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ZenproZenpro

 

Composition
Each capsule contains Omeprazole 20mg

Pharmacology
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.

Pharmacokinetics
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 administration.


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 this action.

 

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 markedly affected.

Indication
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 syndrome)
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.

Dosage
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:
Dual Therapy:
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.
or
Zenpro Capsule 40mg daily with clarithromycin 500mg t.i.d. for two weeks.


Triple Therapy:
Zenpro Capsule 20mg, amoxicillin 1g and clarithromycin 500mg, all twice a day for 7 days
or
Zenpro Capsule 20mg, clarithromycin 250mg and metronidazole 400mg (or tinidazole 500mg), all twice a day for 7 days
or
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.
 

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