Somatropin (Growth Hormone) 100UI

Description

DESCRIPTION:

HGH is a sterile, non-pyrogenic, white lyophilized powder intended for subcutaneous or intramuscular injection, after reconstitution with bacteriostatic water for injection.

U.S.P. PHARMACOLOGY:
In vitro, preclinical, and clinical tests have demonstrated that somatropins are therapeutically equivalent to human growth hormone of pituitary origin and achieve similar pharmacokinetic profiles in normal adults. In pediatric patients who have growth hormone deficiency (GHD), treatment with somatropin stimulates linear growthand normalizes concentrations of Insulin-like Growth Factor -I (IGF-I).In adults with GHD, treatment with somatropin results in reduced fat mass, increased lean body mass, metabolic alterations that include beneficial changes in lipid metabolism, and normalization of IGF-I concentrations.

INDICATIONS AND USAGE:
HGH is indicated for:
•Long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.
•Long-term replacement therapy in adults with growth hormone deficiency (GHD) of either childhood- or adult- onset etiology. GHD should be confirmed by an appropriate growth hormone stimulation test.

DOSAGE AND ADMINISTRATION:
The dosage of HGH must be adjusted for the individual patient. The weekly dose should be divided into daily subcutaneous injections (administered preferably in the evening). HGH may be given in the thigh, buttocks, or abdomen; the site of SC injections should be rotated daily to help prevent lipoatrophy. Pediatric GHD Patients: Generally, a dose of 0.16 to 0.24 mg/kg body weight/week is recommended. Adult GHD Patients: The recommended dosage at the start of therapy is not more than 0.04 mg/kg/week. The dose may be increased at 4- to 8-week intervals according to individual patient requirements to a maximum of 0.08 mg/kg/week, depending upon patient tolerance of treatment. Clinical response, side effects, and determination of age-adjusted serum IGF-I may be used as guidance in dose titration. This approach will tend to result in weight-adjusted doses that are larger for women compared with men and smaller for older and obese patients.

CONTRAINDICATIONS:
HGH should not be used when there is any evidence of neoplastic activity. Intracranial lesions must be inactive and antitumor therapy complete prior to the institution of therapy. HGH should be discontinued if there is evidence of tumor growth.