Salazopyrin Suppositories
1. Name Of The Medicinal Product

Salazopyrin Suppositories

2. Qualitative And Quantitative Composition

Sulfasalazine EP 0.5 g

3. Pharmaceutical Form

Suppository

4. Clinical Particulars 4.1 Therapeutic Indications

Ulcerative colitis or Crohn's Disease affecting the rectum.

4.2 Posology And Method Of Administration

The dose is adjusted according to the severity of the disease and the patient's tolerance of the drug.

Acute attack or relapse - Adults and the Elderly

Two suppositories are to be inserted in the morning and two at bedtime after defecation. After three weeks the dosage is gradually reduced as improvement occurs.

Adjustment to oral therapy - Adults and the Elderly

In severe generalised ulcerative colitis of the rectum or recto sigmoid, or in cases who are responding slowly to oral therapy, one or two suppositories may be given in the morning and at bedtime additional to oral therapy.

Children

The adult dose is reduced on the basis of body weight.

4.3 Contraindications

General

Because of lower absorption levels and shorter retention time in the body, Salazopyrin Suppositories give rise to fewer adverse events than equivalent treatment by mouth. However, because of the theoretical possibility that serious adverse events can arise from treatment from either route, the details below are based on adverse event reports to both oral and rectal treatment.

i) A known hypersensitivity to sulfasalazine, its metabolites or any of theexcipients as well as sulfonamides or salicylates.

ii) Use in infants under two years old.

iii) Porphyria.

4.4 Special Warnings And Precautions For Use

Complete blood counts (including differential white cell count), liver function tests and assessment of renal function (including urinalysis) should be performed in all patients before starting therapy with sulfasalazine, and frequently during the first 3 months of therapy. Thereafter, monitoring should be performed as clinically indicated. The patient should also be counselled to report immediately with any sore throat, fever, malaise, pallor, purpura, jaundice or unexpected non-specific illness during sulfasalazine treatment, this may indicate myelosuppression, haemolysis or hepatoxicity. Treatment should be stopped immediately while awaiting the results of blood tests. .

Sulfasalazine should not be given to patients with impaired hepatic or renal function or with blood dyscrasias, unless the potential benefit outweighs the risk.

Sulfasalazine should be given with caution to patients with severe allergy or bronchial asthma.

Use in children with the concomitant condition systemic onset juvenile rheumatoid arthritis may result in a serum sickness like reaction; therefore sulfasalazine is not recommended in these patients.

Since sulfasalazine may cause haemolytic anaemia, it should be used with caution in patients with G-6-PD deficiency.

Oral sulfasalazine inhibits the absorption and metabolism of folic acid and may cause folic acid deficiency potentially resulting in serious blood disorders (e.g., macrocytosis and pancytopenia), this can be normalised by administration of folic acid or folinic acid (leucovorin).

Because sulfasalazine causes crystalluria and kidney stone formation, adequate fluid intake should be ensured during treatment.

Oligospermia and infertility may occur in men treated with sulfasalazine. Discontinuation of the drug appears to reverse these effects within 2 to 3 months. As far as is know oligospermia has not occurred during therapy per rectum.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There have been no adverse interactions reported, due to the drug largely remaining confined to the rectum. However, there is a potential for interaction as follows:

Reduced absorption of digoxin , resulting in non-therapeutic serum levels, has been reported when used concomitantly with oral sulfasalazine.

Sulfonamides bear certain chemical similarities to some oral hypoglycemic agents. Hypoglycemia has occurred in patients receiving sulfonamides. Patients receiving sulfasalazine and hypoglycemic agents should be closely monitored.

Due to inhibition of thiopurine methyltransferase by salazopyrin, bone marrow suppression and leucopenia have been reported when the thiopurine 6-mercaptopurine or it's prodrug, azathioprine, and oral salazopyrin were used concomitantly.

Coadministration of oral sulfasalazine and methotrexate to rheumatoid arthritis patients did not alter the pharmacokinetic disposition of the drugs. However, an increased incidence of gastrointestinal adverse events, especially nausea, was reported.

4.6 Pregnancy And Lactation

Pregnancy

Reproduction studies in rats and rabbits have revealed no evidence of harm to the fetus. Published data regarding use of sulfasalazine in pregnant women have revealed no evidence of teratogenic hazards. If sulfasalazine is used during pregnancy, the possibility of fetal harm appears remote. Oral sulfasalazine inhibits the absorption and metabolism of folic acid and may cause folic acid deficiency. Because the possibility of harm cannot be completely ruled out, sulfasalazine should be used during pregnancy only if clearly needed.

Lactation

Sulfasalazine and sulfapyridine are found in low levels in breast milk. Caution should be used, particularly if breastfeeding premature infants or those deficient in G-6-PD.

4.7 Effects On Ability To Drive And Use Machines

No specific effects.

4.8 Undesirable Effects

The following have been reported to sulfasalazine given orally or rectally. The drug rectally is well tolerated. Overall, about 75% of adverse drug reactions occur within three months of starting therapy and over 90% by six months. Some undesirable effects are dose-dependent and symptoms can often be alleviated by reduction of the dose.

General

Sulfasalazine is split by intestinal bacteria to sulfapyridine and 5-amino salicylate so adverse drugs reactions to either sulfonamide or salicylate are possible. Patients with slow acetylator status are more likely to experience adverse drug reactions related to sulfapyridine. The most commonly encountered adverse drugs reactions are nausea, headache, rash, loss of appetite and raised temperature.

Specific

The adverse reactions observed during clinical studies conducted with Sulfasalazine have been provided in a single list below by class and frequency (very common (

Additional reactions reported from post-marketing experience are included as frequency Not known (cannot be estimated from the available data) in the list below.

Body System

Adverse drug reactions

Infections and infestations

 

Not known

Pseudomembranous colitis

Blood and Lymphatic System Disorders

 

Common

Leukopenia

Uncommon

Thrombocytopenia*

Not known

Agranulocytosis, aplastic anemia, haemolytic anemia, Heinz body anaemia, hypoprothrombinaemia, lymphadenopathy, macrocytosis, megaloblastic anemia, methaemoglobinaemina, neutropenia, pancytopenia

Immune System Disorders:

 

Not known

Anaphylaxis, polyarteritis nodosa, serum sickness

Metabolism and Nutrition Disorders:

 

Not known

Loss of appetite

Psychiatric Disorders:

 

Common

Insomnia

Uncommon

Depression

Not known

Hallucinations

Nervous System Disorders:

 

Common

Dizziness, headache, taste disorders

Uncommon

Convulsions

Not known

Aseptic meningitis, ataxia, encephalopathy, peripheral neuropathy, smell disorders

Ear and Labyrinth Disorders:

 

Common

Tinnitus

Uncommo

Vertigo

Eye Disorders:

 

Common

Conjuctivial and scleral injection

Cardiac Disorders:

 

Not known

Allergic myocarditis, cyanosis, pericarditis

vascular Disorders:

 

Uncommon

Vasculitis

Respiratory, Thoracic and Mediastinal Disorders:

 

Common

Cough

Uncommon

Dyspnoea

Not known

Fibrosing alveolitis, eosinophilic infiltration, interstitial lung disease

Gastrointestinal Disorders:

 

Very Common

Gastric distress, nausea

Common

Abdominal pain, diarrhoea, vomiting, stomatitis

Not known

Aggravation of ulcerative colitis, pancreatitis, parotitis

Hepato-biliary Disorders:

 

Not known

Hepatic failure, fulminant hepatitis, hepatitis*

Skin and Subcutaneous Tissue Disorders:

 

Common

Pruritus

Uncommon

Alopecia, urticaria

Not known

Epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), toxic pustuloderma, erythema, exanthema, exfoliative dermatitis, periorbital oedema, lichen planus, photosensitivity

Musculoskeletal and Connective Tissue Disorders:

 

Common

Arthralgia

Not known

Systemic lupus erythematosus

Renal and Urinary Disorders:

 

Common

Proteinuria

Not known

Nephrotic syndrome, interstitial nephritis, crystalluria*, haematuria

Reproductive System and Breast Disorders:

 

Not known

Reversible oligospermia*

General Disorders and Administration Site Conditions:

 

Common

Fever

Uncommon

Facial oedema

Not known

Yellow discoloration of skin and body fluids

Investigations:

 

Uncommon

Elevation of liver enzymes

Not known

Induction of autoantibodies

* See Section 4.4 for further information

4.9 Overdose

Overdose with suppositories is unlikely. In the event, evacuate the bowel and treat supportively. The toxicity of sulphasalazine is low in acute dosage. There is no specific antidote.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Therapeutic benefit of sulfasalazine in ulcerative colitis and Crohn's Disease appears to be due to a local action of the sulfasalazine and its split product 5-aminosalicylic acid on the mucous membrane and deeper colonic structures. Pharmacological actions noted for these compounds include inhibition of neutrophil activation, free radical scavenging, inhibition of superoxide production, inhibition of bacterial growth. Sulfasalazine inhibits 15-Prostaglandin dehydrogenase and slows prostaglandin metabolism. Lipoxygenase release in inflammatory cells is also depressed. NK cells and T cell proliferation are inhibited.

