País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A)
Teva Pharmaceuticals USA, 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 capsules are not approved for: - Treatment of severe or complicated P. falciparum malaria. - Prevention of malaria. - Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1) ]. Quinine sulfate capsules are contraindicated in patients with the following: - Prolonged QT interval. One case of a fatal ventricular arrhythmia was reported in an elderly patient with a prolonged QT interval at baseline, who received quinine sulfate intravenously for P. falciparum malaria [see Warnings and Precautions (5.4) ]. - Known hypersensitivity reactions to quinine. These include, but are not limited to, the following [see Warnings and Precautions (5.7) ]: Thrombocytopenia Idiopathic
How Supplied Quinine Sulfate Capsules USP, 324 mg are available as opaque white hard gelatin capsules, imprinted in black “93” over “3002” on the cap portion and “93” over “3002” on the body portion of the capsule, in bottles of 30 (NDC 0093-3002-56). Storage 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, with a child-resistant closure (as required). Keep this and all medications out of the reach of children.
Abbreviated New Drug Application
Teva Pharmaceuticals USA, Inc. ---------- Dispense with Medication Guide available at: www.tevausa.com/medguides MEDICATION GUIDE Quinine Sulfate (kwye’ nine sul’ fate) Capsules, for oral use Read the Medication Guide that comes with quinine sulfate capsules before you start taking them 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 them 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 capsules used to treat or prevent leg cramps may cause serious side effects or even death. Quinine sulfate capsules may 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 nose bleed • blood in urine or stool • bleeding gums • unusual purple, brown or red spots on your skin (bleeding under your skin) • rash • hives • severe itching • severe flushing • swelling of your face • trouble breathing • chest pain • rapid heartbeat • irregular heart rhythm • weakness • sweating • 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 ni Leer el documento completo
QUININE SULFATE- QUININE SULFATE CAPSULE TEVA PHARMACEUTICALS USA, 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 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 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). INDICATIONS AND USAGE Quinine sulfate capsules are a antimalarial indicated for treatment of uncomplicated _Plasmodium_ _falciparum_ malaria. (1) Limitations of Use: Quinine sulfate capsules are not approved for: Treatment of severe or complicated P. falciparum malaria. Prevention of malaria. Treatment or prevention of nocturnal leg cramps DOSAGE AND ADMINISTRATION 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) DOSAGE FORMS AND STRENGTHS 324 mg opaque white hard gelatin capsules, imprinted in black "93" over "3002" on the cap portion and "93" over "3002" on the body portion of the capsule. (3) CONTRAINDICATIONS Quinine sulfate capsules are contraindicated in patients with the following: Prolongation of QT interval (4) Myasthenia gravis (4) Known hypersensitivity to quinine, mefloquine, or quinidine (4) Optic neuritis (4) WARNINGS AND PRECAUTIONS Thro Leer el documento completo