๐ Indications & Clinical Dosage
*Growth failure due to deficiency of endogenous growth hormone:*
BY SC OR IM INJ: Children: 0.025-0.035 mg/kg body weight daily.
*Turner syndrome:*
BY SC INJ: Children: 0.045-0.50 mg/kg body weight daily byin evening.
*Growth retardation in prepubertal children with chronic renal insufficiency:*
BY SC INJ: Children: 0.045-0.050 mg/kg body weight daily.
*Prader-Willi syndrome, Replacement therapy in adults with demonstrated growth hormone deficiency:*
BY SC INJ: Children: 0.035 mg/kg daily or 1 mg/kg daily; max 2.7 mg daily.
BY SC INJ: Adults: Initially 0.15-0.3 mg daily. Increase gradually according to individual requirements; max 1 mg daily.
๐ Mode of Administration
Do not shake. Administer SC or IM. Rotate administration site to avoid tissue atrophy. When administering to newborns do not reconstitute with a diluent that contains benzyl alcohol. SWFI may be used as an alternative.
โ Contraindications
Tumour activity; complete antitumour therapy and ensure intracranial lesions inactive before starting treatment, not to be used after renal transplantation, severe obesity in Prader-Willi
syndrome, severe respiratory impairment in Prader-Willi syndrome, pregnancy, lactation
โ ๏ธ Precautions & Warnings
Diabetes mellitus, disorders of the epiphysis of the hip (monitor for limping), history of malignant disease, hypothyroidism; periodic thyroid function tests are advised, initiation of treatment close to puberty not recommended in child born small for corrected gestational age, papill oedema, relative deficiencies of other pituitary hormones, resolved intracranial hypertension, Silver-Russell syndrome. Monitor thyroid function
๐ Drug Interactions
Drugs metabolised by CYP3A4.
โ ๏ธ Adverse Reactions / Side Effects
Antibody formation, arthralgia, benign intracranial hypertension, carpal tunnel syndrome, fluid retention (peripheral oedema), headache, hyperglycaemia, hypoglycaemia, hypothyroidism, insulin resistance, leukaemia in children with growth hormone deficiency, myalgia, nausea, papilloedema, paraesthesia, reactions at injection site, visual problems, vomiting
๐งช Compatibility & Storage Stability
Stability & Storage: Store at 2T-8C (36F-46F). Do not freeze. Protect from light.
๐ Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.