Inhibita

Inhibita

omeprazole

Manufacturer:

Delta Pharma

Distributor:

Biomed
Full Prescribing Info
Contents
Omeprazole.
Description
Each Delayed Released Capsule contains: Omeprazole 40 mg.
Action
Proton Pump Inhibitor.
Indications/Uses
For the treatment of benign gastric and duodenal ulcers including NSAID induced gastric and duodenal ulcers or gastro duodenal erosions, gastro esophageal reflux disease (GERD), acid related dyspepsia or disorders associated with hyper secretion of gastric acid, such as the Zollinger-Ellison Syndrome. It is also used in combination with antibiotics for eradication of Helicobacter pylori in peptic ulcer disease as triple therapy.
Dosage/Direction for Use
Benign gastric and duodenal ulcers including NSAID induced gastric and duodenal ulcers or gastro duodenal erosions: 20 mg once daily for 4 weeks in duodenal ulceration or 8 weeks in gastric ulceration, in severe cases the dose may be increased to 40 mg daily.
Gastro esophageal reflux disease (GERD): 20 mg once daily for 4 weeks, followed by a further 4-8 weeks if not fully healed; 40 mg daily has to be given for 8 weeks in patients with reflux oesophagitis refractory to other therapy. Patients can be continued at a dosage of 20 mg once daily.
Acid related dyspepsia: the usual dose is 20 mg once for 2-4 weeks depending on the severity and persistence of symptoms. Patients who do not respond after 4 weeks or who relapse shortly afterwards, should be investigated. Zollinger-Ellison Syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (above 80 mg in 2 divided doses). Larger doses of up to 180 mg daily in divided doses may be used.
Helicobacter pylori eradication regimens in peptic ulcer disease: recommended dose is 40 mg once daily in association with antimicrobial drugs as described as follows: *Triple therapy regimens: Omeprazole 20 mg twice daily with one of the following antimicrobial combinations- Amoxycillin 500 mg & Metronidazole 400 mg both 3 times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg (or Tinidazole 500 mg) both twice a day for one week or Amoxycillin 1 g and Clarithromycin 500 mg both twice a day for one week.
Contraindications
Patients with known hypersensitivity to any of the components of the formulation.
Special Precautions
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate symptoms and delay diagnosis. Pediatric use of Omeprazole is not yet established.
Use In Pregnancy & Lactation
Avoid in pregnancy unless there is no safer alternative. Breast feeding should be discontinued if the use of Omeprazole is considered essential.
Side Effects
Omeprazole is well-tolerated. Nausea, diarrhea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
Drug Interactions
Drugs that are metabolized by cytochrome P-450 system such as cyclosporine, disulfiram, benzodiazepines have been reported to show interactions with Omeprazole. Omeprazole can delay the elimination of diazepam, phenytoin and warfarin. Reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to treatment. There is no evidence of an interaction with theophylline, propranolol or antacids.
Storage
Store at a temperatures not exceeding 30°C.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
Inhibita EC cap 40 mg
Packing/Price
100's;20's
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