"For patients with multidrug-resistant tuberculosis (TB), taking at least six potentially effective drugs, particularly including pyrazinamide, significantly increased the likelihood of achieving a sputum culture conversion, according to a prospec"...
OPSUMIT has been administered as a single dose of up to and including 600 mg to healthy subjects (60 times the approved dosage). Adverse reactions of headache, nausea and vomiting were observed. In the event of an overdose, standard supportive measures should be taken, as required. Dialysis is unlikely to be effective because macitentan is highly protein-bound.
OPSUMIT may cause fetal harm when administered to a pregnant woman. OPSUMIT is contraindicated in females who are pregnant. OPSUMIT was consistently shown to have teratogenic effects when administered to animals. If OPSUMIT is used during pregnancy, apprise the patient of the potential hazard to a fetus [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/14/2015
Additional Opsumit Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.