Omepac

Omeprazole.

Each capsule contains Omeprazole 20mg (as enteric coated pellets).
Each vial of lyophilized powder contains: Omeprazole Sodium equivalent to Omeprazole 40 mg.

Pharmacology: Capsule: Mechanism of Action: OMEPAC 20 (omeprazole) is substituted benzimidazole derivative which markedly inhibits basal and stimulated gastric acid secretion by a unique mode of action, specifically blocking the H⁺/ K⁺ATPase enzyme system of the gastric parietal cell (the so called proton pump) which is the terminal step in the acid secretory pathway. It has a quick onset of action and when the drug is discontinued, secretory activity returns gradually over 3 to 5 days.
Injection: 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 cell.
Pharmacokinetics: Capsule: Omeprazole is rapidly absorbed, but to a variable extent, following oral administration.
Absorption of omeprazole is not affected by food but is dose dependent. Bioavailability of Omeprazole may be increased in elderly patients, in some ethnic groups such as Chinese, and in patients with impaired hepatic function, but is markedly affected in patients with renal impairment. Following absorption, Omeprazole is almost completely metabolised in the liver by cytochrome P 450 isoforms and rapidly eliminated, mostly in the urine. Although the elimination half-life from plasma is short, being reported to be about 0.5 to 3 hours, its duration of action with regard to inhibition of acid secretion is much longer allowing it to be used in single daily doses. Omeprazole is highly bound (about 95%) to plasma proteins.
Injection: The absorption of Omeprazole appears to be dose-dependent; increasing the dosage above 40 mg has been reported to increase the plasma concentrations. In addition, absorption is higher after a 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 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 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.

Capsule: OMEPAC 20 is indicated in the treatment of duodenal ulcer, gastric ulcer and reflux oesophagitis. It is also used for the control of acid secretion in pathological hypersecretory conditions eg. Zollinger-Ellison syndrome.
Injection: Omeprazole is used in conditions where inhibition of gastric acid secretion may be beneficial, including aspiration syndromes, dyspepsia, gastro-esophageal reflux disease, peptic ulcer disease, and the Zollinger-Ellison syndrome.

Capsule: Do not chew or crush the capsules.
Duodenal ulcer/Gastric ulcer: OMEPAC 20 mg once daily for 2-4 weeks.
Reflux oesophagitis: OMEPAC 20mg once daily for 4-8 weeks.
Pathological hypersecretory conditions: The recommended initial dose of Omeprazole in these patients is 60 mg once daily. Dosages should be individualised and should be continued for as long as clinically indicated. Dosages higher than 80 mg/day should be administered in divided doses.
No dosage adjustment is necessary for patients with renal impairment, hepatic dysfunction of the elderly.
Injection: In patients who are unsuited to receive oral therapy, Omeprazole sodium may be given on 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 also been given by slow intravenous injection.
Or as prescribed by a physician.

OMEPAC 20 is contraindicated in patients with known hypersensitivity to the drug.

Capsule: Symptomatic response to OMEPAC 20 therapy does not preclude the presence of gastric malignancy. Unless benefits of the treatment outweigh the possible risks, the use of OMEPAC 20 in pregnant and lactating women is not recommended since there are no adequate or well-controlled studies regarding the usage of Omeprazole in such patients. Safely and effectiveness of Omeprazole in children has also not been established.
Injection: 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 hepatic impairment.
Omeprazole should not be given during pregnancy and lactation, unless its use is considered essential.

Capsule: OMEPAC 20 is well tolerated. Nausea, headache, diarrhea, constipation and flatulence have been reported occasionally. Rarely skin rash has occurred in a few patients. These effects are mild and transient and bear no consistent relationship with treatment.
Injection: 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 disturbances, peripheral edema, blood disorders including agranulocytosis, leucopenia, and thrombocytopenia, and interstitial nephritis.
Proton pump inhibitors may increase the risk of gastrointestinal infections because of their acid suppressive effects.

Capsule: Monitoring of patients taking diazepam, warfarin, and phenytoin concomitantly with OMEPAC 20 is recommended to determine whether it is necessary to adjust the dosage of these drugs. OMEPAC 20 may interfere with the metabolism of drugs metabolised by cytochrome 450 enzyme system. No interaction with concomitantly administered antacids has been found.
Injection: 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 an acid gastric pH.

Capsule: Store in a cool, dry place below 30°C. Protect from light.
Injection: Store in a cool & dry place, 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).

POM

DR cap 20 mg x 10 x 10's. Powd for inj (vial) 40 mg x 1's.