Hypoglycemic agents may require dose adjustment when used concomitantly with somatropin.
Source: NLP:somatropin
Brand names: Norditropin
Recombinant Human Growth Hormone
Route: Subcutaneous
Contraindications
4 CONTRAINDICATIONS 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 [see Warnings and Precautions (5.1) ]. • 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 [see Warnings and Precautions (5.2) ]. • Active Malignancy [see Warnings and Precautions (5.3) ]. • Hypersensitivity to NORDITROPIN or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins [see Warnings and Precautions (5.6) ]. • Active proliferative or severe non-proliferative diabetic retinopathy. • Pediatric patients with closed epiphyses. • Acute Critical Illness ( 4 ) • Pediatric patients with Prader-Willi syndrome who are severely obese, have history of severe upper airway obstruction, or have severe respiratory impairment due to risk of sudden death ( 4 ) • Active Malignancy ( 4 ) • Hypersensitivity to somatropin or excipients ( 4 ) • Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy ( 4 ) • Pediatric patients with closed epiphyses ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, there was no evidence of fetal or neonatal harm when pregnant rats were administered subcutaneous NORDITROPIN during organogenesis or during lactation at doses approximately 10-times higher than the maximal clinical dose of 0.016 mg/kg, based on body surface area (see Data). The estimated background risk of birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryo-fetal development study, NORDITROPIN was administered via subcutaneous injection to pregnant rats from gestation Day 6 to 17, corresponding with the period of organogenesis. NORDITROPIN did not adversely affect fetal viability or developmental outcomes at maternal doses that were approximately 10-times the clinical dose of 0.016 mg/kg, based on body surface area. In a pre- and post-natal development study in pregnant rats, NORDITROPIN was administered from gestation Day 17 through lactation Day 21 (weaning). No adverse developmental effects were observed in the offspring at doses up to 1.1 mg/kg (approximately 10 times the clinical dose of 0.016 mg/kg, based on body surface area).
21 interactions on record
Hypoglycemic agents may require dose adjustment when used concomitantly with somatropin.
Source: NLP:somatropin
Somatropin may alter clearance of corticosteroids metabolized by CYP450 liver enzymes; careful monitoring is advised.
Source: NLP:somatropin
Patients treated with cortisone acetate for hypoadrenalism may require increased maintenance or stress doses following somatropin initiation.
Source: NLP:somatropin
Somatropin may alter clearance of cyclosporine metabolized by CYP450 liver enzymes; careful monitoring is advised.
Source: NLP:somatropin
Somatropin may alter clearance of CYP450-metabolized compounds including corticosteroids, sex steroids, anticonvulsants, and cyclosporine. Careful monitoring recommended.
Source: NLP:somatropin
Larger doses of somatropin may be required in women using oral estrogen.
Source: NLP:somatropin
May reduce glucose-lowering effect of glimepiride, leading to worsening glycemic control.
Source: NLP:glimepiride
May reduce glucose-lowering effect of glipizide, leading to worsening glycemic control; monitor closely.
Source: NLP:glipizide
May decrease the blood glucose lowering effect. Dose adjustment and increased glucose monitoring required.
Source: NLP:insulin aspart
May decrease blood glucose lowering effect. Dose adjustment and increased glucose monitoring may be required.
Source: NLP:insulin aspart-szjj
May decrease blood glucose lowering effect. Dosage increases and increased glucose monitoring may be required.
Source: NLP:insulin degludec
May decrease blood glucose lowering effect of insulin glargine; dosage increases and increased glucose monitoring may be required.
Source: NLP:insulin glargine
May decrease blood glucose lowering effect. Dose adjustment and increased glucose monitoring may be required.
Source: NLP:insulin glulisine
Insulin dose may require adjustment when used concomitantly with somatropin.
Source: NLP:somatropin
May decrease blood glucose lowering effect; dose adjustment and increased glucose monitoring required.
Source: NLP:insulin lispro
May decrease blood glucose lowering effect. Dose increases and increased glucose monitoring may be required.
Source: NLP:insulin lispro-aabc
May blunt growth hormone response to MACRILEN. Discontinue at least one week before administering MACRILEN diagnostic test.
Source: NLP:macimorelin acetate
Somatropin may alter clearance of anticonvulsants metabolized by CYP450 liver enzymes; careful monitoring is advised.
Source: NLP:somatropin
Patients treated with prednisone for hypoadrenalism may require increased maintenance or stress doses following somatropin initiation.
Source: NLP:somatropin
May require initiation of glucocorticoid replacement therapy or increase in maintenance doses due to somatropin inhibition of 11βHSD-1 and reduced serum cortisol concentrations.
Source: NLP:somatropin
Somatropin may alter clearance of sex steroids metabolized by CYP450 liver enzymes; careful monitoring is advised.
Source: NLP:somatropin