QUININE SULFATE capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A)

Dostupné z:

Ingenus Pharmaceuticals, LLC

INN (Medzinárodný Name):

QUININE SULFATE

Zloženie:

QUININE SULFATE 324 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Quinine Sulfate Capsules, 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)].   Limitations of Use: Quinine Sulfate is 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 (5.4) ]. - Known hypersensitivity reactions to quinine. These include, but are not limited to, the following [see Warnings and Precautions (5.

Prehľad produktov:

How Supplied Quinine Sulfate Capsules USP, 324 mg are - size '0' capsules with white opaque body and cap, imprinted "201" with black ink on cap and body. Bottles of 30 NDC 50742-238-30                                            Storage Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Ingenus Pharmaceuticals, LLC
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MEDICATION GUIDE
Quinine Sulfate Capsules USP, for oral use
(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 USP, 324 mg?
Quinine Sulfate Capsules USP, 324 mg 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 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)
•
rapid heartbeat
•
irregular heart rhythm
•
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 is 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:
It is not known if Quinine sulfate capsules are safe and effective in
children under 16 years of age.
Who should not take Quinine sulfate capsules?
Do not take Quinine sulfate c

Súhrn charakteristických

QUININE SULFATE- QUININE SULFATE CAPSULE
INGENUS PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUININE SULFATE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR QUININE SULFATE.
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. (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 Capsules, USP is an antimalarial indicated for
treatment of uncomplicated _Plasmodium falciparum _malaria.
(1)
Limitations of Use:
Quinine Sulfate is not approved for:
Treatment of severe or complicated _P. falciparum _malaria.
Prevention of malaria.
Treatment or prevention of nocturnal leg cramps
DOSAGE FORMS AND STRENGTHS
Capsules: 324 mg (3)
CONTRAINDICATIONS
Quinine Sulfate is 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
Thrombocytopenia, including ITP and HUS/TTP, has been reported.
Discontinue drug. (5.2)
Hemolytic Anemia: Monitor hemoglobin and hematocrit. Discontinue drug
if hemolytic anemia occurs. (5.3)
QT Prolongation and Ventricular Arrhythmias: Avoid concomitant use
with drug