QUININE SULFATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A)

Available from:

RICONPHARMA LLC

INN (International Name):

QUININE SULFATE

Composition:

QUININE SULFATE 324 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUININE SULFATE- QUININE SULFATE CAPSULE
RICONPHARMA LLC
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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