Omnitrope

OMNITROPE®
(somatropin [rDNA origin]) Injection

Omnitrope

DRUG DESCRIPTION

Omnitrope® (somatropin-[rDNA] origin) is a polypeptide hormone of recombinant DNA origin. It 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 human growth hormone of pituitary origin (somatropin). Omnitrope® is synthesized in a strain of. Escherichia coli that has been modified by the addition of the gene for human growth hormone. Omnitrope® Cartridge is a clear, colorless, sterile solution for subcutaneous injection. Omnitrope® for Injection is a lyophilized powder that is reconstituted for subcutaneous injection.

Figure 1: Schematic amino acid sequence of human growth hormone including the disulfide bonds

OMNITROPE® (somatropin [rDNA origin] injection)  Structural Formula Illustration

Each Omnitrope® Cartridge or vial contains the following (see Table 4):

Table 4. Contents of Omnitrope® Cartridges and Vial

Product Cartridge 5 mg/1.5 mL Cartridge 10 mg/1.5 mL For Injection 5.8 mg/vial
Component
Somatropin 5 mg 10 mg 5.8 mg
Disodium hydrogen phosphate heptahydrate 1.3 mg 1.70 mg 2.09 mg
Sodium dihydrogen phosphate dihydrate 1.6 mg 1.35 mg 0.56 mg
Poloxamer 188 3.0 mg 3.0 mg -
Mannitol 52.5 mg - -
Glycine - 27.75 mg 27.6 mg
Benzyl alcohol 13.5 mg - -
Phenol - 4.50 mg -
Water for Injection to make 1.5 mL to make 1.5 mL -
Diluent (vials only)     Bacteriostatic Water for Injection
Water for injection     to make 1.14 mL
Benzyl alcohol     17 mg

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 Omnitrope »

Last reviewed on RxList: 6/1/2011
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

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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