(somatropin [rDNA origin]) Injection
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
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|
|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||-|
|Glycine||-||27.75 mg||27.6 mg|
|Benzyl alcohol||13.5 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|
Last reviewed on RxList: 6/1/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Omnitrope Information
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