Norditropin® is contraindicated in patients with:
- Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin
- Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death
- Active Malignancy
- Hypersensitivity to Norditropin® or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
- Active proliferative or severe non-proliferative diabetic retinopathy
- Pediatric patients with closed epiphyses
Norditropin® (somatropin) injection is indicated for the treatment of pediatric patients with:
- growth failure due to inadequate secretion of endogenous growth hormone (GH)
- short stature associated with Noonan syndrome,
- short stature associated with Turner syndrome,
- short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years of age
- Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range
- growth failure due to Prader-Willi syndrome (PWS)
Norditropin® is also indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)
- Pregnancy and Nursing Mothers: There are limited data with somatropin use in pregnant women and nursing mothers to inform a drug-associated risk for adverse developmental outcomes.
- Geriatric Use: The safety and effectiveness in patients aged 65 and over has not been evaluated in clinical studies.
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