Omeprazole Sodium For Injection Vial

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Omeprazole sodium for injection powder is one lyophilized powder in vial, contains omeprazole sodium equivalent to 40mg Omeprazole.

Molecular formular: is C17H18NaN3O3S·H2O,

Molecular weight:385.41.

Omeprazole sodium lyophilized powder for injection is a white or almost white loose masses or powders.

Dose and method of administration In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole Injection 40 mg once daily is recommended. In patients with Zollinger-Ellison syndrome the recommended initial dose of omeprazole given intravenously 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.

Method of Administration Omeprazole Injection 40 mg should be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial 10 mL of the solvent provided. (No other solvent should be used). Discoloration may occur if incorrect reconstitution technique is used. For practical information about the reconstitution see the package insert. After reconstitution the injection should be given slowly over a period of at least 2.5 minutes at a maximum rate of 4 ml per minute. The solution should be used within 4 hours of reconstitution.

Special warnings and precautions for use of Omeprazole sodium for injection

In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, the possibility of malignancy should be excluded as treatment may alleviate symptoms and delay diagnosis.

 

 

 

Metabolism and excretion

The average half-life of the terminal phase of the plasma concentration-time curve following IV administration of omeprazole is approximately 40 minutes. The total plasma clearance is 0.3 to 0.6 L/min. There is no change in half-life during treatment.

Omeprazole is completely metabolised by the cytochrome P450 system (CYP), mainly in the liver. The major part of its metabolism is dependent on the polymorphically expressed, specific isoform CYP2C19 (S-mephenytoin hydroxylase), responsible for the formation of hydroxyomeprazole, the major metabolite in plasma. In accordance with this, as a consequence of competitive inhibition, there is a potential for metabolic drug-drug interactions between omeprazole and other substrates for CYP2C19.

No metabolite has been found to have any effect on gastric acid secretion. Almost 80% of an intravenously given dose is excreted as metabolites in the urine, and the remainder is found in the faeces, primarily originating from bile secretion.

The elimination of omeprazole is unchanged in patients with reduced renal function. The elimination half-life is increased in patients with impaired liver function, but omeprazole has not shown any accumulation with once daily dosing.

Indications:

Omeprazole sodium for injection is substituted indicated primarily for the treatment of Zollinger-Ellison syndrome, and also be used for the treatment of gastric ulcer, duodenal ulcer and reflux oesophagitis when oral medication is inappropriate.

I.V infusion: dissolve the contents in 100ml of 0.9% sodium chloride or 100ml of 5% glucose injection, the duration of the injection process should be persist 20 minutes to 30minutes or exceed the length.

When oral medication in the treatment gastric ulcer, duodenal ulcer and reflux oesophagitis is inappropriate, 40mg of omeprazole sodium daily is recommended.

Zollinger-Ellison syndrome the recommended initial dose of omeprazole sodium for injection given intravenously 40mg 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.

Omeprazole sodium for injection is well tolerated and adverse reaction have generally been mild and reversible. The following events have been reported in clinical trials or reported from routine uses. but in many cases a relationship to treatment with omeprazole has not been established

The following definitions of frequencies are used:

Common ≥1/100

Uncommon ≥1/1,000 and <1/100

Rare <1/1,000

Common

Central and peripheral nervous system: Headache

Gastrointestinal Diarrhoea, constipation, abdominal pain, nausea/vomiting and flatulence

Uncommon

Central and peripheral nervous system:

Dizziness, paraesthesia, somnolence, insomnia and vertigo

Hepatic: Increased liver enzymes

Skin: Rash, dermatitis and/or pruritis. Urticaria

Other: Malaise

Rare:

Central and peripheral nervous system: Reversible mental confusion, agitation, aggression, depression and halluncinations, predominantly in severely ill patients

Endocrine: Gynaecomastia

Gastrointestinal: Dry mouth, stomatitis and gastrointestinal candidiasis

Haematological: Leukopenia, thrombocytopenia, agranulocytosis and pancytopenia

Hepatic: Encephalopathy in patients with pre-existing severe liver disease; hepatitis with or without jaundice, hepatic failure

Musculoskeletal: Arthralgia, muscular weakness and myalgia

Skin: Photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), alopecia

Other: Hypersensitivity reactions eg. angioedema, fever, bronchospasm, interstitial nephritis and anaphylactic shock.

Increased sweating, peripheral oedema, blurred vision, taste disturbance and hyponatraemia.

Irreversible visual impairment has been reported in isolated cases of critically ill patients who have received omeprazole intravenous injection, especially at high doses.

Contraindication:known hypersensitivity to omeprazole.

Warning And Precautions:In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, the possibility of malignancy should be excluded as treatment may alleviate symptoms and delay diagnosis.

Use In Pregnancy And Lactation

Results from animal studies indicate no adverse effects of omeprazole on pregnancy or on the health of the fetus/newborn child. Omeprazole arenot commonly advisedly to used during pregnancy and nurses.

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

Effects on ability to drive and use machines

Omeprazole is not likely to affect the ability to drive or use machines.

Children:There is no experance with omeperazole in children.

Elderly:Dose adjustment is not needed in the elderly.

Drug Interactions

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