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Quinine (Quinine Sulfate)

Trade Name : Quinine Sulfate

Amneal Pharmaceuticals LLC

CAPSULE

Strength 324 mg/1

QUININE SULFATE Antimalarial [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Quinine (Quinine Sulfate) which is also known as Quinine Sulfate and Manufactured by Amneal Pharmaceuticals LLC. It is available in strength of 324 mg/1 per ml. Read more

Quinine (Quinine Sulfate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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 and.
  • 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. (, )
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  • Contraindications, Glucose-6-phosphate dehydrogenase (G6PD) deficiency (4)u00a0 Removedu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0 6/2019n
  • Warnings and Precautions, Hemolytic Anemiau00a0 (5.3)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0u00a0 6/2019
  • Quinine sulfate is an antimalarial drug indicated only for treatment of uncomplicated malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented .
  • Limitations of Use:
  • Quinine sulfate capsules are not approved for:
  • Quinine sulfate is an antimalarial indicated for treatment of uncomplicated malaria. n
  • Limitations of Use:
  • Quinine sulfate capsules are not approved for:
  • Treatment of severe or complicated malaria.
  • Prevention of malaria.
  • Treatment or prevention of nocturnal leg cramps
  • No data
  • Adults (u2265 16 years of age): 648 mg (two capsules) every 8 hours for 7 days. n
  • 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. n
  • Quinine Sulfate Capsules USP, are supplied as clear transparent size u20180u2019 hard gelatin capsule filled with white to off-white powder and imprinting u2018AMNEALu2019 on the cap and u2018811u2019 on the body.
  • Capsules: 324 mg. n n
  • Quinine sulfate capsules are contraindicated in patients with the following:
  • Quinine sulfate capsules are contraindicated in patients with the following:
  • Prolongation of QT interval. n
  • Myasthenia gravis. n
  • Known hypersensitivity to quinine, mefloquine, or quinidine. n
  • Optic neuritis. n
  • No data
  • Thrombocytopenia, including ITP and HUS/TTP, has been reported. Discontinue drug. n n
  • Hemolytic Anemia:
  • QT Prolongation and Ventricular Arrhythmias:
  • Avoid concomitant use with rifampin. Quinine sulfate treatment failures have been reported. n n
  • Avoid concomitant use with neuromuscular blocking agents. Quinine sulfate may potentiate neuromuscular blockade and cause respiratory depression. n n
  • Serious and Life-Threatening Hypersensitivity Reactions:
  • Atrial Fibrillation and Flutter:
  • Hypoglycemia:
  • Quinine can adversely affect almost every body system. The most common adverse events associated with quinine use are a cluster of symptoms called u201ccinchonismu201d, which occurs to some degree in almost all patients taking quinine.
  • Symptoms of mild cinchonism include headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, and disturbance in color perception. More severe symptoms of cinchonism are vomiting, diarrhea, abdominal pain, deafness, blindness, and disturbances in cardiac rhythm or conduction. Most symptoms of cinchonism are reversible and resolve with discontinuation of quinine.
  • The following adverse reactions have been reported with quinine sulfate. Because these reactions have been reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • General:
  • Hematologic:
  • Neuropsychiatric:
  • Dermatologic:
  • Respiratory:
  • Cardiovascular:
  • Gastrointestinal:
  • Hepatobiliary:
  • Metabolic:
  • Musculoskeletal:
  • Renal:
  • Special Senses:
  • Most common adverse reactions are a cluster of symptoms called u201ccinchonismu201d, which occurs to some degree in almost all patients taking quinine: headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, disturbance in color perception, vomiting, diarrhea, abdominal pain, deafness, blindness, and disturbances in cardiac rhythm or conduction. n n
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Table 1 below presents clinically significant drug interactions with quinine sulfate.
  • Table 1: Clinically Significant Drug Interactions with Quinine Sulfate
  • See full prescribing information for a complete list of reported and potential interactions.
  • No data
  • Renal Impairment:
  • Hepatic Impairment:
  • Quinine overdose can be associated with serious complications, including visual impairment, hypoglycemia, cardiac arrhythmias, and death. Visual impairment can range from blurred vision and defective color perception, to visual field constriction and permanent blindness. Cinchonism occurs in virtually all patients with quinine overdose. Symptoms range from headache, nausea, vomiting, abdominal pain, diarrhea, tinnitus, vertigo, hearing impairment, sweating, flushing, and blurred vision, to deafness, blindness, serious cardiac arrhythmias, hypotension, and circulatory collapse. Central nervous system toxicity (drowsiness, disturbances of consciousness, ataxia, convulsions, respiratory depression, and coma) has also been reported with quinine overdose, as well as pulmonary edema and adult respiratory distress syndrome.
  • Most toxic reactions are dose-related; however, some reactions may be idiosyncratic because of the variable sensitivity of patients to the toxic effects of quinine. A lethal dose of quinine has not been clearly defined, but fatalities have been reported after the ingestion of 2 to 8 grams in adults.
  • Quinine, like quinidine, has Class I antiarrhythmic properties. The cardiotoxicity of quinine is due to its negative inotropic action, and to its effect on cardiac conduction, resulting in decreased rates of depolarization and conduction, and increased action potential and effective refractory period. ECG changes observed with quinine overdose include sinus tachycardia, PR prolongation, T wave inversion, bundle branch block, an increased QT interval, and a widening of the QRS complex. Quinineu2019s alpha-blocking properties may result in hypotension and further exacerbate myocardial depression by decreasing coronary perfusion. Quinine overdose has been also associated with hypotension, cardiogenic shock, and circulatory collapse, ventricular arrhythmias, including ventricular tachycardia, ventricular fibrillation, idioventricular rhythm, and torsades de pointes, as well as bradycardia, and atrioventricular block and.
  • Quinine is rapidly absorbed, and attempts to remove residual quinine sulfate from the stomach by gastric lavage may not be effective. Multiple-dose activated charcoal has been shown to decrease plasma quinine concentrations .
  • Forced acid diuresis, hemodialysis, charcoal column hemoperfusion, and plasma exchange were not found to be effective in significantly increasing quinine elimination in a series of 16 patients.
  • Quinine sulfate is a cinchona alkaloid chemically described as cinchonan-9-ol, 6u2019-methoxy-, (8u03b1, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (CHNO)2u2022HSOu20222HO and a molecular weight of 782.96.
  • The structural formula of quinine sulfate is:
  • Quinine sulfate, USP occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, sparingly soluble in boiling water and in alcohol, practically insoluble in ether.
  • u00a0Quinine sulfate capsules, USP are supplied for oral administration containing 324 mg of the active ingredient, quinine sulfate, USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, povidone and silicon dioxide. The capsules also use a monogramming ink which contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.
  • No data
  • Carcinogenesis
  • Carcinogenicity studies of quinine have not been conducted.
  • Mutagenesis
  • Genotoxicity studies of quinine were positive in the Ames bacterial mutation assay with metabolic activation and in the sister chromatid exchange assay in mice. The sex-linked recessive lethal test performed in , the mouse micronucleus assay, and the chromosomal aberration assay in mice and Chinese hamsters were negative.
  • Impairment of Fertility
  • In published studies, quinine produced testicular toxicity in mice at a single intraperitoneal dose of 300 mg/kg corresponding to a dose of approximately 0.75 times the maximum recommended human dose (MRHD; 32 mg/kg/day) and in rats at an intramuscular dose of 10 mg/kg/day, 5 days/week, for 8 weeks corresponding to a daily dose of approximately 0.05 times the MRHD based on body surface area (BSA) comparisons. The findings include atrophy or degeneration of the seminiferous tubules, decreased sperm count and motility, and decreased testosterone levels in the serum and testes. There were no changes in testes weight or testicular histopathology in studies of oral doses of up to 500 mg/kg/day in mice and 700 mg/kg/day in rats (approximately 1.2 and 3.5 times the MRHD respectively based on BSA comparisons).
