Omrazol

COMPOSITION

Omrazol 20 Capsule: Each capsule contains Omeprazole BP 20 mg as enteric coated pellets. Omrazol 40 Capsule: Each capsule contains Omeprazole BP 40 mg as enteric coated pellets.

INDICATIONS

Benign gastric and duodenal ulcers including those complicating NSAID therapy, heartburn and other symptoms associated with GERD, erosive oesophagitis, pathological hypersecretory conditions such as the Zollinger-Ellison syndrome and to eradicate H. pylori in combination with Clarithromycin & Amoxycillin.

DOSAGE AND ADMINISTRATION

Benign gastric and duodenal ulcers including those complicating NSAID therapy: 20 mg once daily for 4 weeks in duodenal ulceration or 40 mg once a day for 4-8 weeks in gastric ulceration. Heartburn and other symptoms associated with GERD: 20 mg daily for up to 4 weeks. Erosive oesophagitis: 20 mg daily for 4-8 weeks. If there is recurrence of erosive oesophagitis or GERD symptoms (e.g., Heartburn), an additional 4-8 weeks therapy may be considered. Maintenance of Healing of Erosive Oesophagitis: 20 mg daily. Zollinger-Ellison syndrome: Adult oral starting dose is 60 mg once a day. Eradication of H. pylori in combination with Clarithromycin & Amoxycillin: 20 mg with Clarithromycin 500 mg & Amoxycillin 1000 mg twice daily for 7-14 days. Paediatric Patients For the treatment of GERD or other acid-related disorders, the recommended dose for paediatric patients 2 years of age and older is as follows: Patient Weight <20 kg : Dose 10 mg, Patient Weight =20 kg : Dose 20 mg.

CONTRAINDICATIONS

There are no known contraindications to the use of Omrazol (Omeprazole). When gastric ulcer is suspected, the possibility of malignancy should be excluded before treatment with Omrazol (Omeprazole) is instituted as treatment may alleviate symptoms and delay diagnosis.

PRECAUTIONS

Symptomatic response to therapy with Omrazol (Omeprazole) does not preclude the presence of gastric malignancy.

SIDE EFFECTS

It is well tolerated. Nausea, diarrhoea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage

DRUG INTERACTIONS

Omrazol (Omeprazole) can delay the elimination of diazepam, phenytoin and warfarin. Reduction of warfarin or phenytoin dose may be necessary when Omrazol (Omeprazole) is added to the treatment.

USE IN PREGNANCY AND LACTATION

It should be used during pregnancy only if the potential benefit to the pregnant woman justifies the potential risk to the fetus. Because Omrazol (Omeprazole) is excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

STORAGE PRECAUTIONS

Store in a cool and dry place, protect from light and moisture. Keep out of the reach of the children.

COMMERCIAL PACK

Omrazol 20 Capsule: Box containing 10 x 5 capsules in Alu-Alu blister pack. Omrazol 40 Capsule: Box containing 10 x 5 capsules in Alu-Alu blister pack.