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OMNITROPE®
(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 |
| 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 | ||
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:
Read All Potential Side Effects and See Pictures of Omnitrope »
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...
Last reviewed on RxList: 6/1/2011
This monograph has been modified to include the generic and brand name in many instances.
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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