5.2 Pharmacokinetic Properties

There are considerable individual differences in the retention time of suppositories in volunteer studies. Consequently uptake values vary widely also. Given that the effect of the drug is almost certainly due to a local effect pharmacokinetics becomes less relevant to therapeutic action than to possible adverse effects related to systemic levels.

A study of five volunteers over three days following insertion of 2 x 0.5 g suppositories gave the following results:

Retention time: mean 8.9 hours (s.d. 5.2), serum concentration at 10 hours: sulfasalazine 1.7 mcg/ml (s.d. 0.46), sulfapyridine less than 1 mcg/ml. Percentage renal excretion: 10.2 (s.d. 4.3). Uptake as reflected by excretion is much below that of the oral rate and may explain the good tolerance of the dose form.

5.3 Preclinical Safety Data

In two-year carcinogenicity studies in rats and mice, sulfasalazine showed some evidence of carcinogenicity. In rats, there was a small increase in the incidence of transitional cell papillomas in the urinary bladder and kidney. The tumours were judged to be induced mechanically by calculi formed in the urine rather than through a direct genotoxic mechanism. In the mouse study, there was a significant increase in the incidence of hepatocellular adenoma or carcinoma. The mechanism of induction of hepatocellular neoplasia has been investigated and attributed to species-specific effects of sulfasalazine that are not relevant to humans.

Sulfasalazine did not show mutagenicity in the bacterial reverse mutation assay (Ames test) or in the L51784 mouse lymphoma cell assay at the HGPRT gene. It did not induce sister chromatid exchanges or chromosomal aberrations in cultured Chinese hamster ovary cells, and in vivo mouse bone marrow chromosomal aberration tests were negative. However, sulfasalazine showed positive or equivocal mutagenic responses in rat and mouse micronucleus assays, and in human lymphocyte sister chromatid exchange, chromosomal aberration and micronucleus assays. The ability of sulfasalazine to induce chromosome damage has been attributed to perturbation of folic acid levels rather than to a direct genotoxic mechanism.

Based on information from non-clinical studies, sulfasalazine is judged to pose no carcinogenic risk to humans. Sulfasalazine use has not been associated with the development of neoplasia in human epidemiology studies.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Povidone

Adepa Solidus

6.2 Incompatibilities

Certain types of extended wear soft contact lenses may be permanently stained during therapy.

6.3 Shelf Life

Five years

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

PVC/Polyethylene laminate moulds

6.6 Special Precautions For Disposal And Other Handling

As the suppositories melt at body temperature they should be kept below 25°C and handled as little as possible before insertion so that they are firm.

Sulfasalazine is an orange dye, and care should thus be taken with clothing, bedding etc with regard to seepage or spillage.

Insertion

Empty the bowel if possible. Push the suppository through the anus with a finger, as far as possible. The urge to expel them will pass in a few minutes, once they have melted.

7. Marketing Authorisation Holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent, CT13 9NJ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00057/1042

9. Date Of First Authorisation/Renewal Of The Authorisation

12 August 2010

10. Date Of Revision Of The Text

12 August 2010

11. LEGAL CATEGORY

POM.

Ref: SZ 6_0 Supp UK

Sentry AV Ornacyn
Dosage Form: FOR ANIMAL USE ONLYBroad-spectrum, antibiotic for use in drinking water as an aid in the treatment of respiratory diseases of pet birds. INDICATIONS & USAGE Treatment of respiratory diseases of pet birds.

Striant

Generic Name: testosterone buccal system (tes TOSS ter one) Brand Names: Striant

What is testosterone buccal system?

Testosterone is a naturally occurring "male" sex hormone necessary for many processes in the body.

Testosterone buccal system is used to treat men with low testosterone levels.

Testosterone buccal system may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about testosterone buccal system? Notify your doctor if you experience nausea; vomiting; swelling of the ankles; changes in skin color; too frequent or prolonged erections; breathing disturbances, including those associated with sleep; yellowing of the skin or eyes; dark colored urine; or problems with urination. Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

What should I discuss with my healthcare provider before using testosterone buccal system? Do not use testosterone buccal system if you have cancer of the breast or prostate. Testosterone may worsen some cancers of these types.

Before using testosterone buccal system, tell your doctor if you have

had a previous allergic reaction to testosterone;

diabetes;

sleep apnea (brief periods of not breathing during sleep) or if you have risk factors for sleep apnea (e.g., obesity, chronic lung disease);

difficulty with urination due to enlargement of the prostate;

heart disease; or

liver disease or kidney disease.

You may not be able to use testosterone buccal system, or you may need a dosage adjustment or special monitoring if you have any of the conditions listed above.

Testosterone buccal system is not approved for use by women and must not be used by women. Testosterone buccal system is in the FDA pregnancy category X. This means that testosterone is known to cause birth defects in an unborn baby. Do not use testosterone buccal system if you are pregnant or could become pregnant during treatment. Testosterone buccal system is not approved for use by women and must not be used by women. It is not known whether testosterone from the buccal system will pass into breast milk.Do not use testosterone buccal system if you are breast-feeding a baby. Men over 65 years of age that use testosterone buccal system may be at increased risk for the development of prostatic enlargement or cancer. You may not be able to use buccal system testosterone, or you may require a lower dose or special monitoring. How should I use testosterone buccal system?

Use testosterone buccal system exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

To use the testosterone buccal system (Striant):

Hold one buccal system with the flat side on your fingertip. Place the curved side onto your gum, as high as possible above the left or right incisor tooth. Hold your finger on the outside of your lip over the system for 30 seconds to ensure the system is attached to the gum. If the system sticks to the cheek and not the gum, this is acceptable.

The buccal system should remain in place for 12 hours. To remove the system, move it slightly toward the back or front of the mouth then slide it toward the teeth from removal. With each new application, rotate to alternate sides of the mouth. This avoids scratching the gum. Check to see that the system is in place after eating, drinking, brushing the teeth, or using mouthwash.

As the buccal system absorbs moisture from the mouth, it will begin to soften and will mold to the shape of the gum. The system does not dissolve completely, but will remain in place. It will not move until you remove it.

If a buccal system falls off before 8 hours of use, remove it and replace it with a new system in the same place.

Change the buccal system and alternate sides of the mouth 12 hours after application of the original system. If a buccal system falls off after 8 hours but before 12 hours of use, remove the system and replace it with a new system above the opposite incisor. This will serve as the second dose for the day.

Do not chew or swallow the testosterone buccal system.

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

Your doctor may want to perform tests to monitor the amount of testosterone in the body, liver function, prostate function, cholesterol levels, or other factors during treatment with testosterone buccal system.

It is important to use testosterone buccal system regularly to get the most benefit.

Dispose of all used systems properly, out of the reach of children and pets.

Store testosterone buccal system at room temperature away from moisture and heat. What happens if I miss a dose?

Apply the next system as soon as you remember. Do not use two doses simultaneously, unless otherwise directed by your doctor.

What happens if I overdose? An overdose of testosterone buccal system is not likely to threaten life. If you do suspect an overdose, or if a system has been ingested, call an emergency room or poison control center for advice. What should I avoid while using testosterone buccal system?

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

Testosterone buccal system side effects If you experience any of the following serious side effects, stop using testosterone buccal system and seek emergency medical attention or contact your doctor immediately:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

nausea or vomiting;

changes in skin color;

swelling of the ankles or legs;

breathing disturbances, including those associated with sleep;

too frequent or prolonged erections;

liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue); or

dark colored urine or problems with urination.

