Omnitrope
OMNITROPE®
(somatropin [rDNA origin]) Injection
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](http://images.rxlist.com/images/rxlist/omnitrope1.gif) |
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 | ||
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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