Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A)
CorePharma, LLC
QUININE SULFATE
QUININE SULFATE 324 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
QUININE SULFATE- QUININE SULFATE CAPSULE COREPHARMA, 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 (5.1). INDICATIONS AND USAGE Quinine Sulfate, USP is a cinchona alkaloid indicated for treatment of uncomplicated _Plasmodium falciparum_ malaria (1). 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 capsules - size ‘0’ capsules with white opaque body and cap, imprinted “201” with black ink on cap and body (3). CONTRAINDICATIONS Quinine Sulfate is contraindicated in patients with the following: Prolongation of QT interval (4) Glucose-6-phosphate dehydrogenase (G6PD) deficiency (4) Myasthenia gravis (4) Known hypersensitivity to quinine, mefloquine, or quinidine (4) Optic neuritis (4) WARNINGS AND PRECAUTIONS Not indicated for the prevention or treatment of nocturnal leg cramps. Risk of serious and life-threatening adverse reactions (1, 5.1). Thrombocytopenia, including ITP and HUS/TTP, has been reported. Di Læs hele dokumentet