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Prolok

Omeprazole BP

NAME STRENGTH PACK SIZE DOSAGE FORM
Prolok 20 20 mg 10X10 Capsule
Prolok 40 40 mg 3X10 Capsule
Prolok 40 IV 40 mg/ Vial 1's IV injection

Description

Prolok is the preparation of Omeprazole.It is a Proton Pump Inhibitor and most potent to neutralize gastric acid secretion.It is used for the relief of duodenal ulcer, gastric ulcer, GERD, GERD with erosive esophagitis, Zollinger-Ellison syndrome, resistant ulcers. Prolok is available as 20 & 40 mg Capsule & 40 IV Injection.

Prolok 20 Capsule: Each capsule contains 20 mg Omeprazole BP as enteric coated pellets. Prolok 40 Capsule: Each capsule contains 40 mg Omeprazole BP as enteric coated pellets. Prolok IV Injection: Each vial contains 40 mg sterile Lyophilized Omeprazole Sodium BP equivalent to 40 mg Omeprazole.

Prolok Capsule: Prolok capsule is used for the relief of duodenal ulcer, gastric ulcer, gastroesophageal reflux disease (GERD), GERD with erosive esophagitis, Zollinger-Ellison syndrome, resistant ulcers, eradication of Helicobacter pylori in combination with antibiotics, lesions associated with NSAIDs & prevention of acid aspiration syndrome. Prolok IV injection: Prolok IV is indicated for the treatment of gastric ulcer, duodenal ulcer, reflux esophagitis and also for the treatment of Zollinger-Ellison syndrome.

Capsule Dosage and Administration : Disease, Dose & Frequency: Duodenal ulcer 20 mg Once daily for 4 to 8 weeks Gastric ulcer 40 mg Once daily for 4 to 8 weeks Gastro-esophageal reflux disease (GERD) 20 mg Once daily for 4 weeks GERD with erosive esophagitis 20 mg Once daily for 4 to 8 weeks Maintenance of healing of erosive esophagit 20 mg Once daily * Zollinger - Ellison syndrome 60 mg * Resistant ulcers * Once daily for 4 to 8 weeks Eradication of Helicobacter pylori in combination with antibiotics20 mg or 40 mg *Lesions associated with NSAIDs 20mg to 40mgOnce daily *Prevention of acid aspiration syndrome * Depends on the severity of the disease. Children (over 2 years): Severe ulcerating reflux esophagitis : 0.7-1.4 mg/kg daily for 4-12 weeks; maximum 40 mg daily (to be initiated by hospital pediatricians). Elderly: Dosage adjustment is not required in elderlypatients. Prolok IV injection: In patients with duodenal ulcer, gastric ulcer or reflux esophagitis 40 mg once daily is recommended. In patients with Zollinger-Ellison syndrome, the recommended initial dose is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided and given twice daily. Impaired renal function: Dose adjustment is not needed in patients with impaired renal function. Impaired hepatic function: As plasma half-life of Omeprazole is increased in patients with impaired hepatic function, a daily dose of 10 - 20 mg may be sufficient. Elderly: Dose adjustment is not needed in the elderly. Children: The safety and effectiveness of Omeprazole injection in children have not yet been established.

Omeprazole is well tolerated and adverse reactions have generally been mild and reversible. Gastrointestinalside effects include diarrhoea, constipation, abdominal pain, nausea/vomiting and flatulence. Central and peripheral nervous system disorders reported include headache, dizziness, paraesthesia, somnolence, insomnia and vertigo. Others include hypersensitivity reactions, e.g angioedema, fever, bronchospasm, interstitial nephritis and anaphylactic shock. Increased sweating, peripheral edema, blurred vision, taste disturbance and hyponatremia.

Omeprazole should be given in reduced dosage to patients with impaired hepatic function. Use in pregnancy: Results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. Omeprazole can be used during pregnancy. Use in lactation: Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. Like other drugs it should only be used during nursing if considered essential.

Use in pregnancy: Results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. Omeprazole can be used during pregnancy. Use in lactation: Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. Like other drugs it should only be used during nursing if considered essential.

The absorption of some medicines might be altered due to the decreased intragastric acidity. As Omeprazole is metabolised in the liver it can prolong the elimination of Diazepam, Warfarin and Phenytoin. Plasma concentrations of Omeprazole and Clarithromycin are increased during concomitant administration but there is no interaction with Metronidazole or Amoxicillin. These antimicrobials are used together with Omeprazole for eradication of Helicobacter pylori.

Doses up to 400 mg have not resulted in severe symptoms. Symptomatic and supportive therapy should be given as appropriate. Omeprazole IV doses of up to 270 mg on a single day and up to 650 mg over a three-day period have been given in clinical trials without any dose-related adverse reactions.

Store in a cool and dry place, protected from light. Keep out of the reach of children.

Patients known to have hypersensitivity to any component of the preparation.

Prolok 20 Capsule: Box containing 10×10 capsules in Alu-Alu blister pack. Prolok 40 Capsule: Box containing 3×10 capsules in Alu-Alu blister pack. Prolok IV Injection: Each combipack contains 1 vial of 40 mg Omeprazole and 1 ampoule of 10 ml of 0.9% Sodium Chloride BP and a sterile disposable syringe (10 ml).