Omeprazole-Najo  20 (E.C.Granules) capsule

Category:  Proton pump inhibitor.

INDICATIONS: Duodenal ulcer, Gastric ulcer, Treatment of gastroesophageal reflux disease (GERD), Maintenance of healing of erosive esophagitis, Pathological hypersecretory conditions.

DOSAGE AND ADMINISTRATION:

Short-Term treatment of active duodenal ulcer: 20 mg once daily. Most patients heal within four weeks.

H. pylori eradication for the reduction of the risk of duodenal ulcer recurrence:

Triple therapy (omeprazole/clarithromycin/amoxicillin) – Omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole 20 mg once daily is recommended.

Dual therapy (omeprazole/clarithromycin) – Omeprazole 40 mg once daily plus clarithromycin 500 mg t.i.d. for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole 20 mg once daily is recommended.

Gastric ulcer: 40 mg once a day for 4-8 weeks.

Gastroesophageal reflux disease (GERD): with no esophageal lesions is 20 mg daily for up to 4 weeks. With erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

Maintenance of healing of erosive esophagitis: 20 mg daily.

Pathological hypersecretory conditions: 60 mg once a day.

Pediatric patients: For the treatment of GERD or other acid-related disorders, the recommended dose for pediatric patients 2 years of age and older is as follows: Patient Weight < 20 kg; Omeprazole Dose 10 mg, Patient Weight >/= 20 kg; Omeprazole Dose 20 mg.

Mechanism of Action: Omeprazole belongs to a new class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H ⁺ /K ⁺ ATPase enzyme system at the secretory surface of the gastric parietal cell.

CONTRAINDICATIONS: Omeprazole capsules are contraindicated in patients with known hypersensitivity to any component of the formulation.  

PRECAUTIONS: Symptomatic response to therapy with Omeprazole does not preclude the presence of gastric malignancy.

Pregnancy: Pregnancy Category C

Nursing Mothers: It is not known whether Omeprazole is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug.

Pediatric Use: The safety and effectiveness of Omeprazole have not been established for pediatric patients less than 2 years of age.

Geriatric Use: Pharmacokinetic studies have shown the elimination rate was somewhat decreased in the elderly and bioavailability was increased.

SIDE EFFECTS: Headache %6.9, Diarrhea %3.0, Abdominal Pain %2.4, Nausea %2.2, URI %1.9, Dizziness % 1.5, Vomiting %1.5.

DRUG INTERACTION: Diazepam, warfarin, Phenytoin, Theophylline, Propranolol, Cyclosporine, Disulfiram, Benzodiazepines, Ketoconazole, Iron salts, Atazanavir, Tacrolimus, Voriconazole, Clarithromycin.

How Supplied: Each pack of 14 capsules in one brown glass bottle.

storage: Store in a tight container protected from light and moisture. Store below 30°C.

For more information please refer to:

USPDI for Professional Health Care 2007, page 2176.

Martindale 35^th edition, page 1579.

IRAN NAJO PHARMACEUTICAL COMPANY

www.irannajo.com
Address: No. 9, West Hoveiseh, Sabounchi St., Sohrevardi Ave., Tehran 1533693317, Iran
Tel: +9821-88747363   Fax: +9821-88740644   info@irannajo.com