Ome-M

Omeprazole (inj: sodium).

Injection: Each vial contains: Omeprazole Sodium BP equivalent to Omeprazole 40 mg.
Each ampoule contains: Sterile Water for Injection BP 10 mL (diluent).

Pharmacology: Pharmacokinetics: Distribution: The apparent volume of distribution in healthy subjects is approximately 0.3 L/kg body weight. Omeprazole is 97% plasma protein bound.
Elimination: Total plasma clearance is about 30-40 L/h after a single dose. The plasma elimination half-life of Omeprazole is usually shorter than one hour both after single and repeated once-daily dosing. Omeprazole is completely eliminated from plasma between doses with no tendency for accumulation during once-daily administration. Almost 80% of a dose of Omeprazole is excreted as metabolites in the urine, the remainder in the faeces, primarily originating from bile secretion.
Special populations: Hepatic impairment: The metabolism of Omeprazole in patients with liver dysfunction is impaired, resulting in an increased AUC. Omeprazole has not shown any tendency to accumulate with once-daily dosing.
Renal impairment: The pharmacokinetics of Omeprazole, including systemic bioavailability and elimination rate, are unchanged in patients with reduced renal function.
Older people: The metabolism rate of Omeprazole is somewhat reduced in elderly subjects (75-79 years of age).

Used in conditions where inhibition of gastric acid secretion may be beneficial, including aspiration syndromes, dyspepsia, gastroesophageal reflux disease, peptic ulcer disease and Zollinger-Ellison syndrome.

Injection: By intravenous injection over 5 minutes or by intravenous infusion over 20 to 30 minutes, prophylaxis of acid aspiration, 40 mg completed 1 hour before surgery.
Benign gastric ulcer, duodenal ulcer and gastroesophageal reflux, 40 mg once daily until oral administration is possible.
Severe peptic ulcer bleeding initial intravenous infusion of 80 mg then by continuous intravenous infusion, 8 mg/hr for 72 hours (then change to oral therapy).
Administration: Omeprazole 40 mg I.V. injection should only be administered intravenously. It should not be given by any other route.
Injection: For I.V. injection, each single dose vial containing lyophilized powder for Omeprazole 40 mg should be reconstituted with 10 mL of Sterile Water for Injection. The resulting concentration is 4 mg/mL of Omeprazole which should be given slowly (over a period of 5 minutes) as an intravenous injection.
Infusion: For I.V. infusion, the single dose vial should be dissolved in either 100 mL of Sodium Chloride injection (0.9% w/v) or 100 mL of Glucose intravenous infusion (5% w/v). No other solution should be used for the infusion. The infusion should be given over a period of 20-30 minutes. Or as prescribed by the physician.

The major clinical features were drowsiness, headache (possibly due to metabolite) and tachycardia.

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. Omeprazole and other proton pump inhibitor should be used with caution in hepatic impairment.
Use in Children: The safety and effectiveness of Omeprazole sodium injections in children have not yet been established.

The adverse effects reported most frequently with Omeprazole and other proton pump inhibitors have been headache, diarrhea, and skin rashes; they have sometimes been severe enough to require stopping treatment. Other effects include pruritus, dizziness, fatigue, constipations, nausea and vomiting, flatulence, abdominal pain, arthralgia and myalgia, urticaria and dry mouth. Isolated cases of photosensitivity, bullous eruption, erythema multiforme, angioedema, and anaphylaxis have been reported. Effects on the CNS include occasional insomnia, somnolence, and vertigo; reversible confusional states, agitation, depression, and hallucinations have occurred, in severely ill patients. Raised liver enzymes, and isolated cases of hepatitis, jaundice and hepatic encephalopathy, have been reported. Other adverse effects reported rarely or in isolated cases include paraesthesia, blurred vision, alopecia, stomatitis sweating, taste disturbances, peripheral oedema, malaise, hyponatremia, blood disorders (including agranulocytosis, leucopenia, and thrombocytopenia), and interstitial nephritis.

Omeprazole and other proton pump inhibitors are metabolized by the cytochromes P450 system primarily by isoenzyme CYP2C19, and may alter the metabolism of some drugs metabolized by these enzymes. 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 with voriconazole, the plasma concentration of both drugs may be increased and a reduced dose of Omeprazole is recommended.

Injection: Direction for Reconstitution: Reconstitute with 10 mL of Sterile Water for Injection to provide a solution of 4 mg/mL of Omeprazole.

Store at temperatures not exceeding 30°C.
Protect from light.

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).

Rx