DEU®-20
Omeprazole

COMPOSITION
DEU®20 Capsule: Each capsule contains Omeprazole BP 20 mg as enteric coated pellets.

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
Adults

Diseases	Dose	Frequency
Duodenal ulcer pneumonia	20 mg	Once daily for 4 to 8 weeks
Gastric ulcer	40 mg	Once daily for 4 to 8 weeks
Gastro esophageal reflux diseases (GERD)	20 mg	Once daily for 4 weeks
Maintenance of healing of erosive esophagitis	20 mg	Once daily for 4 to 8 weeks
Zollinger-Ellison syndrome	60 mg	*
Resistant ulcer	*	Once daily for 4 to 8 weeks
Eradication of Helicobacter Pylori (in combination with antibiotics)	20 mg or 40 mg	*
Lesions associated with NSAIDs	20 mg or 40 mg	Once daily
Prevention of acid aspiration syndrome	*	*

Use in Children
The safety and effectiveness of Omeprazole capsule in children have not yet been established.

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

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.

Elderly Patients
Dosage adjustment is not needed in the elderly patients.

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.

Use in Pregnancy & lactation
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.
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.

Undesirable 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.

PHARMACEUTICAL INFORMATION
Storage Conditions
Store in a cool and dry place, away from light. Keep out of reach of children.
Presentation & Packaging
DEU®20 capsule: Each commercial box contains 12x4's in blister pack.