Remodulin solution

Generic Name: treprostinil (tre-PROST-i-nil)
Brand Name: Remodulin

Remodulin solution is used for:

Treating high blood pressure in the blood vessels of the lungs (pulmonary arterial hypertension [PAH]).

Remodulin solution is a prostaglandin. It works by relaxing blood vessels, which increases blood flow to the lungs.

Do NOT use Remodulin solution if:

  • you are allergic to any ingredient in Remodulin solution

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

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Before using Remodulin solution:

Some medical conditions may interact with Remodulin solution. 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 liver or kidney problems, bleeding problems, low blood pressure, fluid retention (eg, unusual swelling of the arms, hands, legs, or feet), or high sodium levels in the blood

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

  • Blood pressure medicines (eg, lisinopril), diuretics (eg, furosemide), or vasodilators (eg, hydralazine) because the risk of their side effects, such as dizziness, fainting, and very low blood pressure, may be increased
  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased by Remodulin solution
  • Gemfibrozil because it may increase the risk of Remodulin solution's side effects
  • Rifampin because it may decrease Remodulin solution's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Remodulin solution 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 Remodulin solution:

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

  • Remodulin solution is usually given at your doctor's office, hospital, or clinic. If you will be using Remodulin solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Remodulin solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Remodulin solution is usually administered as an infusion by direct injection into the skin. It may be necessary for you to take Remodulin solution for a prolonged period of time, possibly years. Additional treatment may require injecting medicine through the vein.
  • Remodulin solution is for injection beneath the skin or through the vein only.
  • Do not use Remodulin solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from 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 your dose is interrupted, contact your doctor or pharmacist immediately to establish a new dosing schedule.

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

Important safety information:

  • Remodulin solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Remodulin solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not suddenly stop using Remodulin solution. You may experience a recurrence of PAH symptoms (eg, shortness of breath, dizziness, weakness). To avoid interruption in treatment, you should have access to a backup infusion pump and infusion sets should your equipment fail. Discuss any questions or concerns with your doctor.
  • If your symptoms do not get better or if they get worse, check with your doctor.
  • Remodulin solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Tell your doctor or dentist that you take Remodulin solution before you receive any medical or dental care, emergency care, or surgery.
  • Remodulin solution should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Remodulin solution while you are pregnant. It is not known if Remodulin solution is found in breast milk. If you are or will be breast-feeding while you are using Remodulin solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Remodulin solution:

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:

Diarrhea; dizziness; flushing or redness of the skin; headache; jaw pain; light-headedness; mild pain or redness at the injection site; nausea; tiredness.

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); bone pain; burning, numbness, or tingling; chest pain; dark, tarry, or bloody stools; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes (eg, anxiety, restlessness); new or worsening shortness of breath; pain, swelling, redness, heat, tenderness, or hard skin at the injection site; pale skin; severe or persistent dizziness; swelling of the hands, arms, ankles, or feet; unexplained weight gain; unusual bruising or bleeding; unusual tiredness or weakness.

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 fainting; flushing; loss of consciousness; nausea; seizure; severe dizziness, diarrhea, or headache; vomiting.

Proper storage of Remodulin solution:

Remodulin solution is usually handled and stored by a health care provider. If you are using Remodulin solution at home, store Remodulin solution as directed by your pharmacist or health care provider. Keep Remodulin solution out of the reach of children and away from pets.

General information:

  • If you have any questions about Remodulin solution, please talk with your doctor, pharmacist, or other health care provider.
  • Remodulin solution 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 should not be used to decide whether or not to take Remodulin solution 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 Remodulin solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Remodulin solution. 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 Remodulin solution.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
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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