Frazole Forte

Each capsule contains omeprazole 40 mg.

Pharmacokinetics: Omeprazole is rapidly absorbed, but to a variable extent, following oral administration. Absorption of omeprazole is acid-labile and various formulation have been developed in an attempt to improve bioavailability from the gastro-intestinal tract. Consequently, its pharmacokinetics may vary with different formulation of the drug. The absorption of omeprazole, as well as being formulation dependent, also appears to be dose-dependent, is increasing the dosage above 40mg has been reported to increase plasma concentrations in a non-linear fashion.
Bioavailability with omeprazole may be increased in elderly patients. In some ethnic groups such as Chinese, and in patients with impaired hepatic function, but is not markedly affected  in patients with renal impairment.
Following absorption, omeprazole is almost completely metabolized in the liver, primarily  by cytochrome  P450 isoform CYP2C19, and rapidly eliminated mostly in the urine. Although the elimination half-life from plasma is short being reported to be about 0.5 to 3.0 hours, its duration of action with regard to inhibition of acid secretion is much longer allowing it to be used in single daily doses. Omeprazole is highly bound (about 95%) to plasma proteins.

Omeprazole is indicated for the treatment of: Reflux esophagitis.
Acid-peptic ulcer disease.
Zollinger-Ellison syndrome.
Adjunctive in duodenal ulcers associated with H. pylori combined with appropriate antibiotics.
Prophylaxis of acid aspiration before surgery.
Prevention and treatment NSAID associated ulcers.

For peptic ulcer: 20-40mg/day as a single dose after breakfast for 4-8 weeks PO.
For Zollinger-Ellison syndrome: 180mg/day in divided doses PO.
For GERD or severe esophagitis: 20mg/day 4-8 weeks PO, slow IV.
For prophylaxis of acid aspiration: 40mg PO evening before surgery; 2-6 hours before surgery slow IV.
Administration: Administer before food or meals, swallow whole capsule, do not chew or crush.

Hypersensitivity to the drug.
Gastric malignancy.

Severe liver disease.
Dosage adjustment should be considered in Asians who show 4-fold increase in AUC compared with Caucasians given 20mg single dose.

Avoid in pregnancy and breastfeeding.

CNS: reversible  confusional states, agitation, depression, hallucination.
GIT: nausea, diarrhea, abdominal colic.
HEMATOLOGIC: agranulocytosis, pancytopenia, thrombocytopenia.
DERMATOLOGIC: erythematous skin rashes, erythema multiforme, exfoliative dermatitis.
RENAL: interstitial nephritis, hematuria, glycosuria.
OTHERS: hypoglycemia, alopecia, blurred vision, arthralgia.

Enhanced effect of oral anticoagulants, antiepileptics, diazepam, methotrexate, digoxin.
Reduced absorption of ketoconazole, itraconazole, iron salts, ampicillin esters.

Store at temperatures not exceeding 30°C. Protect from light.

Antacids, Antireflux Agents & Antiulcerants

A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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