Peptral 40mg
Generic : Omeprazole
Therapeutic : Omeprazole
Peptral
Omeprazole
Composition :
Peptral 20 Capsule: Each capsule contains Omeprazole BP 20 mg as enteric coated pellets.
Peptral 40 Capsule: Each capsule contains Omeprazole BP 40 mg as enteric coated pellets.
Description :
Omeprazole 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 blocks the final step in acid production, thus reducing gastric acidity.
Indications :
l Benign gastric and duodenal ulcer
l Prevention of relapse in gastric ulcer
l Prevention of relapse in duodenal ulcer
l Erosive esophagitis
l Hypersecretory conditions
l NSAID associated duodenal or gastric ulcer and gastroduodenal erosions
l Duodenal or benign gastric ulcer associated with Helicobacter pylori
l Zollinger-Ellison syndrome
l Gastric acid reduction during general anesthesia
l Gastro-esophageal reflux disease
l Acid-related dyspepsia
Dosage and Administration :
Omeprazole capsule should be taken one hour before meal. According to disease pattern, the recommended dosage & administration:
l Benign gastric and duodenal ulcer, 20 mg once daily for 4 weeks in duodenal ulceration or 8 weeks in gastric ulceration
l Prevention of relapse in gastric ulcer, 20 mg once daily, increased to 40 mg once daily if necessary
l Prevention of relapse in duodenal ulcer, 20 mg once daily (range 10-40 mg daily)
l NSAID associated duodenal or gastric ulcer and gastroduodenal erosions, 20 mg once daily for 4 weeks
l Duodenal or benign gastric ulcer associated with Helicobacter pylori
Recommended regimens for Helicobacter pylori eradication in adults:
l Zollinger-Ellison syndrome, initially 60 mg once daily, usual range 20-120 mg daily (above 80 mg in 2 divided doses)
l Gastric acid reduction during general anesthesia, 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery
l Gastro-esophageal reflux disease, 20 mg once daily for 4 weeks
l Acid-related dyspepsia, 10-20 mg once daily for 2-4 weeks according to response
l 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:
Side effects :
Omeprazole is well tolerated. The adverse events are diarrhea, headache, flatulence, abdominal pain, constipation and dizziness/vertigo.
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.
Contraindications :
Hypersensitivity to Omeprazole or any of the components of this medication.
Precautions :
The daily dose in elderly patients should, as a rule, not exceed 20 mg.
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 away from light and store below 30oC. Keep out of the reach of children.
Commercial Pack :
Peptral 20 Capsule: Each box contains 6 x 10 capsules, in Alu-Alu blister pack.
Peptral 40 Capsule: Each box contains 5 x 6 capsules, in Alu-Alu blister pack.
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