Mep-40

Omeprazole (Mep-40) 40 mg Capsule is a white to off-white enteric coated pellets contained in an orange body/scarlet cap #0 EGC.
Each capsule contains: Omeprazole, USP 40 mg.

Pharmacology: Pharmacodynamics and Pharmacokinetics: Omeprazole belongs under a class of drugs called proton pump inhibitors. Omeprazole blocks or inhibits gastric acid secretion. It reduces gastric acid secretion by inhibiting the enzyme system of hydrogen-potassium adrenaline triphosphate, which is regarded as the acid proton pump of the gastric parietal cells. Also called H+/K+-ATPase, the enzyme responsible for the exchange of hydrogen and potassium ions during the formation of hydrochloric acid.
It is rapidly but variably absorbed following oral administration. Omeprazole is acid-labile and pharmacokinetics may vary between the various formulations developed to improve oral bioavailability. The absorption of omeprazole is not affected by food and appears to be dose dependent; increasing the dosage above 40 mg has been reported to increase the plasma concentrations in a non-linear fashion because of saturable first-pass hepatic metabolism. Absorption is also higher after long-term administration.
Following absorption, omeprazole is almost completely metabolized in the liver, primarily by the cytochrome P450 isoenzyme CYP2C19 to form hydroxyomeprazole, and to a small extent by CYP3A4 to form omeprazole sulfone. The metabolites are inactive, and are excreted mostly in the urine and to a lesser extent in bile. The elimination half-life from plasma is reported to be about 0.5 to 3 hours. Omeprazole is highly bound (about 95%) to plasma proteins.

Reflux oesophagitis; acid-peptic ulcer disease; Zollinger-Ellison syndrome; adjunctive in duodenal ulcers associated with H. pylori combined with appropriate antibiotics; prophylaxis of acid aspiration before surgery; prevention and treatment of NSAID associated ulcers.

(Usual or as prescribed by the physician).
Omeprazole is given by mouth as capsule containing enteric-coated pellets which should be swallowed whole and not crushed or chewed.
Relief of acid-related dyspepsia: 10 mg or 20 mg daily for 2-4 weeks.
Treatment of gastro-oesophageal reflux disease: 20 mg once daily for 4 weeks.
Refractory oesophagitis: 40 mg daily; maintenance therapy is 20 mg once daily and for acid reflux is 10 mg daily.
Peptic ulcer disease: 20 mg once daily or 40 mg once daily for severe cases. Treatment is continued for 4 weeks for duodenal ulcer and 8 weeks for gastric ulcer. A dose of 10 mg to 20 mg once daily may be given for maintenance.
Treatment of NSAID-associated ulceration: 20 mg once daily.
Prophylaxis in patients with a previous history of gastroduodenal lesions who require continued NSAID treatment: 20 mg daily.
Zollinger-Ellison syndrome: Initial dose is 60 mg once daily; majority of patients are effectively controlled by doses between 20 mg-120 mg daily. Daily doses above 80 mg should be administered in divided doses.
Prophylaxis of acid aspiration during general anesthesia: 40 mg the evening before surgery and a further 40 mg 2-6 hours before the procedure.

Rare reports have been received of overdosage with omeprazole. In the literature doses of up to 560 mg have been described and occasional reports have been received when single oral doses have reached up to 2400 mg omeprazole (120 times the usual recommended clinical dose). Nausea, vomiting, dizziness, abdominal pain, diarrhea and headache have been reported from overdose with omeprazole. Also, apathy, depression and confusion have been described in single cases.
The symptoms described in connection to omeprazole overdosage have been transient, and no serious clinical outcome due to omeprazole has been reported. The rate of elimination was unchanged (first-order kinetics) with increased doses and no specific treatment has been needed.

Known hypersensitivity to omeprazole, substituted benzimidazoles or any other constituent of the formulation.

Before giving omeprazole or other proton pump inhibitors to patients with gastric ulcers, the possibility of malignancy should be considered since these drugs may mask symptoms and delay diagnosis. It should be used with caution in hepatic impairment. Administer before food or meals; swallow whole capsule, do not chew or crush.

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.
Omeprazole is excreted in the breast milk but is not likely to influence the child when therapeutic doses are used.

Most frequently reported adverse effects of omeprazole and other proton pump inhibitors are headache, diarrhea and skin rashes. Other adverse effects include pruritus, dizziness, fatigue, constipation, nausea and vomiting, flatulence, abdominal pain, arthralgia and myalgia, urticaria, and dry mouth.

Omeprazole may prolong the elimination of diazepam, phenytoin, and warfarin. Omeprazole and other proton pump inhibitors can reduce the absorption of drugs such as ketoconazole, and possibly itraconazole, whose absorption is dependent on acid gastric pH.

Store at temperatures not exceeding 25°C.

Antacids, Antireflux Agents & Antiulcerants

A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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