What is Ambrisentan used for?

1 INDICATIONS AND USAGE Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%). Ambrisentan tablet is an endothelin receptor antagonist

How does Ambrisentan work?

11 DESCRIPTION Ambrisentan is an endothelin receptor antagonist.

What pharmaceutical form is Ambrisentan available in?

Ambrisentan: Tabletki powlekane 5 mg (doustna)

What are the side effects of Ambrisentan?

6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other sections of the labeling include: Embryo-fetal Toxicity [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 )] Fluid Retention [see Warnings and Precautions ( 5.2 )] Pulmonary Edema with PVOD [see Warnings and Precautions ( 5.3 )] Decreased Sperm Count [see Warnings and Precautions ( 5.4 )] Hematologic Changes [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (>3% compared to

Who should NOT take Ambrisentan?

4 CONTRAINDICATIONS Pregnancy ( 4.1 ) Idiopathic Pulmonary Fibrosis ( 4.2 ) 4.1 Pregnancy Ambrisentan tablets may cause fetal harm when administered to a pregnant female. Ambrisentan tablets are contraindicated in females who are pregnant. Ambrisentan tablets were consistently shown to have teratogenic effects when administered to animals. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the pote

Does Ambrisentan interact with other medications?

7 DRUG INTERACTIONS Multiple dose coadministration of ambrisentan and cyclosporine resulted in an approximately 2-fold increase in ambrisentan exposure in healthy volunteers; therefore, limit the dose of ambrisentan to 5 mg once daily when coadministered with cyclosporine [see Clinical Pharmacology ( 12.3 )] . Cyclosporine increases ambrisentan exposure; limit ambrisentan dose to 5 mg once daily ( 7 ).

Can Ambrisentan be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS Breastfeeding: Choose ambrisentan tablets or breastfeeding ( 8.2 ). Not recommended in patients with moderate or severe hepatic impairment ( 8.7 ). 8.1 Pregnancy Risk Summary Based on data from animal reproduction studies, ambrisentan tablets may cause fetal harm, including birth defects and fetal death, when administered to a pregnant woman and is contraindicated during pregnancy. There are limited data on ambrisentan tablets use in pregnant women

What precautions should be taken with Ambrisentan?

• Caution should be exercised in patients with history of liver or kidney impairment, decreased sperm count, fluid retention, during breastfeeding. • Monitor liver function, complete blood count regularly while taking this medication.

What ATC class does Ambrisentan belong to?

Ambrisentan: ATC C02KX02. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

OTC

Ambrisentan

5 mg, Tabletki powlekane

INN: Ambrisentanum

Data updated: 2026-04-13

Available in:

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Form

Tabletki powlekane

Dosage

5 mg

Route

doustna

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°‍‍‍‍‍‍‍‍C (59°F to 86°F) [see USP Controlled Room Temperature] . Store ambrisentan tablets in its original packaging. Dispense in a tight container [see USP].

User Reviews

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