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:

Lupin Pharmaceuticals, Inc.

INN (International Name):

QUININE SULFATE

Composition:

QUININE SULFATE 324 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quinine sulfate capsule USP 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)] . Quinine sulfate capsules USP are not approved for: - Treatment of severe or complicated P. falciparum malaria. - Prevention of malaria. - Treatment or prevention of nocturnal leg cramps [see WARNINGS AND PRECAUTIONS (5.1)] . Quinine sulfate is contraindicated in patients with the following:   •  Prolonged QT interval. One case of a fatal ventricular arrhythmia was reported in an elderly patient with a prolonged QT interval at baseline, who received quinine sulfate intravenously for P. falciparum malaria [see WARNINGS AND PRECAUTIONS (5.3)].   •  Glucose-6-phosphate dehydrogenase (G6PD) deficiency.   •  Hemolysis can occur in patients with G6PD deficiency receiving quinine.   •  Known hypersensitivity reactions to quin

Product summary:

Quinine sulfate capsules USP, 324 mg are available as size "0" capsules with clear transparent cap and clear transparent body imprinted with "LU" on cap and "Y51" on body in black ink, containing white to off white powder: Bottles of 30                         NDC 68180-560-06 Bottles of 100                      NDC 68180-560-01 Bottles of 500                      NDC 68180-560-02 Bottles of 1000                    NDC 68180-560-03 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] Dispense in a tight container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Lupin Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Quinine Sulfate Capsules USP
(Kwye' nine sul' fate)
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 treatment of
night-time leg cramps.
What is the most important information I should know about quinine
sulfate capsules?
Quinine sulfate capsules used to treat or prevent leg cramps may cause
serious side effects or even death.
•
Quinine sulfate capsules may cause your blood cell (platelet) count to
drop causing serious
bleeding problems. In some people, serious kidney problems can happen.
•
Quinine sulfate capsules may cause problems with your heart rhythm
that can lead to death.
•
Quinine sulfate capsules may cause serious allergic reactions.
Call your healthcare provider right away if you have:
•
easy bruising
•
severe nose bleed
•
blood in urine or stool
•
bleeding gums
•
appearance of unusual purple, brown or red spots on your skin
(bleeding under your skin)
•
rash
•
hives
•
severe itching
•
severe flushing
•
swelling of your face
•
trouble breathing
•
chest pain
•
rapid heartbeat
•
irregular heart rhythm
•
weakness
•
sweating
•
nervousness
Taking quinine sulfate capsules with some other medicines can increase
the chance of serious side effects.
Tell your health care provider if you take any other medicines.
Certain medicines can cause the blood levels of quinine sulfate to be
too high or too low in your body. It
is important for you to tell your healthcare provider about all the
medicines you take, including
prescription and non-prescription medicines, vitamins and herbal
supplements.
Quinine sulfate capsules a

Summary of Product characteristics

QUININE SULFATE- QUININE SULFATE CAPSULE
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUININE SULFATE CAPSULES
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
QUININE SULFATE CAPSULES
USP.
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 capsule 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 size "0" capsules with clear transparent cap and clear
transparent body imprinted with "LU" on cap
and "Y51" on body in black ink, containing white to off white powder
(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-
t