"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
- Patient Information:
Details with Side Effects
Patients should be warned that at the first appearance of a skin rash, they should stop use of Fansidar (sulfadoxine and pyrimethamine) and seek medical attention immediately. Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation.
Patients should also be warned that the appearance of sore throat, fever, arthralgia, cough, shortness of breath, pallor, purpura, jaundice or glossitis may be early indications of serious disorders which require prophylactic treatment to be stopped and medical treatment to be sought.
Patients should be warned to keep Fansidar (sulfadoxine and pyrimethamine) out of reach of children.
Patients also should be advised:
- that malaria can be a life-threatening infection;
- that Fansidar (sulfadoxine and pyrimethamine) is being prescribed to help prevent or treat this serious infection;
- that no chemoprophylactic regimen is 100% effective, and protective clothing, insect repellents, and bednets are important components of malaria prophylaxis;
- to seek medical attention for any febrile illness that occurs after return from a malarious area and inform their physician that they may have been exposed to malaria;
- that in a small percentage of cases, patients are unable to take this medication because of side effects, and it may be necessary to change medications;
- that when used as prophylaxis, the first dose of Fansidar (sulfadoxine and pyrimethamine) should be taken 1 or 2 days prior to arrival in an endemic area;
- that if the patient experiences any symptom that may affect the ability to take this drug as prescribed, the physician should be contacted and alternative antimalarial medication should be considered.
Last reviewed on RxList: 10/10/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Fansidar 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.