BOE-sen-tan
Contraindicated in:
Moderate to severe liver impairment or patients with ↑ liver enzymes;
Pregnancy;
Lactation.Use Cautiously in:
Women of reproductive potential
;CV: edema, hypotension, palpitations
Derm: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), flushing, pruritus, rash
EENT: nasopharyngitis
GI: dyspepsia, HEPATOTOXICITY
GU: ↓sperm counts
Hemat: anemia
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)
Drug-drug:
May ↓ effectiveness of hormonal contraceptives (additional method of contraception recommended).
Therapeutic Classification: vasodilators
Pharmacologic Classification: endothelin receptor antagonists
Absorption: 50% absorbed following oral administration.
Distribution: Well distributed to tissues.
Protein Binding: >98%.
Half-Life: 5 hr.
May cause fetal harm. Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable when administered with bosentan. Instruct women of reproductive potential to use acceptable methods of contraception (one highly effective form of contraception—intrauterine device [IUD] or tubal sterilization, or a combination of methods—hormonal method with a barrier method or two barrier methods) during and for 1 mo after therapy is completed. Hormonal contraceptives alone should not be used for contraception. If partner's vasectomy is the chosen method, a hormonal or barrier method must be used in addition to the vasectomy. Counsel patient on pregnancy prevention and emergency contraception. Patient should discontinue medication and inform health care provider immediately if pregnancy is suspected. Advise patient to avoid breastfeeding during therapy. Inform men that bosentan may cause ↓ sperm count.
NDC Code