Bosentan

🧮 Dose calculator

Pulmonary arterial hypertension (PAH) · Regimen source: FDA Tracleer · 2.2, Table 1

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👥 Special populations

• 🤰 PregnancyContraindicated

  Label: contraindicated in pregnancy. FDA Tracleer · 4

  “Hypersensitivity ( 4.4 ). 4.1 Pregnancy Use of TRACLEER is contraindicated in females who are pregnant [see Boxed Warning , Dosage and Administration (2.1) , Warnings and Precautions (5.3) , Use in Specific Populations (8.1) ] . 4.2 Use with Cyclosporine A Co-administration of cyclosporine A and bosentan resulted in …”

• 🤱 BreastfeedingDangerous / avoid

  Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Tracleer · 8.2

  “Because of the potential for serious adverse reactions, such as fluid retention and hepatotoxicity, in breastfed infants from TRACLEER, advise women not to breastfeed during treatment with TRACLEER.”

• 👶 ChildrenUse with caution

  The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Tracleer · 8.4

  “The efficacy of TRACLEER in patients <18 years is supported by data from an uncontrolled trial in which 19 pediatric patients were treated with TRACLEER.”

• 👴 Older adultsUse with caution

  Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Tracleer · 8.5

  “Clinical studies of TRACLEER did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.”

• ⚥ Females & males of reproductive potentialUse with caution

  Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Tracleer · 8.3

  “Contraception Drug interaction studies show that bosentan reduces serum levels of the estrogen and progestin in oral contraceptives.”