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:

Teva Pharmaceuticals USA, 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 capsules 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 capsules are 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 (5.4) ]. - Known hypersensitivity reactions to quinine. These include, but are not limited to, the following [see Warnings and Precautions (5.7) ]: Thrombocytopenia Idiopathic

Product summary:

How Supplied Quinine Sulfate Capsules USP, 324 mg are available as opaque white hard gelatin capsules, imprinted in black “93” over “3002” on the cap portion and “93” over “3002” on the body portion of the capsule, in bottles of 30 (NDC 0093-3002-56). Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Teva Pharmaceuticals USA, Inc.
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Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Quinine Sulfate (kwye’ nine sul’ fate)
Capsules, for oral use
Read the Medication Guide that comes with quinine sulfate capsules
before you start taking them 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 them 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 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.
•
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 nose bleed
•
blood in urine or stool
•
bleeding gums
•
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
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 ni

Summary of Product characteristics

QUININE SULFATE- QUININE SULFATE CAPSULE
TEVA PHARMACEUTICALS USA, 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 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 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).
INDICATIONS AND USAGE
Quinine sulfate capsules are a antimalarial indicated for treatment of
uncomplicated _Plasmodium_
_falciparum_ malaria. (1)
Limitations of Use:
Quinine sulfate capsules are not approved for:
Treatment of severe or complicated P. falciparum malaria.
Prevention of malaria.
Treatment or prevention of nocturnal leg cramps
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 opaque white hard gelatin capsules, imprinted in black "93"
over "3002" on the cap portion and
"93" over "3002" on the body portion of the capsule. (3)
CONTRAINDICATIONS
Quinine sulfate capsules are contraindicated in patients with the
following:
Prolongation of QT interval (4)
Myasthenia gravis (4)
Known hypersensitivity to quinine, mefloquine, or quinidine (4)
Optic neuritis (4)
WARNINGS AND PRECAUTIONS
Thro