Quinine Sulfate 324 mg Capsule, 34,884-count — NDC 0093-3002-99 (Billing 00093-3002-99)
This is a package of 34,884 capsules of Quinine Sulfate 324 mg Capsule from Teva Pharmaceuticals USA, Inc., marketed since Sep 2012 and currently FDA-listed.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 048201
- GCN: 25092
- GPI-14 (Medi-Span): 13000060100119
- HICL (First Databank): 004142
- AHFS class code: 08:30.08.00
- RxCUI (RxNorm): 997010
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Antimalarial class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Quinine sulfate capsules treat uncomplicated malaria caused by Plasmodium falciparum. They are not approved to prevent malaria or for severe malaria. They should never be used for...
- Take it by mouth with food to ease stomach upset. Adults and teens 16 and older usually take it every 8 hours for 7 days. Follow your prescriber's directions and finish the course.
- Most people get some ringing in the ears, headache, nausea, flushing, dizziness or blurred vision. These usually fade after stopping the medicine. Tell your doctor if they are seve...
- Call for unusual bruising or bleeding, fainting or a racing or irregular heartbeat, signs of allergy like swelling or a serious rash, vision or hearing loss, or signs of low blood...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Quinine Sulfate — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00093-3002-56 0093-3002-56 Main listing | 30 CAPSULE in 1 BOTTLE | $0.6980 / ea | $20.94 | 2012-09-28 | — | Active |
| 00093-3002-99 You're viewing this | 34884 CAPSULE in 1 PAIL | — | — | — | — | Active |
You're viewing the largest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 00093-3002-56?
What NDC number is used to bill for this package of Quinine Sulfate 324 mg Capsule?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Quinine Sulfate 324 mg 50742-0238-30 | Ingenus | 30 capsules | $0.698 | AB | Availability likely | — |
| Quinine Sulfate 324 mgthis 00093-3002-99 | Teva | 34884 capsules | — | AB | FDA listed | — |
| Quinine Sulfate 324 mg 65162-0811-03 | Amneal | 30 capsules | — | AB | FDA listed | — |
| Quinine Sulfate 324 mg 68180-0560-01 | Lupin | 100 capsules | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 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 [ see Indications and Usage ( 1 ) and Warnings and Precautions ( 5.1 ) ] .
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 ▾
1 INDICATIONS AND USAGE 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 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 ▾
2 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 )
2.1Treatment of Uncomplicated P. falciparum Malaria For treatment of uncomplicated P. falciparum malaria in adults: Orally, 648 mg (two capsules) every 8 hours for 7 days [ see Clinical Studies ( 14 ) ]. Quinine sulfate capsules should be taken with food to minimize gastric upset [ see Clinical Pharmacology ( 12.3 ) ].
2.2Renal Impairment In patients with acute uncomplicated malaria and severe chronic renal impairment, the following dosage regimen is recommended: one loading dose of 648 mg quinine sulfate capsules, followed 12 hours later by maintenance doses of 324 mg every 12 hours. The effects of mild and moderate renal impairment on the safety and pharmacokinetics of quinine sulfate are not known [ see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 ) ].
2.3Hepatic Impairment Adjustment of the recommended dose is not required in mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, but patients should be monitored closely for adverse effects of quinine. Quinine should not be administered in patients with severe (Child-Pugh C) hepatic impairment [ see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 ) ].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 324 mg capsules – 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. 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 ▾
4 CONTRAINDICATIONS 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) 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) ]. 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 Cautions ▾
5 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 drugs known to prolong QT interval. ( 5.4 ) Avoid concomitant use with rifampin.
Quinine sulfate treatment failures have been reported. ( 5.5 ) Avoid concomitant use with neuromuscular blocking agents. Quinine sulfate may potentiate neuromuscular blockade and cause respiratory depression.
( 5.6 ) Serious and Life-Threatening Hypersensitivity Reactions : Discontinue drug. ( 4 , 5.7 ) Atrial Fibrillation and Flutter: Paradoxical increase in ventricular rate may occur. Closely monitor digoxin levels if used concomitantly.
( 5.8 ) Hypoglycemia : Monitor for signs and symptoms. ( 5.9 )
5.1Use of Quinine Sulfate for Treatment or Prevention of Nocturnal Leg Cramps Quinine sulfate may cause unpredictable serious and life-threatening hematologic reactions including thrombocytopenia and hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP) in addition to hypersensitivity reactions, QT prolongation, serious cardiac arrhythmias including torsades de pointes, and other serious adverse events requiring medical intervention and hospitalization. Chronic renal impairment associated with the development of TTP, and fatalities have also been reported.