Other, less serious side effects may be more likely to occur. Continue to use testosterone buccal system and talk to your doctor if you experience

irritation or changes in the gum at the system application site;

bitter or unusual taste in the mouth;

headache;

emotional changes;

increased blood pressure;

decreased interest in sex;

changes in blood cholesterol or number of red blood cells (detected by blood tests);

prostate changes or difficulty urinating;

enlarged, swollen or tender breasts; or

acne.

Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.

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. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect testosterone buccal system?

Before using testosterone buccal system, tell your doctor if you are taking any of the following medicines:

warfarin (Coumadin);

insulin or an oral diabetes medication such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), repaglinide (Prandin), rosiglitazone (Avandia), pioglitazone (Actos), and others;

propranolol (Inderal, Inderal LA, others); or

a corticosteroid such as hydrocortisone (Cortef, Hydrocortone, Solu-Cortef), dexamethasone (Decadron, Hexadrol others), methylprednisolone (Depo-Medrol, Medrol, Solu-Medrol), prednisolone (Prelone, Pediapred), prednisone (Deltasone, Orasone, others), and others.

You may not be able to use testosterone buccal system, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with testosterone buccal system. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Striant resources Striant Side Effects (in more detail)Striant Use in Pregnancy & BreastfeedingDrug ImagesStriant Drug InteractionsStriant Support Group0 Reviews for Striant - Add your own review/rating Striant MedFacts Consumer Leaflet (Wolters Kluwer) Striant Advanced Consumer (Micromedex) - Includes Dosage Information Striant Consumer Overview Striant Prescribing Information (FDA) Testosterone Monograph (AHFS DI) Testosterone Prescribing Information (FDA) Testosterone Professional Patient Advice (Wolters Kluwer) AndroGel Prescribing Information (FDA) AndroGel Gel MedFacts Consumer Leaflet (Wolters Kluwer) Androderm Advanced Consumer (Micromedex) - Includes Dosage Information Androderm Patch MedFacts Consumer Leaflet (Wolters Kluwer) Androderm Prescribing Information (FDA) Androgel Consumer Overview Androgel Advanced Consumer (Micromedex) - Includes Dosage Information Axiron Prescribing Information (FDA) Axiron Consumer Overview Axiron Solution MedFacts Consumer Leaflet (Wolters Kluwer) Delatestryl Prescribing Information (FDA) Delatestryl MedFacts Consumer Leaflet (Wolters Kluwer) Depo-Testosterone Prescribing Information (FDA) Depo-Testosterone MedFacts Consumer Leaflet (Wolters Kluwer) Fortesta Gel MedFacts Consumer Leaflet (Wolters Kluwer) Fortesta Consumer Overview Testim Prescribing Information (FDA) Testim Gel MedFacts Consumer Leaflet (Wolters Kluwer) Testosterone Cypionate Prescribing Information (FDA) Testosterone Enanthate Prescribing Information (FDA) Compare Striant with other medications Hypogonadism, Male Where can I get more information? Your pharmacist has additional information about testosterone buccal system written for health professionals that you may read.

See also: Striant side effects (in more detail)

Synvisc

Generic Name: hylan G-F 20 (HI lan G F 20) Brand Names: Synvisc, Synvisc-One

What is hylan G-F 20?

Hylan G-F 20 is similar to the fluid that surrounds the joints in your body. This fluid acts as a lubricant and shock absorber for the joints.

Hylan G-F 20 is used to treat knee pain caused by osteoarthritis.

Hylan G-F 20 is usually given after other arthritis medications have been tried without successful treatment of symptoms.

Hylan G-F 20 may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hylan G-F 20? You should not receive hylan G-F 20 if you are allergic to it, or if you have an infection in your knee or in the skin around your knee.

Before you receive a hylan G-F 20 injection, tell your doctor if you have blood clots or circulation problems in your legs, or an allergy to birds, feathers, or egg products.

For at least 48 hours after your injection, avoid jogging, strenuous activity, high-impact sports, or standing for longer than 1 hour at a time.

Call your doctor at once if you have severe pain or swelling around the knee after the injection. What should I discuss with my health care provider before receiving hylan G-F 20? You should not receive hylan G-F 20 if you are allergic to it, or if you have an infection in your knee or in the skin around your knee.

To make sure you can safely receive hylan G-F 20, tell your doctor if you have:

blood clots or circulation problems in your legs; or

an allergy to birds, feathers, or egg products.

It is not known whether hylan G-F 20 will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether hylan G-F 20 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. Hylan G-F 20 is generally not used in anyone younger than 21 years old. How is hylan G-F 20 given?

Hylan G-F 20 is injected directly into your knee joint. A healthcare provider will give you this injection.

Hylan G-F 20 is usually given once every week for 3 weeks. Follow your doctor's dosing instructions very carefully.

To prevent pain and swelling, your doctor may recommend resting your knee or applying ice for a short time after your injection.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your hylan G-F 20 injection.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving hylan G-F 20?

For at least 48 hours after your injection, avoid jogging, strenuous activity, or high-impact sports such as soccer or tennis. Also avoid weight-bearing activity or standing for longer than 1 hour at a time. Ask your doctor how long to wait before you resume these activities.

Hylan G-F 20 side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe pain or swelling around the knee after the injection.

Less serious side effects may include:

warmth, pain, stiffness, swelling, or puffiness where the medicine was injected;

muscle pain, trouble walking;

fever, chills, nausea;

numbness or tingly feeling;

headache, dizziness;

tired feeling; or

itching or skin irritation around the knee.

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 hylan G-F 20?

There may be other drugs that can interact with hylan G-F 20. 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 Synvisc resources Synvisc Side Effects (in more detail)Synvisc Use in Pregnancy & BreastfeedingSynvisc Drug InteractionsSynvisc Support Group6 Reviews for Synvisc - Add your own review/rating Synvisc Advanced Consumer (Micromedex) - Includes Dosage Information Synvisc Solution MedFacts Consumer Leaflet (Wolters Kluwer) Synvisc Consumer Overview Hylan G-F 20 Compare Synvisc with other medications Osteoarthritis Where can I get more information? Your doctor can provide more information about hylan G-F 20.

See also: Synvisc side effects (in more detail)

SureLac
Pronunciation: LAK-taseGeneric Name: LactaseBrand Name: Examples include Lactaid and SureLac

Sterile Dopamine Concentrate BP 800mg / 5ml
1. Name Of The Medicinal Product

Sterile Dopamine Concentrate B.P. 800mg/5ml.

2. Qualitative And Quantitative Composition

Dopamine Hydrochloride U.S.P., 800mg in 5ml.

3. Pharmaceutical Form

Clear, colourless or pale yellow sterile solution intended for parenteral administration to human beings.

4. Clinical Particulars 4.1 Therapeutic Indications

For the correction of haemodynamic imbalances in low-perfusion circulatory insufficiency associated with myocardial infarction, trauma, septicaemia, cardiac failure and open heart surgery.

4.2 Posology And Method Of Administration

The solution must be diluted before administration. Alkaline solutions such as 5% sodium bicarbonate should NOT be added to dopamine hydrochloride because the drug will be inactivated. The usual dilution is 1,600 micrograms per ml and this may be achieved by transfer, aseptically of 800mg of dopamine hydrochloride to one of the following sterile I.V. solutions: -

Sodium Chloride Injection

5% Dextrose Injection

5% Dextrose and 0.9% Sodium Chloride Injection

5% Dextrose and 0.45% Sodium Chloride Solution

5% Dextrose in Ringer Lactate Solution

Sodium Lactate 1/6 Molar Injection

Lactated Ringer's Injection

A suitable metering device is required in the infusion system to control the rate of flow, and this should be adjusted to the optimum patient response and monitored constantly in the light of the individual patient's response.

Adults: Use as large a vein as possible for infusion. The initial rate of infusion is 2 to 5 micrograms per kilogram bodyweight per minute and this may be increased gradually by increments of 5 to 10 micrograms/kg/minute until the optimum dose for the individual is achieved. Up to 50 micrograms/kg/minute may be required, and even higher doses have been used.

Children: The safety and efficacy of dopamine hydrochloride therapy in children have not been established.

