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:

Concordia Pharmaceuticals Inc.

INN (International Name):

hydroxychloroquine sulfate

Composition:

hydroxychloroquine sulfate 200 mg

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 Microbiology (12.4)] . For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention1  .   PLAQUENIL is indicated for the treatment of acute and chronic rheumatoid arthritis in adults. PLAQUENIL is indicated for the treatment of systemic lupus erythematosus in adults. PLAQUENIL is indicated for the treatment of chronic discoid lupus erythematosus in adults. PLAQUENIL is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to PLAQUENIL during pregnancy. Encourage patients to register by contacting 1-877-311-8972. Risk Summary  Prolonged clinical experience over decades of use and available data from published epidemiologic and clinical studies with PLAQUENIL use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal, or fetal outcomes (see Data ).  There are risks to the mother and fetus associated with untreated or increased disease activity from malaria, rheumatoid arthritis, and systemic lupus erythematosus in pregnancy (see Clinical Considerations ). Animal reproduction studies were not conducted with hydroxychloroquine.   The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.  In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations  Disease-Associated Maternal and/or Embryo-Fetal Risk         Malaria:  Malaria during pregnancy increases the risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth.       Rheumatoid Arthritis:  Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.        Systemic Lupus Erythematosus:  Pregnant women with systemic lupus erythematosus, especially those with increased disease activity, are at increased risk of adverse pregnancy outcomes, including spontaneous abortion, fetal death, preeclampsia, preterm birth, and intrauterine growth restriction. Passage of maternal auto-antibodies across the placenta may result in neonatal illness, including neonatal lupus and congenital heart block. Data Human Data Data from published epidemiologic and clinical studies have not established an association with PLAQUENIL use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes.  Hydroxychloroquine readily crosses the placenta with cord blood levels corresponding to maternal plasma levels.  No retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine in utero .  Available epidemiologic and clinical studies have methodological limitations including small sample size and study design. Risk Summary  Published lactation data report that hydroxychloroquine is present in human milk at low levels. No adverse reactions have been reported in breastfed infants.  No retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine through breastmilk.  There is no information on the effect of hydroxychloroquine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PLAQUENIL and any potential adverse effects on the breastfed child from PLAQUENIL or from the underlying maternal condition. The safety and effectiveness of PLAQUENIL have been established in pediatric patients for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. vivax , and P. ovale , as well as for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.  However, this product cannot be directly administered to pediatric patients weighing less than 31 kg because the film-coated tablets cannot be crushed or divided [see Dosage and Administration (2.1, 2.2)] .   The safety and effectiveness of PLAQUENIL have not been established in pediatric patients for the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus, or systemic lupus erythematosus. Clinical trials of PLAQUENIL did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.  Nevertheless, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. In general, dose selection in geriatric patients should start with the lowest recommended dose, taking into consideration the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. A reduction in the dosage of PLAQUENIL may be necessary in patients with hepatic or renal disease.

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
CONCORDIA PHARMACEUTICALS INC.
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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
RECENT MAJOR CHANGES
Warnings and Precautions, Risks Associated with Use in Porphyria (5.5)
... 7/2023
Warnings and Precautions, Neuropsychiatric Reactions Including
Suicidality (5.9) ... 7/2023
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 we