Xeldrin 40 mg/vial (IV Injection)
Medicine Details
Category | Details |
---|---|
Generic | Omeprazole |
Company | Aci limited |
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
- maintenance dose for recurrent duodenal ulcer, 20 mg once daily
- in prevention of relapse in duodenal ulcer, 10-20 mg daily
- 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 (Long-term management of acid reflux disease)
- 10-20 mg once daily for 2-4 weeks (Acid-related dyspepsia)
- 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery (Prophylaxis of acid aspiration)
- Initially 60 mg once daily for Zollinger-Ellison syndrome
- 20 mg twice daily in association with antimicrobial agents for Helicobacter pylori-induced peptic ulcer
Administration
Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection should be used within 4 hours of reconstitution. Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Interaction
Due to the decreased intragastric acidity, the absorption of ketoconazole may be reduced during Xeldrin treatment. Xeldrin is metabolized in the liver through cytochrome P450, which can delay the elimination of diazepam, phenytoin, and warfarin. Monitoring of patients receiving warfarin or phenytoin is recommended. Plasma concentrations of Xeldrin and clarithromycin are increased during concomitant administration. No evidence of an interaction with phenacetin, theophylline, caffeine, propranolol, metoprolol, cyclosporin, lidocaine, quinidine, estradiol, amoxycillin, or antacids.
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
- 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
- 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 Xeldrin
- Observational studies suggest that 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 Xeldrin
- 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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