QUININE SULFATE- quinine capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Amneal Pharmaceuticals LLC

INN (Medzinárodný Name):

QUININE SULFATE

Zloženie:

QUININE SULFATE 324 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Quinine sulfate 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 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 thrombocytopenia purpura (ITP) and thrombotic thrombocytopenic purpura (TTP) Hemolytic uremic syndrome (HUS) Blackwater fever (acute intravascular hemolysis, hemoglobinuria, and hemoglobinemia) - Thrombocytopenia - Idiopathic thrombocytopenia purpura (ITP) and thrombotic thrombocytopenic purpura (TTP) - Hemolytic uremic syndrome (HUS) - Blackwater fever (acute intravascular hemolysis, hemoglobinuria, and hemoglobinemia) - Known hypersensitivity to mefloquine or quinidine: cross-sensitivity to quinine has been documented [see Warnings and Precautions (5.7)] . - Myasthenia gravis. Quinine has neuromuscular blocking activity, and may exacerbate muscle weakness. - Optic neuritis. Quinine may exacerbate active optic neuritis [see Adverse Reactions (6.1)] . 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 surface area (BSA), produced embryo-fetal toxicity including malformations. Offspring of pregnant rats administered oral quinine sulfate during mating, gestation, and lactation at a dose approximately equivalent to 0.1 times the MRHD based on BSA comparison experienced impaired growth and delayed physical development (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Malaria during and after pregnancy increases the risk for adverse pregnancy and neonatal outcomes, including maternal anemia, severe malaria, spontaneous abortion, stillbirths, preterm delivery, low birth weight, intrauterine growth retardation, congenital malaria, and maternal and neonatal mortality. Maternal adverse reactions An increased incidence of hypoglycemia, due to increased pancreatic secretion of insulin, has been reported with quinine use, in pregnant women, especially during the third trimester1 . Monitor glucose levels in pregnant woman taking quinine. Tinnitus, vomiting, dizziness, and nausea are commonly reported adverse reactions in pregnant women taking quinine. Pregnant women are also at risk for a rare triad of complications: massive hemolysis, hemoglobinemia, and hemoglobinuria2 . Labor or delivery In doses several times higher than those used to treat malaria, quinine may cause uterine contractions; however, there is no evidence that quinine causes uterine contractions at the doses recommended for the treatment of malaria. Data Human Data Quinine crosses the placenta with measurable blood concentrations in the fetus. In 8 women who delivered live infants 1 to 6 days after starting quinine therapy, umbilical cord plasma quinine concentrations were between 1.0 and 4.6 mg/L (mean 2.4 mg/L) and the mean (±SD) ratio of cord plasma to maternal plasma quinine concentrations was 0.32 ± 0.14. Quinine levels in the fetus may not be therapeutic. Adverse outcomes have been identified in the post-marketing experience with quinine during pregnancy. Because these outcomes are reported from varied data sources and have inconsistent findings and/or important methodological limitations, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In studies in which more than 893 pregnant women were treated with quinine for malaria in the first trimester, no quinine-associated increases in the incidence of congenital anomalies were observed compared with other antimalarial drugs3 . A retrospective study of women with P. falciparum malaria who were treated with oral quinine sulfate 10 mg/kg 3 times daily for 7 days at any time in pregnancy reported no significant difference in the rate of stillbirths at > 28 weeks of gestation in women treated with quinine (10 of 633 women [1.6%]) as compared with a control group without malaria or exposure to antimalarial drugs during pregnancy (40 of 2201 women [1.8%]). The overall rate of congenital malformations (9 of 633 offspring [1.4%]) was not different for women who were treated with quinine sulfate compared with the control group (38 of 2201 offspring [1.7%]). The spontaneous abortion rate was higher in the control group (10.9%) than in women treated with quinine sulfate (3.5%) [OR = 3.1; 95% CI 2.1 to 4.7]. An epidemiologic survey that included 104 mother-child pairs exposed to quinine during the first 4 months of pregnancy, found no increased risk of structural birth defects was seen (2 fetal malformations [1.9%]). Case reports describe deafness and optic nerve hypoplasia in children exposed in utero due to maternal ingestion of high doses of quinine. Animal Data In animal developmental studies conducted in multiple animal species4 , pregnant animals received quinine by the subcutaneous, intramuscular, and oral routes at doses 0.25 to 2 