The risk associated with the use of quinine sulfate in the absence of evidence of its effectiveness for treatment or prevention of nocturnal leg cramps, outweighs any potential benefit in treating and/or preventing this benign, self-limiting condition [ see Boxed Warning and Contraindications ( 4 ) ].
5.2Thrombocytopenia Quinine-induced thrombocytopenia is an immune-mediated disorder. Severe cases of thrombocytopenia that are fatal or life threatening have been reported, including cases of HUS/TTP. Chronic renal impairment associated with the development of TTP has also been reported.
Thrombocytopenia usually resolves within a week upon discontinuation of quinine. If quinine is not stopped, a patient is at risk for fatal hemorrhage. Upon re-exposure to quinine from any source, a patient with quinine-dependent antibodies could develop thrombocytopenia that is more rapid in onset and more severe than the original episode.
5.3Hemolytic Anemia Acute hemolytic anemia has been reported in patients receiving quinine for treatment of malaria, including patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. The cause for the acute hemolytic anemia in quinine-treated patients with malaria and its potential relationship with G6PD deficiency has not been determined. Closely monitor hemoglobin and hematocrit during quinine treatment.
Quinine should be discontinued if patients develop acute hemolytic anemia.
5.4QT Prolongation and Ventricular Arrhythmias QT interval prolongation has been a consistent finding in studies which evaluated electrocardiographic changes with oral or parenteral quinine administration, regardless of age, clinical status, or severity of disease. The maximum increase in QT interval has been shown to correspond with peak quinine plasma concentration [ see Clinical Pharmacology ( 12.2 ) ]. Quinine sulfate has been rarely associated with potentially fatal cardiac arrhythmias, including torsades de pointes, and ventricular fibrillation.
Quinine sulfate has been shown to cause concentration-dependent prolongation of the PR and QRS interval. At particular risk are patients with underlying structural heart disease and preexisting conduction system abnormalities, elderly patients with sick sinus syndrome, patients with atrial fibrillation with slow ventricular response, patients with myocardial ischemia or patients receiving drugs known to prolong the PR interval (e.g., verapamil) or QRS interval (e.g., flecainide or quinidine) [ see Clinical Pharmacology ( 12.2 ) ].
Quinine… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions are a cluster of symptoms called "cinchonism", 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Overall Quinine can adversely affect almost every body system. The most common adverse events associated with quinine use are a cluster of symptoms called “cinchonism”, 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: fever, chills, sweating, flushing, asthenia, lupus-like syndrome, and hypersensitivity reactions. Hematologic: agranulocytosis, hypoprothrombinemia, thrombocytopenia, disseminated intravascular coagulation, hemolytic anemia; hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, petechiae, ecchymosis, hemorrhage, coagulopathy, blackwater fever, leukopenia, neutropenia, pancytopenia, aplastic anemia, and lupus anticoagulant.
Neuropsychiatric: headache, diplopia, confusion, altered mental status, seizures, coma, disorientation, tremors, restlessness, ataxia, acute dystonic reaction, aphasia, and suicide. Dermatologic: cutaneous rashes, including urticarial, papular, or scarlatinal rashes, pruritus, bullous dermatitis, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, fixed drug eruption, photosensitivity reactions, allergic contact dermatitis, acral necrosis, and cutaneous vasculitis. Respiratory: asthma, dyspnea, pulmonary edema.
Cardiovascular: chest pain, vasodilatation, hypotension, postural hypotension, tachycardia, bradycardia, palpitations, syncope, atrioventricular block, atrial fibrillation, irregular rhythm, unifocal premature ventricular contractions, nodal escape beats, U waves, QT prolongation, ventricular fibrillation, ventricular tachycardia, torsades de pointes, and cardiac arrest. Gastrointestinal: nausea, vomiting, diarrhea, abdominal pain, gastric irritation, and esophagitis. Hepatobiliary: granulomatous hepatitis, hepatitis, jaundice, and abnormal liver function tests.
Metabolic: hypoglycemia and anorexia. Musculoskeletal: myalgias and muscle weakness. Renal: hemoglobinuria, renal failure, renal impairment, and acute interstitial nephritis.
