


Reminder: The outer packaging is for reference only, please purchase and use under the guidance of a pharmacist. For read by medical and pharmaceutical professionals only.
Ambrisentan is an endothelin receptor antagonist (ERA) used in the management of pulmonary arterial hypertension (PAH). It works by blocking the action of endothelin-1, a potent vasoconstrictor involved in the pathogenesis of PAH. By inhibiting the endothelin receptors, Ambrisentan helps to dilate the pulmonary arteries, reduce pulmonary vascular resistance, and consequently, improve heart function and exercise tolerance in patients with PAH.
The drug is available in tablet form with strengths of 5 mg and 10 mg. It has been shown to be bioequivalent to the reference listed drug (RLD) Letairis (Gilead Sciences) and is therapeutically equivalent for use in treating PAH. The approval of Ambrisentan under the abbreviated new drug application (ANDA) 208252 was granted following a comprehensive review of clinical safety and efficacy data, and it is indicated for long-term use in patients with PAH.
Ambrisentan is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and delay clinical deterioration. PAH is characterized by increased pressure in the pulmonary arteries, which can lead to heart failure. Ambrisentan helps reduce pulmonary vascular resistance and improve cardiac output, thereby enhancing the patient's exercise tolerance and overall quality of life.
Ambrisentan tablets should be taken orally once daily. The typical starting dose is 5 mg once daily. If well tolerated, the dose may be increased to 10 mg once daily, depending on the patient's clinical response. Dosage adjustments may be required in cases of hepatic impairment or other health conditions. The drug should be taken with or without food, and it is essential to follow the dosing schedule without missing doses. Regular monitoring of liver function is advised due to the potential for hepatotoxicity.
