Orpra 40 mg (Capsule (Enteric Coated))
Medicine Details
| Category | Details |
|---|---|
| Generic | Omeprazole |
| Company | Orbit pharmaceuticals ltd |
| Also available as |
Indications
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer
Pharmacology
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
Dosage
- 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration
- 40 mg once daily for severe or recurrent cases
- maintenance dose for recurrent duodenal ulcer, 20 mg once daily
- in prevention of relapse in duodenal ulcer, 10-20 mg daily
- 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed
- 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcers
- 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily
- 10-20 mg daily
- 10-20 mg once daily for 2-4 weeks
- 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery
- Initially 60 mg once daily for Zollinger-Ellison syndrome
- Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents for Helicobacter pylori eradication regimen
- If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks
Administration
- Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route
- Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more
Interaction
- Decreased intragastric acidity may reduce the absorption of ketoconazole during Orpra treatment
- Orpra is metabolised in the liver through cytochrome P450 which can delay the elimination of diazepam, phenytoin and warfarin
- Concomitant treatment with Orpra and clarithromycin can increase plasma concentrations
- No evidence of an interaction with phenacetin, theophylline, caffeine, propranolol, metoprolol, cyclosporin, lidocaine, quinidine, estradiol, amoxycillin or antacids
- No evidence of an interaction with piroxicam, diclofenac or naproxen
- Simultaneous treatment with Orpra and digoxin in healthy subjects lead to a 10% increase in the bioavailability of digoxin as a consequence of the increased intragastric pH
Contraindications
Omeprazole is contraindicated in patients with known hypersensitivity to it. When gastric ulcer is suspected, the possibility of malignancy should be excluded before treatment with omeprazole is instituted.
Side Effects
- Skin rash, urticaria and pruritus
- Photosensitivity, bullous eruption, erythema multiforme, angioedema and alopecia
- Diarrhoea and headache
- Gastrointestinal reactions like constipation, nausea/vomiting, flatulence and abdominal pain
- Dry mouth, stomatitis and candidiasis
- Paraesthesia
- Dizziness, light headedness and feeling faint
- Somnolence, insomnia and vertigo
- Reversible mental confusion, agitation, depression and hallucinations
- Arthritic and myalgic symptoms
- Blurred vision, taste disturbance, peripheral oedema
- Increased sweating, gynaecomastia, leucopenia, thrombocytopenia, agranulocytosis, pancytopenia, anaphylactic shock
- Malaise, fever, bronchospasm
- Encephalopathy in patients with pre-existing severe liver disease
- Increases in liver enzymes
Pregnancy & Lactation
Results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. Omeprazole can be used during pregnancy.
Precautions & Warnings
- Avoid concomitant use of clopidogrel and Orpra
- Proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures
- Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with Orpra
Therapeutic Class
Proton Pump Inhibitor
Storage Conditions
Keep in a dry place away from light and heat. Keep out of the reach of children.