4.3 Contraindications

Dopamine should not be used in patients with –

• Hypersensitivity to dopamine or any of the excipients.

• Phaeochromocytoma or hyperthyroidism

Dopamine should not be used in the presence of uncorrected atrial or ventricular tachyarrhythmias or ventricular fibrillation.

Cyclopropane and halogenated hydrocarbon anaesthetics should be avoided.

4.4 Special Warnings And Precautions For Use

The solution contains an antioxidant, sodium metabisulphite, a sulphite that may cause hypersensitivity reactions including bronchospasm, anaphylaxis and life-threatening episodes in certain susceptible individuals. The prevalence of sulphite-sensitivity in the general population is unknown and is probably low. Sulphite-sensitivity is seen more frequently in persons with a history of asthma or atopic allergy.

Each ampoule of this injection contains 2.42 mg sodium per ml.

Patients who have been treated with MAO inhibitors prior to dopamine should be given reduced doses; the starting dose should be one tenth (1/10th) of the usual dose.

Excess administration of potassium-free solutions may result in significant hypokalaemia.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary oedema.

Precautions:

Hypovolaemia should be corrected where necessary prior to dopamine infusion. Low doses should be used in shock due to acute myocardial infarction.

If a disproportionate rise in diastolic pressure (i.e. a marked decrease in pulse pressure) is observed, the infusion rate should be decreased and the patients observed carefully for further evidence of predominant vasoconstriction activity, unless such an effect is desired.

Patients with a history of peripheral vascular disease should be closely monitored for any changes in colour or temperature of the skin of the extremities. If change of skin colour or temperature occurs and is thought to be the result of compromised circulation to the extremities, the benefits of continued dopamine infusion should be weighed against the risk of possible necrosis. These changes may be reversed by decreasing the rate or discontinuing the infusion. IV administration of phentolamine mesylate 5-10 mg may reverse the ischaemia.

Dopamine hydrochloride in 5% dextrose injection should be infused into a large vein whenever possible to prevent the possibility of infiltration of perivascular tissue adjacent to the infusion site. Extravasation of dopamine hydrochloride during infusion may cause ischaemic necrosis and sloughing of surrounding tissue. Ischaemia can be reversed by infiltration of the affected area with 10-15 ml of saline containing 5 to 10 mg phentolamine mesylate. A syringe with a fine hypodermic needle should be used to liberally infiltrate the ischaemic area as soon as extravasation is noted.

Administration of dopamine hydrochloride should always be under the direct supervision of a physician to whom facilities are available for monitoring cardiovascular and renal indices, including blood volume, cardiac output, blood pressure, electrocardiography and urine flow.

Dextrose solutions should be used with caution in patients with known subclinical or overt diabetes mellitus.

When dopamine is used in patients with a history of occlusive vascular disease, particular attention should be paid to the status of blood circulation in the extremities.

The occurrence of undesirable increases in blood pressure or vasoconstriction or decrease in urinary output requires a reduction in dosage of dopamine hydrochloride.

The routine use of low-dose dopamine hydrochloride in critically ill patients to prevent or treat acute renal failure is not recommended because this may cause adverse effects which could further compromise such patients.

As the effect of dopamine on impaired renal and hepatic function is not known, close monitoring is advised.

Dopamine infusion should be withdrawn gradually, to avoid unnecessary hypotension.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

i) Anaesthetics:

The myocardium is sensitised by the effect of dopamine, cyclopropane or halogenated hydrocarbon anaesthetics, and these should be avoided. This interaction applies both to pressor activity and cardiac beta adrenergic stimulation.

ii) Alpha and Beta Blockers:

The cardiac effects of dopamine are antagonised by ? -adrenergic blocking agents such as propanolol and metoprolol, and the peripheral vasoconstriction caused by high doses of dopamine is antagonised by ? adrenergic blocking agents. Dopamine induced renal and mesenteric vasodilation is not antagonised by either ? or ?- adrenergic blocking agents, but, in animals, is antagonised by haloperidol or other butrophenones, phenothiazines and opiates.

iii) Monoamine Oxidase (MAO) Inhibitors :

MAO inhibitors potentiate the effect of dopamine and its duration of action. Patients who have been treated with MAO inhibitors prior to administration of dopamine will therefore require a substantially reduced dosage. (The starting dose should be reduced to at least 1/10th of the usual dose).

iv) Phenytoin:

Administration of IV phenytoin to patients receiving dopamine has resulted in hypotension and bradycardia; some clinicians recommend that phenytoin be used with extreme caution, if at all, in patients receiving dopamine.

Dopamine may increase the effect of diuretic agents.

The ergot alkaloids should be avoided because of the possibility of excessive vasoconstriction. Tricyclic antidepressants and guanethidine may potentiate the pressor response to dopamine.

4.6 Pregnancy And Lactation

Use in Pregnancy:

Animal studies have shown no evidence of teratogenic effects with dopamine.

However, the effect of dopamine on the human foetus is unknown. Therefore the drug should be used in pregnant women only when the expected benefits outweigh the potential risk to the foetus.

Use in Lactation:

It is not known if dopamine is excreted in breast milk, nor is the effect on the infant known.

4.7 Effects On Ability To Drive And Use Machines

Not applicable in view of the indications for use and the short half-life of the drug.

4.8 Undesirable Effects

Adverse reactions to dopamine are related to its pharmacological action.

More common reactions include-

Cardiovascular: Ectopic heart beats, tachycardia, anginal pain, palpitation, hypotension, vasoconstriction.

Gastrointestinal: Nausea, vomiting

Nervous System: Headache

Respiratory: Dyspnoea

Less common reactions include-

Biochemical Abnormalities- Azotaemia

Cardiovascular: Aberrant conduction, bradycardia, widened QRS complex, hypertension, gangrene, fatal ventricular arrhythmias have been reported on rare occasions.

Eye Disorders: Mydriasis

Nervous system- Piloerection

Serious or Life-threatening Reactions:

Gangrene of the feet has occurred following doses of 10-14 microgram/kg/min and higher in a few patients with pre-existing vascular disease.

4.9 Overdose

Excessive elevation of blood pressure and vasoconstriction can occur due to the alpha adrenergic actions of dopamine, especially in patients with a history of occlusive vascular disease. If desired, this condition can be rapidly reversed by dose reduction or discontinuing the infusion, since dopamine has a half-life of less than 2 minutes in the body.

Should these measures fail, an infusion of an alpha adrenergic blocking agent, e.g., phentolamine mesylate, should be considered.

Dopamine at the infusion site can cause local vasoconstriction hence the desirability of infusing into a large vein. The resulting ischaemia can be reversed by infiltration of the affected area with 10-15 ml of saline containing 5 mg to 10 mg phentolamine mesylate. A syringe with a fine hypodermic needle should be used to liberally infiltrate the ischaemic area as soon as extravasation is noted.

Accidental Overdosage:

Accidental overdosage as evidenced by excessive blood pressure elevation can be controlled by dose reduction or discontinuing the dopamine infusion for a short period, since the duration of action of dopamine is short.

Should these measures fail, an infusion of phentolamine mesylate should be considered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Dopamine (3,4-dihydroxyphenylethylamine) is the third naturally-occurring catecholamine and is a metabolic precursor of noradrenaline and adrenaline. Dopamine is used therapeutically as the hydrochloride and its main effects are seen in the cardiovascular system and the kidneys.

Heart

Dopamine exerts positive inotropic and chronotropic effects on the myocardium, acting as an agonist at beta-adrenergic receptors. In addition to its direct action on beta-adrenergic receptors, dopamine acts indirectly by releasing noradrenaline from sympathetic storage sites.

Blood Vessesls

Depending on the vascular bed being studied and the dose administered, Dopamine can cause relaxation or contraction of vascular smooth muscle.

Dopamine Receptors

Unlike other endogenous catecholamines or sympathomimetic amines, Dopamine caused vasodilatation in renal, coronary, mesenteric and intracerebral arterial vascular beds in anaesthetised dogs. This vasodilator effect is not antagonised by beta-adrenergic blockers, atropine or antihistamines. However, butyrophenones, phenothiazines, apomorphine and bulbocapnine selectively attenuate dopamine-induced vasodilatation, thus suggesting the existence of specific dopamine vascular receptors similar to those in the basal ganglia and other areas in the central nervous system.

