מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A)
Ingenus Pharmaceuticals, LLC
QUININE SULFATE
QUININE SULFATE 324 mg
ORAL
PRESCRIPTION DRUG
Quinine Sulfate Capsules, USP is 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 is 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 is 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.
How Supplied Quinine Sulfate Capsules USP, 324 mg are - size '0' capsules with white opaque body and cap, imprinted "201" with black ink on cap and body. Bottles of 30 NDC 50742-238-30 Storage Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.
Abbreviated New Drug Application
Ingenus Pharmaceuticals, LLC ---------- MEDICATION GUIDE Quinine Sulfate Capsules USP, for oral use (kwye´nine sul´ fate) 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 treatment of night-time leg cramps. What is the most important information I should know about Quinine Sulfate Capsules USP, 324 mg? Quinine Sulfate Capsules USP, 324 mg 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 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) • rapid heartbeat • irregular heart rhythm • 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 is 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: It is not known if Quinine sulfate capsules are safe and effective in children under 16 years of age. Who should not take Quinine sulfate capsules? Do not take Quinine sulfate c קרא את המסמך השלם
QUININE SULFATE- QUININE SULFATE CAPSULE INGENUS PHARMACEUTICALS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE QUININE SULFATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUININE SULFATE. QUININE SULFATE CAPSULES, USP 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 Capsules, USP is an antimalarial indicated for treatment of uncomplicated _Plasmodium falciparum _malaria. (1) Limitations of Use: Quinine Sulfate is not approved for: Treatment of severe or complicated _P. falciparum _malaria. Prevention of malaria. Treatment or prevention of nocturnal leg cramps DOSAGE FORMS AND STRENGTHS Capsules: 324 mg (3) CONTRAINDICATIONS Quinine Sulfate is 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 Thrombocytopenia, including ITP and HUS/TTP, has been reported. Discontinue drug. (5.2) Hemolytic Anemia: Monitor hemoglobin and hematocrit. Discontinue drug if hemolytic anemia occurs. (5.3) QT Prolongation and Ventricular Arrhythmias: Avoid concomitant use with drug קרא את המסמך השלם