Safebo

Safebo

bosentan

Manufacturer:

MSN Lab

Distributor:

Stangen Pharmaceuticals

Marketer:

Mc Graw Pharma
Concise Prescribing Info
Contents
Bosentan
Indications/Uses
Pulmonary arterial HTN to improve exercise ability & to decrease clinical worsening.
Dosage/Direction for Use
Pulmonary HTN, systemic sclerosis w/ ongoing digital ulcer disease Childn >12 yr Initially 62.5 mg bid, increased after 4 wk to maintenance dose of 125 mg bid. Patient w/ low body wt (<40 kg) Initial & maintenance dose: 62.5 mg bid.
Administration
May be taken with or without food.
Contraindications
Moderate to severe hepatic impairment (Child-Pugh class B or C).
Special Precautions
Should not be started in patients w/ conc >3x ULN. Monitor conc every 2 wk & may be continued or reintroduced & aminotransferases be checked after 3 days, after further 2 wk then mthly. Childn <18 yr.
Drug Interactions
Drug metabolized or inhibited by CYP3A4 & CYP2C19. Increased conc w/ ciclosporin. Increased risk of hepatotoxicity & reduced hypoglycemic effect w/ glibenclamide. May reduce plasma conc of some hormonal contraceptives.
MIMS Class
Other Antihypertensives
ATC Classification
C02KX01 - bosentan ; Belongs to the class of other antihypertensives. Used in the treatment of pulmonary arterial hypertension.
Presentation/Packing
Form
Safebo FC tab 125 mg
Packing/Price
30's (P595/film-coated tab, P17,850/box)
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