PowderPowder
Schedule H (Prescription Required - Recombinant Biological)Contraceptives & Hormonal TherapyCode: 2262

Somatropin (Recombinant Human Growth Hormone) 4 IU Injection

Generic Formulation:Somatotropin 4 IU (Recombinant Human Growth Hormone) Powder for Injection
Pack Size:Vial with WFI in Mono Carton
Common Commercial Brand Equivalents:Market reference only
GenotropinNorditropinSaizen

MRP Under Process

Official PMBI MRP is being updated for catalog code 2262.

Locate Jan Aushadhi Kendra
Clinical InformationReport Error

Clinical Overview

Somatotropin 4 IU (Recombinant Human Growth Hormone - rhGH) Powder for Injection is a biosynthetic 191-amino acid polypeptide hormone produced via recombinant DNA technology, identical to human pituitary growth hormone, on the WHO Model List of Essential Medicines. It stimulates hepatic production of Insulin-like Growth Factor-1 (IGF-1), stimulating chondrocyte proliferation, longitudinal linear skeletal growth in children with open epiphyses, skeletal muscle hypertrophy, lipolysis, and protein synthesis. Indicated for growth hormone deficiency (GHD) in children and adults, Turner syndrome, Prader-Willi syndrome, chronic kidney disease-induced growth failure, and small-for-gestational-age (SGA) children failing to catch up by age 2-4 years.

Active Pharmaceutical Ingredients

AI-assistedClinical summary synthesized from pharmacopoeial references (CDSCO, WHO EML, IP/BP/USP). Not clinician-reviewed. Drug code 2262.Report inaccuracy

Usage Guidelines

For Subcutaneous (SC) injection ONLY after reconstitution with the supplied sterile diluent: Reconstitute gently without vigorous agitation (rhGH protein is fragile and denatures easily); inspect for clarity. Administer subcutaneously in the evening (mimicking physiological nocturnal GH secretion pulses) into the abdomen, thigh, or buttock, strictly rotating injection sites daily to prevent lipoatrophy. Individualized weight-based or BSA-based dosing monitored by pediatric endocrinologist via serum IGF-1 levels.

General Administration Advice: Adhere strictly to the prescribed dosage, frequency, and treatment course. For oral medications, swallow with sufficient water. Never stop antibiotics, psychiatric medications, or antihypertensives abruptly without clinical direction.

Possible Side Effects

Common: Injection-site redness/pain, peripheral edema, arthralgia, myalgia, paresthesia, headache, and transient hyperglycemia (anti-insulin effect). Rare/Severe: Slipped capital femoral epiphysis (SCFE - presents as hip/knee pain/limp), pseudotumor cerebri (benign intracranial hypertension with severe headache/papilledema), pancreatitis, and leukemia recurrence.

*Note: Individual physiological responses vary. While many patients experience few or no side effects, notify your treating physician if adverse reactions persist or if hypersensitivity (angioedema, skin rash, dyspnea) occurs.

Precautions & Warnings

Black Box Warning: Contraindicated in patients with active malignancy, acute critical illness due to open heart/abdominal surgery, multiple trauma, or acute respiratory failure. Contraindicated after epiphyseal fusion (closed growth plates). Funduscopic examination recommended before starting and during treatment.

Schedule H (Prescription Required - Recombinant Biological)

This medication is scheduled under statutory drug regulatory frameworks (CDSCO / Drugs & Cosmetics Rules). Dispensing requires a valid medical prescription from a registered medical practitioner. Self-medication or unsupervised dosage adjustment carries significant clinical risks.

Medical Disclaimer: Statutory Gynecological, Obstetric & Endocrinological Disclaimer: The information provided is for educational and price-transparency purposes only and does not constitute medical advice or reproductive healthcare guidance. Hormonal medications, uterotonics, corticosteroids, fertility therapies, and emergency contraceptives have profound systemic actions and must be administered strictly under the supervision of a registered gynecologist, obstetrician, or endocrinologist.