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RIVA-FAMOTIDINE is a brand name for Famotidine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE RIVA-FAMOTIDINE is indicated in the treatment of the following conditions where a controlled reduction of gastric secretion is required: 1. Treatment of acute duodenal ulcer; 2. Prophylactic use in duodenal ulcer; 3. Treatment of acute benign gastric ulcer; 4. Treatment of pathological hypersecretory…
Verbatim from this product's HC label. Tap a section to expand.
DUODENAL ULCER:
Acute Therapy: The recommended adult oral dosage of RIVA-FAMOTIDINE (famotidine) for acute duodenal ulcer is 40 mg once a day at bedtime. Treatment should be given for 4 to 8 weeks, but the duration of treatment may be shortened if healing can be documented.
Healing occurs within 4 weeks in most cases of duodenal ulcer.
Maintenance Therapy:
For the prevention of recurrence of duodenal ulcer, it is recommended that therapy with RIVA- FAMOTIDINE be continued with a dose of 20 mg once a day at bedtime, for a duration of up to 6 to 12 months depending on the severity of the condition.
BENIGN GASTRIC ULCER:
Acute Therapy: The recommended adult oral dosage for acute benign gastric ulcer is 40 mg once a day at bedtime. Treatment should be given for 4 to 8 weeks, but the duration of treatment may be shortened if healing can be documented.
PATHOLOGICAL HYPERSECRETORY CONDITIONS (SUCH AS ZOLLINGER- ELLISON SYNDROME):
The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg every six hours. In some patients, a higher starting dose may be required.
Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 800 mg/day have been administered to some patients with severe Zollinger-Ellison syndrome.
GASTROESOPHAGEAL REFLUX DISEASE:
The recommended dosage for the symptomatic relief of gastroesophageal reflux disease is 20 mg of famotidine twice a day. For the treatment of esophageal erosion or ulceration associated with gastroesophageal reflux disease, the recommended dosage is 40 mg of famotidine twice a day.
For the maintenance of remission of patients with GERD, the recommended dosage is 20 mg of famotidine twice a day.
Concomitant Use with Antacids:
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Famotidine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Antacids may be given concomitantly if needed. Page 8 of 20 Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency In patients with moderate (creatinine clearance 30-50 mL/min) or severe (creatinine clearance < 30 mL/min) renal insufficiency, the elimination half-life of famotidine is increased.
For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse reactions have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient’s clinical response.
Page 9 of 20 PHARMACEUTICAL INFORMATION DRUG SUBSTANCE:
Proper Name: Famotidine Chemical Name: N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4- thiazolyl]methyl]thio]Propanimidamide.
Structural Formula:
Description: Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water and practically insoluble in ethanol. 44 g/mol COMPOSITION RIVA-FAMOTIDINE tablets: Active ingredient: famotidine.
Non-medicinal ingredients:
Colloidal silica anhydrous, Magnesium stearate, Microcrystalline cellulose, Pregelatinized starch, Talc and film coating: Iron oxide red (40 mg only), Iron oxide yellow, Lecithin (soya), Polyethylene glycol, Polyvinyl alcohol, Talc and Titanium dioxide.
STABILITY AND STORAGE RECOMMENDATIONS:
RIVA-FAMOTIDINE tablets: Store between 15°C - 30°C in well-closed, light-resistant containers. Blisters should be stored between 15°C - 30°C and protected from light. AVAILABILITY OF DOSAGE FORMS RIVA-FAMOTIDINE (famotidine) tablets are available as: 20 mg – Yellow colored, round, biconvex film coated tablets debossed with “2V” on one side and plain on the other side.
Supplied:
Bottles of 30, 100 and 1000 tablets and blisters of 30 tablets. Page 10 of 20 40 mg – Brown colored, round, biconvex film coated tablets debossed with “4V” on one side and plain on other side.
Supplied:
Bottles of 30, 100 and 1000 tablets and blister of 30 tablets. Page 11 of 20 INFORMATION FOR THE PATIENT Pr RIVA-FAMOTIDINE Full prescribing information is available to the physician and pharmacist. RIVA-FAMOTIDINE (20 mg and 40 mg tablets) is available only on prescription from your physician.
Famotidine belongs to a class of medicines known as histamine H2-receptor antagonists. It reduces the amount of acid produced by the stomach. For this reason it is used in the treatment of certain ulcers of the stomach or duodenum, and other conditions, for example the treatment of gastroesophageal reflux disease or Zollinger- Ellison syndrome, in which the stomach produces too much acid.
Remember—This medicine is prescribed for the particular condition that you have. Do not give this medicine to other people, nor use it for any other condition. Do not use outdated medicine. Keep out of the reach and sight of children.
Read the following information carefully. If you need any explanations, or further information, ask your physician or pharmacist.
Before Taking this Medicine:
This medicine may not be suitable for some patients. So, tell your physician if you think any of the following applies to you: • Do not take RIVA-FAMOTIDINE if you are allergic to any of its ingredients or to other H2-receptor antagonists.
• You are pregnant or intend to become pregnant. • You are breast-feeding or intend to breast-feed. • You have confirmed kidney or liver ailment. • Your physician also needs to know if you are taking any other medication (example, a prescription or over the counter drugs).
Proper Use of this Medicine: • Take this medicine exactly as directed by your physician. For the treatment of ulcers, it is often recommended as a single dose at bedtime; but some conditions may require different dosing. In any case, follow the […]