Each capsule contains Omeprazole 20mg
Zenpro Capsule (omeprazole) reduces gastric acid secretion through
inhibition of gastric acid pump in the parietal cell. The pharmacological
effects of omeprazole are largely confined to inhibition of gastric acid
secretion and effects that result therefrom.
Orally administered omeprazole is absorbed rapidly but to a variable extent.
Absorption of omeprazole is not affected by food. Its bioavailability
depends upon dose and gastric pH, and it may reach 70% with repeated
It is extensively (more than 95%) bound to plasma protein.
Omeprazole is almost completely metabolized in the liver and rapidly
eliminated, mostly in the urine. Although the elimination half-life from
plasma is short, being reported to be about 0.5 to 3 hours, its duration of
action with regard to inhibition of acid secretion is much longer allowing
it to be used in single daily doses. It is suggested that its distribution
to the tissues, and particularly to the gastric parietal cells, account for
In patients with chronic hepatic disease, the bioavailability
increased to approximately 100%, reflecting decreased first-pass effect, and
the plasma half-life of the drug increased to nearly 3 hours compared to the
half-life in normals of 0.5 to 1 hour.
In patients with chronic renal impairment, elimination of omeprazole is
slowed in proportion to the decreased creatinine clearance because urinary
excretion is a primary route of excretion. However, bioavailability is not
Zenpro Capsule is indicated for:
• Treatment of duodenal and benign gastric ulcers.
• Eradication of Helicobacter pylori in peptic ulcer disease.
Treatment of reflux oesophagitis and symptomatic treatment of heartburn and
regurgitation in gastro-oesophageal reflux disease (GORD).
• Treatment of Pathological Hypersecretory Conditions (Zolliger-Ellison
• Prophylactic treatment in patients with an increased risk of NSAIDs
associated peptic ulcer, gastro-duodenal erosion or dyspeptic symptoms.
• Treatment of NSAIDs induced peptic and gastro-duodenal erosion.
Zenpro Capsules are recommended to be given in the morning and swallowed
whole with liquid.
For patients with swallowing difficulties the capsule might be opened and
the contents swallowed or suspended in a slightly acidic fluid e.g. juice or
soured milk. The suspension should be taken within 30 minutes. Alternatively
these patients can suck the capsule and swallow the contents. The contents
of the capsule should not be chewed or crushed.
Short-term treatment of duodenal and benign gastric ulcers:
The recommended adult oral dose is 20mg once daily. Most patients with
duodenal ulcer heal within 4 weeks, while majorities of patients with benign
gastric ulcer are healed after 8 weeks. In severe cases, the dose may be
increased to 40mg once daily, and healing is usually achieved within 4 weeks
Long-term therapy for patients with a history of recurrent duodenal ulcer:
The recommended dosage is 20mg Zenpro Capsule once daily.
Prevention of relapse in patients with duodenal ulcer:
The recommended dose is 10mg once daily. If needed, the dose can be
increased to 20mg once daily.
The effectiveness of Zenpro Capsule is not affected by concomitant NSAID
treatment, and the usual dose and duration of treatment is recommended.
Eradication of Helicobacter pylori in peptic ulcer disease:
The usual dose is Zenpro Capsule 40mg daily with oral amoxicillin 1.5g daily
(given as 750mg b.d.) for 2 weeks. In clinical studies daily
doses of 1.5 to 2g of amoxicillin have been used.
Zenpro Capsule 40mg daily with clarithromycin 500mg t.i.d. for two weeks.
Zenpro Capsule 20mg, amoxicillin 1g and clarithromycin 500mg, all twice a
day for 7 days
Zenpro Capsule 20mg, clarithromycin 250mg and metronidazole 400mg (or
tinidazole 500mg), all twice a day for 7 days
Zenpro Capsule 40mg once daily with amoxicillin 500mg and metronidazole
400mg both three times a day for one week.
Reflux Esophagitis: The recommended dosage is 20mg once daily. Symptom
resolution is rapid and in most patients healing occurs within 4 weeks. For
those patients who may not be fully healed after the initial course, healing
usually occurs during a further 4 weeks treatment period. In patients with
severe reflux oesophagitis, Zenpro Capsule 40mg once daily is recommended
and healing is usually achieved within 8 weeks.
Symptomatic treatment of
gastro-oesophageal reflux disease:
The recommended dosage is Zenpro Capsule 20mg daily. Symptom relief is
rapid: If symptom control has not been achieved after 4 weeks treatment with
Zenpro Capsule 20mg daily, further investigation is recommended.
Pathological Hypersecretory Conditions: For Zollinger-Ellision
Syndrome, the recommended starting dose is 60mg once daily. The dosage
should be adjusted individually and treatment continued as long as
clinically indicated. Doses up to 120mg daily have been administered. Daily
dosages of greater than 80mg should be administered in divided doses.