Omex 40 mg (Capsule (Enteric Coated))
Unit Price: ৳ 7.02 (20's pack: ৳ 140.40)
Medicine Details
Category | Details |
---|---|
Generic | Omeprazole |
Company | Kemiko pharmaceuticals ltd |
Also available as |
Indications
- Treatment of gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- 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
- Inhibition of gastric acid secretion
- Blockage of hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system
- Onset of antisecretory effect within one hour
- Maximum effect occurring within two hours
- Inhibition of secretion lasting up to 72 hours
- Gradual return of secretory activity over 3 to 5 days after discontinuation
Dosage
- 20 mg once daily for benign gastric and duodenal ulcer
- 40 mg in severe or recurrent cases of benign gastric and duodenal ulcer
- 10-20 mg daily for prevention of relapse in duodenal ulcer
- 20 mg once daily for gastro-esophageal reflux disease
- 40 mg once daily for 8 weeks in refractory gastro-esophageal reflux disease
- 10-20 mg daily for long-term management of acid reflux disease
- 10-20 mg once daily for 2-4 weeks for acid-related dyspepsia
- 40 mg on the preceding evening and 2-6 hours before surgery for prophylaxis of acid aspiration
- 60 mg once daily for Zollinger-Ellison syndrome
- 20 mg twice daily for Helicobacter pylori eradication regimen
- 10-20 mg once daily for pediatric use in severe ulcerating reflux esophagitis (Child > 1 year)
Administration
- Intravenous administration only for Omeprazole lyophilized powder and water for injection
- Intravenous injection given as a slow intravenous injection
- IV infusion given over a period of 20-30 minutes or more
- Solution used within 4 hours of reconstitution for IV injection
- Solution used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose for IV infusion
- Reconstituted solution should not be mixed or co-administered with any other drug in the same infusion set
Interaction
- Reduced absorption of ketoconazole during Omex treatment
- Metabolism in the liver through cytochrome P450
- Delayed elimination of diazepam, phenytoin, and warfarin
- Increased plasma concentrations during concomitant administration with clarithromycin
- No evidence of interaction with phenacetin, theophylline, caffeine, propranolol, metoprolol, cyclosporin, lidocaine, quinidine, estradiol, amoxycillin, or antacids
- No effect on absorption by alcohol or food
- Useful interaction during H. pylori eradication
- Increased bioavailability of digoxin
- No evidence of interaction with piroxicam, diclofenac, or naproxen
Contraindications
- Known hypersensitivity to Omeprazole
- Suspicion of gastric ulcer should exclude possibility of malignancy before treatment
Side Effects
- Mild and reversible adverse reactions
- Skin rash, urticaria, and pruritus
- Photosensitivity, bullous eruption, erythema multiforme, angioedema, and alopecia
- Diarrhea and headache, with severe cases requiring therapy discontinuation
- Gastrointestinal reactions including 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 in severely ill patients
- Arthritic and myalgic symptoms, usually resolving upon therapy cessation
- Blurred vision, taste disturbance, peripheral edema, increased sweating, gynaecomastia, and blood disorders
- Anaphylactic shock, malaise, fever, bronchospasm, encephalopathy, hepatitis, interstitial nephritis, and hepatic failure
- Increases in liver enzymes
Pregnancy & Lactation
- No adverse effects of Omeprazole on pregnancy or fetus/newborn child in prospective epidemiological studies
- Safe for use during pregnancy
- No information on passage into breast milk or effects on the neonate, necessitating discontinuation of breast-feeding if Omeprazole use is essential
- Safety and effectiveness not established in pediatric patients <18 years of age
Precautions & Warnings
- Avoid concomitant use with clopidogrel
- Potential association with increased risk for osteoporosis-related fractures
- Atrophic gastritis noted occasionally in long-term treated patients
- Concomitant use with methotrexate may lead to methotrexate toxicities
Therapeutic Class
- Proton Pump Inhibitor
Storage Conditions
- Dry place away from light and heat, out of the reach of children
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