SANDOSTATIN LAR (OCTREOTIDE) 30MG INJ

KSh146,300.00

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SKU: DP8294 Category:

Description

Therapeutic indications

Symptomatic control and reduction of growth hormone (GH) and IGF-1 plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy. Octreotide is also indicated for acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.

Relief of symptoms associated with functional gastro-entero-pancreatic (GEP) endocrine tumours, e.g. carcinoid tumours with features of the carcinoid syndrome.

Octreotide is not an anti-tumour therapy and is not curative in these patients.

Prevention of complications following pancreatic surgery.

Emergency management to stop bleeding and to protect from re-bleeding owing to gastro-oesophageal varices in patients with cirrhosis. Octreotide is to be used in association with specific treatment such as endoscopic sclerotherapy.

Treatment of TSH-secreting pituitary adenomas:

? when secretion has not normalised after surgery and/or radiotherapy;

? in patients in whom surgery is inappropriate;

? in irradiated patients, until radiotherapy is effective.

Posology and method of administration

Posology

Acromegaly

Initially 50 to 100 micrograms by subcutaneous (s.c.) injection every 8 or 12 hours. Dosage adjustment should be based on monthly assessment of GH and IGF-1 levels (target: GH <2.5 ng/mL; IGF-1 within normal range) and clinical symptoms, and on tolerability. In most patients, the optimal daily dose will be 300 micrograms. A maximum dose of 1500 micrograms per day should not be exceeded. For patients on a stable dose of Octreotide, assessment of GH and IGF-1 should be made every 6 months.

If no relevant reduction in GH levels and no improvement in clinical symptoms have been achieved within 3 months of starting treatment with Octreotide, therapy should be discontinued.

Gastro-entero-pancreatic endocrine tumours

Initially 50 micrograms once or twice daily by s.c. injection. Depending on clinical response, effect on levels of tumour-produced hormones (in cases of carcinoid tumours, on the urinary excretion of 5-hydroxyindole acetic acid), and on tolerability, dosage can be gradually increased to 100 to 200 micrograms 3 times daily. Under exceptional circumstances, higher doses may be required. Maintenance doses have to be adjusted individually.

In carcinoid tumours, if there is no beneficial response within 1 week of treatment with Octreotide at the maximum tolerated dose, therapy should not be continued.

Complications following pancreatic surgery

100 micrograms 3 times daily by s.c. injection for 7 consecutive days, starting on the day of surgery at least 1 hour before laparotomy.

Bleeding gastro-oesophageal varices

25 micrograms/hour for 5 days by continuous intravenous (i.v.) infusion. Octreotide can be used in dilution with physiological saline.

In cirrhotic patients with bleeding gastro-oesophageal varices, Octreotide has been well tolerated at continuous i.v. doses of up to 50 micrograms/hour for 5 days.

Treatment of TSH-secreting pituitary adenomas

The dosage most generally effective is 100 micrograms three times a day by s.c. injection. The dose can be adjusted according to the responses of TSH and thyroid hormones. At least 5 days of treatment will be needed to judge the efficacy.

Use in the elderly

There is no evidence of reduced tolerability or altered dosage requirements in elderly patients treated with Octreotide.

Use in children

Experience with Octreotide in children is limited.

Use in patients with impaired liver function

In patients with liver cirrhosis, the half-life of the drug may be increased, necessitating adjustment of the maintenance dosage.

Use in patients with impaired renal function

Impaired renal function did not affect the total exposure (AUC) to octreotide administered as s.c. injection, therefore no dose adjustment of Octreotide is necessary.

Method of administration

Octreotide may be administered directly by subcutaneous (s.c.) injection or by intravenous (i.v.) infusion after dilution

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