Norditropin

Norditropin® Cartridges
[somatropin (rDNA origin)] Injection

DRUG DESCRIPTION

Norditropin is a polypeptide hormone of recombinant DNA origin. The hormone is synthesized by a special strain of E. coli bacteria that has been modified by the addition of a plasmid which carries the gene for human growth hormone. Norditropin contains the identical sequence of 191 amino acids constituting the naturally occurring pituitary human growth hormone with a molecular weight of about 22,000 Daltons. Norditropin is supplied as a sterile solution for subcutaneous injection in ready-to-administer prefilled pens with a volume of 1.5 mL or 3 mL.

Each Norditropin Cartridge contains the following (see Table 2):

Table 2

Component 5 mg/1.5 mL 10 mg/1.5 mL 15 mg/1.5 mL 30 mg/3 mL
Somatropin 5 mg 10 mg 15 mg 30 mg
Histidine 1 mg 1 mg 17 mg 3.3 mg
Poloxamer 188 4.5 mg 4.5 mg 4.5 mg 9.0 mg
Phenol 4.5 mg 4.5 mg 4.5 mg 9.0 mg
Mannitol 60 mg 60 mg 58 mg 117 mg
HCl/NaOH as needed as needed as needed as needed
Water for Injection up to 1.5 mL up to 1.5 mL up to 1.5 mL up to 3.0 mL

What are the possible side effects of somatropin?

If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe pain in your upper stomach spreading to your...

Read All Potential Side Effects and See Pictures of Norditropin »

What are the precautions when taking somatropin injection (Norditropin)?

Before using somatropin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: eye problems (e.g., diabetic retinopathy), major surgery or trauma, severe breathing problems (acute respiratory failure), undergoing therapy for tumors (cancer), Prader-Willi syndrome (see Side Effects section above), normal growth has stopped (closed epiphyses).

Before using this medication, tell your doctor or pharmacist...

Read All Potential Precautions of Norditropin »

Last reviewed on RxList: 10/24/2014
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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