Special Senses: visual disturbances, including blurred vision with scotomata, sudden loss of vision, photophobia, diplopia, night blindness, diminished visual fields, fixed pupillary dilatation, disturbed color vision, optic neuritis, blindness, vertigo, tinnitus, hearing impairment, and deafness.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 1 below presents clinically significant drug interactions with quinine sulfate capsules. Table 1: Clinically Significant Drug Interactions with quinine sulfate capsules Drug(s) Clinical Impact Recommendation Effects of Drugs and Other Substances on Quinine Pharmacokinetics Antacids Antacids containing aluminum and/or magnesium may delay or decrease absorption of quinine. Concomitant administration of these antacids with quinine sulfate capsules should be avoided.
Antiepileptics (AEDs) (carbamazepine, phenobarbital, and phenytoin) Carbamazepine, phenobarbital, and phenytoin are CYP3A4 inducers and may decrease quinine plasma concentrations if used concurrently with quinine sulfate capsules. If concomitant administration with carbamazepine or phenobarbital cannot be avoided, frequent monitoring of anticonvulsant drug concentrations is recommended. Additionally, patients should be monitored closely for adverse reactions associated with these anticonvulsants.
Histamine H2-receptor blockers [cimetidine, ranitidine (nonspecific CYP450 inhibitors)] When quinine is to be given concomitantly with a histamine H2-receptor blocker, the use of ranitidine is preferred over cimetidine. Although cimetidine and ranitidine may be used concomitantly with quinine sulfate capsules [see Clinical Pharmacology ( 12.3 )] . Patients should be monitored closely for adverse events associated with quinine.
Ketoconazole (CYP3A4 inhibitor) No change in the quinine sulfate capsules dosage regimen is necessary with concomitant ketoconazole [see Clinical Pharmacology ( 12.3 )] . Patients should be monitored closely for adverse reactions associated with quinine. Macrolide antibiotics (erythromycin, troleandomycin) (CYP3A4 inhibitors) Increased quinine plasma levels have been observed when used concomitantly [see Clinical Pharmacology ( 12.3 )] .
Concomitant administration of macrolide antibiotics such as erythromycin or troleandomycin with quinine sulfate capsules should be avoided [see Warnings and Precautions ( 5.4 )] . Rifampin (CYP3A4 inducer) Decreased quinine plasma levels have been observed when used concomitantly [see Clinical Pharmacology ( 12.3 )] . Concomitant administration of rifampin with quinine sulfate capsules should be avoided [see Warnings and Precautions ( 5.5 )] .
Ritonavir Increased quinine plasma levels have been observed when used concomitantly [see Clinical Pharmacology ( 12.3 )] . Concomitant administration of ritonavir with quinine sulfate capsules should be avoided. Tetracycline Tetracycline may be concomitantly administered with quinine sulfate capsules [see Clinical Pharmacology ( 12.3 )] .
Patients should be monitored closely for adverse reactions associated with quinine sulfate. Theophylline or aminophylline No change in the quinine sulfate capsules dosage regimen is necessary with concomitant theophylline or aminophylline [see Clinical Pharmacology ( 12.3 )] . Patients should be monitored closely for adverse reactions associated with quinine.
Urinary alkalizers (acetazolamide, sodium bicarbonate) Urinary alkalinizing agents may increase plasma quinine concentrations. Use caution if using concomitantly. Effects of Quinine on the Pharmacokinetics of Other Drugs Anticonvulsants (carbamazepine, phenobarbital, and phenytoin) Carbamazepine, phenobarbital, and phenytoin are CYP3A4 inducers and may decrease quinine plasma concentrations if used concurrently with quinine sulfate capsules [see Clinical Pharmacology ( 12.3 )] .
If concomitant administration with carbamazepine or phenobarbital cannot be avoided, frequent monitoring of anticonvulsant drug concentrations is recommended. Patients should be monitored closely for adverse reactions associated with these anticonvulsants. Astemizole (CYP3A4 substrate) Elevated plasma astemizole concentrations were reported in a subject who experienced torsades de pointes after receiving three doses of quinine sulfate for nocturnal leg cramps concomitantly with chronic aste… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Renal Impairment: Reduce dose and dosing frequency for patients with severe chronic renal impairment. ( 2.2 , 8.6 , 12.3 ) Hepatic Impairment: Closely monitor for adverse reactions. Quinine should not be administered in patients with severe (Child-Pugh C) hepatic impairment. ( 2.3 , 8.7 , 12.3 )
8.1Pregnancy 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 trimester 1 . 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 hemoglobinuria 2 . 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 drugs 3 . 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 i… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy 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 trimester 1 . 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 hemoglobinuria 2 . 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 drugs 3 . 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… [Excerpted — this section continues on DailyMed.]
