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SciTropin A

SciTropin A

somatropin

Manufacturer:

SciGen

Distributor:

DKSH
Concise Prescribing Info
Contents
Recombinant somatropin
Indications/Uses
Replacement therapy in adults w/ pronounced growth hormone deficiency. Growth disturbance due to insufficient secretion of growth hormone (GHD), associated w/ Turner syndrome or chronic renal insufficiency in infants, childn & adolescents. Growth disturbance in short childn born small for gestational age (SGA) w/ birth wt &/or length below -2 standard deviation, who failed to show catch-up growth by ≥4 yr. Prader-Willi syndrome (PWS) for improvement of growth & body composition.
Dosage/Direction for Use
SC Adult GHD Start w/ 0.15-0.3 mg daily, gradually increase dose according to individual patient requirements. Childn GHD 0.025-0.035 mg/kg daily or 0.7-1 mg/m2 daily. PWS 0.035 mg/kg daily or 1 mg/m2 daily. Max: 2.7 mg daily. Turner syndrome & chronic renal insufficiency 0.045-0.05 mg/kg daily or 1.4 mg/m2 daily. Short childn born SGA 0.035 mg/kg daily or 1 mg/m2 daily until final height is reached.
Contraindications
Hypersensitivity. Evidence of tumour activity. Patients w/ acute critical illness suffering complications following open heart or abdominal surgery, multiple accidental traumas, acute resp failure or similar conditions. Childn w/ closed epiphyses; w/ PWS & severe resp disorder or obesity. Childn <2 yr & neonates.
Special Precautions
Discontinue use if papilloedema is confirmed. Interrupt treatment if signs of upper airway obstruction occur. Not recommended to initiate treatment near onset of puberty in short childn born SGA. Not to be used in patients w/ acute critical illness suffering complications following open heart or abdominal surgery, multiple accidental trauma or acute resp failure; if overt diabetes occurs. Leukaemia; pancreatitis; Silver-Russell syndrome. May induce insulin sensitivity; observe for evidence of glucose intolerance. May unmask previously undiagnosed central hypoadrenalism. Ab formation; GHD secondary to malignant disease treatment. Monitor symptoms of intracranial HTN if treatment is restarted; thyroid function & signs of scoliosis during treatment. Measure fasting insulin & blood glucose prior to & annually in SGA childn. Assess renal function prior to initiation. Evaluate for upper airway obstruction, sleep apnoea or resp infections prior to treatment; strict calorie-restricted diet & wt control in patients w/ PWS. Concomitant use w/ oral oestrogen therapy. Discontinue treatment at renal transplantation. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Not to be used in premature babies or neonates. Examine childn limping during treatment. Elderly >80 yr.
Adverse Reactions
Arthralgia; peripheral oedema. Paraesthesia; rash, urticaria; myalgia, musculoskeletal stiffness. Adults: Carpal tunnel syndrome. Childn: Inj site reaction. Benign intracranial HTN.
Drug Interactions
Inhibited growth-promoting effects w/ glucocorticoids. Decreased cortisone to cortisol conversion. Increased clearance of CYP450 3A4-metabolized compd eg, sex steroids, corticosteroids, anticonvulsants & ciclosporin. Concomitant use w/ oral oestrogen replacement.
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
1.5 mL x 1's
Form
SciTropin A soln for inj 5 mg/1.5 mL (15 IU)
Packing/Price
1.5 mL x 1's
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