Octrea

Octrea Dosage/Direction for Use

octreotide

Manufacturer:

Apexcela

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Symptoms associated with Carcinoid Tumors with features of carcinoid syndrome, VIPomas, Glucagonomas, Gastro-entero-pancreatic endocrine tumors: Adult: initial 50 micrograms (0.05 mg) subcutaneous injection 1-2 times a day, adjusted according to response; increase to 200 micrograms 3 times a day, higher dose may be required exceptionally; maintenance dose are variable; in carcinoid tumors, discontinue after 1 week if no effect.
If rapid response required, initial dose may be given by intravenous injection (with ECG monitoring and after dilution).
Acromegaly, short term treatment before pituitary surgery or long-term treatment in those inadequately controlled by other treatment or by radiotherapy or until radiotherapy become fully effective: By subcutaneous injection,
Adults: 100-200 micrograms 3 times a day, discontinue if no response within 3 months.
Prevention of complication following pancreatic surgery: By subcutaneous injection,
Adults: 100 microgram 3 times daily for 7 consecutive days, starting on the day of operation at least 1 hour before laparotomy.
Bleeding gastro-esophageal varices: 25 micrograms/hour for 5 days by continuous i.v. infusion. Octreotide can be used in dilution with 0.9% normal saline solution. In cirrhotic patients with bleeding gastro-esophageal varices, Octreotide has been well tolerated at continuous i.v. doses of up to 50 micrograms/hour for 5 days.
HIV-associated diarrhea: Initial dosage: 100 microgram, 3 times/day given subcutaneously, the dose may be titrated to 250 mcg 3 times/day if diarrhoea is not controlled after 1 week. Dose adjustment should be based on assessment of stool output and on tolerability.
If this is not effective after 1 further week at a dose 250 microgram, 3 times/day, then the treatment should be stopped.
Special populations: Use in the elderly (> 65 years): Clearance and the elimination half-life of octreotide may be prolonged in elderly patients, dosage adjustments may be necessary.
Pregnancy: Limited information of using Octreotide in pregnancy. Possible effect on fetal growth in animal. Use Octreotide only if potential benefit outweighs risk.
Breast feeding: Limited information of breast feeding in human. Avoid using in breast feeding.
Use in children (< 18 years): Experience with Octreotide in children is limited. Risk and benefit of using octreotide should be evaluated.
Use in patients with liver function impairment: In patients with liver cirrhosis, the half-life of the drug may be increased, adjustment of the maintenance dosage may be necessary.
Use in patients with renal function impairment: Half-life of octreotide may be increased in patients with renal failure requiring dialysis, and adjustment of octreotide dosage may be necessary.
Direction for administration: For intravenous injection or intravenous infusion, dilute with 0.9 % sodium chloride to a concentration of 10-50%. The diluted solution are physically and chemically stable for 24 hours below 25°C. From a microbiological point of view, the diluted solution should preferably be used immediately. Storage should be at 2-8°C.
Single dose prefilled syringes are for single use only. The package should be opened only immediately prior to use.
The solution should be inspected visually for changes of color or solid particles prior to administration.
To reduce local discomfort, let the solution reach room temperature before injection. Avoid multiple injections at short intervals at the same site.
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