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Omesec

 

PRODUCT DESCRIPTION

Hard gelatin capsule with flesh opaque body and light brown opaque cap, each half printed with 'OMESEC 20' in black, holding enteric-coated mini-tablets.

 

COMPOSITION

Active Ingredient : Omeprazole 20 mg/capsule

Preservatives : None

 

PHARMACOLOGICAL ACTION

Omeprazole is a proton-pump inhibitor and thus prevents the secretion of gastric acid. Omeprazole is a weak base and is activated at an acidic pH to a sulphonamide derivative that binds irreversibly to Hydrogen/Potassium Adenosine Triphosphatase (H+/K+ ATPase) enzyme system, the so-called 'proton pump' that is found at the secretory surface of parietal cells. It thereby inhibits the final transport of hydrogen ions (via exchange with potassium ions) into the gastric lumen. Omeprazole inhibits both basal and stimulated acid secretion irrespective of the stimulus. It also inhibits hepatic cytochrome P-450 mixed function oxidase system.

 

PHARMACOKINETICS

Omeprazole is rapidly absorbed, but to a variable extent following oral administration. The absorption of Omeprazole is formulation-dependent and dose-dependent but it is not affected by food. Omeprazole in the form of enteric-coated mini-tablets is absorbed from the small intestines and delivered via the bloodstream to the parietal cell. Oral absorption of the enteric-coated formulation is relatively slow and may be further influenced as a result of delayed gastric emptying.

 

Omeprazole is distributed in tissue, particularly gastric parietal cells. It is highly bound to plasma proteins, approximately 95% bound to albumin and alpha1-acid glycoprotein. The onset of action is within one hour and the time to peak effect is within 2 hours. It has a duration of action of up to 72 hours or more. In a normal hepatic function, the plasma half-life is 30 minutes to 1 hour while in a chronic hepatic disease, the plasma half-life is 3 hours.

 

Omeprazole is almost completely metabolised in the liver. The three major metabolites identifiable in plasma are hydroxyomeprazole, a sulfide derivative and a sulfone. Omeprazole is subject to an important polymorphism of drug metabolism as it is a substrate for CYP2C19, the S-mephenytoin hydroxylase.

 

Omeprazole is rapidly eliminated, mostly in the urine as metabolites. Some is excreted in the faeces. The bioavailability of Omeprazole may be increased in elderly patients and in patients with impaired hepatic function, but is not markedly affected in patients with renal impairment.

 

INDICATIONS

Omeprazole is used in the treatment of gastro-oesophageal reflux disease; duodenal ulcer, benign gastric ulcer and Zollinger-Ellison Syndrome. It is also combined with antibacterial agents in dual or triple therapy regimens for the elimination of Helicobacter Pylori infection in patients with duodenal ulcer.

 

SIDE EFFECTS/ADVERSE REACTIONS

Skin

Skin rash, urticaria and pruritus have been reported, usually resolving after discontinuation of treatment.

 

Central and peripheral nervous system

Headache is a common side effect. Dizziness, paraesthesia, somnolence, insomnia and vertigo are rare. In isolated cases, reversible mental confusion, agitation, depression and hallucinations predominantly in severely ill patients have occurred. Increased sweating, peripheral oedema and blurred vision have been reported in isolated cases.

 

Gastrointestinal

Diarrhoea, constipation, nausea, vomiting, flatulence and abdominal pain.

 

Hepatic

Rarely increased in liver enzymes. In isolated cases, encephalopathy in patients with pre-existing severe liver disease; hepatitis with or without jaundice and hepatic failure have been reported.

 

Endocrine

In isolated cases, gynaecomastia has been reported.

 

Haematological

In isolated cases, leukopenia, thrombocytopenia, agranulocytosis and pancytopenia have been reported.

 

Musculoskeletal

In isolated cases, arthralgia, muscular weakness and myalgia have been reported.

 

PRECAUTIONS/WARNINGS

Pregnancy

Adequate and well-controlled studies in humans have not been done. Studies in pregnant rats did not show Omeprazole to have any teratogenic potential at doses 345 times the human dose. Avoid in pregnancy unless there is no safer alternative.

 

Breast-feeding

It is not known whether Omeprazole is distributed into human milk. However, because Omeprazole has been shown to cause tumourigenic and carcinogenic effects in animals, a decision should be made on whether breast feeding should be discontinued or the medication withdrawn, taking into account the importance of the Omeprazole to the mother.

 

Geriatrics

A decreased rate of elimination and an increased bioavailability are likely to occur in geriatric patients taking Omeprazole.

 

Gastric Ulcers

Before giving Omeprazole to patients with gastric ulcers, the possibility of malignancy should be excluded since Omeprazole may mask symptoms and delay diagnosis.

 

Hepatic Disease

In chronic hepatic disease, dosage reduction may be required due to increased half-life.

 

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