Omex 40 mg (Capsule (Enteric Coated))

Unit Price: ৳ 7.02 (20's pack: ৳ 140.40)

Medicine Details

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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