Atovaquone proguanil warnings and precautions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Warnings And Precautions
Vomiting and Diarrhea
Absorption of atovaquone may be reduced in patients with diarrhea or vomiting. If Atovaquone proguanil is used in patients who are vomiting, parasitemia should be closely monitored and the use of an antiemetic considered. [See Dosage and Administration ] Vomiting occurred in up to 19% of pediatric patients given treatment doses of Atovaquone proguanil. In the controlled clinical trials, 15.3% of adults received an antiemetic when they received atovaquone/proguanil and 98.3% of these patients were successfully treated. In patients with severe or persistent diarrhea or vomiting, alternative antimalarial therapy may be required.
Relapse of Infection
In mixed P. falciparum and Plasmodium vivax infections, P. vivax parasite relapse occurred commonly when patients were treated with Atovaquone proguanil alone.
In the event of recrudescent P. falciparum infections after treatment with Atovaquone proguanil or failure of chemoprophylaxis with Atovaquone proguanil, patients should be treated with a different blood schizonticide.
Hepatotoxicity
Elevated liver laboratory tests and cases of hepatitis and hepatic failure requiring liver transplantation have been reported with prophylactic use of Atovaquone proguanil.
Severe or Complicated Malaria
Atovaquone proguanil has not been evaluated for the treatment of cerebral malaria or other severe manifestations of complicated malaria, including hyperparasitemia, pulmonary edema, or renal failure. Patients with severe malaria are not candidates for oral therapy.[1]
References
Adapted from the FDA Package Insert.