Description

Jintropin vials 10 IU, 1 ml, #5 Solution

Composition

Each vial of Jintropin contains 10 IU of somatropin, a recombinant human growth hormone, in a 1 ml solution. The package includes 5 vials. Additional excipients may include mannitol and phosphate buffer.

Description

Jintropin is a synthetic form of human growth hormone produced using recombinant DNA technology. It is structurally identical to the natural hormone produced by the pituitary gland and is used to promote growth, regeneration, and cellular repair in individuals with growth hormone deficiencies.

Indications

• Treatment of growth failure in children due to inadequate secretion of endogenous growth hormone.
• Adult growth hormone deficiency (AGHD), either of childhood-onset or adult-onset origin.
• May also be prescribed off-label for cachexia, muscle wasting in HIV/AIDS, or anti-aging purposes, under medical supervision.

Contraindications

• Hypersensitivity to somatropin or any formulation components.
• Active malignancy or proliferative retinopathy.
• Children with closed epiphyses (growth plates).
• Critical illness due to surgery, trauma, or acute respiratory failure.
• Severe obesity or respiratory impairment in Prader-Willi syndrome patients.

Administration and Dosage

Jintropin is administered subcutaneously, usually once daily. Dosage is individualized based on weight, age, condition, and therapeutic response:

• Children: 0.025–0.035 mg/kg/day
• Adults: Start at 0.15–0.3 mg/day, titrated up to a maximum of 1 mg/day depending on tolerance

Injection sites should be rotated to avoid lipodystrophy.

Side Effects

• Common: Injection site reactions, headache, joint or muscle pain, edema.
• Serious: Intracranial hypertension, pancreatitis, scoliosis progression, slipped capital femoral epiphysis, glucose intolerance, hypothyroidism.

Drug Interactions

Jintropin may interact with:

• Corticosteroids: may inhibit growth-promoting effect.
• Insulin or oral hypoglycemics: dosage adjustment may be necessary due to altered glucose metabolism.
• Cytochrome P450-metabolized drugs: altered clearance of coadministered medications.

Storage

• Store unopened vials in a refrigerator at 2–8°C (36–46°F).
• Do not freeze.
• Protect from light and keep in original packaging.
• Use immediately after reconstitution; discard any unused portion.

Overdose

Acute overdose may lead to hypoglycemia followed by hyperglycemia. Chronic overdose may cause acromegaly/gigantism and other metabolic abnormalities. Seek immediate medical attention in case of suspected overdose.

Precautions

• Monitor thyroid function and adjust therapy if necessary.
• Evaluate for potential glucose intolerance or diabetes development.
• Screen patients for scoliosis, especially in pediatric cases.
• Not indicated for performance enhancement or cosmetic use without medical necessity.

Warnings

• Monitor for signs of increased intracranial pressure.
• Do not use in patients with active neoplastic disease.
• Discontinue treatment in case of any signs of malignancy recurrence.

Disposal

Dispose of unused or expired Jintropin vials in accordance with local pharmaceutical waste regulations. Do not flush or pour into drains.

Pregnancy and Lactation

Limited data available. Use only if the potential benefit justifies the potential risk to the fetus or infant. Consult a healthcare provider before use.

Manufactured by

GeneScience Pharmaceuticals Co., Ltd. — a biopharmaceutical company specializing in the research and development of recombinant human growth hormone (rhGH) therapies.

Scientific References

• Clinical use of growth hormone in adults and children
• Somatropin – StatPearls (NCBI)