EUTROPIN
SOMATROPIN · by HOFFMANN
Composition
lnj: Somatropin (rbe) 4 IU (1.33 mg); powder in vial. Inj: Somatropin 5 mg(15 IU)
Indications & 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.
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.
Stability
Store at 2T-8C (36F-46F). Do not freeze. Protect from light.
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
Precautions
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
Interactions
Drugs metabolised by CYP3A4.
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