- Approval Id
- 135ece97de7560e5
- Drug Name
- GENOTROPIN FOR INJECTION 16 IU (5.3 MG) /ML
- Product Name
- GENOTROPIN FOR INJECTION 16 IU (5.3 MG) /ML
- Approval Number
- SIN05273P
- Approval Date
- 1990-12-24
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>The dosage and administration schedule should be individualized. Somatropin should be given subcutaneously and the injection site varied to prevent lipoatrophy.</p>
<p><u>Children</u><br>
<em>Growth disturbance due to insufficient secretion of growth hormone in children:</em> Generally, a dose of 0.07 – 0.10 international units/kg (0.025 – 0.035 mg/kg) body weight per day or 2.1 – 3.0 international units/m<sup>2</sup> (0.7 – 1.0 mg/m<sup>2</sup>) body surface area per day is recommended. Even higher doses have been used.</p>
<p><em>Growth disturbance due to Turner syndrome:</em> A dose of 0.14 international units/kg (0.045 – 0.050 mg/kg) body weight per day or 4.3 international units/m<sup>2</sup> (1.4 mg/m<sup>2</sup>) body surface area per day is recommended.</p>
<img src="/TGIF/Genotropin-Table1_030924.png" alt="Genotropin Dosage 1" /><br><br>
<p><u>Adults</u><br>
<em>Growth hormone deficient adult patients:</em> The recommended starting dose is 0.45 – 0.90 international units (0.15 – 0.30 mg) per day. The final dose should be individually titrated as needed with respect to age and gender. The daily maintenance dose seldom exceeds 4 international units (1.33 mg) per day. Women may require higher doses than men. This means that there is a risk that women, especially those on oral estrogen replacement may be under-treated. As normal physiological growth hormone production decreases with age, dose requirements may be reduced. Clinical response, side effects, and determination of IGF-I in serum may be used as guidance for dose titration.</p>
<img src="/TGIF/Genotropin-Table2_030924.png" alt="Genotropin Dosage 2" /><br><br>
- Route Of Administration
- SUBCUTANEOUS, INTRAMUSCULAR
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p><u>Children</u><br>
Growth disturbance due to insufficient secretion of growth hormone and growth disturbance associated with Turner syndrome.</p>
<p><u>Adults</u><br>
Replacement therapy in adults with pronounced growth hormone deficiency.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Somatropin is contraindicated in patients who have evidence of neoplastic activity and in patients with uncontrolled growth of benign intracranial tumors. Anti-tumor therapy must be completed prior to starting somatropin.</p>
<p>Somatropin is contraindicated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure. Two placebo-controlled clinical trials (N=522), conducted in adult patients to evaluate the effects of somatropin 5.3 or 8 mg (16 or 24 international units) on length of stay in intensive care units, showed significantly higher mortality (41.9% vs. 19.3%) in patients treated with somatropin compared with those who received placebo (see section <strong>4.4 Special warnings and precautions for use</strong> in patients who are receiving somatropin for growth hormone replacement – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Hypersensitivity to the active substance or to any of the excipients.</p>
- Atc Code
- H01AC01
- Atc Item Name
- somatropin
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
