Formulary
Bosentan: Indications, Dosing, Side Effects and Interactions
Bosentan clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Bosentan: Indications, Dosing, Side Effects and Interactions
Bosentan clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Pulmonary arterial hypertension (initiated under specialist supervision)**
- **Adult** (By Mouth): Initially 62.5 mg twice daily for 4 weeks, then increased to 125 mg twice daily (max. per dose 250 mg); maximum 500 mg per day.
**Systemic sclerosis with ongoing digital ulcer disease (to reduce number of new digital ulcers)**
- **Adult** (By Mouth): Initially 62.5 mg twice daily for 4 weeks, then increased to 125 mg twice daily.
**Pulmonary arterial hypertension (initiated under specialist supervision) for bosentan**
- **Child 2-17 years (body-weight 10-20 kg)** (By mouth): Initially 31.25 mg once daily for 4 weeks, then increased to 31.25 mg twice daily.
- **Child 2-17 years (body-weight 20-40 kg)** (By mouth): Initially 31.25 mg twice daily for 4 weeks, then increased to 62.5 mg twice daily.
- **Child 12-17 years (body-weight 40 kg and above)** (By mouth): Initially 62.5 mg twice daily for 4 weeks, then increased to 125 mg twice daily (max. per dose 250 mg).
Cautions
Not to be initiated if systemic systolic blood pressure is below 85 mmHg; pulmonary veno-occlusive disease
Contraindications
Acute porphyrias
Side effects
Common or very common Anaemia; diarrhoea; erythema; fluid retention; flushing; gastrooesophageal reflux disease; headache; hypotension; nasal congestion; oedema; palpitations; syncope Uncommon Hepatic disorders; leucopenia; neutropenia; thrombocytopenia Rare or very rare Angioedema Frequency not known Pulmonary oedema; vision blurred
Interactions
**Other interactions (35):**
- In a study of healthy male volunteers, co-administration of the endothelin antagonist, bosentan, (an inducer of CYP3A4 [moderate], CYP2C9 and possibly of CYP2C19) at steady state (125 mg twice a...
- In healthy male volunteers, sildenafil at steady state (80 mg t.i.d.) resulted in a 49.8% increase in bosentan AUC and a 42% increase in bosentan Cmax (125 mg b.i.d.).
- John's wort ( Hypericum perforatum ); bosentan and HIV or HCV protease inhibitors (e.g.
- Coadministration of lurasidone with mild (e.g.
- These products include phenytoin, phenobarbital, primidone, bosentan, carbamazepine, rifampicin, rifabutin and possibly also oxcarbazepine, modafinil, topiramate, felbamate, griseofulvin, some HIV...
- ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan Interaction not studied with any of the components of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Gilead.
Pregnancy
Avoid (teratogenic in animal studies).
Breast feeding
Manufacturer advises avoid-no information available.
Hepatic impairment
Manufacturer advises avoid in moderate-to-severe impairment or if baseline serum transaminases exceed 3 times the upper limit of normal.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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