Somatropin
سوماتروپین (هورمون رشد)
🧬 Systemic Hormonal Preparations, Excl. Sex Hormones And InsulinsRecombinant growth hormone
Market / country: 🇺🇸 USA
Genotropin (US)
🧮 Dose calculator
Growth hormone deficiency and growth disorders (Turner, Prader-Willi, SGA, idiopathic short stature) · Regimen source: FDA Genotropin · 2FDA Genotropin · 2.1
🛡️ Safety & information
Contraindications
- ⛔ Acute critical illness; children with Prader-Willi who are severely obese or have severe respiratory impairment (sudden death); active malignancy; hypersensitivity; active proliferative or severe non-proliferative diabetic retinopathy; children with closed epiphyses. FDA Genotropin · 4
Warnings
- • Neoplasms; impaired glucose tolerance and diabetes; intracranial hypertension; fluid retention; hypoadrenalism and hypothyroidism; slipped capital femoral epiphysis and scoliosis progression in children; pancreatitis. FDA Genotropin · 5
Formulations
- 5 mg two-chamber cartridge — powder for injection 🇺🇸 USA FDA Genotropin · 3
- 12 mg two-chamber cartridge — powder for injection 🇺🇸 USA FDA Genotropin · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Genotropin · 8.1
“Risk Summary Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Genotropin · 8.2
“Risk Summary There is no information regarding the presence of somatropin in human milk.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Genotropin · 8.4
“Safety and effectiveness of GENOTROPIN in pediatric patients have been established in growth failure due to Prader-Willi syndrome (PWS), growth failure in children born small for gestational age (SGA) with no catch-up growth by age 2 years, growth failure associated with Turner syndrome, idiopathic short stature (ISS) …”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Genotropin · 8.5
“A lower starting dose and smaller dose increments should be considered for older patients [see Dosage and Administration (2.2) ].”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA020280
- DailyMed (FDA label)FDA Genotropin
- MedlinePlus (NIH)Somatropin Injection
- WHO ATC/DDDH01AC01
- Darooyab (Iran)Somatotropin
🇮🇷 Registered in Iran Darooyab · G-2700/Somatotropin
Dosage forms with Iranian generic codes, per Darooyab.
- 17791 · SOMATROPIN 10MG 1.5ML PEN · قلم تزریقی سوماتروپین ۱۰ میلیگرم ۱٫۵ میلیلیتر
- 01981 · SOMATROPIN 12U AMP · آمپول سوماتروپین ۱۲ واحد
- 20878 · SOMATROPIN 16U INJ · فرآورده تزریقی سوماتروپین ۱۶ واحد
- 01161 · SOMATROPIN 4U AMP · آمپول سوماتروپین ۴ واحد
- 09808 · SOMATROPIN 5MG 1.5ML PEN · قلم تزریقی سوماتروپین ۵ میلیگرم ۱٫۵ میلیلیتر
- 50071 · SOMATROPIN INJECTION PARENTERAL 10 [iU]/1mL 1.5 mL · فرآورده تزریقی سوماتروپین ۱۰ واحد بینالمللی / ۱ میلیلیتر ۱٫۵ میلیلیتر
- 50423 · SOMATROPIN INJECTION PARENTERAL 20 [iU]/1mL 1.5 mL · فرآورده تزریقی سوماتروپین ۲۰ واحد بینالمللی / ۱ میلیلیتر ۱٫۵ میلیلیتر
- 24054 · SOMATROPIN INJECTION, SOLUTION PARENTERAL 30 [iU]/2.7mL · محلول تزریقی سوماتروپین ۳۰ واحد بینالمللی / ۲٫۷ میلیلیتر
- 52346 · SOMATROPIN INJECTION, SOLUTION PARENTERAL 4 [iU]/0.5mL · محلول تزریقی سوماتروپین ۴ واحد بینالمللی / ۰٫۵ میلیلیتر
- 50024 · SOMATROPIN INJECTION, SOLUTION PARENTERAL 15 [iU]/1mL 1.5 mL · محلول تزریقی سوماتروپین ۱۵ واحد بینالمللی / ۱ میلیلیتر ۱٫۵ میلیلیتر
- 52212 · SOMATROPIN INJECTION, SOLUTION PARENTERAL 6 mg/1.03 mL · محلول تزریقی سوماتروپین ۶ میلیگرم / ۱٫۰۳ میلیلیتر
- 52210 · SOMATROPIN INJECTION, SOLUTION PARENTERAL 8 mg/1mL 1.5 mL · محلول تزریقی سوماتروپین ۸ میلیگرم / ۱ میلیلیتر ۱٫۵ میلیلیتر
- 52211 · SOMATROPIN INJECTION, SOLUTION PARENTERAL 8 mg/1mL 2.5 mL · محلول تزریقی سوماتروپین ۸ میلیگرم / ۱ میلیلیتر ۲٫۵ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Genotropin · 3FDA Genotropin · 2FDA Genotropin · 2.1FDA Genotropin · 2.2FDA Genotropin · 4FDA Genotropin · 5FDA Genotropin · 8.1FDA Genotropin · 8.2FDA Genotropin · 8.4FDA Genotropin · 8.5FDA Genotropin · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-2700/Somatotropin
- Clinical review⚠ Unverified