Indication and uses
Ambrisentan is indicated for the treatment of Pulmonary Arterial Hypertension
(PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening.
Dosage and administration
Initial treatment is 5 mg once daily, and can be increased to 10 mg once daily if 5
mg is tolerated. Tablets may be administered with or without food.
Contraindications
Ambrisentan may cause fetal harm when administered to a pregnant woman.
Ambrisentan is contraindicated in women who are or may become pregnant. If
this drug is used during pregnancy, or if the patient becomes pregnant while
taking this drug, the patient should be apprised of the potential hazard to a fetus.
Pregnancy must be excluded before the initiation of treatment with Ambrisentan
and prevented during treatment and for one month after stopping treatment.
Ambrisentan is contraindicated in patients with Idiopathic Pulmonary Fibrosis
(IPF) including IPF patients with pulmonary hypertension (WHO Group 3).
Adverse effect
Decreases in hemoglobin concentration and hematocrit have followed administration
of other endothelin receptor antagonists and were observed in clinical
studies with Ambrisentan.
Warnings and precautions
Fluid Retention: Peripheral edema is a known class eect of endothelin receptor
antagonists, and is also a clinical consequence of PAH and worsening PAH.
Pulmonary Veno-occlusive Disease: If patients develop acute pulmonary edema
during initiation of therapy with vasodilating agents such as Ambrisentan, the
possibility of pulmonary veno-occlusive disease should be considered, and if
conrmed. Ambrisentan should be discontinued. Hematological Changes:
Decreases in hemoglobin concentration and hematocrit have followed administration
of other endothelin receptor antagonists and were observed in clinical
studies with Ambrisentan. Hepatic impairment: Ambrisentan is not recommended
in patients with moderate or severe hepatic impairment.
Drug interactions
Multiple dose co-administration 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 co-administered
with Cyclosporine.
Use in pregnancy and lactation
Pregnancy Category X. It is not known whether Ambrisentan is excreted in human
milk. Breastfeeding while receiving Ambrisentan is not recommended
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