Tev-Tropin (Somatropin, rDNA Origin, for Injection) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 10, 2012

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Tev-Tropin

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TEV-TROPIN®
[somatropin (rDNA origin) for injection] 5 mg (15 IU)

DRUG DESCRIPTION

TEV-TROPIN® (somatropin, rDNA origin, for injection), a polypeptide of recombinant DNA origin, has 191 amino acid residues and a molecular weight of about 22,124 daltons. It has an amino acid sequence identical to that of human growth hormone of pituitary origin. TEV-TROPIN® is a strain of Escherichia coli modified by insertion of the human growth hormone gene.

TEV-TROPIN® is a sterile, white, lyophilized powder, intended for subcutaneous administration, after reconstitution with bacteriostatic 0.9% sodium chloride injection, USP, (normal saline) (benzyl alcohol preserved). The quantitative composition of the lyophilized drug per vial is:

5 mg (15IU) vial:

Somatropin 5 mg (15 IU)
Mannitol 30 mg

The diluent contains bacteriostatic 0.9% sodium chloride injection, USP, (normal saline), 0.9% benzyl alcohol as a preservative, and water for injection. A 5 mL vial of the diluent will be supplied with each dispensed vial of TEV-TROPIN®.

TEV-TROPIN® is a highly-purified preparation. Reconstituted solutions have a pH in the range of 7.0 to 9.0.

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 Tev-Tropin »

What are the precautions when taking somatropin, rdna origin, for injection (Tev-Tropin)?

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 Tev-Tropin »

Last reviewed on RxList: 8/29/2011
This monograph has been modified to include the generic and brand name in many instances.