OMEPRA 20

OMEPRA 20

OMEPRA 20

Anti-Ulcer/Acid/Flatulence

Omeprazole belongs to a new class of antisecretory
 compounds, that inhibits gastric acid secretion by irreversibly
 blocking the H+/K+ ATPase enzyme system, (the proton 
 pump) of the gastric parietal cell, so 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.
-OMEPRA®  capsules contain an enteric coated pellets
 formulation of Omeprazole (because Omeprazole is
 acid-labile), so that absorption of Omeprazole begins only
 after the pellets leave the stomach. Omeprazole is rapidly
 absorbed from the small intestine and its absorption is not 
 affected by food. Peak plasma levels of Omeprazole
 occurring within 0.5 to 3.5 hours. It is highly bound to plasma
 proteins (about 95%),extensively metabolized in the liver and
 rapidly eliminated as inactive metabolites mostly in the urine. 
 

Indecation

OMEPRA®  is indicated for the treatment of: 
- Peptic  ulcer (gastric and duodenal ulcers).
- Reflux oesophagitis. 
- Gastro-oesophageal reflux disease.
- Zollinger-Ellison syndrome. 
 

Dosage & Administration

OMEPRA® should be taken before meals. 
- Peptic ulcers and reflux oesophagitis: 1 -2 capsules once
  daily in the morning for 4 -12 weeks. For the prevention of
  relapse , a maintenance dose of 10- 20 mg once daily is
  recommended. 
- Gastro-oesophageal reflux disease: 20 to 40 mg once daily
  for 4 to 12 weeks.  Maintenance therapy: 20 mg once daily. 
- Zollinger-Ellison syndrome: long term management
  requires administration of 60 mg up to 120 mg daily of 
  OMEPRA® in divided doses, In some cases it may require
  more than 120 mg daily given in 2 or 3 divided doses.
- For the eradication of Helicobacter pylori in peptic

ulceration:
* Triple therapy regimens: OMEPRA® 40 mg daily combined with Amoxicillin 500 mg and Metronidazole 400 mg both three times daily or with Clarithromycin 250 mg and Metronidazole 400 mg (or Tinidazole 500mg) both twice daily or with Amoxicillin 1 g and Clarithromycin 500 mg both twice daily. These regimens are given for 1 week.


* Dual therapy regimens: OMEPRA®  40 -80 mg daily with Amoxicillin 1.5 g daily in divided doses for 2 weeks or OMEPRA®  40 mg once daily and Clarithromycin 500 mg three times a day for two weeks. 
-Or as directed by the physician.

Each capsule of OMEPRA®  20 contains: 
   Omeprazole   20 mg       (As enteric coated pellets)


Hypersensitivity to Omeprazole. 


  the metabolism of some other drugs metabolised by these 
  enzymes. It can prolong the elimination of Diazepam, 
  Phenytoin and Warfarin. 
- The decreased gastric acidity caused by Omeprazole may 
  affect the absorption of other drugs given concomitantly
  such as: Ketoconazole, Ampicillin esters and Iron salts. 
- Plasma concentrations of Omeprazole and Clarithromycin
  are increased during concomitant administration. 
 

OMEPRA®  should not be administered during pregnancy
  and lactation unless strictly indicated, and as directed by the
  physician .

OMEPRA® is well tolerated and adverse reactions have
  generally been mild and reversible. 
- The most frequent side effects are gastro-intestinal
  disturbances, in particular diarrhoea, skin rash, and 
  headache. 
- The rare side effects include arthralgia, myalgia, and blood
  disorders. 


- OMEPRA®  is not recommended for patients with
  suspected gastric tumors as it might alleviate symptoms and
  delay diagnosis.  
- Dosage should be reduced in hepatic impairment. 


- Plastic jar of 14 capsules with a desiccant.
- Strip of 10 capsules, pack of 10 strips. 
- Hospital packs of different sizes.

Store in a dry place at a temperature below 30oC, protected from light and humidity.