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of quinine sulfate in pediatric patients under the age of 16 has not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use 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.
🆘 Overdosage ▾
10 OVERDOSAGE 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. Quinine’s 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 [ see Warnings and Precautions ( 5 ) and Clinical Pharmacology ( 12.3 ) ].
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 [ see Clinical Pharmacology ( 12.3 ) ]. 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Quinine is an antimalarial agent [ see Microbiology ( 12.4 ) ].
12.2Pharmacodynamics QT c interval prolongation was studied in a double-blind, multiple dose, placebo- and positive-controlled crossover study in young (N=13, 20 to 39 years) and elderly (N=13, 65 to 78 years) subjects. After 7 days of dosing with quinine sulfate 648 mg three times daily, the maximum mean (95% upper confidence bound) differences in QTcI from placebo after baseline correction was 27.7 (32.2) ms. Prolongation of the PR and QRS interval was also noted in subjects receiving quinine sulfate.
The maximum mean (95% upper confidence bound) difference in PR from placebo after baseline-correction was 14.5 (18.0) ms. The maximum mean (95% upper confidence bound) difference in QRS from placebo after baseline-correction was 11.5 (13.3) ms. [ see Warnings and Precautions ( 5.4 ) ].
12.3Pharmacokinetics Absorption The oral bioavailability of quinine is 76 to 88% in healthy adults. Quinine exposure is higher in patients with malaria than in healthy subjects. After a single oral dose of quinine sulfate, the mean quinine T max was longer, and mean AUC and C max were higher in patients with uncomplicated P. falciparum malaria than in healthy subjects, as shown in Table 2 below.
Table 2: Pharmacokinetic Parameters of Quinine in Healthy Subjects and Patients with Uncomplicated P. falciparum Malaria after a Single Dose a of Oral Quinine Sulfate Capsules Healthy Subjects (N=23) Mean ± SD Uncomplicated P. falciparum Malaria Patients (N=15) Mean ± SD Dose (mg/kg) a 8.7 10 T max (h) 2.8 ± 0.8 5.9 ±
4.7C max (mcg/mL) 3.2 ± 0.7
8.4AUC 0-12 (mcg * h/mL) 28.0 73.0 a Quinine sulfate dose was 648 mg (approximately 8.7 mg/kg) in healthy subjects; and 10 mg/kg in patients with malaria Quinine sulfate capsules may be administered without regard to meals. When a single oral 324 mg capsule of quinine sulfate was administered to healthy subjects (N=26) with a standardized high-fat breakfast, the mean T max of quinine was prolonged to about 4.0 hours, but the mean C max and AUC 0-24h were similar to those achieved when quinine sulfate capsule was given under fasted conditions [ see Dosage and Administration ( 2.1 ) ].
Distribution In patients with malaria, the volume of distribution (Vd/F) decreases in proportion to the severity of the infection. In published studies with healthy subjects who received a single oral 600 mg dose of quinine sulfate, the mean Vd/F ranged from 2.5 to
7.1L/kg. Quinine is moderately protein-bound in blood in healthy subjects, ranging from 69 to 92%. During active malarial infection, protein binding of quinine is increased to 78 to 95%, corresponding to the increase in α 1 -acid glycoprotein that occurs with malaria infection.
Intra-erythrocytic levels of quinine are approximately 30 to 50% of the plasma concentration. Quinine penetrates relatively poorly into the cerebrospinal fluid (CSF) in patients with cerebral malaria, with CSF concentration approximately 2 to 7% of plasma concentration. In one study, quinine concentrations in placental cord blood and breast milk were approximately 32% and 31%, respectively, of quinine concentrations in maternal plasma.
The estimated total dose of quinine secreted into breast milk was less than 2 to 3 mg per day [ see Use in Specific Populations ( 8.1 , 8.2 ) ]. Elimination Metabolism Quinine is metabolized almost exclusively via hepatic oxidative cytochrome P450 (CYP) pathways, resulting in four primary metabolites, 3-hydroxyquinine, 2´-quinone, O -desmethylquinine, and 10,11-dihydroxydihydroquinine. Six secondary metabolites result from further biotransformation of the primary metabolites.
