Omnitrope (Somatropin)
What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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Prescription Required
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Product Details
Description
Omnitrope (somatropin) is an injectable medication prescribed for the treatment of growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature in children. It is also used to treat adults diagnosed with adult onset or childhood onset GHD.
Omnitrope is available in the following dosage forms and strengths:
- 5 mg/1.5 mL and 10 mg/1.5 mL prefilled sterile solution in a glass cartridge for use with the Omnitrope pen
- 5.8 mg vials
Fact Table
Formula
C990H1528N262O300S7
License
US FDA, EMA
Bioavailability
70-90%
Legal status
Prescription only
Chemical Name
Somatropin
Elimination half-life
20-30 minutes
Dosage (Strength)
5 mg, 10 mg, 15 mg
Pregnancy
Consult a doctor
Brands
Genotropin, Humatrope, Norditropin, Omnitrope, Saizen
Protein binding
Low
PubChem CID
16132222
MedlinePlus
a682922
ChEBI
63712
ATC code
H01AC01
DrugBank
DB00052
KEGG
D05915
Routes of administration
Subcutaneous, Intramuscular
Directions
A healthcare provider will determine an appropriate Omnitrope dosage for you or your child. You should also receive training on the proper preparation, administration, and disposal of the medication.
Omnitrope may be injected in the thigh, buttocks, or abdomen. Tell your healthcare provider or pharmacist if you have any questions or concerns. Refer to the medication guide that comes with your prescription for detailed instructions for use.
Do not share needles, syringes, or pens with other people.
Storing Omnitrope:
Refrigerate Omnitrope between 2°C and 8°C (36°F to 46°F) in the original carton and out of light. It should not be frozen.
Ingredients
The active ingredient in Omnitrope is somatropin. Inactive ingredients may include benzyl alcohol, mannitol, poloxamer 188, dibasic sodium phosphate heptahydrate, monobasic sodium phosphate dihydrate, glycine, phenol, and water.
Contraindications
Patients with any of the following should not receive Omnitrope:
- Acute critical illness
- Prader-Willi Syndrome in children who are severely obese or have severe respiratory problems
- Active cancer
- Allergy to somatropin or to any of the other ingredients in Omnitrope
- Active proliferative or severe nonproliferative diabetic retinopathy
- Closed epiphyses in children
Cautions
- Before you or your child begins treatment with Omnitrope, talk to a healthcare provider about:
- All the prescription and over-the-counter medications you or your child takes
- You or your child’s allergies
- You or your child’s current health problems and past medical history
- Your pregnancy or breastfeeding status
- Omnitrope may be associated with the following:
- Acute critical illness
- Prader-Willi Syndrome in children: patients should be evaluated for upper airway obstruction and sleep apnea before they begin treatment with Omnitrope.
- Tumors. Patients should be evaluated for tumors that have progressed or keep coming back.
- Impaired glucose tolerance and diabetes: blood sugar levels should be checked periodically. Diabetic medications may require dose adjustments.
- Increased pressure around the brain that is usually reversible once Omnitrope is stopped or the dose is decreased.
- Serious allergic reactions
- Fluid retention, which may require a dose adjustment
- Decreased cortisol levels that may need an increased dose of glucocorticoid in those with hypoadrenalism
- Thyroid problems
- Slipped capital femoral epiphysis. Children should be evaluated if they start having a limp or pain in the hips and/or knees.
- Progression of scoliosis
- Pancreatitis
Side Effects
Injection site reactions, rashes, loss of fat tissue, and headaches are common Omnitrope side effects. However, other side effects may also occur. Immediately inform your healthcare provider of side effects that bother you or your child or won’t go away.
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Reference:
Omnitrope. Princeton, NJ: Sandoz Inc.; 2019.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14439
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