Overview:
Cinnatropin 10 mg/1.5 ml is a recombinant human growth hormone (rhGH) used primarily for the treatment of growth hormone deficiencies (GHD) in both children and adults. The active ingredient, Somatropin, is a bioengineered version of the naturally occurring growth hormone produced by the pituitary gland, vital for growth, cell reproduction, and regeneration. Cinnatropin is manufactured using advanced recombinant DNA technology, ensuring a high degree of purity and bioactivity, making it effective for a range of medical conditions associated with growth hormone deficiency.
This product is supplied as a sterile solution for subcutaneous or intramuscular injection and comes in a vial containing 10 mg of Somatropin (approximately 30 IU) per 1.5 ml. The ready-to-use format offers patients ease of administration, improving compliance and reducing preparation time.
Composition:
- Active ingredient: Somatropin (recombinant human growth hormone) 10 mg/1.5 ml (approx. 30 IU)
- Excipients: Sodium chloride, water for injection, stabilizers, and preservatives to ensure sterility and efficacy
Mechanism of Action:
Cinnatropin mimics the activity of natural human growth hormone. It binds to the growth hormone receptor (GHR) on target cells, initiating intracellular signaling pathways that promote growth and development. The hormone plays a key role in stimulating skeletal growth, increasing the size and number of muscle cells, and regulating metabolism by promoting protein synthesis and reducing fat accumulation. It also enhances the production of insulin-like growth factor 1 (IGF-1) in the liver, which contributes to bone growth, muscle development, and overall tissue repair.
Indications:
Cinnatropin is prescribed for a variety of conditions, including but not limited to:
- Growth Hormone Deficiency (GHD) in Children:
- Children with inadequate endogenous growth hormone production leading to stunted growth.
- Cinnatropin helps these patients achieve a near-normal height by promoting bone growth, increasing muscle mass, and reducing body fat.
- Growth Hormone Deficiency in Adults:
- Adults with GHD, often due to pituitary gland damage, require exogenous growth hormone to maintain normal physiological functions, including muscle strength, bone density, and metabolism.
- Turner Syndrome:
- A genetic disorder in females characterized by short stature and lack of ovarian development. Growth hormone therapy can help increase height in these patients.
- Chronic Renal Insufficiency:
- Growth failure in children with chronic renal insufficiency. Somatropin assists in improving linear growth in these patients.
- HIV-Associated Wasting or Cachexia:
- Cinnatropin helps to counteract severe muscle wasting and fat loss in patients with HIV, improving lean body mass and overall health.
- Short Bowel Syndrome:
- Somatropin is used in conjunction with specialized nutritional support to improve the absorption of nutrients in patients with short bowel syndrome.
Dosage and Administration:
The dosage of Cinnatropin is individualized based on the patient’s weight, age, and medical condition. Treatment should be supervised by a healthcare professional experienced in growth hormone therapy.
- Children with GHD: The typical dosage is 0.025 to 0.035 mg/kg of body weight per day. The injection is administered subcutaneously, and the site of injection should be rotated to avoid lipoatrophy.
- Adults with GHD: An initial dose of 0.15-0.3 mg/day is recommended, which may be gradually increased based on the patient’s tolerance and clinical response. The maintenance dose varies, generally in the range of 0.15-0.75 mg/day.
- Turner Syndrome, Chronic Renal Insufficiency, and Short Bowel Syndrome: Dosages are tailored to the specific needs of the patient based on their condition and clinical evaluation.
Administration Instructions:
Cinnatropin is typically self-administered by the patient after proper training. It is injected subcutaneously or intramuscularly, and the patient or caregiver should be instructed on the correct handling of the syringe, needle, and vials to ensure sterility and safety.
- Storage: Store Cinnatropin in a refrigerator between 2°C to 8°C (36°F to 46°F) until use. Once removed from refrigeration, the vial can be kept at room temperature for up to 4 weeks, but should not be exposed to extreme heat or direct sunlight.
