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:

Mylan Pharmaceuticals Inc.

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
MYLAN PHARMACEUTICALS INC.
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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
BOXED WARNING (SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED
WARNING.)
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 is a cinchona alkaloid indicated for treatment of
uncomplicated _Plasmodium falciparum _malaria. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
Quinine sulfate capsules are contraindicated in patients with the
following:
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions are a cluster of symptoms called
“cinchonism”, which occurs to some degree in almost all
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)
324 mg buff opaque cap and buff opaque body, hard-shell gelatin
capsules axially printed with MYLAN over QS 324
in black ink on cap and body.
Prolongation of QT interval (4)
Glucose-6-phosphate dehydrogenase (G