Somatropindrug info
somatropin 5 MG/ML Injectable Solution [Zomacton]
What it is used for
ZOMACTON is a recombinant human growth hormone indicated for: Pediatric: Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Turner syndrome, idiopathic short stature (ISS), short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency, and short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years.
Adult: Replacement of endogenous GH in adults with GH deficiency
1.1 Pediatric
Patients ZOMACTON is indicated for the treatment of pediatric patients with: growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Turner syndrome, idiopathic short stature (ISS), height standard deviation score (HSDS) ≤-2.25 and associated with growth rates unlikely to permit attainment of adult height in the normal range, short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency, short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age. 1.2 Adult Patients ZOMACTON is indicated for the replacement of endogenous GH in adults with GH deficiency.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective April 20, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of about 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. ZOMACTON (somatropin) for injection is a sterile, white lyophilized powder, intended for subcutaneous injection after reconstitution with the accompanying diluent. ZOMACTON 5 mg single-patient-use vial contains 5 mg of somatropin and mannitol (30 mg). Each 5 mg vial is co-packaged with a 5 mL vial of diluent containing Bacteriostatic Sodium Chloride Injection, USP, with 0.9% benzyl alcohol as a preservative, and Water for Injection, USP. ZOMACTON 10 mg single-patient-use vial contains 10 mg of somatropin, mannitol (10 mg), dibasic sodium phosphate (1.415 mg), and monobasic sodium phosphate (0.608 mg). Each 10 mg vial is co-packaged with a 1 mL syringe of diluent containing Bacteriostatic Water for Injection, USP with 0.33% metacresol as a preservative. Reconstituted solutions have a pH in the range of 7 to 9.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective April 20, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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