INSTRUCTION FOR MEDICAL USE
SOMATROP
International Nonproprietary Name (INN): Somatropin
Pharmacotherapeutic group: Pituitary hormones and their analogues
ATC code: H01AC01
Dosage form: Lyophilized powder for solution for injection
Strength: 10 IU (3.33 mg) per vial
Package: 10 vials × 3.33 mg (total 100 IU)
Manufacturer: American Pharmaceutical, Inc. Ohio, USA
PHARMACEUTICAL FORM
Active substance: Each vial contains somatropin (recombinant human growth hormone) — 10 IU (3.33 mg).
Somatropin consists of 191 amino acids and is produced by recombinant DNA technology.
Excipients: Mannitol, Glycine, Sodium Phosphate.
White or almost white lyophilized powder.
After reconstitution, the solution should be clear and colorless, without visible particles.
COMPOSITION
PHARMACOLOGICAL PROPERTIES
Absorption:
After subcutaneous administration, the bioavailability of somatropin is approximately 80%.
Distribution:
Peak serum concentrations are reached within 3–6 hours after administration.
Elimination:
The elimination half-life following subcutaneous administration is approximately 2–3 hours.
Special populations:
Pharmacokinetic data in elderly patients, children, and patients with renal or hepatic impairment are limited.
Somatropin is a metabolic hormone that plays a key role in the regulation of protein, lipid, and carbohydrate metabolism.
In children with endogenous growth hormone deficiency, somatropin stimulates linear skeletal growth and increases growth velocity.
In both children and adults, somatropin contributes to the maintenance of normal body composition by increasing nitrogen retention, stimulating skeletal muscle growth, and mobilizing fat stores, particularly visceral adipose tissue.
Somatropin increases serum concentrations of insulin-like growth factor-1 (IGF-1) and IGF-binding protein-3 (IGFBP-3).
Lipid metabolism:
Somatropin stimulates hepatic LDL receptors, leading to a reduction in LDL cholesterol and apolipoprotein B levels.
Carbohydrate metabolism:
Somatropin may increase insulin secretion. Fasting glucose levels usually remain unchanged, although impaired glucose tolerance may occur in susceptible individuals.
Water and electrolyte balance:
Growth hormone deficiency is associated with reduced plasma and extracellular fluid volume. Somatropin increases sodium, potassium, and phosphorus retention.
Bone metabolism:
Somatropin stimulates bone remodeling. Long-term therapy in patients with growth hormone deficiency may increase bone mineral density.
Physical capacity:
Long-term treatment may increase muscle strength and physical endurance.
PHARMACOKINETICS
PHARMACODYNAMICS
THERAPEUTIC INDICATIONS
Children
• Growth disorders due to insufficient secretion of growth hormone
• Growth failure associated with Turner syndrome
• Growth failure associated with chronic renal insufficiency
• Growth disorders in children born small for gestational age who fail to achieve catch-up growth
• Growth disorders in Prader–Willi syndrome (diagnosis must be genetically confirmed)
Adults
• Replacement therapy in adults with confirmed severe growth hormone deficiency, diagnosed by appropriate stimulation testing
CONTRAINDICATIONS
SPECIAL WARNINGS AND PRECAUTIONS
Treatment should be initiated and monitored by physicians experienced in the diagnosis and management of growth hormone disorders.
Glucose metabolism:
Somatropin may reduce insulin sensitivity. Blood glucose levels should be monitored, particularly in patients with diabetes or risk factors for diabetes.
Thyroid function:
Somatropin may unmask hypothyroidism. Thyroid function should be monitored.
Adrenal function:
Somatropin may reveal previously undiagnosed central hypoadrenalism.
Intracranial hypertension:
Rare cases of benign intracranial hypertension have been reported. In case of severe headache, visual disturbances, nausea, or vomiting, treatment should be discontinued.
Neoplasms:
Patients with a history of malignancy should be carefully monitored for tumor recurrence.
• Hypersensitivity to somatropin or any excipient
• Evidence of active tumor growth
• Closed epiphyseal growth plates (for growth stimulation)
• Acute critical illness following major surgery, trauma, or acute respiratory failure
• Active proliferative or severe non-proliferative diabetic retinopathy
• Severe obesity or severe respiratory impairment in patients with Prader–Willi syndrome
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS
PREPARATION INSTRUCTIONS
METHOD OF ADMINISTRATION AND DOSAGE
• Glucocorticoids may inhibit the growth-promoting effects of somatropin
• Somatropin may affect the metabolism of drugs metabolized by CYP3A4
• Dose adjustment of insulin or antidiabetic agents may be requirede.
Dosage and treatment regimen should be individualized based on indication, patient age, body weight, and clinical response.
SOMATROP is intended for subcutaneous injection.
• Add 1 ml of sterile water for injection to the vial
• Gently swirl until fully dissolved
• Do not shake
UNDESIRABLE EFFECTS
Possible adverse reactions include:
• Injection site reactions
• Edema
• Arthralgia or myalgia
• Headache
• Glucose intolerance
• Rarely, benign intracranial hypertension
• Store at 2–8°C
• Protect from light
• Do not freeze
After reconstitution, store at 2–8°C and use within 30 days.
Acute overdose may cause hypoglycemia followed by hyperglycemia.
Long-term overdose may lead to signs consistent with excessive growth hormone exposure.
STORAGE CONDITIONS
OVERDOSE
Prescription-only medicinal product.
• Shelf life: 24 months
• Manufacturing date: 08/09/2025
• Expiration date: 08/09/2027
LEGAL STATUS
SHELF LIFE
info@americanpharma.com
012-345-6789
