Somatropin

PRESENTATION

• 5 x 5 mg lyophilized powder vials

• 5 x 2 ml bacteriostatic water vials (for reconstitution)

ACTIVE INGREDIENT

Each vial contains:

• Somatropin 100 IU (equivalent to 3.33 mg)

DESCRIPTION

Somatropin is a synthetic form of human growth hormone (hGH) produced by recombinant DNA technology. It is structurally identical to naturally occurring growth hormone, which is secreted by the pituitary gland. Somatropin promotes growth and development in various tissues, including bone and muscle, and regulates metabolism.

The product is provided as a sterile, lyophilized powder for reconstitution.

PHARMACOLOGICAL CLASSIFICATION

Growth Hormone (GH)

PHARMACOLOGICAL PROPERTIES

Mechanism of Action: Somatropin stimulates growth and cellular reproduction in humans. It binds to the growth hormone receptor, triggering downstream signaling pathways that promote growth in bone, muscle, and cartilage. It also enhances protein synthesis and helps regulate metabolism by promoting fat breakdown and increasing glucose levels.

Pharmacokinetics:

• Absorption: After subcutaneous or intramuscular injection, Somatropin is absorbed into the bloodstream.
• Distribution: Widely distributed to various tissues, including muscles and liver.
• Metabolism: Primarily metabolized in the liver and kidneys.
• Excretion: Excreted primarily via urine.

INDICATIONS

Somatropin is indicated for:

Growth Hormone Deficiency (GHD): Treatment of children and adults with growth hormone deficiency.

Growth Disorders in Children: Including idiopathic short stature, Turner syndrome, and chronic kidney disease.

Muscle Wasting: Treatment of muscle wasting associated with HIV/AIDS.

Short Bowel Syndrome: To improve intestinal absorption in patients with short bowel syndrome.

Anti-Aging and General Well-being: Investigated for its potential benefits in enhancing muscle mass, reducing fat, and improving overall vitality in aging individuals.

DOSAGE AND ADMINISTRATION

Dosage:

• For Pediatric Growth Hormone Deficiency: 0.16 to 0.24 mg/kg body weight per week, administered as a daily subcutaneous injection.
• For Adult Growth Hormone Deficiency: Typically, a starting dose of 0.15 to 0.30 mg/day, adjusted based on individual response.
• Anti-Aging or Performance Enhancement: Dosages vary between 1 to 3 IU per day, based on individual goals and under physician supervision.

Administration:

1. Reconstitute the lyophilized powder with bacteriostatic water.
2. Administer subcutaneously or intramuscularly.
3. Rotate injection sites to prevent localized irritation or lipoatrophy.

Reconstitution:

• Use 1 to 2 ml of bacteriostatic water to reconstitute the powder.
• Store the reconstituted solution in the refrigerator and use within 14 days.

CONTRAINDICATIONS

• Active Neoplasia: Somatropin should not be used in patients with active malignancies.
• Hypersensitivity: Contraindicated in individuals with hypersensitivity to any component of the product.
• Diabetic Retinopathy: Should not be used in patients with proliferative or pre-proliferative diabetic retinopathy.
• Pregnancy and Breastfeeding: Not recommended for use in pregnant or breastfeeding women unless clearly indicated.

WARNINGS AND PRECAUTIONS

1. Risk of Neoplasia: Patients with a history of cancer should be monitored closely as growth hormone can potentially increase the risk of neoplasia recurrence.

2. Risk of Hyperglycemia: Somatropin can affect glucose metabolism and lead to insulin resistance or hyperglycemia. Caution is advised for individuals with diabetes or those at risk of developing diabetes.

3. Fluid Retention: Somatropin may cause fluid retention, leading to swelling, joint pain, and carpal tunnel syndrome, especially at higher doses.

4. Hormone Imbalances: Prolonged use may affect other endocrine functions, such as thyroid and adrenal function. Regular monitoring is recommended.

ADVERSE REACTIONS

Common side effects:

• Injection site reactions (pain, redness, or swelling)
• Joint pain or muscle stiffness
• Edema (fluid retention)
• Increased blood glucose levels
• Headache

Serious adverse effects:

• Intracranial Hypertension: Rare cases of increased intracranial pressure and optic disk swelling have been reported.
• Carpal Tunnel Syndrome: Particularly at higher doses.
• Hypothyroidism: Somatropin may unmask previously undiagnosed hypothyroidism.

INTERACTIONS

• Insulin and Oral Hypoglycemic Agents: Somatropin may interfere with glucose control, and adjustments to insulin or diabetes medications may be required.
• Corticosteroids: Concurrent use may reduce the efficacy of Somatropin, requiring dose adjustments.
• Anabolic Steroids: Using Somatropin with anabolic steroids may enhance muscle-building effects, but should be monitored due to the potential for hormonal imbalances.

USE IN SPECIFIC POPULATIONS

Pregnancy and Lactation: Somatropin should be used during pregnancy only if clearly needed and under medical supervision. It is unknown whether Somatropin is excreted in human milk, and caution is advised in breastfeeding women.

Pediatric Use: Somatropin is indicated for pediatric use in the treatment of growth hormone deficiency and other growth disorders.

Geriatric Use: Elderly patients may be more sensitive to the effects of growth hormone, and a lower starting dose may be required.

OVERDOSAGE

Symptoms of overdose may include signs of acromegaly (enlarged extremities, increased bone density), fluid retention, and hyperglycemia. In case of overdose, discontinue use and seek medical attention.

STORAGE

• Store the lyophilized powder at room temperature (20°C to 25°C / 68°F to 77°F).
• After reconstitution, store the solution in the refrigerator at 2°C to 8°C (36°F to 46°F) and use within 14 days.
• Protect from light and do not freeze.
• Keep out of reach of children.

PACKAGING

Somatropin is supplied in the following packaging:

• 5 x 100 IU vials of lyophilized powder
• 5 x 2 ml vials of bacteriostatic water

MANUFACTURER

Oxydine Metabolics Switzerland

Oxydine.org
Hi@Oxydine.org