Composition
Solution in vial for I/V Infusion contains 10 mg of
Famotidine / 1 ml.
Oral suspension: each 5 ml contains 40 mg famotidine.
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Indications
1. Short term treatment of active duodenal ulcer.
2.Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.
3. Short term treatment of gastroesophageal reflux disease (GERD).
4. Short term treatment of active beign gastric ulcer.
5. Zollinger-Ellison Syndrome.
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Dosage
Gastrofam® Solution in vial for I/V Infusion: 20 mg every 12 h.
Gastrofam® Oral suspension:
- Active duodenal Ulcer: 40 mg once a day at bedtime.
- Maintenance Therapy: 20 mg once a day at bedtime.
- Benign Gastric Ulcer: 40 mg once a day at bedtime.
- Gastroesophageal Reflux Disease (GERD): 20 mg b.i.d. for up to 6 weeks.
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How Supplied
Carton box contains a granules to obtain 60 ml of oral
suspension and an inner leaflet.
Carton box contains 5 vials each 2 ml and an inner leaflet.
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Mechanism of action
Gastrofam® (Famotidine) is a competitive inhibitor of histamine H2-receptors.
The primary clinically important pharmacologic activity of Gastrofam® is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by
Gastrofam®, while changes in pepsin secretion are proportional to volume output.
After oral administration, the onset of the antisecretory effect occurred within one hour; the
maximum effect was dose-dependent, occurring within one to three hours. Duration of inhibition of secretion by doses of 20 and 40 mg was 10 to 12 hours.
After intravenous administration, the maximum effect was achieved within 30 minutes.
Single intravenous doses of 10 and 20 mg inhibited nocturnal secretion for a period of 10 to 12 hours. The 20 mg dose was associated with the longest duration of action in most subjects.
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