Application Nr Approved Date Route Status External Links
NDA009768 2009-07-10 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Malaria Plaquenil Is Indicated For The Treatment Of Uncomplicated Malaria Due To P. Falciparum, P. Malariae, P. Ovale, And P. Vivax. Plaquenil Is Indicated For The Prophylaxis Of Malaria In Geographic Areas Where Chloroquine Resistance Is Not Reported. Limitations Of Use In Malaria • Plaquenil Is Not Recommended For The Treatment Of Complicated Malaria. • Plaquenil Is Not Effective Against Chloroquine Or Hydroxychloroquine-Resistant Strains Of Plasmodium Species (see Clinical Pharmacology – Microbiology ). Plaquenil Is Not Recommended For The Treatment Of Malaria Acquired In Geographic Areas Where Chloroquine Resistance Occurs Or When The Plasmodium Species Has Not Been Identified. • Plaquenil Is Not Recommended For Malaria Prophylaxis In Geographic Areas Where Chloroquine Resistance Occurs. • Plaquenil Does Not Prevent Relapses Of P. Vivax Or P. Ovale Because It Is Not Active Against The Hypnozoite Forms Of These Parasites. For Radical Cure Of P. Vivax And P. Ovale Infections, Concomitant Therapy With An 8-Aminoquinoline Compound Is Necessary (see Clinical Pharmacology – Microbiology ). Prior To Prescribing Plaquenil For The Treatment Or Prophylaxis Of Malaria, Consult The Centers For Disease Control And Prevention (cdc) Malaria Website (http://www.cdc.gov/malaria). Lupus Erythematosus Plaquenil Is Indicated For The Treatment Of Chronic Discoid Lupus Erythematosus And Systemic Lupus Erythematosus In Adults. Rheumatoid Arthritis Plaquenil Is Indicated For The Treatment Of Acute And Chronic Rheumatoid Arthritis In Adults.

All Formulated Excipients (1 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Hydroxychloroquine Sulfate HYDROXYCHLOROQUINE SULFATE ZINC1530652

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