COMPOSITION

Xelopes TM 20 Capsule: Each capsule contains Omeprazole BP 20 mg (as enteric coated pellets) Xelopes TM Lyophilized Powder for Injection : Each 10 ml vial contains Omeprazole BP 40 mg (as Lyophilized Powder)

PHARMACOLOGICAL INFORMATION

Pharmacological Action

The proton pump inhibitor Omeprazole inhibits gastric acid by blocking the hydrogen-potassium adenosine triphosphatase enzyme system ( the protom pump) of the gastric parietal cell. Proton pump inhibitors are effective for short-term treatment of gastric and duodenal ulcers; it is also used in combination with antibacterials for the eradication of Helicobacter pylori. Omeprazole is also used in the prevention and treatment of NSAID-associated ulcers.

Mechanism of Action

Omeprazole is chemically a novel substituted benzimidazole derivative, which suppresses the final step in gastric acid production by forming a covalent bond to two sites of the H+K+- ATPase enzyme system at the secretory surface of the gastric parietal cell. This leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the H+K+-ATPase results in duration of antisecretory effect that persists longer than 24 hours. Omeprazole is quantitatively absorbed and bioavailability does not change upon multiple dosing.

CLINICAL INFORMATION

Therapeutic Indications

***  Omeprazole is indicated where suppression of acid secretion is of therapeutic benefit.                ***  Omeprazole is registered for the following Indications: -               ***  Duodenal ulcer                ***  Peptic ulcer diseases (PUD)                ***  Gastro esophageal reflux diseases (GERD)                ***  Treatment of ulcer resistant to H2 receptor antagonists (H2RAs)                ***  Treatment of ulcers induced by NSAIDs drugs                ***  Gastrointestinal (GI) bleeding from stress or peptic acid diseases                ***  Eradication of Helicobacter pylori (in combination with antibiotics)                ***  Prophylaxis for acid aspiration syndrome during induction of anesthesia     ***  Zollinger-ellison syndrome

Dosage and Administration

Benign gastric and duodenal ulcers ( including those complicating NSAID therapy) 20 mg daily 4 weeks for duodenal ulceration and 8 weeks for gastric ulceration; in severe cases increases to 40 mg daily. Zollinger-Ellison syndrome initially 60 mg once daily; usual range 20-120 mg daily ( above 80 mg in 2 divided doses). Reflux oesophagitis 20 mg daily for 4 weeks, followed by a further 4-8 weeks if not fully healed; 40 mg daily has been given for 8 weeks in reflux oesophagitis refractory to other treatment; may be continued at 20 mg daily.

Use in Pregnancy & Lactation

Lactating mother: There are no data on the excretion of Omeprazole into the breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother. Pregnant women: No data are available on administration of Omeprazole to pregnant women. However this drug should be used during pregnancy, only if clearly needed.

Use in Children

The safety and effectiveness of Omeprazole capsule or injection in children have not yet been established.

Use in Elderly

40 mg daily for 2-4 weeks and follow the physician advice.

Use in patient with Impaired Hepatic Function

Dosage reduction may be required in patients with impaired liver fuction as Omeprazole is extensively metabolized in the liver and its elimination rate is prolonged in such patients when compared to normal persons. The daily dose of 10-20 mg is recommended in patients with severe liver disease.

Use in patient with Impaired Renal Function

It is not necessary to adjust the dose of Omeprazole in patients with renal insufficiency.

Drug Interactions

Omeprazole is metabolized through the cytochrome P-450 system, and subsequently undergoes Phase II conjugation but no interaction has been observed and no dosage adjustment is needed with concomitant use of the following drugs; theophylline, antipyrine, caffeine, carbamazepine, diclofenac, digoxin, ethanol, glyburide, an oral contraceptive (Levonorgestrel/ethinyl estradiol), metoprolol, nifedipine.

Precautionss

Omeprazole may delay the elimination of diazepam, phenytoin and warfarin.

Side Effects

Potentially life-threatening effects: None has been reported with respect to Omeprazole. Severe or irreversible adverse effects: No serious adverse reactions have been described yet to date. Symptomatic adverse effects: Headache (1.3%) and diarrhoea (1.5%) are the two commonest reported adverse events. Peripheral edema has occasionally been reported in female patients. Other side effects may include abdominal pain, dizziness, nausea, epigastric discomfort, flatulence, skin rash, pruritus etc.

Contraindications

Patiens who are hypersensitive to Omeprazole or any of the inactive ingredients of Omeprazole are contraindicated to use of Omeprazole.

PHARMACEUTICAL INFORMATION

Storage Conditions

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

Presentation & Packaging

Xelopes   TM 20:: Each commercial box contains 64 capsules in Alu-Alu pack. XelopesTM Lyophilized Powder for Injection : Each commercial box contains 1 combipack in Alu-PVC pack.

Xelopes   TM Lyophilized Powder for Injection : Each commercial box contains 1 combipack in Alu-PVC pack.