Generic Name: somatropin (rdna origin - refrigerated) (SOE-ma-TROE-pin)
Brand Name: Tev-Tropin
Tev-Tropin is used for:
Treating certain children when the body does not produce enough growth hormone. It may also be used for other conditions as determined by your doctor.
Tev-Tropin is a growth hormone that produces effects that are identical to the body's naturally occurring growth hormone. It affects the growth of bones, muscles, internal organs, and other tissues of the body.
Do NOT use Tev-Tropin if:
- you are allergic to any ingredient in Tev-Tropin including benzyl alcohol
- you have been or are currently being treated for cancer or any unusual growths or tumors (especially in the brain) that may still be growing
- you have premature epiphyseal closure (your bone growth is complete) or a serious illness caused by complications from surgery, trauma, or severe breathing problems (eg, respiratory failure)
- you have Prader-Willi syndrome and are severely overweight or have severe breathing problems
Contact your doctor or health care provider right away if any of these apply to you.
Before using Tev-Tropin:
Some medical conditions may interact with Tev-Tropin. 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 (especially benzyl alcohol)
- if you have endocrine problems including pituitary or adrenal gland problems, diabetes or a family history of diabetes, or an underactive thyroid
- if you have a history of leukemia, unusual growths or tumors (especially in the brain), or cancer
- if you have curvature of the spine (scoliosis), kidney or liver problems, ear or hearing problems (eg, repeated ear infections), Prader-Willi syndrome, are severely overweight, or have had recent major surgery or trauma
Some MEDICINES MAY INTERACT with Tev-Tropin. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticonvulsants (eg, phenytoin, carbamazepine) or cyclosporine because the risk of their side effects may be increased or their effectiveness may be decreased by Tev-Tropin
- Corticosteroids (eg, prednisone) because they may decrease Tev-Tropin's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Tev-Tropin 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 Tev-Tropin:
Use Tev-Tropin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tev-Tropin is usually given as an injection at your doctors office, hospital, or clinic. If you will be using Tev-Tropin at home, a health care provider will teach you how to use it. Be sure you understand how to use Tev-Tropin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Tev-Tropin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Always change the location where you inject Tev-Tropin.
- Do not shake Tev-Tropin. Swirl the vial gently to mix it.
- If you miss a dose of Tev-Tropin, 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 Tev-Tropin.
Important safety information:
- Tev-Tropin may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tev-Tropin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Rare, sometimes fatal, lung and breathing problems may be caused by Tev-Tropin in CHILDREN with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or children with existing serious lung or breathing problems. Children should be checked for certain breathing problems before and during treatment. If your child develops a limp or complains of hip or knee pain during treatment with Tev-Tropin, contact your doctor immediately. Tell your doctor immediately if your child becomes very sick or is hospitalized while using Tev-Tropin. Tev-Tropin may need to be stopped.
- Pancreas inflammation (pancreatitis) has been reported rarely in patients who take Tev-Tropin. 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 Tev-Tropin 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.
- Never reuse needles and syringes. Follow your health care provider's instructions for proper disposal of needles and syringes. Ask your health care provider or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full.
- Tev-Tropin may contain benzyl alcohol, metacresol, or glycerin. Tell your doctor if you have ever had sensitivity or an allergic reaction to benzyl alcohol, metacresol, or glycerin.
- Diabetes patients - Tev-Tropin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine or your diet.
- Lab tests, including blood sugar levels and thyroid function, may be performed while you use Tev-Tropin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Tev-Tropin with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tev-Tropin while you are pregnant. It is not known if Tev-Tropin is found in breast milk. If you are or will be breast-feeding while you use Tev-Tropin, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Tev-Tropin:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Pain at the injection site.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; confusion; constant feeling of need to empty the bowel; curvature of the spine; depression; ear pain, discharge, or discomfort; excessive thirst or hunger; fast heartbeat; fever; frequent urination; hearing problems; increased pressure in the head or eye; infection; nausea; one-sided weakness; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; slurred speech; sudden, severe, or persistent headache or dizziness; visual changes; vomiting.
Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain; leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.
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 (http://www.aapcc.org ), or emergency room immediately. Symptoms may include: excessive thirst or hunger; frequent urination; headache; nausea or vomiting; swelling of the ankles, feet, or hands.Proper storage of Tev-Tropin:
Before mixing, store Tev-Tropin in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Do not use Tev-Tropin past the expiration date on the product label. After mixing, store Tev-Tropin according to the product label. Contact your pharmacist if you have any questions about the proper storage of Tev-Tropin. Keep Tev-Tropin, as well as needles and syringes, out of the reach of children and away from pets.
- If you have any questions about Tev-Tropin, please talk with your doctor, pharmacist, or other health care provider.
- Tev-Tropin 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 Tev-Tropin. 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.
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.