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Arja 320(Gemifloxacin Mesylate, 320mg)Carsel 100 Tablets (Metoprolol Tartrate 100mg)

Basil 40 Tablets (Famotidine 40mg)
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Basil 40 Tablets (Famotidine 40mg)

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BASIL (Famotidine) is a highly effective, long-acting histamine H2 receptor antagonist. BASIL has a rapid onset of action and shows a high degree of specificity for the H2 receptor. BASIL reduces the acid and pepsin content, as well as the volume, of basal and stimulated gastric secretion. In clinical studies, BASIL 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.

BASIL is highly effective in the treatment of duodenal ulcer, benign gastric ulcer, and hypersecretory conditions such as the Zollinger-Ellison syndrome as well as other conditions where reduction of gastric secretion is desirable.

In the treatment of gastroesophageal reflux disease (GERD). BASIL has been shown to relieve symptoms and promote healing of erosions or ulcerations of the esophageal mucosa.

Furthermore, BASIL has been demonstrated to prevent the relapse of symptoms and erosions or ulceration associated with GERD

BASIL has also been shown to be highly effective for the prevention of relapse of duodenal and benign gastric ulceration.

INDICATIONS:

  • Duodenal ulcer
  • Benign gastric ulcer
  • Hypersecretory conditions such as Zollinger-Ellison syndrome.
  • Prevention of relapse of duodenal ulceration.
  • Prevention of relapse of benign gastric ulcerSymptomatic relief of gastroesophageal reflux disease.
  • Healing of esophageal erosion or ulceration associated with gastroesophageal reflux disease.
  • Prevention of relapse of symptoms and erosions or ulceratiors associated with GERD.

DOSAGE AND ADMINISTRATION:

DUODENAL ULCER

Initial Therapy: The recommended dose of BASIL is one 40 mg tablet 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. In those patients whose ulcers have not healed completely after 4 weeks, treatment should be continued for a further 4-week period.

Maintenance Therapy: For the prevention of recurrence of duodenal ulceration, it is recommended that therapy with BASIL be continued, with a dose of BASIL 20mg daily taken at night.

BENIGN GASTRIC ULCER
The recommended dose of BASIL is one 40mg tablet daily at night. Treatment should be given for 4-8 weeks but the duration of treatment may be shortened if endoscopy reveals that the ulcer has healed.

Maintenance Therapy: For the prevention of recurrence of benign gastric ulcer, the recommended dosage is BASIL 20mg taken at night which may be given for up to one year.

ZOLLINGER-ELLISON SYNDROME:

Patients without prior antisecretory therapy should be started on a dose of BASIL 20mg every 6 hours. Dosage should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 800mg daily have been used for up to 1 year without the development of significant side effects or tachyphylaxis. Patients who have been receiving another H2 antagonist may be switched directly to BASIL 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 BASIL 20mg twice daily.

For the treatment esophageal erosion or ulceration associated with GERD, the recommended dosage is BASIL 40mg twice daily.

Maintenance Therapy: For the prevention of recurrence of symptoms and erosions or ulceration associated with GERD, the recommended dosage is BASIL 20mg 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 BASIL should be reduced to 20mg taken at night (See PRECAUTIONS).

CONTRAINDICATIONS :

Hypersensitivity to any component of this product.

PRECAUTIONS:

GASTRIC NEOPLASM
Gastric malignancy should be excluded prior to initiation of therapy of gastric ulcer with BASIL. Symptomatic response of gastric ulcer to BASIL therapy does not preclude the presence of gastric malignancy.

RENAL DYSFUNCTION:

Since BASIL is excreted primarily by the kidney, caution should be observed in patients with impaired renal function. A reduction in daily dosage should be considered if creatinine clearance falls below 10ml/min (see DOSAGE AND ADMINISTRATION).

USE IN PREGNANCY

Famotidine is not recommended for use in pregnancy, and should be prescribed only if clearly needed. Before a decision is made to use famotidine during pregnancy, the physician should weigh the potential benefits from the drug against the possible risks involved.

NURSING MOTHERS:

Famotidine is detectable in human milk. Nursing mothers should either stop this drug or stop nursing.

PEDIATRIC USE:

Safety and effectiveness of famotidine in children have not been established.

USE IN THE ELDERLY:

When famotidine was administered to elderly patients in clinical trials, no increase in the incidence or change in the type of drug-related side effects was observed. No dosage adjustment is required based on age alone.

DRUG INTERACTIONS:

No drug interactions of clinical importance have been identified. BASIL dose not interact with the cytochrome P450-linked drug metabolizing enzyme system. Compounds metabolized by this system which have been tested in man have included warfarin, theophylline, phenytoin, diazpam, propranolol, aminopyrine and antipyrine. Indocyanine green as an index of hepatic blood flow and / or hepatic drug extraction has been tested and no significant effects have been found.

Studies in patients stabilized phenprocoumon therapy have shown no pharmacokinetic interaction with famotidine and no effect on the pharmacokinetic or anticoagulant activity of phenprocoumon.

In addition, studies with famotidine have shown no augementation of expected blood alcohol levels resulting from alcohol ingestion.

SIDE EFFECTS:

BASIL 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, abdominal discomfort or distention anorexia, fatique, rash, pruritus and urticaria, liver enzyme abnormalities, cholestatic jaundice, anaphylaxis, angiodema, arthralgia, muscle cramps, reversible psychic disturbances including depression, anxiety disorders, agitation, confusion and hallucinations. Toxic epidermal necrolysis has been reported very rarely with H2-receptor antagonists.

OVERDOSAGE:

There is no experience to date with overdosage.
Patient with Zollinger-Ellison syndrome have been tolerated doses up to 800mg/day for more than a year without development of significant side effects.
The usual measure to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.

PRESENTATION:

BASIL40:- Blister Pack of 1 x10's tablets.
Each tablet contains Famotidine 40mg.........U.S.P.

BASIL 20:- Blister Pack of2 x 10's tablets.
Each tablet contains Famotidine 20mg........ U.S.P.