December 1, 2015
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"The US Food and Drug Administration (FDA) is investigating the "rare but serious" risk for slowed or difficult breathing in children 17 and younger treated with the opioid analgesic tramadol.

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Patients should be warned that at the first appearance of a skin rash they should stop use of DARAPRIM and seek medical attention immediately. Patients should also be warned that the appearance of sore throat, pallor, purpura, or glossitis may be early indications of serious disorders which require treatment with DARAPRIM to be stopped and medical treatment to be sought.

Women of childbearing potential who are taking DARAPRIM should be warned against becoming pregnant. Patients should be warned to keep DARAPRIM out of the reach of children. Patients should be advised not to exceed recommended doses. Patients should be warned that if anorexia and vomiting occur, they may be minimized by taking the drug with meals.

Concurrent administration of folinic acid is strongly recommended when used for the treatment of toxoplasmosis in all patients.

Last reviewed on RxList: 9/30/2015
This monograph has been modified to include the generic and brand name in many instances.

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