国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH)
Northstar RxLLC
ORAL
PRESCRIPTION DRUG
Hydroxychloroquine sulfate is indicated in adult and pediatric patients for the: Limitations of Use Hydroxychloroquine sulfate is not recommended for: For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention.1 Hydroxychloroquine sulfate is indicated for the treatment of acute and chronic rheumatoid arthritis in adults. Hydroxychloroquine sulfate is indicated for the treatment of systemic lupus erythematosus in adults. Hydroxychloroquine sulfate is indicated for the treatment of chronic discoid lupus erythematosus in adults. Hydroxychloroquine sulfate 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 hydroxychloroquine sulfate during pregnancy. Encourage patients to register by contacting 1-877-311-8972. Risk Summary Prolonged clinical experience over decades of use an
Hydroxychloroquine sulfate tablets, USP for oral administration are available as: 200 mg : Round, Off White, Standard Cup Tablet Core, Debossed GG 260 on One Side and Plain on the Reverse Side, Film Coated White NDC 16714-753-01 bottles of 100 Each tablet contains 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg base). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF. KEEP OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED NORTHSTAR RXLLC ---------- 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 INDICATIONS AND USAGE Hydroxychloroquine sulfate is an antimalarial and antirheumatic indicated for the: • • • • • Limitations of Use (1.1): Hydroxychloroquine sulfate is not recommended for the: • • • • • DOSAGE AND ADMINISTRATION Malaria in Adult and Pediatric Patients (2.2): • • Rheumatoid Arthritis in Adults (2.3): • • Systemic Lupus Erythematosus in Adults (2.4): • Chronic Discoid Lupus Erythematosus in Adults (2.5): • DOSAGE FORMS AND STRENGTHS Tablets: 200 mg of hydroxychloroquine sulfate (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 forms of these parasites. For radical cure of _P. vivax_ and _P. ovale_ infections, concomitant therapy with an 8-aminoquinoline drug is necessary. Prophylaxis: Beg 阅读完整的文件