BOSENTANMONOHYDRATE

Indications & Dose:

Hypertension:

•  BY MOUTH

Adult Initially 62.5 mg twice daily for 4 weeks, increasing to maintenance of 125 mg twice daily. Some patients may benefit from 250 mg twice daily.

Children; Not recommended

Systemic sclerosis 

• BY MOUTH

Adults: Initially 62.5 mg twice daily for 4 weeks, increasing to maintenance of 125 mg twice daily.

Children: Not recommended.

Contraindications:

Hypersensitivity to bosentan or its components, concurrent use of cyclosporine or glyburide, pregnancy

Side Effects:

Cautions:

Precautions:

Interaction:

DRUGS

atorvastatin, lovastatin, simvastatin: Decreased level and efficacy of these drugs cyclosporine, ritonavir: Markedly increased blood bosentan level

glyburide: Increased liver enzyme and possibly glucose levels; possibly decreased

blood level of both drugs (and of other oral antidiabetics metabolized by CYP2C9 or CYP3A4) hormonal contraceptives (oral, injected, implanted): Possibly decreased effects of these drugs

ketoconazole and other CYP3A4 inhibitors: Increased bosentan blood level and effects rifampicin: Possibly decreased blood bosentan level tacrolimus: Possibly marked increase in blood bosentan level warfarin: Increased elimination and decreased blood level of warfarin

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

CNS: Fatigue, headache

CV: Edema, hypotension, palpitations

EENT: Nasopharyngitis

GI: Elevated liver function test results, hepatic injuryindigestionliver failure

GU: Decreased sperm count

HEME Decreased hemoglobin level an hematocrit,thrombocytopenia

SKIN Flushing,pruritus,rash

Other: Hypersensitivity

Patient And Carer Advice: