Friday, September 13, 2013


GasecTM - 20 Proton pump inhibitor 
Gasec-20 Gastrocaps 
Each Gastrocaps contains 
Omeprazole 20 mg 
(in the form of enterlc-coated pellets) Properties, 
effects Omeprazole belongs to the group of proton pump inhibitors, and inhibits both the basal and stimulated secretion of stomach acid and reduces the amount of pepsin. The duration of effect for stimulated and non- stimulated acid secretion is at least 24 hours. 
Reduction in acid secretion excludes a major aggressive factor in the pathogenesis of peptic ulcers and other gastrointestinal disorders, leading to relief of pain and to accelerated healing of the mucous membrane defect. 
Pharmacokinetics Gasec-20 Gastrocaps contain an enteric-coated pellet formulation of omeprazole (because omeprazole is acid-labile, so that absorption of omeprazole only begins after the pellets leave the stomach. Absorption is rapid after oral intake on an empty stomach,) with peak plasma levels occurring within 0.5 to 3.5 hours. Absorption may be delayed by food.
The plasma half-life is 0.5 to 1 hour. Omperazole has a limited volume of distribution of 0.3-0.4 I/kg and is initially confined to extracellular fluids; plasma protein binding is approximately 95%. 
Following absorption, omeprazole is almost completely metabolized in the liver and rapidly eliminated, mostly in the urine. Although the elimination half-life from plasma is short reported to be about 0.5 to 3 hours, its duration of action with regard to acid secretion is much longer, allowing it to be used in single daily doses. 
Distribution is rapid, and by 4 hours is limited to gastric mucosa, liver and gallbladder. After 48 hours, omeprazole remains only in the gastric mucosa. Passage across the blood-brain barrier appears to be limited. 
Following single-dose oral administration, the major part of the dose (about 77%) is eliminated in urine as at least six metabolites. Two have been Identified as hydroxymeprazole and the corresponding carboxylic acid. The remainder of the dose is recoverable in faeces. This implies considerable biliary excretion of the metabolites of omeprazole. Three metabolites have been identified in plasma 
- the sulphide and sulphone derivatives of omeprazole. These metabolites have little or no antisecretory activity.
In patients with chronic hepatic disease, the bioavailability increases to 100% compared to an IV dose, reflecting decreased first- pass effect, and the plasma half-life of the drug increases to nearly 3 hours compared to the half-life in normal subjects of 0.5-1 hour. 
In patients with chronic renal impairment, there is a slight increase in bioavailability. Because urinary excretion is a primary route of omeprazole metabolites, their elimination slows in proportion to the decreased creatinine clearance and their concentration increases. 
Indications Gasac-20 is used in conditions in which acid reduction is appropriate, with once-daily administration: - Gastroduodenal ulceration: peptic ulcer: duodenal ulcer, benign stomach ulcer, relapsing ulcer, including NSAID-induced peptic ulcer; peptic ulcer after surgery; duodenal ulcer associated with Helicobacter pylon. - Gastritis - Hyperacidic, irritable stomach - Gastroesophageal reflux - Bleeding from ulcerations or erosions In the oesophagus, stomach or duodenum. - Prophylaxis against ulceration and bleeding in the upper gastrointestinal tract in risk patients. - Acute mucosal stress ulceration. - Aspiration syndrome. - Zollinger-Elison Syndrome. 111111
150227018011 Dosage, application Usual dosage 
Duodenal ulcers, benign gastric ulcers, postoperative ulcers, recurring ulcers: 
For short-term management the normal daily dose is 20 mg increasing to 40 mg once daily in severe or refractory cases. A single daily dose of 20 mg before breakfast or before the evening meal produces effective gastric suppression for 16 to 18 hours. This dose can be doubled when the response is not satisfactory. Duration of treatment 
Duodenal ulcer: at least 4 weeks. Gastric ulcer: at least 6-8 weeks Duodenal ulcer associated with 
Helicobacter pylon: 
The usual dose is 40 mg daily with amoxycillin 1.5 g(750 mg b.d.) for 2 weeks. Up to 2 g/day of amoxycillin has been used in clinical trials. 
Gastrooesophageal reflux / erosive oesophagitis: 
Usual daily dosage: 20 mg to 40 mg. depending on the severity of the lesion. Duration of treatment: 4 to 8 weeks, depending on the severity of the lesion. At the beginning of treatment, and in case of continuing pain, antacids may be prescribed. Both in recurrent peptic ulcer and chronic gastroesophageal reflux, pulsed maintenance treatment giving 20 mg of omeprazole for 3 days 
each week, instead of continuous 
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