KINZOLE CAPSULES 20 MG

Composition:

Each hard gelatin capsule contains :

Omeprazole B.P.  20 mg. (As Enteric Coated Granules)

Excipients  q.s.

Action:

Omeprazole belongs to a new class of antisecretory compounds, the substituted

benzimidazoles, that do not exhibit anticholinergic or H2 histamine antagonistic

properties, but that suppress gastric acid secretion by specific inhibition of the H+/K+

ATPase enzyme system at the secretory surface of the gastric parietal cell. Because

this enzyme system is regarded as the acid (proton) pump within the gastric mucosa.

Omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks

the  final step of acid production. This effect is dose-related and leads to  inhibition of both basal and stimulated acid secretion irrespective of  the stimulus

Indications:

Omeprazole  capsules are indicated for short-term treatment of active duodenal  ulcer, of active benign gastric ulcer, of erosive esophagitis which has  been diagnosed by

endoscopy. Omeprazole capsules are indicated to maintain healing of erosive

esophagitis, for the long-term treatment of pathological hypersecretory conditions (e.g;

Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis).

Contraindications:

Hypersensitivity to Omeprazole. Risk-benefit should be considered if current or history

of chronic hepatic disease exists. Dosage reduction may be required due to increased

half-life in chronic hepatic disease.

Precautions:

Pharmacokinetic studies in Asian subjects showed an approximately fourfold increase

in the area under the plasma concentration-time curve (AUC) as compared to

Caucasian subjects. Dosage adjustments should be considered for Asian patients.

Omeprazole have not been established for pediatric patients less than 2 years of age.

Use of Omeprazole in the age group 2 years to 16 years is supported by evidence from

adequate  and well-controlled studies of Omeprazole in adults with additional  clinical, pharmacokinetic, and safety studies performed in pediatric  patients.

In geriatric patients a somewhat decreased elimination and an increased bioavailability

are likely to occur. Omeprazole concentrations have been measured in breast milk of a

woman following oral administration of 20 mg. The peak concentration of Omeprazole

in breast milk was less than 7% of the peak serum concentration. This concentration

would correspond to 0.004 mg to Omeprazole in 200 mL of milk. Because Omeprazole

is excreted in human milk, because of the potential for serious adverse reactions in

nursing  infants from Omeprazole, and because of the potential for  tumorigenicity shown for Omeprazole in rat carcinogenicity studies, a  decision should be made whether to discontinue nursing or to discontinue  the drug, taking into account the importance of the drug to the mother.

Although in normal subjects no interaction with theophylline or propranolol was found,

there have been clinical reports of interaction with other drugs metabolized via the

cytochrome P-450 system (e.g; cyclosporine, disulfiram, benzodiazepines). Patients

should  be monitored to determine if it is necessary to adjust the dosage of  these drugs when taken concomitantly with Omeprazole.

Because of its profound and long lasting inhibition of gastric acid secretion, it is

theoretically possible that Omeprazole may interfere with absorption of drugs where

gastric pH is an important determinant of their bioavailability (e.g; ketoconazole,

ampicillin esters, and iron salts). In the clinical trials, antacids were used concomitantly

with the administration of Omeprazole.

Concomitant administration of Omeprazole has been reported to reduce the plasma

levels of atazanavir, thus appropriate clinical monitoring is recommended.

Concomitant administration of Omeprazole and tacrolimus may increase the serum

levels of tacrolimus.

Dosage and Administration:

There is no specific antidote for Omeprazole. Treatment is primarily symptomatic and

supportive. Due to extensive plasma protein binding, Omeprazole is not readily

dialysable. Clinical effects of overdose are: Blurred vision, confusion, drowsiness,

dryness of the mouth, flushing, headache, nausea, tachycardia.

Manufactured For :(A Division of Schwitz Biotech)C/101, Satya Appartments, Near Sai Baba Temple,Ghatlodia, AHMEDABAD - 61, GUJARAT, INDIA