HATRIZOL
HATRIZOL
COMPOSITION: Omeprazole ................... 20 mg
Excipients.q.s ...........1 capsule
(Mannitol, HPMC, methacrylic acid copolymer, sodium lauryl sulfate, disodium hydrogen phosphate, sucrose, titanium dioxide, PVP K30, calcium carbonate, talc, diethyl phthalate, polysorbate 80, sodium hydroxide, methylparaben sodium, propylparaben sodium).
DOSAGE FORM: Gastro-resistant capsule.
PRESENTATIONS: Box of 2 blisters x 7 capsules. Box of 3 blisters x 10 capsules. Bottle of 150 capsules. Bottle of 100 capsules.
PHARMACODYNAMICS:
Omeprazole inhibits secretion of gastric acid and is considered to do so by reversibly blocking the enzyme of hydrogen/potassium adenosine triphosphatase, the so-called proton pump of the gastric parietal cells. Action of omeprazole is quick, prolonged, but reversible. Omeprazole has no effects on acetylcholine or histamine receptors. Maximum effect achieved within four days of treatment.
PHARMACOKINETICS:
Absorption of omeprazole takes place in the small intestine and is usually completed within 3 - 6 hrs. The bioavailability is about 60%. Concomitant intake of food has no influence on the absorption. Omeprazole may improve its own absorption and relative bioavailability by inhibiting the secretion of gastric acid. Omeprazole is highly bound (about 95%) to plasma proteins and distributed to the tissues, particularly to the gastric parietal cells. After repeated once-daily administration, the bioavailability increases to about 60%. Although the elimination half-life is short (about 40 minutes), the duration of action with regard to inhibition of acid secretion is longer allowing it to be used in single daily doses. Omeprazole is completely metabolised mainly in the liver. About 80% of an orally given dose is excreted in the urine and the remainder is found in the feces. The metabolites of omeprazole are mostly inactive but may interact with other medicines due to inhibition of cytochrome P450 enzyme. The pharmacokinetics of omeprazole is insignificantly changed in the elderly or in patients with renal impairment. In patients with impaired hepatic function, the bioavailability of omeprazole is increased and the clearance of omeprazole is decreased, but there is no drug accumulation or metabolites in the body.
INDICATIONS:
Gastroesophageal reflux disease. Gastric and duodenal ulcers. Zollinger-Ellison syndrome.
CONTRAINDICATIONS:
Hypersensitivity to any components of the drug.
PRECAUTIONS:
Before receiving omeprazole therapy, the possibility of malignancy should be excluded since the drug may mask symptoms and delay diagnosis.
PREGNANCY AND LACTATION:
Experimentally, omeprazole causes no deformity and toxicity to fetus. However, omeprazole should not be administered during pregnancy, particularly in the first-trimester of pregnancy.
Omeprazole should not be administered in breast-feeding mothers.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
The drug can induce certain adverse effects e.g., headache, drowsiness, dizziness; therefore, the drug should not be taken during driving or operating machinery.
INTERACTIONS:
Omeprazole may prolong the elimination of diazepam, phenytoin, and warfarin and certain drugs metabolised by the cytochrome P450 system. Omeprazole may enhance the plasma concentration of ciclosporin and the action of dicoumarol and antibiotics for H. pylori eradication. Omeprazole may reduce at least 20% of nifedipine metabolism and may enhance the effects of nifedipine. Clarithromycin inhibits the metabolism of omeprazole and makes omeprazole concentration being double.
ADVERSE EFFECTS:
Frequently: headache, drowsiness, dizziness, vomiting, nausea, constipation, abdominal distension.
Infrequently: insomnia, fatigue, sensation disorders, pruritus, urticaria, temporary increase in transaminase hepatic enzyme.
Rarely: sweating, peripheral oedema; hypersensitivity reactions, including angioedema, fever, anaphylaxis, hypoleukemia, thrombocytopenia, low blood cell counts, granulocytopenia, reversible confusion, agitation, depression, hallucinations in the elderly, particularly in severely ill patients, hearing disorder, gynaecomastia, candidiasis, dryness of mouth, hepatitis with jaundice or without jaundice, encephalopathy in patients with pre-existing liver disease, bronchospasm, arthralgia, myalgia, nephritis, etc.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE:
In the event of overdosage, only treating symptoms, no having specific drugs.
DOSAGE & ADMINISTRATION:
Omeprazole should be orally taken 30 minutes before breakfast.
Treatment of reflux oesophagitis: The recommended dose is 20 - 40 mg (1 - 2 capsules) within 4 - 8 weeks. A maintenance dose is 20 mg once daily.
Treatment of ulcers: Oral dose of 20 mg (1 capsule) once daily. In severe cases, doses of 40 mg (2 capsules) once daily within 4 weeks in case of duodenal ulcer; within 8 weeks in case of gastric ulcer.
Treatment of Zollinger-Ellison syndrome: Oral dose of 60 mg (3 capsules) once daily. Doses more than 80 mg (4 capsules) should be divided and given twice daily.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescription only.
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer's.