Bosentan (Oral Route)

1. Tracleer

Appropriate studies have not been performed on the relationship of age to the effects of bosentan in the pediatric population. Safety and efficacy have not been established.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Edema (fluid retention or body swelling) or
• Heart failure or
• Liver disease, mild or
• Lung problems—Use with caution. Bosentan may make these conditions worse.

• Liver disease, moderate or severe—Should not be used in patients with this condition.