Genotropin

Genotropin

somatropin

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Somatropin
Indications/Uses
Replacement therapy in adults w/ pronounced growth hormone deficiency. Growth disturbance due to insufficient secretion of growth hormone & associated w/ Turner syndrome in childn.
Dosage/Direction for Use
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 secretion of growth hormone 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.
Contraindications
Hypersensitivity. Evidence of neoplastic activity; uncontrolled growth of benign intracranial tumors. Acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute resp failure.
Special Precautions
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 the start of treatment & after dose adjustments. Comcomitant use of 11β-hydroxysteroid dehydrogenase type 1 & oral oestrogen. Monitor signs of malignancy relapse in patients w/ growth hormone deficiency secondary to treatment of malignant disease. Consider diagnosis of benign intracranial HTN or discontinuation if papilledema is confirmed. 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. Discontinue at renal transplantation. Pregnancy & lactation. Evaluate childn who develop a limp during treatment. Ineffective for growth promotion in childn w/ closed epiphyses. Elderly >60 yr.
Adverse Reactions
Adult: Arthralgia; peripheral edema. Paresthesia, carpal tunnel syndrome; myalgia, musculoskeletal stiffness. Childn: Inj site reaction (in growth hormone deficiency), arthralgia (in Turner syndrome).
Drug Interactions
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). Oral oestrogen replacement (higher dose may be required).
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
H01AC01 - somatropin ; Belongs to the class of somatropin and somatropin agonists. Used in anterior pituitary lobe hormone and analogue preparations.
Presentation/Packing
Form
Genotropin powd for soln for inj 16 IU (5.3 mg)
Packing/Price
([GoQuick pre-filled pen (2-chamber cartridge)] + solvent 1.15 mL x 1's) 1's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Already a member? Sign in
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Already a member? Sign in