Alpha-adrenergic Receptors

Dose response studies indicate that with a sufficiently large dose, the vasoconstrictor effect of dopamine predominates over its vasodilator effect. This dopamine-induced vasoconstrictor effect is antagonised by alpha-adrenoreceptor blocking agents such as phentolamine and phenoxybenzamine, indicating that vasoconstriction results from the action of dopamine on alpha-adrenergic receptors.

Kidney

Intravenous infusions of dopamine (2.6 to 7.1µg/kg/min.) to seven normal subjects increased estimated average renal plasma flow from 507 to 798ml/min., insulin clearance from 109 to 136ml/min. and average sodium excretion from 171 to 571µEq./min. Although the diuretic and natriuretic effects of dopamine may result from vasodilatation in renal vascular bed (vide supra), disassociation between natriuresis and increments in renal blood flow has been observed, suggesting that other mechanisms such as redistribution of intrarenal blood flow may be involved.

5.2 Pharmacokinetic properties

Dopamine is inactive when taken orally and its vasoconstrictor properties preclude its administration by subcutaneous or intramuscular injection. Dopamine hydrochloride is administered by intravenous infusion.

Dopamine is a metabolic precursor of nor-adrenaline and, whereas a proportion is excreted as the metabolic products of nor-adrenaline, the majority is mainly metabolised into 3,4,-Dihydroxyphenylacetic Acid (DOPAC) and 3-methoxy-4-hydroxyphenylacetic (HVA) which are rapidly excreted in the urine.

The plasma half-life of dopamine is approximately two minutes.

5.2 Pharmacokinetic Properties

Dopamine is inactive when taken orally and its vasoconstrictor properties preclude its administration by subcutaneous or intramuscular injection. Dopamine hydrochloride is administered by intravenous infusion.

Dopamine is a metabolic precursor of nor-adrenaline and, whereas a proportion is excreted as the metabolic products of nor-adrenaline, the majority is mainly metabolised into 3,4,-Dihydroxyphenylacetic Acid (DOPAC) and 3-methoxy-4-hydroxyphenylacetic (HVA) which are rapidly excreted in the urine.

The plasma half-life of dopamine is approximately two minutes.

5.3 Preclinical Safety Data

No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium Metabisulphite B.P.

Water for Injections B.P.

6.2 Incompatibilities

Iron salts, alkalis or oxidising agents.

6.3 Shelf Life

3 years (36 months)

6.4 Special Precautions For Storage

Do not store above 25°C.

Keep the container in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

5ml Clear glass one point-cut (OPC) ampoules, glass type I Ph Eur. with white ring packed in cardboard cartons to contain 10 x 5ml ampoules.

6.6 Special Precautions For Disposal And Other Handling

This solution must be diluted before use.

Do not dilute with alkaline solution.

Do not use the injection if it is darker than slightly yellow or discoloured in any other way.

For the preparation of Dopamine Hydrochloride Intravenous Infusion.

Use as directed by the physician.

Keep out of reach of children.

7. Marketing Authorisation Holder

Antigen International Ltd.,

Roscrea,

Co. Tipperary,

Ireland.

8. Marketing Authorisation Number(S)

PL 02848/0131.

9. Date Of First Authorisation/Renewal Of The Authorisation

14 September 1989 / 25 July 1997

10. Date Of Revision Of The Text

18/03/2010

Strong Pholcodine Linctus BP
1. Name Of The Medicinal Product

Strong Pholcodine Linctus BP

2. Qualitative And Quantitative Composition

Each 5ml contains Pholcodine BP 10mg

3. Pharmaceutical Form

Oral solution: Clear, colourless, raspberry and cola flavoured syrup.

4. Clinical Particulars 4.1 Therapeutic Indications

Suppression of non-productive cough.

4.2 Posology And Method Of Administration

Adults:

5ml spoonful 3-4 times daily

Children:

Not recommended.

4.3 Contraindications

Liver disease, ventilatory failure, asthma, bronchitis, bronchiectasis. Use in patients with hypersensitivity or idiosyncratic response to the active ingredient, use in children.

4.4 Special Warnings And Precautions For Use

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Depressant effects may occur with concurrent alcohol ingestion; concurrent (or within 2 weeks) use of MAOIs may lead to excitation; the depressant effects might be increased by phenothiazines, MAOIs and tricyclic anti-depressants.

4.6 Pregnancy And Lactation

This product should not be used during pregnancy or lactation unless it is considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

Pholcodine may induce drowsiness. Patients receiving this medication should not drive or operate machinery unless it has been shown not to affect mental or physical ability.

4.8 Undesirable Effects

Constipation, nausea and drowsiness occasionally occur.

Immune system disorders: hypersensitivity reactions, anaphylaxis.

4.9 Overdose

Restlessness, excitement and ataxia may occur after large doses. A toxic dose in children is reported to be about 200mg.

Treatment: Gastric lavage with supportive and symptomatic measures. In severe cases, and where respiratory depression occurs an opioid antagonist such as Naloxone – should be considered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Morphine or codeine derivatives. By tradition used mainly as an antitussive. It suppresses the cough reflex by a direct central action, probably in the medulla or pons. It has little or no analgesic or euphorigenic activity.

5.2 Pharmacokinetic Properties

Metabolised in the liver.

5.3 Preclinical Safety Data

Not stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Citric Acid BP

Sodium Carboxymethylcellulose 7HOF BP

Glycerol BP

Sodium Benzoate BP

Saccharin Sodium BP

Lycasin 80/55 HSE

Ethanol 96% BP

Raspberry/Cola flavour

Purified Water BP to volume

6.2 Incompatibilities

None known

6.3 Shelf Life

Amber glass bottles – 2 years

High density polyethylene bottles – 2 years

6.4 Special Precautions For Storage

Store below 20°C. Protect from light.

6.5 Nature And Contents Of Container

Amber Grade III glass bottle with pilfer proof screw cap, 100ml, 125ml, 200ml and 500ml.

Virgin HDPE bottle with tamper evident screw cap, 500ml, 1 Litre, 2 Litres.

6.6 Special Precautions For Disposal And Other Handling

As for all medicines – no special requirements.

Administrative Data 7. Marketing Authorisation Holder

Pinewood Laboratories Ltd.,

Ballymacarbry, Clonmel,

Co. Tipperary, Ireland

8. Marketing Authorisation Number(S)

PL 04917/0005

9. Date Of First Authorisation/Renewal Of The Authorisation

15 August 1991

10. Date Of Revision Of The Text

February 2008

Suprane

Generic Name: desflurane (Inhalation route)

des-FLOO-rane

Commonly used brand name(s)

In the U.S.

Suprane

Available Dosage Forms:

Liquid Solution

Therapeutic Class: Volatile Liquid

Chemical Class: Haloalkane

Uses For Suprane

Desflurane belongs to the group of medicines known as general anesthetics. Desflurane is used to cause general anesthesia (loss of consciousness) before and during surgery. It is breathed in (inhaled). Although desflurane can be used by itself, combinations of anesthetics are often used together. This helps produce more effective anesthesia in some patients.

General anesthetics are given only by or under the immediate supervision of a medical doctor trained to use them. If you will be receiving a general anesthetic during surgery, your doctor will give you the medicine and closely follow your progress.

Before Using Suprane

In 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:

Allergies

Tell 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.

Pediatric

Desflurane has been tested in children. It is not used to start anesthesia in children who are awake because it causes irritation and other unwanted effects. However, when it is used to continue general anesthesia that has been started with another anesthetic, desflurane does not cause different side effects or problems in children than it does in adults.

Geriatric

Desflurane has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older people usually need smaller amounts of an anesthetic than younger people. Your doctor will take your age into account when deciding on the right amount of desflurane for you.

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 Feeding

There 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 Medicines

Although 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 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.

