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"DRUG's INFO"
| Monday, February 05, 2007 |
| Losec 40 mg |
1. Composition
one vial of dry substance contains : omeprazole sodium equivalent to omeprazole 40 mg.
2. Indication
Duodenal ulcer, gastric ulcer and reflux oesophagitis, zollinger-ellison syndrome.
3. Administration
- Duodenal ulcer, gastric ulcer and reflux oesophagitis :
Patients who cannot be given oral medication can be treatted parenteraly with 40 mg once daily. The usual treatment period before transfer to oral treatment is 2-3 days.
- In Zollinger- Ellison Syndrome the dose should be adjusted individually.
Intravenous treatment can be given as an infusion over a period of 2-30 minutes. After reconstitution start the infusion immediately.
Impaired Renal Fungtion
A dose adjustment is not necessary for patients with impaired renal fuction.
Impaired Liver Function
In patients with impaired liver function clearance is greatly reduced.
Elderly patients
A dose adjustment is not necessary in elderly patients.
Children
There is only limited experience of Treatment in children.
4. Contraindications
known hypersensitivity to omeprazole.
5. Special warnings and special precautions for use
Suspected ulcer disease must be verified objectively at an early stage by means of X-ray or endoscopy in order to avoid in adequate treatment.
When gastric ulcer is present or suspected or in the presence of any of the following alarm symptoms : significant unintentional weight loss, reccurent vomiting, dysphagia, haematemesis or melena, malignancy should be excluded as treatment may alleviate symptoms and delay diagnosis.
6. Interactions
Effect of omeprezole on the pharmakcokinetics of other drugs :
The following combination with losec powder for solution for infusion should be avoided : ketoconazole and intraconazole. Omeprazole might influence the absorption of other drugs due to its effect on the gastric PH.
Omeprazole inhibits the enzyme CYP2C19 and therefore increased plasma level of other drugs (diazepam, warfarin, Phenytoin). During concomitant administration of clarithromycin or erythromycin and omeprazole the plasma concretration will be increased.
7. Pregnancy and lactation
Pregnacy : well conducted epidemiological studies indicate no adverse effects of omeprazole on pregnancy or no the helath of the foetus/newborn child. Omeprazole can be used during pregnancy.
Lactation : Omeprazole is excreted in breast milk. Influence, if any on the child is unknown.
8. Effect on ability to drive and use machines.
Losec is not likely to affect the ability to drive or use machines.
9. Overdose
intravenoue doses up to 270 mg in day and up to 650 mg over a three day period have been studied in clinical trials without any dose related adverse reactions.
Symptoms : Dizziness, apathy, headache, Tachycardi, neusea, vomiting, flatulence, diarrhoea. see also undesirable effects.
Reference :
Kuwait Drug index, 2006. |
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