Ambrisentan(Endobloc)
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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.
Generic name
Ambrisentan(Endobloc)
Alternative Names
Endobloc
Indications
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.
Therapeutic Target
The therapeutic target of Ambrisentan is the endothelin-1 receptor.
Active Ingredients
The active ingredient in Ambrisentan Tablets is Ambrisentan, a selective endothelin receptor antagonist.
specifications
5 mg tablets,10 mg tablets
Description
Ambrisentan is a selective endothelin receptor antagonist used for managing pulmonary arterial hypertension (PAH). It targets and inhibits endothelin-1, a potent vasoconstrictor, which helps to relax and widen the pulmonary arteries, lowering pulmonary artery pressure. This effect improves right ventricular function, exercise capacity, and reduces the clinical progression of PAH. The drug is bioequivalent to Gilead Sciences' Letairis, a previously approved treatment for PAH.
Ambrisentan is approved by the FDA under the abbreviated new drug application (ANDA) 208252, following successful clinical trials demonstrating its safety and efficacy. It is critical for patients with PAH to receive adequate monitoring while on this medication to detect potential adverse effects and ensure continued effectiveness.
Dosage and Administration
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.
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