"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"...
Patients should be instructed:
- to take MALARONE at the same time each day with food or a milky drink.
- to take a repeat dose of MALARONE if vomiting occurs within 1 hour after dosing.
- to take a dose as soon as possible if a dose is missed, then return to their normal dosing schedule. However, if a dose is skipped, the patient should not double the next dose.
- that rare serious adverse events such as hepatitis, severe skin reactions, neurological, and hematological events have been reported when MALARONE was used for the prophylaxis or treatment of malaria.
- to consult a healthcare professional regarding alternative forms of prophylaxis if prophylaxis with MALARONE is prematurely discontinued for any reason.
- that protective clothing, insect repellents, and bednets are important components of malaria prophylaxis.
- that no chemoprophylactic regimen is 100% effective; therefore, patients should seek medical attention for any febrile illness that occurs during or after return from a malaria-endemic area and inform their healthcare professional that they may have been exposed to malaria.
- that falciparum malaria carries a higher risk of death and serious complications in pregnant women than in the general population. Pregnant women anticipating travel to malarious areas should discuss the risks and benefits of such travel with their physicians.
Last reviewed on RxList: 3/19/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Malarone Information
Malarone - User Reviews
Malarone User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
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.