ZEDEX
(FAMOTIDINE)

POTENT SELECTIVE BLOCKER OF H2-RECEPTORS
- ZEDEX (famotidine) is highly effective, long-acting histamine H2-receptor antagonist.
- ZEDEX has a rapid onset of action and shows a high degree of specificity for the H2-receptor.
- ZEDEX reduces the acid and pepsin content, as well as the volume, of basal and stimulated gastric secretion. In clinical studies, ZEDEX relieved the pain associated with peptic ulceration usually within the first week of treatment, and suppressed gastric acid secretion with once a-day dosage at night.
- ZEDEX is highly effective in the treatment of duodenal ulcer, and hypersecretory conditions such as the Zollinger-Ellison syndrome, as well as other conditions where reduction of gastric secretion is desirable.
- ZEDEX has also been shown to be highly effective for the prevention of relapses of duodenal ulceration.
 

INDICATIONS:
Duodenal ulcer.
Benign gastric ulcer.
Hypersecretory conditions such as Zollinger-Ellison syndrome.
Prevention of relapses of duodenal ulceration.
Symptomatic relief of gastroesophageal reflux disease.
 

DOSAGE & ADMINISTRATION:
Duodenal & Benign Gastric Ulcer:
The recommended dose of ZEDEX is one 40 mg tablet or two 20 mg tablets daily taken at night. Treatment should be given for 4 to 8 weeks, but the duration of treatment may be shortened if endoscopy reveals that the ulcer has healed. In most cases of duodenal ulcer, healing occurs within 4 weeks on this regimen.
Maintenance Therapy:
For the prevention of recurrence of duodenal ulceration, it is recommended that therapy with ZEDEX should be continued with a dose of one 20 mg tablet daily taken at night.
Zollinger-Ellison Syndrome:
Patients without prior antisecretory therapy should be started on a dose of 20 mg every 6 hours. Dosage should be adjusted to individual patient needs and should continue for as long as clinically indicated.
Note:
Patients who have been receiving another H2 antagonism may be switched directly to ZEDEX at a starting dose higher than that recommended for new cases; this starting dose will depend on the severity of the condition and the last dose of the H2 antagonist previously used.
Gastroesophageal Reflux Disease:
The recommended dosage for the symptomatic relief of gastroesophageal reflux disease is 20 mg of ZEDEX taken orally twice daily.
Dosage Adjustment for Patients with Severe Renal Insufficiency:
In patients with severe renal insufficiency, (creatinine clearance less than 10 ml/min) the dose of ZEDEX should be reduced to 20 mg taken at night.
 

CONTRAINDICATIONS:
Hypersensitivity to famotidine.
 

PRECAUTIONS:
Gastric Neoplasm:
Gastric malignancy should be excluded prior to initiation of therapy of gastric ulcer with ZEDEX. Symptomatic response of gastric ulcer to ZEDEX therapy does not preclude the presence of gastric malignancy.


Use In Pregnancy:
ZEDEX is not recommended for use in pregnancy, and should be prescribed only if clearly needed. Before a decision is made to use ZEDEX during pregnancy, the physician should weigh the potential benefits from the drug against the possible risks involved.
Use In Nursing Mothers:
the lactation should be discontinued when the physician decide that the drug is important for the mother.
 

DRUG INTERACTIONS:
ZEDEX has drug interaction with anti-acid, the drug should be taken with 2 hours intervals.
Probenecid: decreases the tubular secretion of the drug.
 

SIDE EFFECTS:
ZEDEX has been demonstrated to be generally well-tolerated. Headache, dizziness, constipation and diarrhea have been reported rarely. Other side effects reported even less frequently included dry mouth, nausea and/or vomiting, rash, abdominal flatulence, anorexia, and fatigue.
 

PRESENTATION & COMPOSITION:
ZEDEX 20:
2 Strips x 10 film-coated tablets each tablet contains:
Famotidine 20 mg.
ZEDEX 40:
2 Strips x 10 film-coated tablets each tablet contains:
Famotidine 40 mg.
 

STORAGE:
Store at room temperature, protect from moisture.
Keep out of the reach of the children.