Section :
Omezol
COMPOSITION :
Each capsule contains : Omeprazole 20 mg (As enteric coated pellets) .
DESCRIPTION :
Omezol (Omeprazole) is a proton – pump inhibitor. It inhibits the secretion of gastric acid by irreversibly
blocking the enzyme system of H+/ K+ - ATPase (the proton pump) in the parietal cells . It inhibits both basa
and stimulated acid secretion irrespective of the stimulus. Omeprazole is rapidly absorbed and its absorptio
is not affected by food. It is almost completely metabolized in the liver and rapidly eliminated mostly in the
urine. The elimination half-life is about 0.5 to 3 hrs. Omeprazole is highly bound (about 95%) to plasma
proteins.
INDICATIONS :
Omezol is indicated in the treatment of :
- Gastro-oesophageal reflux disease.
- Gastric ulcer .
- Duodenal ulcer.
- Zollinger-Ellison syndrome.
- Reflux oesophagitis.
DOSAGE & ADMINISTRATION :
- Gastro-oesophageal reflux disease : 20 to 40 mg once daily for 4 to 12 weeks. Maintenance therapy : 20 m
once daily .
- Gastric ulcer : 20 mg once daily for 8 weeks. For the prevention of relapse a maintenance dose of 10-20 m
once daily is recommended .
- Duodenal ulcer : 20 mg once daily for 4 weeks. For the prevention of relapse a maintenance dose of
10-20 mg once daily is recommended.
- Zollinger-Ellison syndrome : Long term management requires administration of 60 mg up to 120 mg daily o
Omezol in divided doses. In some cases it may require more than 120mg daily given in 2 or 3 divided dos
- Reflux oesophagitis : 20 mg once daily for 4-8 weeks .
- Helicobacter Pylori associated peptic ulcer disease : 40 - 80 mg daily with amoxicillin 1.5 gm daily in divide
doses for 2 weeks .
RESTRICTIONS ON USE :
Contraindications
Hypersensitivity to Omeprazole .
Use in pregnancy and lactation
It is not recommended unless prescribed by the physician.
Precautions
Treatment with Omeprazole may mask symptoms of malignancy and therefore delay diagnosis .
DRUG INTERACTIONS :
- Omeprazole can prolong the elimination of diazepam , warfarin and phenytoin.
- It may increase absorption of digoxin and decrease the effectiveness of prednisone.
- Omeprazole inhibits the activity of some hepatic cytochrome P- 450 enzymes.
ADVERSE EFFECTS :
Omezol is well tolerated.The most common adverse effects are diarrhoea, skin rash , and headache which a
mild and transient. The rare adverse effects include arthralgia, myalgia and blood disturbances.
STORAGE INSTRUCTIONS:
- Store below 30°C, protect from light and humidity .
- Close the bottle tightly after each use .
- Discard three months from the date of opening .
PRESENTATION:
Omezol 20 : Pack of 14 capsules .