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bosentan |
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bosentan,
a vasodilator used to treat pulmonary arterial hypertension. bosentan Tracleer Pharmacologic class: Endothelin-receptor antagonist, vasodilator Therapeutic class: Antihypertensive Pregnancy risk category X FDA Boxed Warning• Drug causes at least 3 x ULN (upper limit of normal) of alanine aminotransferase and aspartate aminotransferase levels in about 11% of patients (along with elevated bilirubin in a few cases). These changes indicate potentially serious hepatic injury. Obtain serum transaminase levels before therapy begins and then monthly. ActionBinds to and blocks receptor sites for endothelin A and B in endothelium and vascular smooth muscle. This action reduces elevated endothelin levels in patients with pulmonary arterial hypertension, and inhibits vasoconstriction resulting from endothelin-1 (ET-1). AvailabilityTablets: 62.5 mg, 125 mg ⊘Indications and dosages ➣ To improve exercise ability and slow clinical deterioration in patients with pulmonary arterial hypertension who have World Health Organization class III or class IV symptoms Adults: Initially, 62.5 mg P.O. b.i.d. for 4 weeks; increase to maintenance dosage of 125 mg P.O. b.i.d. In patients older than age 12 who weigh less than 40 kg (88 lb), initial and maintenance dosages are 62.5 mg b.i.d. Dosage adjustment• Moderate to severe hepatic dysfunction Contraindications• Hypersensitivity to drug PrecautionsUse cautiously in: Administration• Give tablets in morning and evening, with or without food.
Adverse reactionsCNS: headache, fatigue CV: edema, hypotension, palpitations EENT: nasopharyngitis GI: dyspepsia Hepatic: hepatic dysfunction, hepatic injury, hepatotoxicity Skin: pruritus, flushing InteractionsDrug-drug. Cyclosporine: decreased cyclosporine blood level, increased bosentan blood level Glyburide: decreased blood levels of both drugs, increased risk of hepatic damage Hormonal contraceptives: decreased bosentan efficacy Ketoconazole: increased bosentan blood level and effects Simvastatin and other statins: decreased effects of these drugs Drug-diagnostic tests. Hematocrit, hemoglobin: decreased values Transaminases: increased values Patient monitoring• Assess serum transaminase levels within first 3 days of therapy and then monthly. Patient teaching• Tell patient to take drug with or without food in morning and evening. bosentan Vascular disease A mixed ETA–endothelin and ETB receptor antagonist, used as a long-term antihypertensive, which ↓ BP without reflex neurohormonal activation. See Endothelin ETA receptor, Endothelin ETB receptor. Want to thank TFD for its existence? Tell a friend about us, add a link to this page, add the site to iGoogle, or visit the webmaster's page for free fun content. |
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No references found | Products with REMS in effect (from FDA Federal Register notice) * Generic Brand Abarelix Plenaxis Alosetron Lotronex Ambrisentan Letairis Bosentan Tracleer Clozapine Clozaril, Fazaclo ODT Dofetilide Tikosyn Eculizumab Soliris Fentanyl PCA Ionsys Fentanyl citrate Actiq Isotretinoin Accutane, Amnesteem, Claravis, Sotret Lenalidomide Revlimid Mifepristone Mifeprex Natalizumab Tysabri Small pox (Vaccinia) ACAM2000 Vaccine, Live Sodium oxybate Xyrem * Not all brand names were identified After reviewing the Actelion website, CDER's Office of Medical Policy Division of Drug Marketing, Advertising and Communications (DDMAC) issued the firm a warning letter for advertising claims for Tracleer (bosentan) tablets. Tracleer (bosentan) acts against a hormone called endothelin causing constriction of blood vessels and elevating blood pressure. |
Tracleer |
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