Prazomax 20

Composition

Prazomax 20 capsule: Each capsule contains Omeprazole BP 20 mg as enteric coated pellets.

Prazomax 40 capsule: Each capsule contains Omeprazole BP 40 mg as enteric coated pellets.

Description

It is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Omeprazole reduces gastric acidity by blocking the final step in acid production.

Indication

• Benign gastric and duodenal ulcer • NSAID associated duodenal or gastric ulcer and gastroduodenal erosions • Gastro-esophageal reflux disease • Duodenal or benign gastric ulcer associated with Helicobacter pylori • Prevention of relapse in gastric ulcer • Prevention of relapse in duodenal ulcer • Erosive esophagitis • Zollinger-Ellison Syndrome • Gastric acid reduction during general anesthesia • Acid-related dyspepsia.

Dosage and Administration

Omeprazole should be taken before meal.

 Adults

Indication

Dosage and Administration

Benign gastric ulcer

20 mg once daily for 8 weeks, increased to 40 mg   once daily if necessary

Duodenal ulcer

20 mg once daily for 4 weeks, increased to 40 mg   once daily if necessary

NSAID associated duodenal or gastric ulcer and gastroduodenal erosions

20 mg once daily for 4 weeks

Gastro-esophageal reflux disease

20 mg once daily for 4 weeks

Duodenal or benign gastric ulcer associated with Helicobacter pylori

20 mg twice daily plus Amoxicillin 500 mg four times daily plus Metronidazole 400 mg thrice daily for 2 weeks

Prevention of relapse in gastric ulcer

20 mg once daily, increased to 40 mg once daily if necessary

Prevention of relapse in duodenal ulcer

20 mg once daily (range 10-40 mg daily )

Zollinger-Ellison Syndrome

Initially 60 mg once daily, usual range 20-120 mg daily ( above 80 mg in 2 divided doses )

Gastric acid reduction during general anesthesia

40 mg on the preceding evening, then 40 mg 2-6 hours before surgery

Acid-related dyspepsia

10-20 mg once daily for 2-4 weeks according to response

Pediatric Patients: For the treatment of Gastro-esophageal reflux disease and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients (1-16 years of age) is as follows:

Patient Weight

Omeprazole Daily Dose

5 to < 10 kg

5 mg

10 to < 20 kg

10 mg

> 20 kg

20 mg

Side effect

Omeprazole is well tolerated. The adverse events are diarrhea, headache, flatulence, abdominal pain, constipation and dizziness/vertigo.

Contraindication

Hypersensitivity to Omeprazole or any of the components of this medication.

Use in special group

Pregnancy: The safety of Omeprazole in pregnancy has not been established. It should not be administered to pregnant women unless the expected benefits outweigh the potential risks.

Lactation: It is not known if Omeprazole is secreted in human milk. It should not be given to nursing mothers unless its use is considered essential. Pediatric use: The safety and effectiveness of Omeprazole for the treatment of Gastro-esophageal reflux disease in patients < 1 year of age have not been established. The safety and effectiveness of Omeprazole for other pediatric uses have not been established.

Drug Interaction

Omeprazole can delay the elimination of diazepam, phenytoin and warfarin. There is no evidence of interaction with theophylline, propranolol, metoprolol, lidocaine, quinidine, amoxicillin or antacids. The absorption of Omeprazole is not affected by alcohol or food.

Storage

Keep out of the reach of children. Keep below 30°C, protect from light.

How Supplied

Prazomax 20 capsule: Each box contains 10X10’s capsule in blister pack. Prazomax 40 capsule: Each box contains 3X10’s capsule in blister pack.