PLAQUENIL- hydroxychloroquine sulfate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

hydroxychloroquine sulfate (UNII: 8Q2869CNVH) (hydroxychloroquine - UNII:4QWG6N8QKH)

Available from:

Aphena Pharma Solutions - Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PLAQUENIL is indicated in adult and pediatric patients for the: • Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax,  and Plasmodium ovale. • Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use: PLAQUENIL is not  recommended for: • Treatment of complicated malaria. • Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of Plasmodium  species [see Microbiology (12.4)]   • Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium  species has not been identified. • Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. • Prevention of relapses of P. vivax  or P. ovale  because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax  and P. ovale  infections, concomitant therapy with an 8-aminoquinoline drug is necessary [see Microbiolog

Product summary:

PLAQUENIL tablets contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). White to off-white film coated, no score, tablet imprinted with “PLAQUENIL” on one face in black ink.  The tablets are available in bottles of: • 60 tablets - NDC 59212-562-60  • 100 tablets - NDC 59212-562-10 and NDC 59212-562-11 Dispense in a tight, light-resistant container as defined in the USP/NF.  Store at room temperature up to 30°C (86°F) and allow for excursions between 15°C and 30°C (59°F and 86°F).

Authorization status:

New Drug Application

Summary of Product characteristics

PLAQUENIL - HYDROXYCHLOROQUINE SULFATE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PLAQUENIL® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PLAQUENIL.
PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1955
INDICATIONS AND USAGE
PLAQUENIL is an antimalarial and antirheumatic indicated for the:
• Treatment of uncomplicated malaria due to _Plasmodium falciparum,
Plasmodium malariae, Plasmodium_
_ovale_, and _Plasmodium vivax _in adult and pediatric patients. (1.1)
• Prophylaxis of malaria in geographic areas where chloroquine
resistance is not reported in adult and
pediatric patients (1.1)
• Treatment of rheumatoid arthritis in adults.(1.2)
• Treatment of systemic lupus erythematosus in adults.(1.3)
• Treatment of chronic discoid lupus erythematosus in adults. (1.4)
Limitations of Use (1.1):
PLAQUENIL is NOT recommended for the:
• Treatment of complicated malaria.
• Treatment of chloroquine or hydroxychloroquine-resistant strains
of _Plasmodium_ species.
• Treatment of malaria acquired in geographic areas where
chloroquine resistance occurs or when
the _Plasmodium_ species has not been identified.
• Prophylaxis of malaria in geographic areas where chloroquine
resistance occurs.
• Prevention of relapses of_ P. vivax _or _P. ovale _because it is
not active against the hypnozoite liver stage
forms of these parasites. For radical cure of _P. vivax_ and _P.
ovale_ infections, concomitant therapy with an
8-aminoquinoline drug is necessary.
DOSAGE AND ADMINISTRATION
Malaria in Adult and Pediatric Patients (2.2):
Prophylaxis: Begin weekly doses 2 weeks prior to travel to the endemic
area, continue weekly doses
while in the endemic area, and continue the weekly doses for 4 weeks
after leaving the endemic area:
-Adults: 400 mg once a week
-Pediatric patients ≥ 31 kg: 6.5 mg/kg up to 400 mg, once a week
Treatment of Uncomplicated Malaria: