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Qualaquin (Quinine Sulfate) - Summary



QUALAQUIN® 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 QUALAQUIN use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit (see WARNINGS).



Qualaquin (quinine sulfate) is an antimalarial drug.

Qualaquin is supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base.

Treatment of Malaria:
Qualiquin is 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).

Qualiquin oral capsules are not approved for patients with severe or complicated P. falciparum malaria.

Qualiquin oral capsules are not approved for prevention of malaria.

Qualiquin oral capsules are not approved for the treatment or prevention of nocturnal leg cramps.

See all Qualaquin indications & dosage >>


Media Articles Related to Qualaquin (Quinine)

Antimalarial Drug May Be Effective Against PML
Source: Medscape Infectious Diseases Headlines [2017.09.26]
Mefloquine, an antimalarial drug, may control JC virus, the cause of progressive multifocal leukoencephalopathy, a small, preliminary study suggests.
Medscape Medical News

Source: MedicineNet Antiphospholipid Syndrome Specialty [2016.08.26]
Title: Malaria
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 8/26/2016 12:00:00 AM

more news >>

Published Studies Related to Qualaquin (Quinine)

Quinine-induced thrombocytopenia: drug-dependent GPIb/IX antibodies inhibit megakaryocyte and proplatelet production in vitro. [2011.06.02]
The development of immune cytopenias is a well-recognized side effect of many drugs...

Limited ability of Plasmodium falciparum pfcrt, pfmdr1, and pfnhe1 polymorphisms to predict quinine in vitro sensitivity or clinical effectiveness in Uganda. [2011.02]
Quinine is a standard drug for treating severe malaria in Africa, and it is also increasingly used to treat uncomplicated disease. However, failures of quinine therapy are common, and it is unknown if failures in Africa are due to drug resistance... Our data suggest that quinine sensitivity is a complex trait and that known polymorphisms in pfcrt, pfmdr1, and pfnhe1, while associated with quinine sensitivity, are not robust markers for quinine resistance.

Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial. [2010.11.13]
BACKGROUND: Severe malaria is a major cause of childhood death and often the main reason for paediatric hospital admission in sub-Saharan Africa. Quinine is still the established treatment of choice, although evidence from Asia suggests that artesunate is associated with a lower mortality. We compared parenteral treatment with either artesunate or quinine in African children with severe malaria... INTERPRETATION: Artesunate substantially reduces mortality in African children with severe malaria. These data, together with a meta-analysis of all trials comparing artesunate and quinine, strongly suggest that parenteral artesunate should replace quinine as the treatment of choice for severe falciparum malaria worldwide. FUNDING: The Wellcome Trust. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

Efficacy and safety of artemether-lumefantrine compared with quinine in pregnant women with uncomplicated Plasmodium falciparum malaria: an open-label, randomised, non-inferiority trial. [2010.11]
BACKGROUND: Malaria in pregnancy is associated with maternal and fetal morbidity and mortality. In 2006, WHO recommended use of artemisinin-based combination treatments during the second or third trimesters, but data on efficacy and safety in Africa were scarce. We aimed to assess whether artemether-lumefantrine was at least as efficacious as oral quinine for the treatment of uncomplicated falciparum malaria during the second and third trimesters of pregnancy in Mbarara, Uganda... INTERPRETATION: Artemisinin derivatives are not inferior to oral quinine for the treatment of uncomplicated malaria in pregnancy and might be preferable on the basis of safety and efficacy. FUNDING: Medecins Sans Frontieres and the European Commission. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

Comparison of quinine and rabeprazole with quinine monotherapy in the treatment of uncomplicated falciparum malaria. [2010.09]
OBJECTIVE: This study was conducted to assess the effect of combination treatment of quinine and rabeprazole in the treatment of uncomplicated Plasmodium falciparum malaria... CONCLUSION: The study results suggest that addition of rabeprazole to quinine regimen resulted in an increase in the parasite elimination rate, which may be helpful in reducing the duration of treatment and increasing patient compliance.

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Clinical Trials Related to Qualaquin (Quinine)

Drug-Drug Interaction Study of Qualaquin and Midazolam [Completed]
This is an open label non-randomized single sequence, single group two way drug interaction study in healthy adult volunteers to determine the extent to which quinine, an inducer of cytochrome p450 CYP 3A4, affects the pharmacokinetics of midazolam, an accepted probe drug for CYP 3A4. The study will also determine the extent to which midazolam affects the pharmacokinetics of quinine.

Drug - Drug Interaction Study of Quinine Sulfate and Ciprofloxacin [Completed]
Ciprofloxacin is moderate inhibitor of cytochrome P450 1A2 (CYP1A2), one of the enzymes responsible for the metabolism of quinine. This study will evaluate the effect of ciprofloxacin-related inhibition of CYP1A2 on the pharmacokinetics of quinine sulfate.

Comparative Study of Quinine Sulfate in Healthy Patients and in Patients With Renal Impairment [Terminated]
The effects of mild or moderate renal impairment (creatinine clearance 30 to 50 ml/min or >50 to 80 ml/min, respectively) on the pharmacokinetic profile of quinine and its active metabolite, 3'-hydroxyquinine, will be investigated. Safety and tolerability in healthy subjects versus those with mild to moderate renal impairment will be compared, as well.

Drug - Drug Interaction Study Between Quinine Sulfate and Theophylline [Completed]
In a prior in vitro study using human hepatocytes quinine was shown to induce the activity of Cytochrome p450 CYP 1A2. The present study will evaluate the extent to which quinine sulfate-related induction of this enzyme effects the pharmacokinetics of theophylline, a sensitive probe drug for the activity of CYP 1A2. It will also evaluate the effect of single-dose theophylline on the pharmacokinetics of steady-state quinine sulfate.

Drug-Drug Interaction Study Between Quinine Sulfate and Rosiglitazone [Completed]
Rosiglitazone is predominantly metabolized by cytochrome P450 (CYP) 2C8. Quinine sulfate is an inhibitor of CYP 2C8. This study will evaluate the effect of multiple doses of quinine sulfate at steady-state on the pharmacokinetics of single-dose rosiglitazone in healthy adult subjects.

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Reports of Suspected Qualaquin (Quinine) Side Effects

OFF Label USE (7)Hypoacusis (2)Hearing Impaired (2)Pruritus (1)Tinnitus (1)Deafness (1)Pruritus Generalised (1)Oedema Peripheral (1)Ecchymosis (1)Nervousness (1)more >>

Page last updated: 2017-09-26

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