Genotropin

Replacement therapy in adults w/ pronounced growth hormone deficiency. Growth disturbance due to insufficient secretion of growth hormone & associated w/ Turner syndrome in childn.

SC Individualized dosage. Adult Growth hormone deficiency Initially 0.45-0.9 IU (0.15-0.3 mg) daily. Daily maintenance dose seldom exceeds 4 IU (1.33 mg) daily. Childn Growth disturbance due to insufficient growth hormone secretion 0.07-0.1 IU/kg (0.025-0.035 mg/kg) daily or 2.1-3 IU/m² (0.7-1 mg/m²) BSA daily. Growth disturbance due to Turner syndrome 0.14 IU/kg (0.045-0.05 mg/kg) daily or 4.3 IU/m² (1.4 mg/m²) BSA daily.

Hypersensitivity. Evidence of neoplastic activity & uncontrolled growth of benign intracranial tumors; patient must complete anti-tumor therapy prior to starting somatropin. Acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute resp failure.

Consider myositis if myalgia or disproportionate pain at inj site develops. May induce state of insulin resistance or hyperglycemia; observe evidence of glucose intolerance. Risk of developing diabetes in patients w/ obesity, family history of diabetes, on treatment w/ steroids or prior impaired glucose tolerance. Adjust dose of antidiabetic therapy in patients w/ pre-existing DM. Perform thyroid function test after starting treatment & dose adjustments. Possible inhibition of 11β-hydroxysteroid dehydrogenase type 1 & reduced serum cortisol conc. Concomitant use w/ oral estrogen. Monitor signs of malignancy relapse in patients w/ growth hormone deficiency secondary to treatment of malignant disease. Consider diagnosis of benign intracranial HTN or treatment discontinuation if papilledema is confirmed. Carefully monitor symptoms of intracranial HTN if growth hormone treatment is restarted for patients w/ resolved intracranial HTN. Progression of scoliosis can occur in patients who experience rapid growth. Renal function should be <50% of normal before instituting somatropin therapy in patients w/ chronic renal insufficiency. Discontinue use at renal transplantation. Pregnancy & lactation. Evaluate childn who develop limp during treatment. Ineffective for growth promotion in childn w/ closed epiphyses. Elderly >60 yr.

Adult: Arthralgia; peripheral edema. Paresthesia, carpal tunnel syndrome; myalgia, musculoskeletal stiffness. Childn: Inj site reaction (in growth hormone deficiency); arthralgia (in Turner syndrome).

Inhibited growth-promoting effects w/ glucocorticoids. May unmask previously undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective. May increase the clearance of compd metabolized by CYP450 3A4 (eg, sex steroids, corticosteroids, anticonvulsants & cyclosporin). Higher dose of growth hormone may be required in women on oral estrogen replacement.

Trophic Hormones & Related Synthetic Drugs

H01AC01 - somatropin ; Belongs to the class of somatropin and somatropin agonists. Used in anterior pituitary lobe hormone and analogue preparations.

POM