times the maximum recommended human dose (MRHD) based on body surface area (BSA). Increases in fetal death were observed in utero in pregnant rabbits at maternal doses ≥ 100 mg/kg/day and in pregnant dogs at ≥ 15 mg/kg/day corresponding to dose levels approximately 0.5 and 0.25 times the MRHD respectively based on BSA comparisons. Rabbit offspring had increased rates of degenerated auditory nerve and spiral ganglion and increased rates of CNS anomalies such as anencephaly and microcephaly at a dose of 130 mg/kg/day corresponding to a maternal dose approximately 1.3 times the MRHD based on BSA comparison. Guinea pig offspring had increased rates of cochlear hemorrhage at maternal doses of 200 mg/kg corresponding to a dose level of approximately 1.4 times the MRHD based on BSA comparison. No fetal malformations were observed in rats at maternal doses up to 300 mg/kg/day and in monkeys at maternal doses up to 200 mg/kg/day corresponding to doses approximately 1 and 2 times the MRHD respectively based on BSA comparisons. In a pre-postnatal study, pregnant rats received quinine sulfate in feed beginning two weeks prior to mating, through gestation, and lactation. An estimated oral dose of quinine sulfate of 20 mg/kg/day corresponding to approximately 0.1 times the MRHD based on BSA comparison resulted in offspring with impaired growth, lower body weights at birth and during the lactation period, and delayed physical development of teeth eruption and eye opening during the lactation period. Risk Summary Quinine is present in human milk. It is estimated that breastfed infants would receive less than 2 to 3 mg per day of quinine base (< 0.4% of the maternal dose) via breast milk (see Data) . There are no data on the effects of quinine on the breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for quinine sulfate and any potential adverse effects on the breastfed child from quinine sulfate or from the underlying maternal condition. Data No toxicity was reported in infants in a single study where oral quinine sulfate (10 mg/kg every 8 hours for 1 to 10 days) was administered to 25 lactating women. Quinine concentrations in breast milk are approximately 31% of quinine concentrations in maternal plasma. Infertility In a published study5 in 5 men receiving oral tablets of 600 mg quinine three times a day for one week, sperm motility was decreased and percent sperm with abnormal morphology was increased, but sperm count and serum testosterone were unaffected. Based on findings from animal studies, quinine sulfate may impair fertility [see Nonclinical Toxicology (13.1)] . The safety and efficacy of quinine sulfate in pediatric patients under the age of 16 has not been established. Clinical studies of quinine sulfate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond to treatment differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Clearance of quinine is decreased in patients with severe chronic renal failure. The dosage and dosing frequency should be reduced [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)] . In patients with severe hepatic impairment (Child-Pugh C), quinine oral clearance (CL/F) is decreased, volume of distribution (Vd /F) is increased, and half-life is prolonged, relative to subjects with normal liver function. Therefore, quinine is not indicated in patients with severe hepatic impairment and alternate therapy should be administered [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)] . Close monitoring is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, as exposure to quinine may be increased relative to subjects with normal liver function [see Clinical Pharmacology (12.3)] .

Prehľad produktov:

How Supplied Quinine Sulfate Capsules USP, 324 mg are clear transparent size ‘0’ hard gelatin capsules filled with white to off-white powder and imprinting ‘AMNEAL’ on the cap and ‘811’ on the body. They are available as follows: Bottles of 30:                                      NDC 65162-811-03 Bottles of 90:                                      NDC 65162-811-09 Bottles of 500:                                    NDC 65162-811-50 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.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Amneal Pharmaceuticals LLC
----------
MEDICATION GUIDE
Quinine Sulfate (kwye’ nine sul’ fate) Capsules, USP
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 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 night-time leg cramps
It is not known if quinine sulfate capsules are safe and effective i

Súhrn charakteristických

QUININE SULFATE- QUININE CAPSULE
AMNEAL PHARMACEUTICALS LLC
----------
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)
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 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
Capsules: 324 mg. (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 PREC