Cisatracurium Hydromorphone Oxycodone St John's Wort Interactions with Food/Tobacco/Alcohol

Certain 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 Problems

The 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:

The presence of other medical problems may affect the use of desflurane. Make sure you tell your doctor if you have any other medical problems, especially:

Diseases that can cause muscle weakness, such as familial periodic paralysis, muscular dystrophy, myasthenia gravis, or Eaton-Lambert syndrome, or Heart or blood vessel disease—The chance of side effects may be increased, but serious problems can be prevented if your doctor knows that these conditions are present before giving you an anesthetic Malignant hyperthermia, during or shortly after receiving an anesthetic (history of, or family history of). Signs of malignant hyperthermia include very high fever, fast and irregular heartbeat, muscle spasms or tightness, and breathing problems—This side effect may occur again Proper Use of Suprane Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your age. Your general physical condition. The kind of surgery being performed. Other medicines you are taking or will receive before and during surgery. Precautions While Using Suprane

For patients going home within 24 hours after receiving a general anesthetic:

General anesthetics may cause some people to feel drowsy, tired, or weak for a while after they have been given. They may also cause problems with coordination and one's ability to think. Therefore, for about 24 hours (or longer if necessary) after receiving a general anesthetic, do not drive, use machines, or do anything else that could be dangerous if you are not alert. Unless otherwise directed by your doctor or dentist, do not drink alcoholic beverages or take other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness) for about 24 hours after you have received a general anesthetic. To do so may add to the effects of the anesthetic. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; other sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; and muscle relaxants. Suprane Side Effects

Along 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.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Coughing nausea or vomiting Less common or rare Dizziness headache irritated or red eyes nervousness and restlessness sore throat

Other 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: Suprane side effects (in more detail)

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 Suprane resources Suprane Side Effects (in more detail)Suprane Use in Pregnancy & BreastfeedingSuprane Drug InteractionsSuprane Support Group0 Reviews for Suprane - Add your own review/rating Suprane Prescribing Information (FDA) Desflurane Compare Suprane with other medications Anesthesia

Sanctura

Generic Name: Trospium ChlorideClass: Genitourinary Smooth Muscle RelaxantsVA Class: GU201

Sanorex

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 you

have 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

Statrol Ophthalmic Solution
Dosage Form: ophthalmic solution DESCRIPTION

STATROL® (Neomycin and Polymyxin B Sulfates Ophthalmic Solution, USP) is a sterile ophthalmic drug combining two antibacterials in solution form.

Each mL of solution contains: Active: Neomycin Sulfate equivalent to 3.5 mg Neomycin base, Polymyxin B Sulfate equal to 16,250 polymyxin B units.

Preservative: Benzalkonium Chloride .004%. Vehicle: 0.5% Hydroxypropyl Methylcellulose 2910. Inactive: Boric Acid, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH), Purified Water. DM-02

CLINICAL PHARMACOLOGY

The anti-infective components in Statrol Ophthalmic Solution provide action against specific organisms susceptible to them. Polymyxin B Sulfate and Neomycin Sulfate are active in vitro against Staphylococcus aureus, Escherichia coli, Klebsiella/Enterobacter species, Neisseria species, Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens, Streptococci, including Streptococcus pneumoniae.

INDICATIONS AND USAGE

STRATOL Ophthalmic Solution is indicated in the topical treatment of infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis, and keratoconjunctivitis, blepharitis and blepharoconjunctivitis, acute meibomianitis and dacryocystitis.

CONTRAINDICATIONS

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.

WARNINGS

NOT FOR INJECTION INTO THE EYE. Should a sensitivity reaction occur, discontinue use. Neomycin Sulfate may cause cutaneous sensitization. Remove contact lenses before using.

PRECAUTIONS General

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate measures should be initiated. Whenever clinical judgment dictates; the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, corneal staining.

Information for patients

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with Polymyxin B Sulfate. Treatment of cultured human lymphocytes in-vitro with neomycin increased the frequency of chromosome aberrations at the highest concentrations (80 µg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

Polymyxin B Sulfate has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.

Pregnancy Teratogenic Effects

Pregnancy Category C. Animal reproduction studies have not been conducted with STATROL® (Neomycin and Polymyxin B Sulfates Ophthalmic Solution, USP). It is also not known whether Neomycin Sulfate and/or Polymyxin B Sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Statrol Ophthalmic Solution should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Statrol Ophthalmic Solution is administered to a nursing mother.

ADVERSE REACTIONS

Adverse reactions have occurred with the anti-infective components. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations. (SEE WARNINGS.)

DOSAGE AND ADMINISTRATION

Instill one or two drops in the lower conjunctival sac(s) three or more times daily as required.

HOW SUPPLIED

STATROL (Neomycin and Polymyxin B Sulfates Ophthalmic Solution, USP) in 5 mL plastic DROP-TAINER® dispenser: NDC 0998-0623-05.

STORAGE: Store at 46° - 80°F (8° - 27°C).

Federal (USA) law prohibits dispensing without prescription.

Alcon®

Senna Plus
Pronunciation: DOCK-yoo-sate/SEN-oh-sidesGeneric Name: Docusate/SennosidesBrand Name: Examples include Senna Plus and Senokot S

Solifenacin
Pronunciation: SOE-li-FEN-a-sinGeneric Name: SolifenacinBrand Name: VESIcare

Sumatriptan Injection
Dosage Form: injection, solutionSumatriptan Succinate Injection

Stemetic

Generic Name: trimethobenzamide (Intramuscular route)

trye-meth-oh-BENZ-a-mide

Commonly used brand name(s)

In the U.S.

Arrestin Benzacot Stemetic Ticon Tigan Tribenzagan

Available Dosage Forms:

Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Anticholinergic

Uses For Stemetic

Trimethobenzamide is used to treat nausea and vomiting .

This medicine is available only with your doctor's prescription .

Before Using Stemetic

In 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:

Allergies

Tell 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.

Pediatric

No information is available on the relationship of age to the effects of intramuscular trimethobenzamide in the pediatric population. However, because of this medication's toxicity, use in children is contraindicated. Intramuscular trimethobenzamide should never be used in children .

Geriatric

No information is available on whether the risk of trimethobenzamide-induced adverse effects is increased in the elderly. However, because of this medication's toxicity, it should be used with caution, after less toxic alternatives have been considered and/or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy .

Breast Feeding

There 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 Medicines

Although 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.

Metoclopramide Interactions with Food/Tobacco/Alcohol

Certain 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 Problems

The 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:

Dehydration or Electrolyte imbalance (high or low levels of minerals in the blood) or High fever or Intestinal infection, severe—May cause side effects to become worse . Proper Use of trimethobenzamide

This section provides information on the proper use of a number of products that contain trimethobenzamide. It may not be specific to Stemetic. Please read with care.

Trimethobenzamide is only used to relieve or prevent nausea and vomiting. A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into one of your muscles .

Your doctor may only give you a few doses of this medicine until your condition improves, and then may 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 Stemetic

Trimethobenzamide will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicines or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using trimethobenzamide .

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert .

Stemetic Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare Body spasm, with head and heels bent backward and body bowed forward convulsions (seizures) depression shakiness or tremors skin rash sore throat or fever unusual tiredness vomiting (severe or continuing) yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Drowsiness Less common Blurred vision diarrhea dizziness headache muscle cramps

Other 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: Stemetic side effects (in more detail)

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 Stemetic resources Stemetic Side Effects (in more detail)Stemetic Use in Pregnancy & BreastfeedingDrug ImagesStemetic Drug InteractionsStemetic Support Group3 Reviews for Stemetic - Add your own review/rating Compare Stemetic with other medications Nausea/Vomiting

Serc

Serc-8

Serc-16

Betahistine dihydrochloride

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Serc is and what it is used for 2. Before you take Serc 3. How to take Serc 4. Possible side effects 5. How to store Serc 6. Further information What Serc is and what it is used for

Serc contains betahistine. This medicine is called a histamine analogue. It is used to treat:

dizziness (vertigo) ringing in the ears (tinnitus) hearing loss suffered by people with M?ni?re's disease

This medicine works by improving blood flow in the inner ear. This lowers the build up of pressure.

Before you take Serc Do not take Serc if: You are allergic to any of the ingredients in the tablets (see section 6 for further details). You have high blood pressure due to an adrenal tumour (phaeochromocytoma).

If any of the above applies to you, do not take this medicine and talk to your doctor.

Take special care and tell your doctor if: you have a stomach ulcer you have asthma you are pregnant or planning to become pregnant you are breast-feeding

If any of the above applies to you, talk to your doctor before taking this medicine. Your doctor will tell you whether it is safe for you to start taking this medicine. Your doctor may also want to monitor your asthma while you take Serc.

