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Omnitrope

Generic Name: somatropin (rdna origin - refrigerated) (SOE-ma-TROE-pin)
Brand Name: Omnitrope

Omnitrope is used for:

Treating certain children or adults whose bodies do not produce enough growth hormone. It may also be used for other conditions as determined by your doctor.

Omnitrope is a growth hormone. It works by stimulating growth in patients who do not make enough natural growth hormone.

Do NOT use Omnitrope if:

  • you are allergic to any ingredient in Omnitrope
  • you have active or recurring cancer, a brain tumor, or other unusual growths
  • you have severe breathing problems (eg, respiratory failure) or serious illness caused by complications from surgery or injury
  • you have a certain type of eye problem caused by diabetes (diabetic retinopathy)
  • the patient is a child who has Prader-Willi syndrome and is severely overweight or has severe breathing problems (eg, airway blockage, respiratory infection, sleep apnea)
  • the patient is a child who has epiphyseal closure (bone growth is complete)

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Omnitrope:

Some medical conditions may interact with Omnitrope. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney problems, lung or breathing problems (eg, airway blockage, sleep apnea), an underactive thyroid, heart problems, or endocrine problems (eg, pituitary or adrenal gland problems)
  • if you have a history of diabetes or high blood sugar levels, or if a member of your family has had diabetes
  • if you have a history of leukemia, other types of cancer, or any unusual growths or tumors (especially in the brain)
  • if you have curvature of the spine (scoliosis) or Prader-Willi syndrome
  • if you are very overweight or have had recent major surgery or injury

Some MEDICINES MAY INTERACT with Omnitrope. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Corticosteroids (eg, prednisone) or estrogens because they may decrease Omnitrope's effectiveness
  • Anticonvulsants (eg, carbamazepine) or cyclosporine because the risk of their side effects may be increased by Omnitrope
  • Insulin or other medicines for diabetes because their effectiveness may be decreased by Omnitrope

This may not be a complete list of all interactions that may occur. Ask your health care provider if Omnitrope may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Omnitrope:

Use Omnitrope as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Omnitrope. Talk to your pharmacist if you have questions about this information.
  • Omnitrope is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Omnitrope. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do NOT shake Omnitrope.
  • Omnitrope should be clear and colorless. Do not use Omnitrope if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Omnitrope may be injected in the thigh, buttocks, or abdomen. Be sure to rotate your injection site as directed to help avoid thickening or hardening of the skin.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Omnitrope, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Omnitrope.

Important safety information:

  • Pancreas inflammation (pancreatitis) has been reported rarely in patients who take Omnitrope. The risk may be greater in children, especially in girls who have Turner syndrome. Contact your doctor right away if you develop stomach or back pain.
  • Rarely, children using Omnitrope have experienced a slipped growth plate in the hip. Contact the doctor right away if the patient develops hip or knee pain or a limp.
  • Diabetes patients - Omnitrope may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including blood sugar levels and thyroid function, may be performed while you use Omnitrope. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Omnitrope with caution in the ELDERLY; they may be more sensitive to its effects.
  • Omnitrope has benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Omnitrope while you are pregnant. It is not known if Omnitrope is found in breast milk. If you are or will be breast-feeding while you use Omnitrope, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Omnitrope:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; mild swelling (eg, of the hands or feet); muscle or joint pain; prickling sensation of the skin; redness or itching at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; hip or knee pain; limp; nausea or vomiting; new growth on the skin; severe or persistent stomach or back pain; severe or persistent swelling of the hands, ankles, or feet; sudden, severe, or persistent headache; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); thickened or hardened skin at the injection site; unusual bruising; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; excessive thirst or hunger; fainting; fast heartbeat; frequent urination; swelling of the ankles, feet, or hands.

Proper storage of Omnitrope:

Store in refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Do not use Omnitrope past the expiration date on the product label.

For 1.5 mg vial: After the medicine is mixed, it may be stored in the refrigerator for up to 24 hours. Throw away any medicine left in the vial after 24 hours.

For 5.8 mg vial: After the medicine is mixed, it may be stored in the refrigerator for up to 3 weeks (21 days). Throw away any medicine left in the vial after 3 weeks.

Contact your pharmacist if you have any questions about how to properly store Omnitrope. Keep Omnitrope out of the reach of children and away from pets.

General information:

  • If you have any questions about Omnitrope, please talk with your doctor, pharmacist, or other health care provider.
  • Omnitrope is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Omnitrope. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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