Scitropin A

Scitropin A

somatropin

Manufacturer:

SciGen

Distributor:

Metro Drug
Concise Prescribing Info
Contents
Somatropin (rbe)
Indications/Uses
Childn: Growth disturbance due to insufficient secretion of growth hormone [growth hormone deficiency (GHD)]; growth disturbance associated w/ Turner syndrome & chronic renal insufficiency; growth disturbance (current height standard deviation score (SDS) < -2.5 & parental adjusted height SDS < -1) in short childn born small for gestational age (SGA) w/ birth wt &/or length < -2 standard deviation (SD) who fail to show catch-up growth (height velocity SDS <0 during the last year) by 4 yr or later; Prader-Willi syndrome (PWS). Adult: Replacement therapy w/ pronounced GHD.
Dosage/Direction for Use
Adult Restart at 0.2-0.5 mg/day in patients who continue growth hormone therapy after childhood GHD. Start at 0.15-0.3 mg/day in patients w/ onset GHD. Doses should be gradually increased or decreased according to individual requirements as determined by the insulin-like growth factor conc. Maintenance: Seldom exceeds 1 mg/day. Childn GHD 0.025-0.035 mg/kg body wt or 0.7-1 mg/m2 BSA/day. PWS 0.035 mg/kg body wt or 1 mg/m2 BSA/day. Turner syndrome & chronic renal insufficiency 0.045-0.050 mg/kg body wt or 1.4 mg/m2 BSA/day. Born SGA 0.035 mg/kg body wt or 1 mg/m2 BSA/day. Elderly >60 yr 0.1-0.2 mg/day then increase slowly according to individual requirements. Maintenance: Seldom exceeds 0.5 mg/day.
Contraindications
Hypersensitivity. Evidence of activity or growth of a tumour; growth promotion in childn w/ closed epiphyses. Childn w/ PWS & corresponding severe resp disorder or severe obesity. Patients w/ acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute resp failure or similar conditions. Do not use 5 mg/1.5 mL soln in newborns (due to its preservative & benzyl alcohol).
Special Precautions
DM, glucose intolerance. Monitor thyroid function. Discontinue use if benign intracranial HTN is confirmed. Leukemia. Perform testing for antibodies in patients w/ unexplained lack of response. Maintain calorie-restricted diet in childn w/ PWS. Assess upper airway obstruction, sleep apnoea or resp infections before initiation of therapy. Monitor signs of scoliosis. Measure fasting insulin & blood glucose in SGA childn before start of treatment & annually thereafter; IGF-I before start of treatment & twice a year thereafter. Perform oral glucose tolerance in patients w/ increased risk of DM. Not recommended to initiate near onset of puberty. Increased risk of developing pancreatitis in childn. Patients w/ Silver-Russell syndrome. Male patients w/ PWS. Not recommended during pregnancy & lactation. Elderly >80 yr.
Adverse Reactions
Formation of antibodies. Adult: Paraesthesia; stiffness in the extremities, arthralgia; myalgia; peripheral oedema. Childn: Transient local skin reactions.
Drug Interactions
May inhibit growth-promoting effects w/ glucocorticoids. May increase clearance of drugs metabolized by CYP450 3A4 (eg, sex steroids, corticosteroids, anticonvulsants, 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 inj 30 IU
Packing/Price
1's
Form
Scitropin A inj 15 IU
Packing/Price
1's
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