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ZOMACTON (somatropin) for injection, is a recombinant human growth hormone. It is 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. ZOMACTON is produced in a strain of modified by insertion of the human growth hormone gene.

ZOMACTON is a sterile, white, lyophilized powder, for subcutaneous use, after reconstitution with the accompanying diluent.

ZOMACTON 5 mg vial contains recombinant somatropin 5 mg and mannitol 30 mg. The 5 mg vial is supplied in a combination package with an accompanying 5 mL vial of diluting solution. The diluent contains bacteriostatic 0.9% sodium chloride injection, USP, (normal saline), 0.9% benzyl alcohol as a preservative, and water for injection.

ZOMACTON 10 mg vial contains recombinant somatropin 10 mg, mannitol 10 mg, disodium phosphate dodecahydrate 3.57 mg, and sodium dihydrogen phosphate dehydrate 0.79 mg. The 10 mg vial is supplied in a combination package with an accompanying 1 mL syringe of diluting solution. The diluent contains bacteriostatic water for injection with 0.33% metacresol as a preservative.

Reconstituted solutions have a pH in the range of 7 to 9.

What does ZOMACTON look like?

What are the available doses of ZOMACTON?

ZOMACTON for injection is available as ( ):

What should I talk to my health care provider before I take ZOMACTON?

How should I use ZOMACTON?

ZOMACTON is indicated for the treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous growth hormone (GH).

Administer by subcutaneous injection to the back of upper arm, abdomen, buttock, or thigh with regular rotation of injection sites ( )

Pediatric dosage:

Adult dosage:

See Full Prescribing Information for reconstitution instructions ( )

What interacts with ZOMACTON?

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What are the warnings of ZOMACTON?

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What are the precautions of ZOMACTON?

Sorry No Records found

What are the side effects of ZOMACTON?

Sorry No records found

What should I look out for while using ZOMACTON?

ZOMACTON is contraindicated in patients with:

What might happen if I take too much ZOMACTON?

Acute overdosage may lead initially to hypoglycemia and subsequently to hyperglycemia. Long-term overdosage may result in signs and symptoms of gigantism or acromegaly consistent with the known effects of excess endogenous human GH.

How should I store and handle ZOMACTON?

40 mg tablets : NDC 55289-861-30 bottles of 3040 mg tablets : NDC 55289-861-30 bottles of 3040 mg tablets : NDC 55289-861-30 bottles of 30


Clinical Information

Chemical Structure

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Clinical Pharmacology

Somatropin binds to dimeric GH receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit. Somatropin has direct tissue and metabolic effects or mediated indirectly by IGF-1, including stimulation of chondrocyte differentiation, and proliferation, stimulation hepatic glucose output, protein synthesis and lipolysis.

Somatropin stimulates skeletal growth in pediatric patients with GHD as a result of effects on the growth plates (epiphyses) of long bones. The stimulation of skeletal growth increases linear growth rate (height velocity) in most somatropin-treated pediatric patients. Linear growth is facilitated in part by increased cellular protein synthesis.

Non-Clinical Toxicology
ZOMACTON is contraindicated in patients with:

The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects.

Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a narrow therapeutic index.

Mean oxybutynin chloride plasma concentrations were approximately 3 to 4 fold higher when oxybutynin chloride was administered with ketoconazole, a potent CYP3A4 inhibitor.

Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C and AUC). The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are co-administered.

Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic doses of somatropin . Two placebo-controlled clinical trials in non-GH deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3 mg/day-8 mg/day) compared to those receiving placebo. The safety of continuing ZOMACTON treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. ZOMACTON is not indicated for the treatment of non-GH deficient adults.

The following important adverse reactions are also described elsewhere in the labeling:



This information is obtained from the National Institute of Health's Standard Packaging Label drug database.

While we update our database periodically, we cannot guarantee it is always updated to the latest version.



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