Contraindications:
Cinnatropin is contraindicated in the following conditions:
- Active Malignancy: Growth hormone therapy may promote the growth of pre-existing tumors.
- Acute Critical Illness: Patients recovering from major surgeries, trauma, or those with acute respiratory failure should not be treated with growth hormone due to an increased risk of mortality.
- Hypersensitivity to Somatropin: Patients who have exhibited allergic reactions to any component of Cinnatropin should avoid this medication.
Warnings and Precautions:
- Diabetes Mellitus: Growth hormone therapy can affect glucose metabolism, potentially leading to insulin resistance or exacerbating existing diabetes. Blood glucose levels should be monitored regularly in patients with diabetes or prediabetes.
- Intracranial Hypertension: Rare cases of intracranial hypertension (increased pressure within the skull) have been reported, particularly during the initial weeks of treatment. Patients should be monitored for symptoms such as headaches, visual disturbances, and nausea.
- Hypothyroidism: Growth hormone therapy may unmask previously undiagnosed hypothyroidism. Thyroid function should be monitored, and thyroid hormone replacement should be administered if necessary.
- Scoliosis: Rapid growth in children can exacerbate existing scoliosis. Regular monitoring of spinal health is advised.
Adverse Effects:
While Cinnatropin is generally well-tolerated, some patients may experience side effects. Common side effects include:
- Injection Site Reactions: Pain, redness, or swelling at the injection site is common but typically resolves with time.
- Fluid Retention: Swelling in the hands or feet due to fluid retention may occur, especially in adults.
- Joint and Muscle Pain: Some patients may experience joint stiffness or muscle pain, particularly during the early stages of treatment.
- Carpal Tunnel Syndrome: In rare cases, patients may develop carpal tunnel syndrome, characterized by numbness, tingling, or pain in the hands.
- Metabolic Changes: Increases in blood sugar levels, changes in cholesterol levels, or alterations in lipid metabolism have been reported.
Drug Interactions:
Certain medications may interact with Cinnatropin, potentially affecting its efficacy or safety. Key interactions include:
- Glucocorticoids: High doses of glucocorticoids can counteract the growth-promoting effects of Somatropin. Dose adjustments may be required if patients are on long-term steroid therapy.
- Antidiabetic Medications: Growth hormone can alter glucose metabolism, requiring adjustments in the dosages of insulin or oral hypoglycemic agents in diabetic patients.
- Thyroid Hormone Replacement Therapy: Patients receiving both growth hormone and thyroid hormone replacement may need to adjust the dose of one or both medications to optimize treatment outcomes.
Monitoring:
Patients on Cinnatropin should undergo regular monitoring, which includes:
- Growth Rate (in children): Height and weight should be measured regularly to assess the effectiveness of the treatment.
- IGF-1 Levels: Blood levels of IGF-1 should be checked to ensure the appropriate dose of Somatropin is being administered.
- Blood Glucose and Lipid Profiles: Regular monitoring is recommended to detect any changes in glucose tolerance or lipid metabolism, particularly in adults.
Patient Counseling Information:
Patients and caregivers should be provided with clear instructions on the proper storage, preparation, and administration of Cinnatropin. It is essential to rotate injection sites to avoid tissue damage, and patients should report any unusual symptoms, such as persistent headaches or joint pain, to their healthcare provider immediately.
Conclusion:
Cinnatropin 10 mg/1.5 ml is a highly effective growth hormone therapy designed to address a range of medical conditions associated with growth hormone deficiency. With its proven efficacy and safety profile, it offers patients an opportunity to improve growth outcomes, metabolic function, and overall well-being. Regular monitoring and adherence to prescribed dosages are crucial to ensure optimal results and minimize the risk of side effects. As with all medications, Cinnatropin should be used under the supervision of a qualified healthcare professional, ensuring personalized care tailored to each patient’s unique needs.
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