COMPOSITION:
Each capsule contains: Omeprazole B.P. 20 mg
(as enteric coated pellets)

ACTION:
OMESEC (omeprazole) belongs to a new class of anti-secretory compounds, the substituted benzimidazloes, that suppresses gastric acid secretion by specific inhibition of the H+ / K+ ATPase enzyme system at the secretory surface of the gastric parietal cells. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, OMESEC (omeperazole) has been characterized as a "GASTRIC ACID PUMP INHIBITOR", in that it blocks the final step of acid production. This effect is dose related and leads to inhibition of both basal and stimulated acid secretions. OMESEC capsule once daily provides rapid and effective inhibition of day and night time gstric acid secretion with maximum effect being achieved within 4 days of treatment. As a consequence of reduced acid secretion and intragastric activity, OMESEC (omeprazole) dose dependently reduces/normalizes acid exposure of the oesophagus in patients with gastro-oesophageal reflux disease (GORD). No tachyphylaxis has been observed during treatment with omeprazole.

EFFECT ON THE HELICOBACTER PYLORI:
Helicobacter pylori is associated with acid peptic disease, including duodenal and gastric ulcer disease, in which about 95% and 70% of patients respectively are infected with this bacterium.
OMESEC (omeprazole) has a bactericidal effect on H, Pylori in vitro. Eradication of H.Pylori with omeprazole and antimicrobials is associated with rapid symptom relief , high rates of healing of any mucosal lesion.

PHARMACOKINETICS:
OMESEC (omeprazole) capsule contains an enteric coated pellet formulation of omeprazole (because omeprazole is acid labile), so that absorption of omeprazole begins only after the granules leave the stomach. Absorption is rapid, with peak plasma levels of omeprazole occurring within 0.5 to 3.5 hours. Plasma half-life is 0.5 to 1 hour. Protein binding is approximately 95%.The majority of the drug (about 77%) is eliminated via the kidneys and the remaining in faeces.

INDICATION:

• OMESEC is indicated for the treatment of duodenal ulcer, gastric ulcer, reflux oesophagitis, symptomatic gastro-oesophageal reflux disease.
  
• NSAID associated gastric and duodenal ulcers, or erosions.
  
• Helicobacter pylori eradication in peptic ulcer disease.
  
• Zollinger - Ellison syndrome.

DOSAGE AND ADMINISTRATION:
OMESEC capsules are recommended to be given in the morning.

Duodenal Ulcer:
Acute ulcer : 20mg daily for 2 to 4 weeks.
Chronic ulcer : 40mg daily in divided doses for 4 weeks.

Gastric Ulcer:
Acute ulcer : 20mg daily for 4 weeks.
Chronic ulcer : 40mg daily in divided doses for 4 weeks.

Gastro-Oesophageal Reflux Disease (GORD) Or Reflux Oesophagitis:
20mg daily for 4 weeks. In severe cases 20mg daily for 8 weeks.
NSAID associated gastric or duodenal ulcers or erosions:
20mg daily for 3 weeks.
Helicobacter pylori (HP) eradications in peptic ulcer disease:

TRIPLE therapy regimen:
OMESEC 20mg, amoxicillin 1G and clarithromycin 500mg, all twice a day for ONE week,
OR
OMESEC 20mg, clarithromycin 250mg and metronidazole 400mg (or tinidazole 500mg), all twice
a day for ONE week,
OR
OMESEC 40mg once daily with amoxicillin 500mg and metronidazole 400mg both three times a day for ONE week.
DUAL therapy regimen:
OMESEC 40mg daily with amoxicillin 1.5G daily in divided doses for TWO weeks.

NOTE:
In each regimen if the patient is still HP positive, therapy may be repeated.
Zollinger-Ellison Syndrome :
The dosage should be individually adjusted and treatment continued as long as is clinically indicated.
80mg daily in divided doses, [2 capsules morning, 2 capsules evening].

CONTRAINDICATION:
Known hypersensitivity to omeprazole.

SIDE EFFECT:
OMESEC is very well tolerated and adverse effects have generally been mild and reversible.

NOTE
When gastric ulcer is suspected, the possibility of malignancy should be excluded as treatment may alleviate symptoms and delay diagnosis.

PRESENTATION:
Bottle pack of 14 capsules.

STORAGE:
Keep in a cool place away from light and moisture.Keep all medicines away from children.