a prescription under the brand names Mazanor and Sanorex. 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.
Mazanor 1 mg--white, round, scored tablets
Sanorex 1 mg--white, round tablets
Sanorex 2 mg--white, round, scored tablets
Generic Name: pantoprazole (Intravenous route)
pan-TOE-pra-zole
Commonly used brand name(s)In the U.S.
Protonix Protonix IVAvailable Dosage Forms:
Powder for SolutionPharmacologic Class: Proton Pump Inhibitor
Uses For ProtonixPantoprazole injection is used to treat certain conditions in which there is too much acid in the stomach. It is used for short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) with a history of erosive esophagitis. GERD is a condition in which the acid in the stomach washes back up into the esophagus. This medicine may also be used to treat Zollinger-Ellison syndrome or other conditions (e.g., cancer) in which the stomach produces too much acid.
Pantoprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.
This medicine is available only with your doctor's prescription.
Before Using ProtonixIn 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 pantoprazole injection in the pediatric population. Safety and efficacy have not been established.
GeriatricAppropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pantoprazole injection 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 receiving 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.
RilpivirineUsing 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.
Atazanavir Citalopram Dasatinib Erlotinib Methotrexate Mycophenolate Mofetil Nelfinavir NilotinibUsing 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.
Cranberry Itraconazole Warfarin 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:
Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Osteoporosis (bone problem) or Zinc deficiency—Use with caution. May make these conditions worse. Proper Use of pantoprazoleThis section provides information on the proper use of a number of products that contain pantoprazole. It may not be specific to Protonix. Please read with care.
A nurse or other trained health professional will give you this medicine in a clinic or hospital. This medicine is given through a needle placed in one of your veins.
It may take several days before this medicine begins to relieve stomach pain. To help relieve this pain, antacids may be taken with pantoprazole, unless your doctor has told you not to use them.
Tell your doctor if you have had problems with a lack of zinc in your body. Your doctor may want you to take zinc supplements.
Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.
Precautions While Using ProtonixIt is important that your doctor check your progress at regular visits. If your condition does not improve, or if it becomes worse, check with your doctor.
This medicine may cause a serious type of allergic reaction called 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 after you receive the medicine.
This medicine may cause thrombophlebitis. Check with your doctor right away if you notice any of these side effects at the injection site: changes in skin color, pain, tenderness, or swelling of the foot or leg.
Pantoprazole injection may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.
Do not stop using this medicine without first checking with your doctor, or unless told to do so by your doctor.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription (e.g., atazanavir, Reyataz®) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Protonix 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 or nurse immediately if any of the following side effects occur:
Less common Accumulation of pus bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site changes in skin color, pain, tenderness, or swelling of the foot or leg fever stomach pain swollen, red, tender area of infection Incidence not known Abdominal or stomach pain absence of or decrease in body movement blindness blistering, peeling, or loosening of the skin bloating of abdomen or stomach bloody or cloudy urine bloody, black, or tarry stools blurred vision chills constipation continuing ringing or buzzing or other unexplained noise in the ears cough dark-colored urine decreased vision diarrhea difficulty with speaking difficulty with swallowing dizziness or lightheadedness fast heartbeat feeling of constant movement of self or surroundings greatly decreased frequency of urination or amount of urine hearing loss hives increased watering of the mouth indigestion itching joint or muscle pain large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs light-colored stools loss of appetite mood or mental changes muscle cramps or spasms muscle pain or stiffness nausea or vomiting pains in the stomach, side, or abdomen, possibly radiating to the back pale skin puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue red skin lesions, often with a purple center red, irritated eyes sensation of spinning shortness of breath skin rash sore throat sores, ulcers, or white spots on the lips or in the mouth swelling of the feet or lower legs swollen glands tightness in the chest unexplained bleeding or bruising unusual tiredness or weakness vomiting wheezing yellow eyes or skinSome 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:
Less common Acid or sour stomach belching dizziness headache heartburn indigestion runny nose sleeplessness sneezing stomach discomfort, upset, or pain stuffy nose trouble sleeping unable to sleepOther 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: Protonix Intravenous side effects (in more detail)
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More Protonix Intravenous resources Protonix Intravenous Side Effects (in more detail)Protonix Intravenous Use in Pregnancy & BreastfeedingDrug ImagesProtonix Intravenous Drug InteractionsProtonix Intravenous Support Group27 Reviews for Protonix Intravenous - Add your own review/rating Compare Protonix Intravenous with other medications Barrett's EsophagusDuodenal UlcerErosive EsophagitisGERDHelicobacter Pylori InfectionPeptic UlcerStomach UlcerStress Ulcer ProphylaxisZollinger-Ellison SyndromeAlbuterol
Pronunciation: al-BUE-ter-olGeneric Name: AlbuterolBrand Name: Generic only. No brands available.
Methylprednisolone Suspension
Pronunciation: METH-il-pred-NIS-oh-loneGeneric Name: MethylprednisoloneBrand Name: Depo-Medrol
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