Xelopes 40 mg/vial (IV Injection)
Medicine Details
Category | Details |
---|---|
Generic | Omeprazole |
Company | Beacon pharmaceuticals plc |
Also available as |
Indications
- 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
Inhibitor of gastric acid secretion, blocks hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system, onset of antisecretory effect occurs within one hour, maximum effect within two hours, inhibition of secretion lasts up to 72 hours, secretory activity returns gradually over 3 to 5 days after discontinuation.
Dosage
- 20 mg once daily for benign gastric and duodenal ulcer
- 40 mg once daily for severe or recurrent cases
- 10-20 mg daily for long-term management of acid reflux disease
- 10-20 mg once daily for acid-related dyspepsia
- 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery for prophylaxis of acid aspiration
- 20-120 mg daily for Zollinger-Ellison syndrome
- Omeprazole is recommended at a dose of 20 mg twice daily for Helicobacter pylori eradication regimen in peptic ulcer disease
- Pediatric use: 10-20 mg once daily for 4-12 weeks (body-weight 10-20 kg), 20-40 mg once daily for 4-12 weeks (body-weight over 20 kg)
- IV Injection: 40 mg slowly as an intravenous injection, one hour before surgery for prophylaxis of acid aspiration
Administration
Omeprazole IV injection should be given as a slow intravenous injection, the solution for IV infusion should be given over a period of 20-30 minutes or more, must not be given by any other route, reconstituted solution should not be mixed with any other drug.
Interaction
Decreased intragastric acidity may reduce the absorption of ketoconazole, can delay the elimination of diazepam, phenytoin and warfarin, monitoring of patients receiving warfarin or phenytoin is recommended, plasma concentrations of Omeprazole and clarithromycin are increased during concomitant administration, no evidence of interaction with phenacetin, theophylline, caffeine, propranolol, metoprolol, cyclosporin, lidocaine, quinidine, estradiol, amoxycillin, antacids, piroxicam, diclofenac, naproxen, absorption not affected by alcohol or food, simultaneous treatment with digoxin leads to a 10% increase in the bioavailability of digoxin.
Contraindications
Contraindicated in patients with known hypersensitivity to it, possibility of malignancy should be excluded before treatment with omeprazole is instituted when gastric ulcer is suspected.
Side Effects
- Skin rash, urticaria, and pruritus
- Photosensitivity, bullous eruption, erythema multiforme, angioedema, and alopecia
- Diarrhea and headache
- 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
- Arthritic and myalgic symptoms
- Blurred vision, taste disturbance, peripheral edema, increased sweating, gynaecomastia, leucopenia, thrombocytopenia, agranulocytosis, pancytopenia, anaphylactic shock, malaise, fever, bronchospasm, encephalopathy in patients with pre-existing severe liver disease, hepatitis with or without jaundice, interstitial nephritis, hepatic failure, increases in liver enzymes observed
Pregnancy & Lactation
No adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child, use during pregnancy is safe, no information available on the passage of Omeprazole into breast milk or its effects on the neonate, breast-feeding should be discontinued if the use of Omeprazole is considered essential, safety and effectiveness not established in pediatric patients less than 18 years of age.
Precautions & Warnings
- Avoid concomitant use of clopidogrel and Xelopes
- 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 Xelopes
- Concomitant use of PPIs with methotrexate may lead to methotrexate toxicities
Therapeutic Class
Proton Pump Inhibitor
Storage Conditions
Keep in a dry place away from light and heat, keep out of the reach of children
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