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Drug MEPRAZ have composition Omeprazole 20 mg, treat of for Gastric ulcer, Gastroesophageal Reflux Disease, Short-term treatment (4-8 weeks) of severe erosive esophagitis, symptomatic gastroesophageal reflux disease

Maalox indication treatment of Gastritis,  Dyspepsia, Peptic ulcer, Hiatal hernia

Pepsane indicated for the treatment of stomach ache. Pepsane : oral gel – sachets

Air-X therapeutic indications accumulation of gas in the gastrointestinal tract

COMPOSITION: Each MEPRAZ capsule contains:

Active ingredient: Omeprazole 20 mg

DOSAGE FORM: Capsule (as enteric coated granules).

MEPRAZ Active ingredient - Omeprazole 20 mg

PACKAGING SIZE

– Box of 5 strips of 4 capsules

– 1 strip of 4 capsules in a strip-pack.

PROPERTIES

Mechanism of Action: MEPRAZ belongs to a new class of antisecretory compounds which inhibits enzyme H+/K+ ATPase (the proton pump) of the gastric mucosal cells. Its mechanism differs from anticholinergic or H2 histamine antagonistic agents. MEPRAZ combines with enzyme H+/K+ ATPase system and blocks the final step of acid production. This effect leads to inhibition of both basal acid secretion and stimulated acid secretion which are caused by stimulus of unknown etiology.

Anti-secretory Activity: After oral administration, the onset of the antisecretory effect of MEPRAZ occurs within 1h, with the maximum effect occurring within 2 hours. The inhibition of secretion is about 50% of maximum at 24 hours and the duration of inhibition lasts up to 72 hours. The anti-secretory effect thus lasts far longer than would be expected from the very short (less than 1h) plasma half-life, apparently due to prolonged binding to the parietal H+/K+ ATPase enzyme. When the drug is discontinued, secretory activity returns gradually over 3-5 days. The Inhibitory effect of MEPRAZ on acid secretion increases with repeated once-daily dosing, reaching a plateau after 4 days.

Pharmacokinetics:

Absorption

Absorption is rapid, with peak plasma levels of omeprazole occurring within 0.5 to 3.5 hours. Peak plasma concentrations of omeprazole and AUC are approximately proportional to doses up to 40 mg. Absolute bioavailability (compared with intravenous administration) is about 30-40% at doses of 20-40 mg, due in large part to presystemic metabolism. In healthy subjects the plasma half-life is 0.5 to 1 hour, and the total body clearance is 500-600 ml/min. Distribution: Protein binding is approximately 95%.

Metabolism:

Omeprazole 20mg is extensively metabolized by the cytochrome P450 (CYP) enzyme system.

Excretion: The majority of the dose (about 77%) was eliminated in urine as metabolites. Little if any unchanged drug was excreted in urine.

INDICATIONS

– Short-term treatment of active duodenal ulcer (MEPRAZ should not be used as maintenance therapy for treatment of patients with duodenal ulcer disease).

– Gastric ulcer.

– Gastroesophageal Reflux Disease (GERD):

– Short-term treatment (4-8 weeks) of severe erosive esophagitis (grade 2 or above) which has been diagnosed by endoscopy.

– Short-term treatment (4-8 weeks) of symptomatic gastroesophageal reflux disease (esophagitis) poorly responsive to customary medical treatment, usually including an adequate course of a histamine baroceptor antagonist.

– Long-term treatment of pathological hypersecretory conditions (Zolllnger-Ellison syndrome, multiple endocrine adenomas).

DOSAGE & ADMINISTRATION

– Short-Term Treatment of Active Duodenal Ulcer: The recommended adult oral dose is 20 mg once daily. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.

– Gastric ulcer: 20mg once daily tor 4 – 8 weeks.

– Severe Erosive esophagitis or poorly Responsive Gastroesophageal Reflux Disease (GERD): The recommended adult oral dose is 20 mg daily for 4 to 8 weeks.

– Pathological Hypersecretory Conditions: The recommended adult oral starting dose is 60 mg once a day.

Doses should be adjusted to Individual patient needs and should continue for as long as clinically responses.

Doses up to 120 mg T.I.D have been administered. Daily dosage of greater than 80 mg should be administered in divided doses.

– No dosage adjustment is necessary for patients with renal impairment, hepatic dysfunction or tor the elderly.

– MEPRAZ should be taken before eating.

– MEPRAZ capsules should not be opened, chewed or crushed. It should be swallowed whole.

CONTRAINDICATIONS

– Hypersensitivity to any component(s) ot drug.

– MEPRAZ should not be used in pregnant women.

ADVERSE REACTIONS

MEPRAZ is well tolerated. Its adverse reactions occur rarely: nausea, headache, diarrhea, constipation, flatulence and skin rashes.

INFORM YOUR DOCTOR IN CASE OF ANY ADVERSE REACTION RELATED TO DRUG USE

WARNING

– Symptomatic response to MEPRAZ therapy does not preclude the presence of gastric malignancy diseases.

– The breast-feeding of infants should be discontinued in mothers receiving MEPRAZ.

DRUG INTERACTIONS

-The absorption of some drugs might be altered due to the decreased intragastric acidity: the absorption of Ketoconazole will decrease during MEPRAZ treatment.

– MEPRAZ is metabolised in the liver through cytochrome P450. it can prolong the elimination of Diazepam. Warfarin and Phenyltoin. However, concomitant treatment with MEPRAZ does not change the blood concentration of these drugs.

– Plasma concentrations of MEPRAZ and Clarithromycin are increased during concomitant administration.

– No interaction with food or concomitantly administered antacids has been found.

OVERDOSE

Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth. Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.

STORAGE: Store at temperature below 30°C. Avoid direct sunlight and moisture.

SPECIFICATIONS USP.

EXPIRY DATE: 30 months from the manufacturing date.

Keep out of reach of children Read the package insert carefully before use Ask your doctor for further information Use upon doctor’s prescription only

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