Zolat

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Indication:

Zolat capsule is indicated for gastro esophageal reflux disease including reflux esophagitis, acid reflux disease, duodenal and benign gastric ulcers, Helicobacter pylori eradication in peptic ulcer disease, prophylaxis of acid aspiration, Zollinger-Ellison Syndrome (ZSE) and for the treatment of NSAID associated gastric ulcers, duodenal ulcers or gastroduodenal erosions.

Composition:

Zolat 20 Capsule: Each capsule contains Omeprazole enteric coated pellets 8.5% pharma grade 235.294 mg is equivalent to Omeprazole BP 20 mg.

Zolat 40 Capsule: Each capsule contains Omeprazole enteric coated pellets 8.5% pharma grade 470.588 mg is equivalent to Omeprazole BP 40 mg.

Therapeutic Class: Anti-Ulcerant

Generic Name: Omeprazole BP

Trade Name:

Category: Tag:

Description

 Pharmacology: Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. Omeprazole inhibits secretion of gastric acid by blocking the hydrogen-potassium adenosine triphosphatase enzyme system, the so called “proton pump” of the gastric parietal cell. If is an effective treatment for gastric and duodenal ulcers and particularly for erosive reflux esophagitis. Orally administered Omeprazole is absorbed rapidly but to a variable extent. Following absorption omeprazole is almost completely metabolized and rapidly eliminated mostly in the urine. Although the elimination half-life from plasma is short, being reported to be 0.5 to 1.5 hours, its duration of action with regard to inhibition of acid secretion is much longer and it is suggested that its distribution to the tissues particularly to the gastric parietal cells accounts for this action. Omeprazole is highly bound (about 95%) to plasma proteins.

 Dose and Administration: Capsule Omeprazole should be taken before meal.

Disease Gastro esophageal reflux disease including reflux esophagitis

Acid reflux disease

Duodenal and benign gastric ulcers Helicobacter pylori eradication in peptic ulcer

Dosage and administration The usual dosage is 20 mg Omeprazole once daily. The majority of patients are healed after 4 weeks. For long-term management, Omeprazole 10 mg once daily is recommended, increasing to 20 mg if symptoms return. The usual dose is 20 mg Omeprazole once daily. The majority of patients with duodenal ulcer are healed after 4 weeks. Omeprazole is recommended at a dose of 40 mg once daily or 20 mg twice daily. For patient considered to be at risk of aspiration of the gastric contents during general anesthesia, the recommended dosage is Omeprazole 40 mg on the evening before surgery followed by Omeprazole 40 mg 2-6 hours prior to surgery. The recommended initial dosage is 60 mg Omeprazole once daily, treatment continued as long as clinically indicated. With dose above 80 mg daily, the dose should be divided and given twice daily. The recommended dosage of Omeprazole is 20 mg once daily. Symptom resolution is rapid and in most patients healing occurs within 4 weeks.

Prophylaxis of acid aspiration

Zollinger-Ellison syndrome

For the treatment of NSAID associated gastric ulcers, duodenal ulcers or gastro duodenal erosions.

Geriatric use: No overall differences in safety and efficacy have been observed between the elderly and younger individuals.

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

Warning and Precaution: Symptomatic response to therapy with Omeprazole does not preclude the presence of gastric malignancy.

Side Effects:

a) Common: 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.

b) Rare: Side effects that may be seen very rarely include hair loss, chronic inflammation of the stomach, bone fracture.

Use in Pregnancy and Lactation In pregnancy: No adverse effect of omeprazole on pregnancy or on the health of the fetus / new born child. Omeprazole can be used during pregnancy.

Lactation: Omeprazole excreted in breast milk, but it is not likely to influence the child when therapeutic dose are used.

Use in children & adolescents: (1-16 Years) Weight Dose 10-20 kg

10 mg once daily, if needed 20 mg once daily > 20 kg

20 mg daily, if needed 40 mg once daily

Drug Interaction:

a) With medicine: 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 interaction with theophylline, propranolol or antacids.

b) With Food and others: It’s fine to drink alcohol in moderation while taking omeprazole it won’t affect the medicine specifically. However, if omeprazole makes feel dizzy then drinking alcohol is likely to make this worse.

Overdose: Symptoms were transient, and no serious clinical outcome has been reported with Omeprazole overdose. No specific antidote for omeprazole overdose is known. Omeprazole is extensively bound with plasma protein and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and supportive.

Storage: Store in a cool (below 30°C) and dry place, protected from light. Keep out of reach of the children.

Packing:

Zolat 20 Capsule: Each box containing 30’s/42’s/50’s/70’s/100’s capsules in Alu-Alu blister pack.

Zolat 40 Capsule: Each box containing 32’s/48’s/50’s/100’s capsules in Alu-Alu blister pack.

Additional information

Weight

20 mg

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