Taking other medicines

No interaction between Serc and other medicines are known. If you notice any unwanted effects tell your doctor or pharmacist.

Please tell your doctor or pharmacist if you are taking or have taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

Taking Serc with food and drink

You can drink alcohol while taking Serc.

You can take Serc with or without food.

Pregnancy and breast-feeding

Do not take Serc if you are pregnant unless your doctor has decided that it is absolutely necessary. Ask your doctor for advice.

Do not breast-feed while using Serc unless instructed by your doctor. It is not known if Serc passes into breast milk.

Driving and using machines

You can drive and use machines while you are taking this treatment, so long as this medicine does not make you sleepy. Make sure you know how this medicine affects you before you drive or use machines.

How to take Serc How to take Serc Swallow the tablets with water. Take the tablet with or after a meal. How much Serc to take

Always follow your doctor’s instructions because your doctor might adjust your dose.

Serc is available in two strengths, an 8 mg tablet and a 16 mg tablet. The usual starting dose is 16 mg three times a day (48 mg). Your doctor may lower your dose to 8 mg three times a day (24 mg).

Keep taking your tablets. The tablets can take a while to start to work.

Serc is not recommended for use in children.

How to stop taking Serc

Keep taking your tablets until your doctor tells you to stop.

Even when you start feeling better, your doctor may want you to carry on taking the tablets for some time to make sure that the medicine has worked completely.

If you take more Serc than you should

If you or someone else takes too much Serc (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Serc

If you miss a tablet, wait until the next dose is due. Do not try to make up for the dose you have missed.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Serc Side Effects

Like all medicines Serc can cause side effects (unwanted effects or reactions), but not everyone gets them.

The following serious side effects may occur during treatment with Serc: Allergic reactions such as: swelling of your face, lips, tongue or neck. This may cause difficulty breathing. a red skin rash, inflamed itchy skin

If any of these side effects occur you should stop treatment immediately and contact your doctor.

Common side effects (at least 1 in 100 and less than 1 in 10 patients):

Nausea, indigestion.

Other side effects

Headache, itching, rash, hives, mild gastric complaints such as vomiting, stomach pain and bloating. Taking Serc with food can help reduce any stomach problems.

If any of the side effects become serious, or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist.

How to store Serc Keep out of the reach and sight of children. This medicine should preferably be locked in a cupboard or medicine cabinet. Do not use the tablets after the expiry date which is printed on the carton and blister pack. Do not store your tablets above 25°C and keep them in the original package. If your doctor stops your treatment, return any unused tablets to a pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information What Serc contains

Each tablet contains 8 or 16 mg of betahistine dihydrochloride.

The tablets also contain microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica and talc.

What Serc looks like and contents of the pack

Serc-8 are round, flat and white to almost white with ‘256’ imprinted on the one face and "S" with an upside down triangle underneath on the reverse.

Serc-16 are round, biconvex, scored and white to almost white with ‘267’ imprinted on the one face and "S" with an upside down triangle underneath on the reverse.

Serc-8 is available in packs of 120 tablets and containers with 500 or 1000 tablets.

Serc-16 is available in packs of 84 tablets and containers with 500 or 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

Solvay Healthcare Ltd. Southampton SO18 3JD UK

The Manufacturer is:

Solvay Pharmaceuticals 01400 Ch?tillon-sur-Chalaronne France

This leaflet was last approved in July 2009.

Registered trademark

1068890 CL929

Secondary Hyperparathyroidism Medications

Definition of Secondary Hyperparathyroidism: The parathyroids are four glands in the neck that produce parathyroid hormone to help control calcium metabolism. Excessive production of this hormone caused by increased activity of these glands is known as hyperparathyroidism. When this occurs in response to low blood calcium caused by another condition, the condition is called secondary hyperparathyroidism.

Drugs associated with Secondary Hyperparathyroidism

The following drugs and medications are in some way related to, or used in the treatment of Secondary Hyperparathyroidism. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Secondary Hyperparathyroidism

Medical Encyclopedia:

Secondary hyperparathyroidism Drug List:HectorolSensiparZemplar

Summers Eve Anti-Itch

Generic Name: pramoxine topical (pra MOX een TOP i kal) Brand Names: Anest Hemor, Blistex Pro Relief, Calaclear, Caladryl Clear, Callergy Clear, Curasore, Fleet Pain Relief Pad, Gold Bond Anti-Itch, Itch-X, PrameGel, Pramox, Prax, Proctofoam, Proctozone-P, Sarna Sensitive, Sarna Sensitive Eczema Itch Relief, Sarna Ultra, Soothe-It Plus Hemmorhoidal Pad, Summers Eve Anti-Itch, Tronolane

What is Summers Eve Anti-Itch (pramoxine topical)?

Pramoxine is an anesthetic, or "numbing medicine." It works by interfering with pain signals sent from the nerves to the brain.

Pramoxine topical (for the skin) is used to treat pain or itching caused by insect bites, minor burns or scrapes, hemorrhoids, and minor skin rash, dryness, or itching. Pramoxine topical is also used to treat chapped lips, and pain or skin irritation caused by coming into contact with poison ivy, poison oak, or poison sumac.

Pramoxine topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Summers Eve Anti-Itch (pramoxine topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all.

What should I discuss with my health care provider before using Summers Eve Anti-Itch (pramoxine topical)? You should not use this medication if you are allergic to pramoxine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you are allergic to any drugs or any other numbing medicines.

FDA pregnancy category C. It is not known whether pramoxine topical will harm an unborn baby. Do not use this medication without medical advice if you are pregnant. It is not known whether pramoxine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby. How should I use Summers Eve Anti-Itch (pramoxine topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Pramoxine is usually applied to the affected area 3 to 5 times daily, depending on which form of this medication you use. Follow the label directions or your doctor's instructions about how much medication to use and how often.

Pramoxine hemorrhoid cream, lotion, foam, or medicated wipe may be used on the rectum after each bowel movement to treat hemorrhoid pain and itching.

Wash your hands before and after applying pramoxine topical. Wash the affected skin area with warm water and a mild soap. Rinse and dry the area thoroughly.

To use pramoxine on the skin, (spray, lotion, gel, or stick), apply just enough of the medication to cover the area to be treated.

To use the pramoxine medicated wipe to treat the hemorrhoid area, apply the medication by patting the wipe onto the rectal area. Avoid harsh rubbing. You may fold the wipe and leave it in place for up to 15 minutes. Each pramoxine medicated wipe is for one use only. Throw the wipe away after using.

Shake the pramoxine rectal foam before each use. Squirt only a small amount of the medicine onto a clean tissue and apply it to your rectum. Do not insert this medication or the medicated wipe into your rectum. Use pramoxine topical only on the outside of the area.

Stop using pramoxine and call your doctor if your symptoms do not improve after 7 days of treatment, or if your condition clears up and then comes back.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Since pramoxine topical is used on an as needed basis, you are not likely to miss a dose.

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 using Summers Eve Anti-Itch (pramoxine topical)? Avoid getting this medication in your eyes or nose. If this does happen, rinse with water. Do not use pramoxine topical on deep skin wounds, blistered skin, severe burns, or large skin areas. Seek medical attention for more severe skin irritation or injury.

Avoid using other medications on the areas you treat with pramoxine topical unless you doctor tells you to.

Summers Eve Anti-Itch (pramoxine topical) 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 pramoxine topical and call your doctor at once if you have a serious side effect such as:

any new redness or swelling where the medicine was applied; or

severe pain, burning, or stinging where the medicine is applied.

Less serious side effects are more likely, and you may have none at all.

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 Summers Eve Anti-Itch (pramoxine topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied pramoxine. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Summers Eve Anti-Itch resources Summers Eve Anti-Itch Side Effects (in more detail)Summers Eve Anti-Itch Use in Pregnancy & BreastfeedingSummers Eve Anti-Itch Support Group0 Reviews for Summers Eve Anti-Itch - Add your own review/rating Caladryl Clear MedFacts Consumer Leaflet (Wolters Kluwer) Itch-X Foam MedFacts Consumer Leaflet (Wolters Kluwer) PrameGel Gel MedFacts Consumer Leaflet (Wolters Kluwer) Pramoxine Hydrochloride Monograph (AHFS DI) Prax Lotion MedFacts Consumer Leaflet (Wolters Kluwer) Proctofoam Foam MedFacts Consumer Leaflet (Wolters Kluwer) Sarna Sensitive Lotion MedFacts Consumer Leaflet (Wolters Kluwer) Tronolane Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Summers Eve Anti-Itch with other medications Anal ItchingPruritus Where can I get more information? Your pharmacist can provide more information about pramoxine topical.

