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Kotidine

Al-Tinez Pharmaceuticals Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Tel: 01-4826452; 0802-307-7320, 0803-305-7978

Brand Name

Kotidine

Manufacturer

Baroque Pharmaceuticals Pvt. Ltd, Sokhada-388 620, Ta. Khambhat, Gujarat, India. Mfg. Lic. No G/1217

Therapeutic Class

Antiulcerants, H2-receptor antagonists (H2RA)

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: 04-3793): Famotidine USP 20/40 mg.

Pack sizes: 30's; 100's; 200's; 500's; 1000's.

kotidine

Pharmacology

KOTIDINE Tab. 20 mg is Blue film ceased round tablet.

KOTIDINE Tab. 40 mg is light green film coated round tablet.

Famotidine is a competitive inhibitor of histamine H2-receptors. The primary clinically important pharmacologic activity of Famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by Famotidine, while changes in pepsin secretion are proportional to volume output.

Indications

l. Short term treatment of active duodenal ulcer. Most patients heal Within 4 weeks; there is rarely reason to use.

KOTIDINE at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks.

2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer: Controlled Studies have not extended beyond one year.

3. Short term treatment of active benign gastric ulcer: Most patients heal within 6 Weeks.

Studies have not assessed the safely or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.

4. Short term treatment of gastroesophageal reflux disease (GERD):

  • KOTIDINE is indicated for short term treatment of patients with symptoms of GERD.
  • KOTIDINE is also indicated for the short term treatment of esophagitis due to GERD including erosive ulcerative disease diagnosed by endoscopy.

5. Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas).

Contra-indications

Hypersensitivity to any components of these products or any histamine H2-receptor antagonists.

Precautions/Warnings

Gastric carcinoma: Gastric malignancy should be excluded prior to initiation of therapy of gastric ulcer with Famotidine. Symptomatic response of gastric ulcer to the therapy with Kotidine does not preclude the presence of gastric malignancy.

Impaired renal function: Since Famotidine is primarily excreted via the kidney, caution should be exercised when treating patients with impaired renal function. The dose should be reduced to 20 mg nocte when creatinine clearance falls below 10 mL/min.

Interactions

Drug interactions: No clinically important drug interaction have been identified. Famotidine does not interact with the cytochrome P450-linked drug metabolishing enzyme system.

Side-effects: In controlled studies, Famotidine has been shown to be generally well tolerated.

Headache dizziness, constipation and diarrhoea have been reported rarely.

Adverse Effects

In controlled studies, Famotidine has been shown to be generally well tolerated. Headache, dizziness, constipation, and diarrhoea have been reported rarely.

Dosage & Administration

Adult:

Duodenal ulcer, Benign ulcer: 20 mg tablet two times after meal daily or 40 mg tablet one time at night.

Zollinger-Ellison Syndrome: 20 mg tablet two times after meal daily or 40 mg tablet one time at night

Gastro-oesophageal reflux disease: 20 mg tablet two times after meal daily or 40 mg tablet one time at night.

Maintenance therapy: 10 mg two times after meal daily or 20 mg one time at night.

Overdosage:

There is no experience to date with overdosage, The usual measures to remove unabsorbed material from the gastro-intestinal tract, clinical monitoring, and supportive therapy only should be employed.

Patients with Zollinger-Ellison syndrome have tolerated a dosage of 800 mg daily for up to a year without significant adverse effects.

Storage/Handling Recommendations

Store at room temperature. (1-30oC)

Keep out of reach of children.

Review Date

2017-10-25 03:31:09