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Omnitrope
Overview
What is Omnitrope?
Omnitrope (somatropin) 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 contains the following (see ):
What does Omnitrope look like?
What are the available doses of Omnitrope?
Omnitrope Cartridges and vials (for injection) are available:
What should I talk to my health care provider before I take Omnitrope?
How should I use Omnitrope?
Omnitrope (somatropin) injection is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH).
Omnitrope (somatropin) injection is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi Syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing .
Omnitrope (somatropin) injection is indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years.
Omnitrope (somatropin) injection is indicated for the treatment of growth failure associated with Turner syndrome.
Omnitrope (somatropin) injection is indicated for the treatment of idiopathic short stature (ISS), also called non-growth hormone-deficient short stature, defined by height standard deviation score (SDS) ≤ -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means.
The weekly dose should be divided over 6 or 7 days ofinjections.
Therapy with Omnitrope should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with GHD, Prader-Willi Syndrome (PWS), Turner syndrome (TS), those who were born small for gestational age (SGA), Idiopathic Short Stature (ISS) and adult patients with either childhood onset or adult onset GHD.
What interacts with Omnitrope?
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What are the warnings of Omnitrope?
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What are the precautions of Omnitrope?
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What are the side effects of Omnitrope?
Sorry No records found
What should I look out for while using Omnitrope?
Treatment with pharmacologic amounts of somatropin is contraindicated 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 .
Somatropin is contraindicated in patients with Prader-Willi Syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients .
In general, somatropin is contraindicated in the presence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Since GHD may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor .
Omnitrope is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses.
What might happen if I take too much Omnitrope?
How should I store and handle Omnitrope?
Store Omnitrope refrigerated at 2° to 8°C (36° to 46°F).Do not freeze.Omnitrope is light sensitive and should be stored in the carton.Store Omnitrope refrigerated at 2° to 8°C (36° to 46°F).Do not freeze.Omnitrope is light sensitive and should be stored in the carton.Store Omnitrope refrigerated at 2° to 8°C (36° to 46°F).Do not freeze.Omnitrope is light sensitive and should be stored in the carton.Pioglitazone tablets USP are available in 15 mg, 30 mg, and 45 mg tablets as follows:45 mg tablet: White to off-white, flat, round, uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘45’ on the other side, available in:NDC 68788-6888-3 Bottles of 30 NDC 68788-6888-6 Bottles of 60 NDC 68788-6888-9 Bottles of 90 NDC 68788-68881- Bottles of 100 Pioglitazone tablets USP are available in 15 mg, 30 mg, and 45 mg tablets as follows:45 mg tablet: White to off-white, flat, round, uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘45’ on the other side, available in:NDC 68788-6888-3 Bottles of 30 NDC 68788-6888-6 Bottles of 60 NDC 68788-6888-9 Bottles of 90 NDC 68788-68881- Bottles of 100 Pioglitazone tablets USP are available in 15 mg, 30 mg, and 45 mg tablets as follows:45 mg tablet: White to off-white, flat, round, uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘45’ on the other side, available in:NDC 68788-6888-3 Bottles of 30 NDC 68788-6888-6 Bottles of 60 NDC 68788-6888-9 Bottles of 90 NDC 68788-68881- Bottles of 100 Pioglitazone tablets USP are available in 15 mg, 30 mg, and 45 mg tablets as follows:45 mg tablet: White to off-white, flat, round, uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘45’ on the other side, available in:NDC 68788-6888-3 Bottles of 30 NDC 68788-6888-6 Bottles of 60 NDC 68788-6888-9 Bottles of 90 NDC 68788-68881- Bottles of 100 Pioglitazone tablets USP are available in 15 mg, 30 mg, and 45 mg tablets as follows:45 mg tablet: White to off-white, flat, round, uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘45’ on the other side, available in:NDC 68788-6888-3 Bottles of 30 NDC 68788-6888-6 Bottles of 60 NDC 68788-6888-9 Bottles of 90 NDC 68788-68881- Bottles of 100 Pioglitazone tablets USP are available in 15 mg, 30 mg, and 45 mg tablets as follows:45 mg tablet: White to off-white, flat, round, uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘45’ on the other side, available in:NDC 68788-6888-3 Bottles of 30 NDC 68788-6888-6 Bottles of 60 NDC 68788-6888-9 Bottles of 90 NDC 68788-68881- Bottles of 100
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Somatropin (as well as endogenous GH) binds to a dimeric GH receptor in the cell membrane of target cells resulting in intracellular signal transduction and a host of pharmacodynamic effects. Some of these pharmacodynamic effects are primarily mediated by IGF-1 produced in the liver and also locally (e.g., skeletal growth, protein synthesis), while others are primarily a consequence of the direct effects of somatropin (e.g., lipolysis) .
Non-Clinical Toxicology
Treatment with pharmacologic amounts of somatropin is contraindicated 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 .Somatropin is contraindicated in patients with Prader-Willi Syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients .
In general, somatropin is contraindicated in the presence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Since GHD may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor .
Omnitrope is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses.
The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta-adrenergic blocking agents. When such drugs are administered to a patient receiving glipizide, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving glipizide, the patient should be observed closely for loss of control. binding studies with human serum proteins indicate that glipizide binds differently than tolbutamide and does not interact with salicylate or dicumarol. However, caution must be exercised in extrapolating these findings to the clinical situation and in the use of glipizide with these drugs.
Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving glipizide, the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving glipizide, the patient should be observed closely for hypoglycemia.
A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, topical, or vaginal preparations of miconazole is not known. The effect of concomitant administration of fluconazole and glipizide has been demonstrated in a placebo-controlled crossover study in normal volunteers. All subjects received glipizide alone and following treatment with 100 mg of fluconazole as a single daily oral dose for 7 days. The mean percentage increase in the glipizide AUC after fluconazole administration was 56.9% (range: 35 to 81%).
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 amounts of somatropin . Two placebo-controlled clinical trials in non-growth hormone 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 5.3-8 mg/day) compared to those receiving placebo. The safety of continuing somatropin treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with somatropin in patients experiencing acute critical illnesses should be weighed against the potential risk.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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