  • Quinine has been used worldwide for hundreds of years in the treatment of malaria. Thorough searches of the published literature identified over 1300 references to the treatment of malaria with quinine, and from these, 21 randomized, active-controlled studies were identified which evaluated oral quinine monotherapy or combination therapy for treatment of uncomplicated malaria. Over 2900 patients from malaria-endemic areas were enrolled in these studies, and more than 1400 patients received oral quinine.
  • The following conclusions were drawn from review of these studies:
  • Completion of a 7-day oral quinine treatment regimen may be limited by drug intolerance, and shorter courses (3 days) of quinine combination therapy have been used. However, the published data from randomized, controlled clinical trials for shorter regimens of oral quinine in conjunction with tetracycline, doxycycline, or clindamycin for treatment of uncomplicated malaria is limited, and these shorter course combination regimens may not be as effective as the longer regimens.
  • No data
  • How Supplied
  • Quinine Sulfate Capsules USP, are clear transparent size u20180u2019 hard gelatin capsules filled with white to off-white powder and imprinting u2018AMNEALu2019 on the cap and u2018811u2019 on the body.
  • They are available as follows:
  • Bottles of 30:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 65162-811-03
  • Bottles of 90:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 65162-811-09
  • Bottles of 500: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 65162-811-50
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Dispense in a tight container as defined in the USP.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide)
  • Important Administration Instructions
  • Instruct patients to:
  • Missed Doses
  • Advise patients that if a dose is missed, patients should not double the next dose. If more than 4 hours has elapsed since the missed dose, the patient should wait and take the next dose as previously scheduled.
  • Manufactured by:n Ahmedabad 382220, INDIA
  • Distributed by:n Bridgewater, NJ 08807
  • Rev. 08-2019-02
  • Quinine Sulfate (kwyeu2019 nine sulu2019 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.u00a0
  • What is the most important information I should know about quinine sulfate capsules?
  • Quinine sulfaten- capsules used to treat or prevent leg cramps may cause serious side effects or even death.
  • Quinine sulfate capsules may cause
  • Call your healthcare provider right away if you have:
  • Quinine sulfate capsules can have other serious side effects. See u201cn u201d
  • What are quinine sulfate capsules?
  • Quinine sulfate capsules are a prescription medicine used to treat uncomplicated malaria caused by the parasite .
  • 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 capsules if you have:
  • What should I tell my healthcare provider before taking quinine sulfate capsules?
  • Before taking quinine sulfate capsules, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
  • Do not start taking a new medicine without telling your healthcare provider or pharmacist.
  • How should I take quinine sulfate capsules?
  • What are the possible side effects of quinine sulfate capsules?
  • Quinine sulfate capsules may cause serious side effects, including:
  • The most common side effects of quinine sulfate capsules include:
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of quinine sulfate capsules. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store quinine sulfate capsules?
  • Keep quinine sulfate capsules and all medicines out of the reach of children.
  • General information about the safe and effective use of quinine sulfate capsules.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use quinine sulfate capsules for a condition for which it was not prescribed. Do not give quinine sulfate capsules to other people, even if they have the same symptoms that you have. It may harm them.
  • This Medication Guide summarizes the most important information about quinine sulfate capsules. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about quinine sulfate capsules that is written for health professionals.
  • What are the ingredients in quinine sulfate capsules?
  • Active Ingredients:
  • Inactive Ingredients:
  • All trademarks are property of their respective owners.
  • For more information, go to www.amneal.com or call Amneal Pharmaceuticals at 1-877-835-5472.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:n Ahmedabad 382220, INDIA
  • Distributed by:n Bridgewater, NJ 08807
  • Rev. 08-2019-02
  • No data

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