Norsec Injection

Composition :

Each vial NORSEC® Powder Injection contain Omeprazole sodium equivalent with Omeprazole 40 mg

Each ml solvent NORSEC® contain:

  • Polyethylene glycol 400 0,40000 gr
  • Citric acid monohydrate cryst. EMPROVE 0,00050 gr
  • Sodium hydroxide pellet 0,00020 gr
  • Aqua sterile pro injection 0,59930 gr

 

Pharmacology :

Omeprazole reversibly reduces gastric acid secretion by specifically inhibiting the protective enzyme of the H + / K + – ATPase proton pump in parietal cells. Omeprazole is a substituted benzimidazole. Omeprazole is a combination of two active enantiomers. The secretion of hydrochloric acid in the stomach is inhibited by Omeprazole through the specific effects on proton pumps in parietal cells. The effects of acid secretion are reversible. Omeprazole is a weak base, which is concentrated and converted into an active form in the acidic environment in parietal cells, where Ompeprazole inhibits H +, K + ATPase, the last stage in gastric acid production. Inhibition depends on the dose, and affects the basal and stimulation of acid secretion, regardless of the type of stimulation. Omeprazole is not affected by cholinergic and histaminergic receptors. As the treatment uses H2 receptor inhibitors, treatment with Omeprazole results in decreased acidity in the stomach and the increase is reversible. During long-term treatment, the possibility of cysts in the gland may increase. This change is physiological and the consequence of inhibition of acid secretion. The cyst is benign and reversible. Decreased gastric acid with proton pump inhibitors or other acid inhibitors increases the amount of bacteria normally found in the gastrointestinal tract, as such treatment may lead to a slight increased risk of gastrointestinal infections such as Salmonella and Campylobacter. 95% Omeprazole sodium is bound to plasma proteins. Omeprazole is metabolized perfectly, especially in the liver, about 80% of metabolites are excreted through urine and the rest through feces.

 

Indication :

Omeprazole for intravenous use is indicated as an alternative to oral therapy for the following indications:

  • Duodenal ulcer, peptic ulcer and reflux esophagitis.
  • Zollinger’s syndrome – Ellison

 

Dosage :

Duodenal ulcer, gastric ulcer and reflux esophagitis, patients who can not be administered oral medication may be given parenteral therapy 40 mg once daily. Long treatment before switching to oral medication usually is 2 – 3 days. In Zollinger-Ellison syndrome, the dose should be adjusted individually. Higher doses and for some daily doses may be required. Intravenous treatment may be given as an injection, where after dissolved with an injection solvent, the solution should be administered slowly for at least 2½ minutes and at a maximum rate of 4 ml per minute.

Impaired kidney function

No need adjustment in patients with impaired renal function.

Impaired Liver function

In patients with impaired liver function, a daily dose may be 10 to 20 mg.

Elderly ( > 65 years old )

It is not necessary dose adjustment in elderly patients.

Children

The study was limited to administration Omeprazole Injection in children.

 

Administration :

For using I.V. :

Reconstitute the powder with the solvent provided, shake until completely dissolved. After reconstitution, store at a temperature below 250C, use the solution before 4 hours after reconstitution.

 

Presentation and Registration Number:

NORSEC® Powder Injection Box, 1 vial @ 40 mg and 1 ampoule solvent @ 10 ml; DKL1408021544A1

 

ON MEDICAL PRESCRIPTION ONLY

 

 

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