Cisen Pharmaceuticals


Endure Medical
Full Prescribing Info
Omeprazole sodium.
Each vial contains: Omeprazole (as Sodium) 40 mg.
Pharmacology: Omeprazole is a proton pump inhibitor. It inhibits secretion of gastric acid by irreversibly blocking the enzyme system of hydrogen/potassium adenosine triphosphate (H+/K+ ATPase), the proton pump of the gastric parietal cells.
Pharmacokinetics: The absorption of Omeprazole appears to be dose-dependent; increasing the dosage to above 40 mg has been reported to increase the plasma concentrations. In addition, absorption is higher after long term administration. Bioavailability of Omeprazole may be increased in elderly patients, in some ethnic groups such as Chinese, and in patients with impaired hepatic function, but it is not markedly affected in patients with renal impairment. 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 CYP3A to form Omeprazole sulfone. The metabolites are inactive and are excreted mostly in the urine and to a lesser extent to the bile. The elimination half-life form plasma is reported to be about 0.5 to 3 hours. Omeprazole is highly bound (about 95%) to plasma proteins.
Treatment of conditions where inhibition of gastric acid secretion may be beneficial, including aspiration syndromes, dyspepsia, gastroesophageal reflux disease, peptic ulcer disease and the Zollinger-Ellison syndrome.
Dosage/Direction for Use
Omeprazole sodium may be given in a short term basis by intravenous infusion, in a usual dose equivalent to 40 mg of Omeprazole over a period of 20 to 30 minutes. It has been given by slow intravenous injection. Or as prescribed by the physician.
Direction for Reconstitution: For IV injection, dissolve 40 mg vial Omeprazole with the 10 mL of sterile water for injection. For IV infusion, dissolve 40 mg vial in a 100 mL of 0.9% sodium chloride or 5% glucose. Discard any unused portion.
Special Precautions
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 inhibitors should be used with caution in patients with hepatic impairment. Omeprazole should not be given during pregnancy and lactation, unless its use is considered essential.
Adverse Reactions
Most frequent adverse effects experienced with Omeprazole have been headache, diarrhea and skin rashes. They have sometimes been severe enough to discontinue the treatment. Other adverse effects include pruritus, dizziness, fatigue, constipation, 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 hallucination 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, taste disturbance, peripheral edema, hyponatremia, blood disorders (including agranulocytosis, leucopenia and thrombocytopenia) and intestinal nephritis. Proton pump inhibitors may increase the risk of gastrointestinal infection because of their acid suppressive effects.
Drug Interactions
Omeprazole is metabolized by the cytochrome P450 system primarily by isoenzyme CYP2C19, and may alter the metabolism of some other drugs metabolized by these enzymes. Omeprazole may prolong the elimination of diazepam, phenytoin and warfarin. Omeprazole can reduce the absorption of drugs such as ketoconazole, and possibly itraconazole, whose absorption is dependent on gastric acid pH.
Store at temperatures not exceeding 25°C.
ATC Classification
A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Lyophilized powd for inj (vial + 10 mL diluent) 40 mg x 5's.
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