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.
Pharmacology
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 & 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:
Contra-indication
Hypersensitivity to Omeprazole or any of the components of this medication.
|
Patient Weight |
Omeprazole Daily Dose |
|
5 to < 10 kg |
5 mg |
|
10 to < 20 kg |
10 mg |
|
> 20 kg |
20 mg |
Warning & precaution
Omeprazole may alleviate symptoms and delay diagnosis of gastric carcinoma.
Side effects
Omeprazole is well tolerated. The adverse events are diarrhea, headache, flatulence, abdominal pain, constipation and dizziness/vertigo.
Use in pregnancy & lactation
Pregnancy: Recent studies show no adverse effects of Omeprazole on pregnancy or on the health of the fetus or newborn child. Omeprazole can be used during pregnancy.
Lactation: Omeprazole is excreted in breast milk, but it is not likely to influence the child when therapeutic doses are used.
Use in children & adolescents
Doctor will decide the correct dose based on the child's weight.
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.
Overdose
Symptoms were transient, and no serious clinical outcome has been reported with Omeprazole overdose. No specific antidote for Omeprazole overdose is known. Omeprazole is extensively bound with protein and is, therefore, not readily dialyzable. In the event of overdose, treatment should be symptomatic and supportive.
Storage
Keep out of the reach of children. Keep below 30°C, protect from light.
Packing
Prazomax 20 capsule: Each box contains 10X10's capsule in blister pack.
Prazomax 40 capsule: Each box contains 3X10's capsule in blister pack.
