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Ambrisentan

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WARNING

If you are trying to get pregnant or are already pregnant, avoid taking ambrisentan. The foetus may suffer from abrisentan. You should wait to start taking ambrisentan if you are a woman who is capable of getting pregnant until a pregnancy test has revealed that you are not pregnant. While using this drug and for one month after discontinuing therapy, you must utilise two effective birth control methods. Never engage in unprotected sex. Discuss effective birth control options with your doctor. If you miss a period while taking ambrisentan or believe you could be pregnant, call your doctor right away.

Ambrisentan is only accessible to females through a unique restricted distribution programme due to the danger of birth abnormalities. To ensure that female patients receive the proper lab tests both before and during ambrisentan administration, a programme called Ambrisentan REMS (Risk Evaluation and Mitigation Strategy) has been established. Only women who have registered for this programme are eligible to receive ambrisentan. You must be enrolled in this programme by your doctor. Only pharmacies that take part in the programme are allowed to provide you with the medication. If you have any queries on how to enrol in the programme or obtain your medication, consult your doctor.

Keep all of your appointments with your physician and the lab. Throughout your ambrisentan treatment, your doctor will request a number of tests.

The patient information sheet (Medication Guide) from the manufacturer will be provided to you by your doctor or pharmacist when you start taking ambrisentan and each time you need a new prescription. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

The dangers of using ambrisentan should be discussed with your doctor.

Why is this medication prescribed?

To treat pulmonary arterial hypertension, ambrisentan is either taken alone or in conjunction with tadalafil (Adcirca, Cialis) (PAH, high blood pressure in the vessels that carry blood to the lungs). Ambrisentan may help PAH patients exercise more effectively and prevent their symptoms from getting worse. Ambrisentan belongs to the group of drugs known as endothelin receptor antagonists. It functions by blocking endothelin’s activity, a naturally occurring chemical that causes PAH patients’ blood vessels to constrict and obstruct normal blood flow.

How should this medicine be used?

Ambrisentan is available as an oral tablet. It is typically taken once day, with or without food. Take ambrisentan every day at around the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take ambrisentan as prescribed by your doctor. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not chew, break, or crush the tablets; instead, swallow them whole.

Your doctor might prescribe a modest dose of ambrisentan at first and then gradually increase it.

Ambrisentan manages PAH’s symptoms but does not treat the condition. Even if you feel well, keep taking ambrisentan. Without consulting your doctor, do not discontinue taking ambrisentan. Your issue could get worse if you stop taking ambrisentan abruptly.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking ambrisentan,

  • If you have an allergy to ambrisentan, any other medications, or any of the ingredients in ambrisentan tablets, let your doctor and pharmacist know right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Mentioning that you take cyclosporine is important (Gengraf, Neoral, Sandimmune). Your doctor might need to adjust the dosage of your drugs or keep a close eye out for any negative side effects.
  • If you have idiopathic pulmonary fibrosis, let your doctor know (scarring of the lungs with an unknown cause). Most likely, your doctor will advise against taking ambrisentan.
  • Inform your doctor if you have or have ever had liver illness or anaemia (having fewer red blood cells than normal).
  • Inform your doctor if you are nursing a child. If you are on ambrisentan, you should not breastfeed.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Ambrisentan might have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Flushing
  • Light skin
  • Rapid heart rate
  • Headache

Some adverse effects can be very harmful. Call your doctor right away if you encounter any of these symptoms, or seek emergency care:

  • Swelling of the lower legs, hands, feet, ankles, or face, neck, tongue, lips, eyes, or mouth
  • Hoarseness
  • Breathing or swallowing issues
  • Rash
  • Unexpected weight gain
  • Extreme fatigue
  • Reduced appetite
  • Not enough energy
  • Nausea
  • Vomiting
  • Upper right stomach area discomfort
  • The skin or eyes turning yellow
  • Flu-like signs
  • Itching
  • Urine with a dark colour

Some men who took a drug resembling ambrisentan experienced lower-than-normal sperm counts (number of male reproductive cells), which may have an impact on their capacity to become fathers. If you want to become a parent in the future, discuss the dangers of taking ambrisentan with your doctor.

There may be more adverse effects from abbrisentan. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Headache
  • Flushing
  • Dizziness
  • Nausea
  • Nasal clogging

What other information should I know?

No one else should take your medication.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Letairis®
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