Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
Quinine Sulfate (UNII: KF7Z0E0Q2B) (Quinine - UNII:A7V27PHC7A)
Sun Pharmaceutical Industries, Inc.
Quinine Sulfate
Quinine Sulfate 324 mg
ORAL
PRESCRIPTION DRUG
Quinine sulfate capsules are an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14) ]. Limitations of Use: Quinine sulfate oral capsules are not approved for: Quinine sulfate capsules are contraindicated in patients with the following: Risk Summary Prolonged experience with quinine in pregnant women over several decades, based on published prospective and retrospective observational studies, surveys, safety and efficacy studies, review articles, case reports and case series have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data) . In animal reproduction studies, administration of quinine by multiple routes of administration to pregnant rabbits, dogs, guinea pigs, rats, and monkeys during the period of organogenesis at doses of 0.25 to 2 times the m
How Supplied Quinine sulfate capsules, USP, 324 mg are available as clear/clear capsules imprinted AR 102: Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.
New Drug Application Authorized Generic
Sun Pharmaceutical Industries, Inc. ---------- MEDICATION GUIDE QUININE SULFATE CAPSULES for oral use Read the Medication Guide that comes with quinine sulfate capsules before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about quinine sulfate capsules when you start taking it and at regular checkups. Quinine sulfate capsules are not approved for the prevention or treatment of night-time leg cramps. What is the most important information I should know about quinine sulfate capsules? Quinine sulfate capsulesused to treat or prevent leg cramps may cause serious side effects or even death. Quinine sulfate capsulesmay cause: • your blood cell (platelet) count to drop causing serious bleeding problems. In some people, serious kidney problems can happen. • problems with your heart rhythm that can lead to death. • serious allergic reactions. Call your healthcare provider right away if you have: • easy bruising • severe flushing • severe nose bleed • swelling of your face • blood in urine or stool • trouble breathing • bleeding gums • chest pain • unusual purple, brown or red spots on your skin (bleeding under your skin) • irregular heart rhythm • rapid heartbeat • rash • weakness • hives • sweating • severe itching • nervousness Quinine sulfate capsules can have other serious side effects. See “What are the possible side effects of quinine sulfate capsules?” What are quinine sulfate capsules? Quinine sulfate capsules are a prescription medicine used to treat uncomplicated malaria caused by the parasite Plasmodium falciparum. Quinine sulfate capsules are not approved to: • Prevent malaria • Treat severe or complicated Plasmodium falciparum malaria • Prevent or treat night-time leg cramps It is not known if quinine sulfate capsules are safe and effective in children u Lue koko asiakirja
QUININE SULFATE- QUININE SULFATE CAPSULE SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE QUININE SULFATE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUININE SULFATE CAPSULES. QUININE SULFATE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2005 WARNING: HEMATOLOGIC REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ QUININE SULFATE CAPSULES USE FOR THE TREATMENT OR PREVENTION OF NOCTURNAL LEG CRAMPS MAY RESULT IN SERIOUS AND LIFE-THREATENING HEMATOLOGIC REACTIONS, INCLUDING THROMBOCYTOPENIA AND HEMOLYTIC UREMIC SYNDROME/THROMBOTIC THROMBOCYTOPENIC PURPURA (HUS/TTP). CHRONIC RENAL IMPAIRMENT ASSOCIATED WITH THE DEVELOPMENT OF TTP HAS BEEN REPORTED. THE RISK ASSOCIATED WITH QUININE SULFATE CAPSULES USE IN THE ABSENCE OF EVIDENCE OF ITS EFFECTIVENESS IN THE TREATMENT OR PREVENTION OF NOCTURNAL LEG CRAMPS OUTWEIGHS ANY POTENTIAL BENEFIT. (1, 5.1) RECENT MAJOR CHANGES Contraindications, Glucose-6-phosphate dehydrogenase (G6PD) deficiency (4) Removed 6/2019 Warnings and Precautions, Hemolytic Anemia (5.3) 6/2019 INDICATIONS AND USAGE Quinine sulfate is an antimalarial indicated for treatment of uncomplicated _Plasmodium falciparum_ malaria. (1) Limitations of Use: Quinine sulfate is not approved for: • • • DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS Capsules: 324 mg (3) CONTRAINDICATIONS Quinine sulfate capsules are contraindicated in patients with the following: • • • • WARNINGS AND PRECAUTIONS • • • • Treatment of severe or complicated P. falciparum malaria. Prevention of malaria. Treatment or prevention of nocturnal leg cramps Adults (≥ 16 years of age): 648 mg (two capsules) every 8 hours for 7 days. (2.1) Patients with Severe Chronic Renal Impairment: One loading dose of 648 mg (two capsules) followed 12 hours later by 324 mg (one capsule) every 12 hours for 7 days. (2.2) Prolongation of QT interval (4) Myasthenia gravis (4) Known Lue koko asiakirja