|Contents||Vial: HGH (191aa Human Growth Hormone) lyophilised powder 10iu.
Ampoule: 2ml Sterile water for injection.
|Administration||Intramuscular or Subcutaneous injection.|
|Storage||Store at room temperature away from heat and direct sunlight pre reconstitution. Refrigerate between 2-8’C post Reconstitution.|
|Dosage||Adult: SC Growth hormone deficiency Initial: 6 mcg/kg/day. May increase dose gradually. Max: 12.5 mcg/kg/day. HIV-associated wasting or cachexia 0.1 mg/kg/day at bedtime. May take on alternate days for patients at increased risk of adverse effects. Max: 6 mg/day. Short bowel syndrome100 mcg/kg/day for 4 wk. Max: 8 mg/day.|
|Contraindications||Acute critical illness due to heart or abdominal surgery, multiple accidental trauma or respiratory failure; active neoplasms, proliferative or preproliferative diabetic retinopathy; lactation; patients with closed epiphyses. Intracranial lesions. Patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment.|
|Special Precautions||Monitor thyroid function; benign intracranial hypertension. DM; may require dose reduction in insulin. Pregnancy. Discontinue treatment if there is evidence of tumour growth. Monitoring in patients with scoliosis is recommended due to risk of progression of scoliosis.|
|Adverse Drug Reactions||Hypothyroidism, peripheral oedema; headache; muscle and joint pain; benign intracranial hypertension. Loss of glycaemic control in diabetics.|
|Drug Interactions||High doses of corticosteroid may inhibit growth-promoting effects of somatropin.|
|Pregnancy Category (US FDA)||Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).|
|ATC Classification||H01AC01 – somatropin ;|