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Opsumit

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Opsumit

Overdosage
Contraindications

OVERDOSE

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.

CONTRAINDICATIONS

Pregnancy

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].

Last reviewed on RxList: 11/5/2013
This monograph has been modified to include the generic and brand name in many instances.

Overdosage
Contraindications
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