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SciTropin A

SciTropin A Dosage/Direction for Use

somatropin

Manufacturer:

SciGen

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with the therapeutic indication of use.
The dosage and administration schedule should be individualized.
The injection should be given subcutaneously and the site varied to prevent lipoatrophy.
Paediatric population: Growth disturbance due to insufficient secretion of growth hormone in children: Generally a dose of 0.025-0.035 mg/kg body weight per day or 0.7-1.0 mg/m2 body surface area per day is recommended. Even higher doses have been used.
Prader-Willi syndrome, for improvement of growth and body composition in children: Generally a dose of 0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day is recommended. Daily doses of 2.7 mg should not be exceeded. Treatment should not be used in paediatric patients with a growth velocity less than 1 cm per year and near closure of epiphyses
Growth disturbance due to Turner syndrome: A dose of 0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day is recommended.
Growth disturbance in chronic renal insufficiency: A dose of 1.4 mg/m2 body surface area per day (0.045-0.050 mg/kg body weight per day) is recommended. Higher doses can be needed if growth velocity is too low. A dose correction can be needed after six months of treatment.
Growth disturbance in short children born small for gestational age (SGA): A dose of 0.035 mg/kg body weight per day (1.0 mg/m2 body surface area per day) is usually recommended until final height is reached. Treatment should be discontinued after the first year of treatment if the height velocity SDS is below +1. Treatment should be discontinued if height velocity is <2 cm/year and, if is required, bone age is >14 years (girls) or >16 years (boys), corresponding to epiphyseal closure.
Patients with epiphyseal closure who were treated with Somatropin replacement therapy in childhood should be re-evaluated before continuation of somatropin therapy at the reduced dose level recommended for GH deficient adults. (See Table 4.)

Click on icon to see table/diagram/image

Treatment should not be used in children with a growth velocity less than 1 cm per year and near closure of epiphyses.
Growth hormone deficient adult patients: Therapy should start with a low dose, 0.15-0.3 mg per day. The dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration. Treatment goal should be insulin-like growth factor (IGF-I) concentrations within 2 SDS from the age corrected mean of healthy adults. Patients with normal IGF-I concentrations at the start of the treatment should be administered growth hormone up to an IGF-I level into upper range of normal, not exceeding the2 SDS. Clinical response and side effects may also be used as guidance for dose titration. The daily maintenance dose seldom exceeds 1.0 mg per day. Woman may require higher dose than men, while men showing an increasing IGF-I sensitivity overtime. This means that there is a risk that women, especially those on oral oestrogen replacement are under-treated while men are over-treated. The accuracy of the growth hormone dose should therefore be controlled every 6 months. As normal physiological growth hormone production decreases with age, dose requirements may be reduced. The minimum effective dose should be used.
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