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:

Quinine sulfate capsules are 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 oral capsules are not approved for: Quinine sulfate capsules are 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 m

Product summary:

How Supplied 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 Authorized Generic

Patient Information leaflet

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
QUININE SULFATE CAPSULES
for oral use
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 prevention or
treatment of night-time leg cramps.
What is the most important information I should know about quinine
sulfate capsules?
Quinine sulfate capsulesused to treat or prevent leg cramps may cause
serious side effects or even death.
Quinine sulfate capsulesmay 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)
•
irregular heart rhythm
•
rapid heartbeat
•
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 are 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:
•
Prevent malaria
•
Treat severe or complicated Plasmodium falciparum malaria
•
Prevent or treat night-time leg cramps
It is not known if quinine sulfate capsules are safe and effective in
children u

Summary of Product characteristics

QUININE SULFATE- 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
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
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 is an antimalarial indicated for treatment of
uncomplicated _Plasmodium falciparum_
malaria. (1)
Limitations of Use:
Quinine sulfate is not approved for:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Capsules: 324 mg (3)
CONTRAINDICATIONS
Quinine sulfate capsules are contraindicated in patients with the
following:
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
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