See also: Summers Eve Anti-Itch side effects (in more detail)

Simple Linctus Sugar Free (Pinewood Healthcare)
1. Name Of The Medicinal Product

Simple Linctus Sugar Free

2. Qualitative And Quantitative Composition

Simple Linctus Sugar Free: Citric Acid Monohydrate 125 mg/5 ml equivalent to 114.29mg/5ml Anhydrous Citric Acid.

3. Pharmaceutical Form

Clear Pink Sugar Free Syrup

4. Clinical Particulars 4.1 Therapeutic Indications

For the management of a mild non-specific cough.

4.2 Posology And Method Of Administration

Adults: One 5 ml spoonful orally 3-4 times daily.

Children: Not appropriate

4.3 Contraindications

Not known

4.4 Special Warnings And Precautions For Use

This medicine contains maltitol liquid. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None Known

4.6 Pregnancy And Lactation

No data available

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

Not Applicable

4.9 Overdose

Sufficient prolonged overdose of citric acid may cause erosion of the teeth and have a local irritant action.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Absorption: Citric Acid Monohydrate is absorbed after oral administration.

Distribution: Citric Acid is found naturally in the body and is widely distributed, about 70% of the citric acid in the body is in hard bone and this accounts for 1.5% of bone content.

Metabolic Reactions: It is an important intermediate in carbohydrate metabolism and its major role is in the tricarboxylic acid cycle (Krebs citric acid cycle); it is metabolised to carbon dioxide and water.

Excretion: Citric acid is normally excreted in the urine in amounts ranging from 0.4 to 1.5g daily and this amount is not increased unless very large doses are administered. The urinary excretion of citric acid is increased in alkaline urine

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glycerol (E422)

Sodium Carboxymethylcellulose

Sodium Benzoate (E211)

Saccharin Sodium (E954)

Lycasin 80/55 (E965)

Ethanol (96%)

Anise Oil

Chloroform

Natural Red DI (E163)

Purified Water

6.2 Incompatibilities

Not appropriate

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Do not Store above 25°C.

6.5 Nature And Contents Of Container

Amber glass bottles with pilfer screw closure

High density Polyethylene with screw on closure

Pack sizes of 100ml, 125ml, and 200ml for Amber Glass Bottles

Pack size of 2000ml for High Density Polyethylene dispensary pack.

6.6 Special Precautions For Disposal And Other Handling

As with all medicines.

7. Marketing Authorisation Holder

Pinewood Laboratories Limited

Ballymacarbry

Clonmel

Co Tipperary

8. Marketing Authorisation Number(S)

PL 04917/0006

9. Date Of First Authorisation/Renewal Of The Authorisation

28 August 1991

10. Date Of Revision Of The Text

November 2008

sumatriptan oral/nasal

Generic Name: sumatriptan (oral/nasal) (soo ma TRIP tan) Brand Names: Imitrex, Imitrex Nasal

What is sumatriptan?

Sumatriptan is a headache medicine that narrows blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Sumatriptan is used to treat migraine headaches. Sumatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Sumatriptan should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Use this medication only if your condition has been confirmed by a doctor as migraine headaches.

Sumatriptan may also be used for purposes not listed in this medication guide.

What is the most important information I should know about sumatriptan? You should not use this medication if you are allergic to sumatriptan, if you have any history of heart disease, or if you have coronary heart disease, angina, blood circulation problems, lack of blood supply to the heart, uncontrolled high blood pressure, severe liver disease, ischemic bowel disease, a history of a heart attack or stroke, or if your headache seems to be different from your usual migraine headaches. Do not use sumatriptan within 24 hours before or after using another migraine headache medicine, including sumatriptan injection, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), rizatriptan (Maxalt), naratriptan (Amerge), zolmitriptan (Zomig), or ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine). Do not use sumatriptan 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.

Before using sumatriptan, tell your doctor if you have liver or kidney disease, seizures, high blood pressure, a heart rhythm disorder, or coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Also tell your doctor if you are taking an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

Sumatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

After taking a sumatriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 200 mg of sumatriptan tablets in 24 hours.

After using sumatriptan nasal spray, you must wait two (2) hours before using a second spray. Do not use more than 40 mg of sumatriptan nasal spray in 24 hours.

What should I discuss with my healthcare provider before using sumatriptan? You should not use this medication if you are allergic to sumatriptan, or if you have:

coronary heart disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;

a history of heart disease, heart attack, or stroke, including "mini-stroke";

severe or uncontrolled high blood pressure;

severe liver disease;

ischemic bowel disease; or

a headache that seems different from your usual migraine headaches.

Do not use sumatriptan 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.

To make sure you can safely use sumatriptan, tell your doctor if you have any of these other conditions:

liver disease; kidney disease;

epilepsy or other seizure disorder;

high blood pressure, a heart rhythm disorder; or

coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

FDA pregnancy category C. It is not known whether sumatriptan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Your name may need to be listed on a sumatriptan pregnancy registry when you start using this medication.

Sumatriptan can pass into breast milk and may harm a nursing baby. Do not breast-feed within 12 hours after using sumatriptan. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby. This medicine should not be given to anyone under 18 or over 65 years of age. How should I use sumatriptan?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Overuse of migraine headache medicine can actually make your headaches worse.

Use sumatriptan as soon as you notice headache symptoms, or after an attack has already begun.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to see if you have any serious side effects.

Take one sumatriptan tablet whole with a full glass of water. Do not split the tablet.

After taking a tablet: If your headache does not completely go away, or goes away and comes back, take a second tablet two (2) hours after the first. Do not take more than 200 mg of sumatriptan oral tablets in 24 hours. If your symptoms have not improved, contact your doctor before taking any more tablets.

Sumatriptan nasal spray comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. Blow your nose to clear your nasal passages before using the nasal spray. Try not to sneeze or blow your nose just after using the spray.

After using the nasal spray: If your headache does not completely go away after using the spray, call your doctor before using a second spray of sumatriptan. If your headache goes away and then comes back, you may use a second spray if it has been at least two hours since you used the first spray. Do not use more than 40 mg of sumatriptan nasal spray in 24 hours. If your symptoms do not improve, contact your doctor before using any more sprays.

Contact your doctor if you have more than four headaches in one month (30 days).

Store sumatriptan at room temperature away from moisture, heat, and light. What happens if I miss a dose?

Since sumatriptan is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using sumatriptan.

After taking a sumatriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 200 mg of sumatriptan tablets in 24 hours.

After using sumatriptan nasal spray, you must wait two (2) hours before using a second spray. Do not use more than 40 mg of sumatriptan nasal spray in 24 hours.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include tremors or shaking, skin redness, breathing problems, blue-colored lips or fingernails, vision problems, watery eyes or mouth, weakness, lack of coordination, or seizure (convulsions).

What should I avoid while using sumatriptan? Do not use sumatriptan within 24 hours before or after using another migraine headache medicine, including:

sumatriptan injection, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), or zolmitriptan (Zomig); or

ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

Sumatriptan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Sumatriptan 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 sumatriptan and call your doctor if you have a serious side effect such as:

feeling of pain or tightness in your jaw, neck, or throat;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

sudden and severe stomach pain and bloody diarrhea;

seizure (convulsions);

numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or

(if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects may include:

mild headache (not a migraine);

pressure or heavy feeling in any part of your body;

feeling hot or cold;

dizziness, spinning sensation;

drowsiness;

nausea, vomiting, drooling;

unusual taste in your mouth after using the nasal spray;

burning, numbness, pain or other irritation in your nose or throat after using the nasal spray; or

warmth, redness, or mild tingling under your skin.

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.

Sumatriptan Dosing Information

Usual Adult Dose for Cluster Headache:

Initial dosage when symptoms of headache appear:Subcutaneously: 4 to 6 mg; may repeat if needed at least 1 hour after initial dose; maximum: 12 mg/day.

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