The major metabolite, 3-hydroxyquinine, is less active than the parent drug. In vitro studies using human liver microsomes and recombinant P450 enzymes have shown that quinine is metabolized mainly by CYP3A4. Depending on the in vitro experimental conditions, other enzymes, includ… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Quinine is an antimalarial agent [ see Microbiology ( 12.4 ) ].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 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.
📋 Description ▾
11 DESCRIPTION Quinine sulfate, USP is a cinchona alkaloid chemically described as bis[( R )-(6-methoxyquinolin-4-yl)-[2 S ,4 S ,5 R )-5-ethenyl-1-azabicyclo[2.2.2]oct-2-yl]methanol] sulfate. The structural formula of quinine sulfate, USP is: C 40 H 50 N 4 O 8 S•2H 2 O M.W. 783.0 Quinine sulfate, USP occurs as a white or almost white, crystalline powder that darkens on exposure to light.
It is odorless and has a persistent very bitter taste. It is slightly soluble in water, sparingly soluble in boiling water and in alcohol, and practically insoluble in ether. Quinine Sulfate Capsules USP are supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate, USP equivalent to 269 mg free base.
Inactive ingredients: colloidal silicon dioxide, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, and titanium dioxide. The imprinting ink may contain potassium hydroxide. FDA approved dissolution test specifications differ from USP. quinine sulfate structural formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide) Important Administration Instructions Instruct patients to: Take all of the medication as directed. Take no more of the medication than the amount prescribed. Take with food to minimize possible gastrointestinal irritation.
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. Brands listed are the trademarks of their respective owners.
Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In Canada By: Teva Canada Limited Toronto, Canada M1B 2K9 Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. I 1/2023
💬 Medication Guide ▾
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 night-time leg cramps 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: changes in the electrical activity of your heart called QT prolongation. had allergic reactions to quinine (the active ingredient in quinine sulfate capsules), such as low platelets, which are necessary for your blood to clot. had allergic reactions to mefloquine (Lariam) or quinidine. an autoimmune disease (myasthenia gravis) that leads to muscle weakness. an inflammation of the nerve important for vision (optic neuritis). 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: have heart problems. have kidney problems. have liver problems. are pregnant or plan to become pregnant. Treatment of malaria is important because it can be a serious disease for a pregnant woman and her unborn baby. Talk to your healthcare provider about the benefits and risks of taking quinine sulfate capsules during pregnancy.
Low blood sugar (hypoglycemia) can happen in pregnant women while taking quinine sulfate capsules. Signs and symptoms of low blood sugar can include sweating, weakness, nausea, vomiting, and confusion. You and your healthcare provider can decide if quinine sulfate capsules are right for you. are breastfeeding or plan to breastfeed.
Quinine sulfate can pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while taking quinine sulfate capsules. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Quinine sulfate capsules and other medicines may affect each other causing serious side effects. Certain medicines can cause the blood levels of quinine sulfate capsules to be too high or too low in your body. Do not start taking a new medicine with… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
8.3Females and Males of Reproductive Potential Infertility In a published study 5 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 capsules may impair fertility [see Nonclinical Toxicology ( 13.1 )] .
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption The oral bioavailability of quinine is 76 to 88% in healthy adults. Quinine exposure is higher in patients with malaria than in healthy subjects. After a single oral dose of quinine sulfate, the mean quinine T max was longer, and mean AUC and C max were higher in patients with uncomplicated P. falciparum malaria than in healthy subjects, as shown in Table 2 below.
Table 2: Pharmacokinetic Parameters of Quinine in Healthy Subjects and Patients with Uncomplicated P. falciparum Malaria after a Single Dose a of Oral Quinine Sulfate Capsules Healthy Subjects (N=23) Mean ± SD Uncomplicated P. falciparum Malaria Patients (N=15) Mean ± SD Dose (mg/kg) a 8.7 10 T max (h) 2.8 ± 0.8 5.9 ±
4.7C max (mcg/mL) 3.2 ± 0.7
8.4AUC 0-12 (mcg * h/mL) 28.0 73.0 a Quinine sulfate dose was 648 mg (approximately 8.7 mg/kg) in healthy subjects; and 10 mg/kg in patients with malaria Quinine sulfate capsules may be administered without regard to meals. When a single oral 324 mg capsule of quinine sulfate was administered to healthy subjects (N=26) with a standardized high-fat breakfast, the mean T max of quinine was prolonged to about 4.0 hours, but the mean C max and AUC 0-24h were similar to those achieved when quinine sulfate capsule was given under fasted conditions [ see Dosage and Administration ( 2.1 ) ].
