QUALAQUIN- 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:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

Quinine Sulfate

Composition:

Quinine Sulfate 324 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

QUALAQUIN 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: QUALAQUIN is not approved for: QUALAQUIN is contraindicated in patients with the following: Risk Summary Prolonged experience with quinine in pregnant women over several decades, based on published prospective and retrospective observational studies, surveys, safety and efficacy studies, review articles, case reports and case series have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data) . In animal reproduction studies, administration of quinine by multiple routes of administration to pregnant rabbits, dogs, guinea pigs, rats, and monkeys during the period of organogenesis at doses of 0.25 to 2 times the maximum recommended human dose (MRHD) based on body su

Product summary:

How Supplied QUALAQUIN® (quinine sulfate) Capsules, USP, 324 mg are available as clear/clear capsules imprinted AR 102: Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.

Authorization status:

New Drug Application

Patient Information leaflet

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
QUALAQUIN® (kwol-a-kwin)
(quinine sulfate)
capsules, for oral use
Read the Medication Guide that comes with QUALAQUIN 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 QUALAQUIN when you start taking it and at regular
checkups. QUALAQUIN is not
approved for the prevention or treatment of night-time leg cramps.
What is the most important information I should know about QUALAQUIN?
QUALAQUIN used to treat or prevent leg cramps may cause serious side
effects or even death.
QUALAQUIN 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:
QUALAQUIN can have other serious side effects. See “What are the
possible side effects of
QUALAQUIN?”
What is QUALAQUIN?
QUALAQUIN is a prescription medicine used to treat uncomplicated
malaria caused by the parasite
Plasmodium falciparum.
QUALAQUIN is not approved to:
•
Prevent malaria
•
Treat severe or complicated Plasmodium falciparum malaria
•
Prevent or treat night-time leg cramps
It is not known if QUALAQUIN is safe and effective in children under
16 years of age.
Who should not take QUALAQUIN?
Do not take QUALAQUIN if you have:
•
changes in the electrical activity of your heart called QT
prolongation.
•
had allergic reactions to quinine (the active ingredient in
QUALAQUIN), such as low platelets,
which are necessary for your blood to clot.
•
had allergic reactions to mefloquine (Lariam) or quinidine.
•
an autoimmune disease (myasthenia gravis) that leads to muscle
weakness.
•
an inflammation of the nerve important for vision (optic neuritis).
What sho

Summary of Product characteristics

QUALAQUIN- QUININE SULFATE CAPSULE
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUALAQUIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR QUALAQUIN.
QUALAQUIN (QUININE SULFATE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2005
WARNING: HEMATOLOGIC REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
QUALAQUIN 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
QUALAQUIN 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
INDICATIONS AND USAGE
QUALAQUIN is an antimalarial indicated for treatment of uncomplicated
_Plasmodium falciparum _malaria. (1)
Limitations of Use:
QUALAQUIN is not approved for:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Capsules: 324 mg (3)
CONTRAINDICATIONS
QUALAQUIN is contraindicated in patients with the following:
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
®
Contraindications, Glucose-6-phosphate dehydrogenase (G6PD) deficiency
(4) Removed 6/2019
Warnings and Precautions, Hemolytic Anemia (5.3) 6/2019
Treatment of severe or complicated _P. falciparum_ malaria.
Prevention of malaria.
Treatment or prevention of nocturnal leg cramps
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)
Prolongation of QT interval (4)
Myasthenia gravis (4)
Known hypersensitivity to quinine, mefloquine, or quinidine (4)
Optic neu