SciTropin A

SciTropin A

somatropin

Manufacturer:

SciGen

Distributor:

Keen Health
Concise Prescribing Info
Contents
Somatropin (recombinant)
Indications/Uses
Replacement therapy in adults w/ pronounced growth hormone deficiency (GHD): Patients who have severe growth hormone deficiency associated w/ multiple hormone deficiencies as a result of known hypothalamic or pituitary pathology, & who have at least 1 known deficiency of a pituitary hormone not being prolactin; patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Infants, childn & adolescents: Growth disturbance due to insufficient secretion of growth hormone; associated w/ Turner syndrome; or associated w/ chronic renal insufficiency. Growth disturbance [current height standard deviation score (SDS) < -2.5 & parental adjusted height SDS < -1] in short childn/adolescents born small for gestational age, w/ a birth wt &/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last yr) by 4 yr of age or later. Prader-Willi syndrome (PWS), for improvement of growth & body composition.
Dosage/Direction for Use
Adult Childhood onset GHD Recommended restart dose 0.2-0.5 mg/day, gradually increased or decreased according to individual requirements. Adult onset GHD 0.15-0.3 mg/day, gradually increased according to individual requirements. Childn Growth disturbance due to insufficient secretion of growth hormone 0.025-0.035 mg/kg/day or 0.7-1 mg/m2/day. Prader-Willi syndrome, for improvement of growth & body composition 0.035 mg/kg/day or 1 mg/m2/day. Max daily dose: 2.7 mg. Growth disturbance due to Turner syndrome 0.045-0.05 mg/kg/day or 1.4 mg/m2/day. Growth disturbance in chronic renal insufficiency 0.045-0.05 mg/kg/day or 1.4 mg/m2/day. Growth disturbance in short children/adolescents born small for gestational age 0.035 mg/kg/day or 1 mg/m2/day. Elderly >60 yr Initially 0.1-0.2 mg/day, slowly increased to individual requirements.
Contraindications
Hypersensitivity. Any evidence of activity of a tumour. Must not be used for growth promotion in childn w/ closed epiphyses. Patients w/ acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute resp failure or similar conditions.
Special Precautions
May result in inhibition of 11βHSD-1 & reduced serum cortisol conc. May reduce insulin sensitivity; closely monitor patients w/ diabetes, glucose intolerance, or additional risk factors for DM during therapy. Monitor thyroid function in all patients. Pay attention to signs of relapse of malignancy in patients w/ GHD secondary to treatment of malignant disease. Slipped epiphyses of the hop may occur more frequently. Benign intracranial HTN. Risk of developing Ab to SciTropin A. Adult patients w/ acute critical illness. Women concomitantly taking oral oestrogen therapy. Risk of pancreatitis in paed patients. Before initiation of treatment, patients w/ PWS should be evaluated for upper airway obstruction, sleep apnoea or resp infections. Resolve resp disorder prior to treatment initiation. PWS patients should have effective wt control before & during treatment. Monitor for signs of scoliosis during treatment. In SGA patients, measure fasting insulin & blood glucose before treatment & annually thereafter; measure IGF-1 level before treatment & twice a yr thereafter; not recommended to initiate treatment near onset of puberty. In chronic renal insufficiency, renal function should be <50% of normal before institution of therapy. Must not be given to premature babies or neonates. May cause toxic & anaphylactoid reactions in infants & childn ≤3 yr. Not recommended in pregnancy & in women of childbearing potential not using contraception. Lactation. Elderly >80 yr.
Adverse Reactions
Adult: Arthralgia, myalgia, musculoskeletal stiffness; oedema peripheral; paraesthesia, carpal tunnel syndrome. Childn w/ GHD, chronic renal insufficiency, SGA: Inj site reaction. Childn w/ Turner syndrome: Arthralgia. Childn w/ PWS: Paraesthesia, benign intracranial HTN; arthralgia, myalgia; oedema peripheral.
Drug Interactions
Inhibited growth-promoting effect w/ glucocorticoids. May render low glucocorticoid replacement doses ineffective. Higher doses of growth hormone may required if patient is on oral oestrogen replacement. May increase clearance of CYP3A4 substrates (eg, sex steroids, corticosteroids, anticonvulsanta, cyclosporin).
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
SciTropin A soln for inj 10 mg/1.5 mL (30 IU)
Packing/Price
1's
Form
SciTropin A soln for inj 5 mg/1.5 mL (15 IU)
Packing/Price
1's
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