Nutropin (Somatropin (rDNA origin) for Inj) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

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Nutropin

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Nutropin®
[somatropin (rDNA origin)] for Injection

DRUG DESCRIPTION

Nutropin® [somatropin (rDNA origin) for injection] is a human growth hormone (hGH) produced by recombinant DNA technology. Nutropin (somatropin rdna origin for inj) has 191 amino acid residues and a molecular weight of 22,125 daltons. The amino acid sequence of the product is identical to that of pituitary-derived human growth hormone. The protein is synthesized by a specific laboratory strain of E coli as a precursor consisting of the rhGH molecule preceded by the secretion signal from an E coli protein. This precursor is directed to the plasma membrane of the cell. The signal sequence is removed and the native protein is secreted into the periplasm so that the protein is folded appropriately as it is synthesized.

Nutropin (somatropin rdna origin for inj) is a highly purified preparation. Biological potency is determined using a cell proliferation bioassay.

Nutropin (somatropin rdna origin for inj) is a sterile, white, lyophilized powder intended for subcutaneous administration after reconstitution with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). The reconstituted product is nearly isotonic at a concentration of 5 mg/mL growth hormone (GH) and has a pH of approximately 7.4.

Each 5 mg Nutropin (somatropin rdna origin for inj) vial contains 5 mg (approximately 15 IU) somatropin, lyoph ilized with 45 mg mannitol, 1.7 mg sodium phosphates (0.4 mg sodium phosphate monobasic and 1.3 mg sodium phosphate dibasic), and 1.7 mg glycine.

Each 10 mg Nutropin (somatropin rdna origin for inj) vial contains 10 mg (approximately 30 IU) somatropin, lyophilized with 90 mg mannitol, 3.4 mg sodium phosphates (0.8 mg sodium phosphate monobasic and 2.6 mg sodium phosphate dibasic), and 3.4 mg glycine.

Bacteriostatic Water for Injection, USP is sterile water containing 0.9 percent benzyl alcohol per mL as an antimicrobial preservative packaged in a multidose vial. The diluent pH is 4.5-7.0.

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; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

sudden...

Read All Potential Side Effects and See Pictures of Nutropin »

What are the precautions when taking somatropin (rdna origin) for inj (Nutropin)?

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 Nutropin »

Last reviewed on RxList: 2/26/2008
This monograph has been modified to include the generic and brand name in many instances.