Meprol Omeprazole Capsules

MEPROL®
(Omeprazole Capsules 20mg)

 

CATEGORY

Anti-ulcer: Proton Pump Inhibitors.

 

COMPOSITION

Each capsule contains Omeprazole capsules BP 20mg

 

STRENGTH

20mg per capsule

 

DOSAGE FORM

Meprol is presented as hard gelatin capsules.

 

PROPERTIES AND ACTIONS

Omeprazole, is a racemic mixture of R- and S- isomers, the S-Isomer, esomeprazole (S-omeprazole), is eliminated less rapidly than R-omeprazole, which theoretically provides a therapeutic advantage because of the increased half life.

Omeprazole is a prodrug that requires activation in an acid environment. Alter absorption into the systemic circulation, the prodrug diffuses into the parietal cells of the stomach and accumulates in the acidic secretory canaliculi. Here, it is activated by proton-catalyzed formation of a tetracyclic sulfenamide. The activated form then binds covalently with sulfhydryl groups of cysteines in the H+, K+ – ATPase, irreversibly inactivating the pump molecule.

Acid secretion resumes only after new pump molecules are synthesized and inserted into the luminal membrane, providing a long suppression of acid secretion, despite the shorter plasma half-life.

 

INDICATIONS

Meprol is indicated in the treatment of:

– Heartburns

– GERD (Gastro Esophageal Reflux Disease)

– Stress ulceration

– Gastric & duodenal ulcers

– Zollinger-Ellison Syndrome

– Acid related disorders

– Prophylaxis in long term NSAIDs therapy and acid aspiration.

 

RECOMMENDED DOSE

Active duodenal ulcer: 20mg/day for 2 weeks in most cases and up to 4-8 weeks (in severe cases)

Erosive oesophagitis, heartburn, symptoms associated with GERD: 20mg/day for up to 4-8 weeks, depending on the type of oesophagitis.

Gastric ulcer: 20mg/day for up to 4-8 weeks

In patients with duodenal ulcer, gastric or reflux oesophagitis, symptoms relief is rapid and healing occurs within 2 weeks in most cases. For those patients who may not have been fully healed after the initial course, healing usually occurs during a further 2 weeks treatment period with duodenal ulcer, and a further 4 weeks treatment for patients with gastric ulcer or reflux oesorphagitis.

Zollinger-Ellison Syndrome:
In patients refractory to other treatment course: The dosage should be adjusted individually and treatment continued as long as clinically indicated. In refractory patients, 20-120mg daily has been maintained with effective cure rate in over 90% of patients. Dose above 80mg daily should be divided during administration.

Maintenance Zollinger-Ellison syndrome:
The safety of omeprazole in long term treatment of indicated ailments has been established. Patients have been treated for upward of 3 years with omeprazole without any hazardous clinical results.

Eradication of H. pylori:
Omeprazole 20mg daily with amoxicillin 500mg t.d.s and metronidazole 400mg b.d have been given for 7 days for successful eradication of H.pylori. Other regimens that have been used for eradication are: omeprazole 20mg daily with amoxicillin 500mg t.d.s and clarithromycin 500mg b.d for 7 days.

Gastric Ulcers: 40mg once daily for 4-8 weeks.

 

DRUG INTERACTIONS

Meprol can prolong the elimination of Diazepam and Phenytoin and other drugs that are metabolized by oxidation in the liver. Monitoring and possible dose reduction is recommended where necessary. No interaction with Theophylline has been reported, but interactions with other drugs metabolized via cytochrome P450 enzyme system e.g Warfarin is possible. No interaction with concomitantly administered antacid has been reported.

 

MODE OF ADMINISTRATION

Oral: Capsules

 

CONTRAINDICATIONS

Pregnancy and lactation.

Use In Pregnancy And Lactation
Use of Meprol in pregnancy and lactation should be avoided except where considered essential. There is no evidence of foetal toxicity or teratogenicity with the use of omeprazole.

 

PRECAUTIONS/WARNINGS

When gastric ulcer is suspected, the possibility of malignancy should be excluded as treatment may exacerbate symptoms and delay diagnosis.

Bioavailability may be increased in geriatric patients; therefore, there may be need for dose adjustment.

 

UNDESIRABLE EFFECTS

Nausea, headache, diarrhea, constipation and flatulence are among the rarely reported side effects of omeprazole. These episodes are mild and transient.

 

STORAGE CONDITION

Store in a cool, dry place, protected from light. Keep out of reach of children.

 

PRESENTATION

Box containing 1 x 10, 2 x 10, 10 x 10’s Alu/Alu, Blisters.

For further information, please contact your Doctor or Pharmacist.

NAFDAC Reg. No.: A4-2924

 

 

Manufactured for

CHANMedi Pharm Ltd/Gte
Little Rayfleld Road, Jos
Plateau state – Nigerta
www.chaomedi-pharm.org

 

Manufactured by

Medopharm

34B, Industrial Area,

Malur-563130, India.

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