Zomacton

Zomacton

somatropin

Manufacturer:

Ferring

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Somatropin
Indications/Uses
Long-term treatment of childn w/ growth failure due to inadequate secretion of growth hormone (GH); long-term treatment of growth retardation due to Turner's syndrome confirmed by chromosome analysis.
Dosage/Direction for Use
Individualized dosing. GH deficiency 0.17-0.23 mg/kg/wk divided into 6-7 SC inj, corresponding to daily inj of 0.02-0.03 mg/kg. Max total wkly dose: 0.27 mg/kg, corresponding to daily inj of up to 0.04 mg/kg. Turner's syndrome 0.33 mg/kg/wk divided into 6-7 SC inj, corresponding to daily inj of 0.05 mg/kg.
Contraindications
Hypersensitivity. Patient w/ evidence of tumour growth. Do not use for growth promotion in childn w/ closed epiphysis. Acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute resp failure or similar conditions. Discontinue at renal transplantation in childn w/ chronic renal disease. Premature babies or neonates.
Special Precautions
Not indicated for long term treatment of paed patients w/ growth failure due to Prader-Willi syndrome w/ risk factors (severe obesity, history of upper airway obstruction, sleep apnoea or unidentified resp infection). Funduscopy for papilloedema is recommended in the event of severe or recurring headache, visual problems & nausea/vomiting; if papilloedema is confirmed consider benign intracranial HTN diagnosis. Carefully monitor intracranial HTN symptoms if GH treatment is restarted. Possible leukemia. Test for Ab in any patient who fails to respond to therapy. Monitor thyroid function. Closely monitor standard replacement therapy in patients w/ hypopituitarism. Monitor for evidence of glucose intolerance in patient w/ DM or in those w/ family history predisposition for the disease. Frequently monitor for progression or recurrence of underlying disease process in patients w/ GH deficiency secondary to intracranial lesion; discontinue therapy if progression or recurrence of the lesion occurs. Monitor for signs & symptoms of relapse in patients w/ previous malignant diseases. Monitor for signs of scoliosis during treatment. Slipped capital femoral epiphysis may occur more frequently in patients w/ endocrine disorders. Evaluate patient who develops limp or complains of hip or knee pain. Weigh benefit/risk ratio in acutely critically ill patients. Consider pancreatitis especially in childn who develop abdominal pain. Solvent contains benzyl alcohol. Not recommended during pregnancy & in woman of childbearing potential not using contraception. Lactation. Infant & childn up to 3 yr.
Adverse Reactions
Oedema, peripheral oedema; mild hyperglycaemia; arthralgia, myalgia; headache, paresthesia. Hypothyroidism, inj site reactions, asthenia; Ab building; impaired glucose tolerance; stiffness in the extremities; hypertonia, insomnia.
Drug Interactions
Inhibited growth-promoting effect w/ glucocorticoid replacement therapy. High doses of androgens, oestrogens or anabolic steroids. Induced state of insulin resistance; may adjust insulin dose in diabetic patients receiving concomitant Zomacton. Lower plasma levels of compd metabolised by CYP450 3A4 (eg, sex steroids, corticosteroids, anticonvulsants & cyclosporine).
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
Zomacton powd for inj 4 mg
Packing/Price
(+ solvent amp) 10 × 1's; (+ solvent amp) 1's; (+ solvent amp) 5 × 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