Generic name: somatropin [ soe-ma-TROE-pin ]
Drug class: Growth hormones
What is Omnitrope?
Omnitrope is a form of human growth hormone important for the growth of bones and muscles.
Omnitrope is used to treat growth failure in children and adults who lack natural growth hormone. This includes people with with Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes.
Omnitrope may also be used for purposes not listed in this medication guide.
You should not use Omnitrope if you have cancer, eye problems caused by diabetes, or if you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems. You should not use Omnitrope if you have a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma.
Before you receive Omnitrope, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.
Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using Omnitrope. Do not stop using a steroid suddenly or change any of your medication doses without your doctor's advice.
Call your doctor at once if you have sudden and severe pain in your upper stomach with nausea and vomiting, fast heartbeat, increased thirst or urination, weight loss, or vision changes and sudden, severe pain behind your eyes.
Before taking this medicine
You should not use Omnitrope if you are allergic to somatropin or benzyl alcohol, or if you have:
a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma;
eye problems caused by diabetes (diabetic retinopathy); or
if you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems (including sleep apnea).
To make sure Omnitrope is safe for you, tell your doctor if you have:
cancer (especially during childhood);
breathing problems, sleep apnea (breathing stops during sleep);
a pituitary gland disorder;
abnormal curvature of the spine (scoliosis);
a head injury or brain tumor; or
childhood brain cancer and radiation treatment.
It is not known whether Omnitrope will cause harm to an unborn baby when used by a pregnant woman.
Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.
Omnitrope contains benzyl alcohol, an ingredient that can cause serious side effects or death in very young or premature babies. Do not give this medicine to a child without medical advice.
How should I use Omnitrope?
Use Omnitrope exactly as prescribed by your doctor. Your dose will depend on what you are being treated for. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Omnitrope is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.
Your care provider will show you the best places on your body to inject Omnitrope. Use a different place each time you give an injection. Do not inject Omnitrope into the same place two times in a row.
Prepare your injection only when you are ready to give it. Do not shake the medicine. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.
Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
While using Omnitrope, you may need frequent blood tests. Your growth progress will need to be tested often. Your eyes may also need to be checked.
If you have Prader-Willi syndrome, your treatment program may also include weight control. Follow your doctor's instructions very closely.
Throw away any Omnitrope left over after the expiration date on the label has passed.
What happens if I miss a dose?
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Call your doctor if you miss more than 3 doses in a row.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.
What should I avoid while using Omnitrope?
Get emergency medical help if you have signs of an allergic reaction to Omnitrope: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Serious breathing problems may occur in patients with Prader-Willi syndrome who use Omnitrope. 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.
Also call your doctor at once if you have:
pain in your knees or hips, walking with a limp;
ear pain, swelling, warmth, or drainage;
numbness or tingling in your wrist, hand, or fingers;
severe swelling or puffiness in your hands and feet;
changes in behavior;
vision problems, unusual headaches;
changes in the shape or size of a mole;
pain or swelling in your joints;
pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting;
high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;
increased pressure inside the skull - severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
signs of an adrenal gland problem - extreme weakness, severe dizziness, weight loss, changes in skin color, feeling very weak or tired.
Common Omnitrope side effects may include:
swelling, rapid weight gain;
muscle or joint pain;
pain, itching, or skin changes where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Omnitrope?
Tell your doctor about all your current medicines, and those you start or stop using during your treatment with Omnitrope, especially:
birth control pills or hormone replacement therapy
insulin or oral diabetes medicine; or
steroid medicine (prednisone, dexamethasone, methylprednisolone, and others).
This list is not complete. Other drugs may interact with somatropin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Omnitrope only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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