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Ambrisentan

 
  Generic Name: Ambrisentan (am bri SEN tan)
 
  Brand Names: Letairis  
     
   
 

What is ambrisentan?

Ambrisentan prevents thickening of the blood vessels, especially those in the lungs and heart. Ambrisentan also lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Ambrisentan is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

Ambrisentan may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about ambrisentan?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you miss a menstrual period during treatment with ambrisentan. Use two reliable forms of birth control together while you are taking the medication and for at least 1 month after your treatment ends.

You will probably be required to take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.

Ambrisentan can cause severe liver problems. Symptoms include nausea, stomach pain, itching, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. Your liver function will need to be tested before you start taking ambrisentan, and again each month during your treatment. Do not stop taking ambrisentan without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Ambrisentan is available only under a special program called LEAP (Letairis Education and Access Program). You must be registered in the program and sign agreements to use birth control and undergo pregnancy and blood testing as required by the program. Read all program brochures and agreements carefully.

What should I discuss with my healthcare provider before taking ambrisentan?

Your should not use this medication if you are allergic to ambrisentan, or if you are pregnant.

Before taking ambrisentan, tell your doctor if you have liver disease or if you have ever had liver problems caused by other medications.

Ambrisentan can cause severe liver problems. Symptoms include nausea, stomach pain, itching, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. Your liver function will need to be tested before you start taking ambrisentan, and again each month during your treatment. FDA pregnancy category X. This medication can cause birth defects. Do not use ambrisentan if you are pregnant. Tell your doctor right away if you miss a menstrual period during treatment with ambrisentan. Use two reliable forms of birth control while you are taking this medication and for at least 1 month after your treatment ends.

You will probably be required to take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.

It is not known whether ambrisentan passes into breast milk or if it could harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

Ambrisentan may lower a man's sperm count and could affect fertility (your ability to have children).

How should I take ambrisentan?

Take ambrisentan exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor.

Ambrisentan is available only under a special program called LEAP (Letairis Education and Access Program). You must be registered in the program and sign agreements to use birth control and undergo pregnancy and blood testing as required by the program. Read all program brochures and agreements carefully.

Ambrisentan can be taken with or without food.

Ambrisentan is usually taken twice a day, morning and evening.

Do not crush, chew, or split the tablet. Swallow the pill whole.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your liver function may also need to be checked. Do not miss any scheduled visits to your doctor.

Do not stop taking ambrisentan without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store ambrisentan at room temperature away from moisture and heat. Keep this medicine in its original container.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include feeling like you might pass out.

What should I avoid while using ambrisentan?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using ambrisentan.

Ambrisentan side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • feeling short of breath;

  • fast or pounding heartbeats;

  • swelling of the feet, ankles, or legs;

  • nausea, stomach pain, loss of appetite, low fever, itching;

  • dark urine, clay-colored stools; or

  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache;

  • stomach pain, constipation;

  • stuffy nose, sinus pain, sore throat; or

  • warmth, redness, or tingly feeling under your skin.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Ambrisentan Dosing Information

Usual Adult Dose for Pulmonary Hypertension:

pulmonary arterial hypertension in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening:
5 mg orally once a day with or without food

What other drugs will affect ambrisentan?

Before taking ambrisentan, tell your doctor if you are using any of the following drugs:

  • cyclosporine (Sandimmune, Neoral, Gengraf);

  • omeprazole (Prilosec);

  • rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  • antibiotics such as erythromycin (E-Mycin, E.E.S., Ery-Tab, Erythrocin), itraconazole (Sporanox), ketoconazole (Nizoral), or telithromycin (Ketek); or

  • HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), and others.

This list is not complete and there may be other drugs that can interact with ambrisentan. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about ambrisentan.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 4/12/2009 4:46:18 PM.;
 
 
 
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