Saizen

Saizen

somatropin

Manufacturer:

Merck

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Somatropin
Indications/Uses
Growth failure in childn caused by decreased or absent secretion of endogenous growth hormone (GH); in girls w/ gonadal dysgenesis (Turner syndrome), confirmed by chromosomal analysis. Growth disturbance in short childn born small for gestational age (SGA). Replacement therapy in adults w/ pronounced GH deficiency as diagnosed by single dynamic test for GH deficiency.
Dosage/Direction for Use
Growth failure due to inadequate endogenous GH 0.7-1 mg/m2 daily or 0.025-0.035 mg/kg daily SC/IM. Growth failure in girls due to gonadal dysgenesis (Turner syndrome) & prepubertal childn due to chronic renal failure 1.4 mg/m2 daily or 0.045-0.05 mg/kg daily SC. Growth failure in short childn born SGA 0.035 mg/kg daily or 1 mg/m2 daily SC. GH deficiency in adult Initially 0.15-0.3 mg daily SC, adjust dose stepwise, controlled by insulin-like growth factor 1 (IGF-1) values. Max recommended final GH dose: 1 mg daily. Older or overwt patient Lower doses may be necessary.
Contraindications
Hypersensitivity. Not to be used in any evidence of tumour activity; in case of proliferative or preproliferative diabetic retinopathy. Acute critical illness suffering complications following open heart or abdominal surgery, multiple accidental trauma, acute resp failure. Not to be used in childn w/ chronic renal failure, closed epiphyses.
Special Precautions
Discontinue use if papilloedema is confirmed. Not recommended to initiate treatment near onset of puberty in SGA patients. Not to be used if overt diabetes occurs. Intra- or extracranial neoplasia in remission; GH deficiency secondary to intracranial tumour; leukemia; retinopathy; slipped capital femoral epiphysis; acute critical illnesses; persistent oedema or severe paraesthesia; pancreatitis. Unmasked secondary adrenal insufficiency. Formation of Ab. Closely monitor patients w/ diabetes or glucose tolerance. Monitor thyroid function & signs of scoliosis during treatment. Periodically examine for evidence of renal osteodystrophy progression. Concomitant use w/ oral oestrogen therapy. Lipoatrophy. Prolonged use. Growth failure due to chronic renal failure. Not recommended in women of childbearing potential & during pregnancy. Lactation. Not for long-term treatment of paed patients w/ growth failure due to Prader-Willi syndrome. Elderly >60 yr. Powd for inj 3.33 mg: Anaphylactic reactions due to benzyl alcohol. Infants & child up to 3 yr. Not to be given to premature babies or neonates.
Adverse Reactions
Headache; inj site reactions, localised lipoatrophy. Adult: Carpal tunnel syndrome; fluid retention (peripheral oedema, stiffness, arthralgia, myalgia paraesthesia).
Drug Interactions
Inhibited effects w/ corticosteroids, glucocorticoids. Decreased cortisone to cortisol conversion. Increased clearance of CYP450-metabolised compds eg, sex steroids, corticosteroids, anticonvulsants, cyclosporine. Higher GH dose required during oral oestrogen replacement therapy.
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
Saizen soln for inj 20 mg
Packing/Price
1's
Form
Saizen soln for inj 12 mg
Packing/Price
1's
Form
Saizen powd for inj (Clickeasy vial) 8 mg
Packing/Price
1's
Form
Saizen soln for inj 6 mg
Packing/Price
1's
Form
Saizen powd for inj (vial) 3.33 mg
Packing/Price
1's
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