HYDROXYCHLOROQUINE SULFATE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH)

Sẵn có từ:

Major Pharmaceuticals

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Hydroxychloroquine sulfate tablets are indicated in adult and pediatric patients for the: Limitations of Use: Hydroxychloroquine sulfate tablets are not  recommended for: For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention1 . Hydroxychloroquine sulfate tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults. Hydroxychloroquine sulfate tablets are indicated for the treatment of systemic lupus erythematosus in adults. Hydroxychloroquine sulfate tablets are indicated for the treatment of chronic discoid lupus erythematosus in adults. Hydroxychloroquine sulfate tablets are 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 hydroxychloroquine sulfate tablets 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 hydroxychloroquine sulfate tablets 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 to 4% and 15 to 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 hydroxychloroquine sulfate tablets 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 hydroxychloroquine sulfate tablets and any potential adverse effects on the breastfed child from hydroxychloroquine sulfate tablets or from the underlying maternal condition. The safety and effectiveness of hydroxychloroquine sulfate tablets 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 hydroxychloroquine sulfate tablets have not been established in pediatric patients for the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus, or systemic lupus erythematosus. Clinical trials of hydroxychloroquine sulfate tablets 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 hydroxychloroquine sulfate tablets may be necessary in patients with hepatic or renal disease.

Tóm tắt sản phẩm:

Hydroxychloroquine Sulfate Tablets, USP are white to off-white, capsule shaped film-coated tablet debossed with “AC 384” on one side and plain on the other side. Each film-coated tablet contains Hydroxychloroquine Sulfate, USP 200 mg (equivalent to 155 mg base). Carton of 50 tablets (10 tablets per blister pack x 5), NDC 0904-7046-06 Carton of 100 tablets (10 tablets per blister pack x 10), NDC 0904-7046-61 Dispense in a tight, light-resistant container as defined in the USP/NF.  Store at room temperature [20° to 25°C (68° to 77°F), allow for excursions between 15° and 30°C (59° and 86°F)].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET
MAJOR PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROXYCHLOROQUINE
SULFATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
HYDROXYCHLOROQUINE SULFATE TABLETS. 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
INDICATIONS AND USAGE
Hydroxychloroquine Sulfate Tablets are an antimalarial and
antirheumatic indicated for the: (1)
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Limitations of Use (1.1):
Hydroxychloroquine Sulfate Tablets are NOT recommended for the: (1)
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DOSAGE AND ADMINISTRATION
Malaria in Adult and Pediatric Patients (2.2): (2)
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Rheumatoid Arthritis in Adults (2.3): (2)
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Systemic Lupus Erythematosus in Adults (2.4): (2)
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Chronic Discoid Lupus Erythematosus in Adults (2.5): (2)
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DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg, 200 mg, 300 mg and 400 mg of hydroxychloroquine
sulfate (3) (3)
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)
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 f