Distribution In patients with malaria, the volume of distribution (Vd/F) decreases in proportion to the severity of the infection. In published studies with healthy subjects who received a single oral 600 mg dose of quinine sulfate, the mean Vd/F ranged from 2.5 to
7.1L/kg. Quinine is moderately protein-bound in blood in healthy subjects, ranging from 69 to 92%. During active malarial infection, protein binding of quinine is increased to 78 to 95%, corresponding to the increase in α 1 -acid glycoprotein that occurs with malaria infection.
Intra-erythrocytic levels of quinine are approximately 30 to 50% of the plasma concentration. Quinine penetrates relatively poorly into the cerebrospinal fluid (CSF) in patients with cerebral malaria, with CSF concentration approximately 2 to 7% of plasma concentration. In one study, quinine concentrations in placental cord blood and breast milk were approximately 32% and 31%, respectively, of quinine concentrations in maternal plasma.
The estimated total dose of quinine secreted into breast milk was less than 2 to 3 mg per day [ see Use in Specific Populations ( 8.1 , 8.2 ) ]. Elimination Metabolism Quinine is metabolized almost exclusively via hepatic oxidative cytochrome P450 (CYP) pathways, resulting in four primary metabolites, 3-hydroxyquinine, 2´-quinone, O -desmethylquinine, and 10,11-dihydroxydihydroquinine. Six secondary metabolites result from further biotransformation of the primary metabolites.
The major metabolite, 3-hydroxyquinine, is less active than the parent drug. In vitro studies using human liver microsomes and recombinant P450 enzymes have shown that quinine is metabolized mainly by CYP3A4. Depending on the in vitro experimental conditions, other enzymes, including CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1 were shown to have some role in the metabolism of quinine.
Excretion Quinine is eliminated primarily via hepatic biotransformation. Approximately 20% of quinine is excreted unchanged in urine. Because quinine is reabsorbed when the urine is alkaline, renal excretion of the drug is twice as rapid when the urine is acidic than when it is alkaline.
In various published studies, healthy subjects who received a single oral 600 mg dose of quinine sulfate exhibited a mean plasma clearance ranging from 0.08 to
0.47 L/h/kg (median value:
0.17L/h/kg) with a mean plasma elimination half-life of 9.7 to 12.5 hours. In 15 patients with uncomplicated malaria who received a 10 mg/kg oral dose of quinine sulfate, the mean total clearance of quinine was slower (approximately
0.09 L/h/kg) during the acute phase of the infection, and faster (approximately
0.16L… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics QT c interval prolongation was studied in a double-blind, multiple dose, placebo- and positive-controlled crossover study in young (N=13, 20 to 39 years) and elderly (N=13, 65 to 78 years) subjects. After 7 days of dosing with quinine sulfate 648 mg three times daily, the maximum mean (95% upper confidence bound) differences in QTcI from placebo after baseline correction was 27.7 (32.2) ms. Prolongation of the PR and QRS interval was also noted in subjects receiving quinine sulfate.
The maximum mean (95% upper confidence bound) difference in PR from placebo after baseline-correction was 14.5 (18.0) ms. The maximum mean (95% upper confidence bound) difference in QRS from placebo after baseline-correction was 11.5 (13.3) ms. [ see Warnings and Precautions ( 5.4 ) ].
🔬 Clinical Studies ▾
14 CLINICAL STUDIES 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 P. falciparum 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: In areas where multi-drug resistance of P. falciparum is increasing, such as Southeast Asia, cure rates with 7 days of oral quinine monotherapy were at least 80%; while cure rates for 7 days of oral quinine combined with an antimicrobial agent (tetracycline or clindamycin) were greater than 90%. In areas where multi-drug resistance of the parasite was not as widespread, cure rates with 7 days of quinine monotherapy ranged from 86 to 100%. Cure was defined as initial clearing of parasitemia within 7 days without recrudescence by day 28 after treatment initiation.
P. falciparum malaria that is clinically resistant to quinine has been reported in some areas of South America, Southeast Asia, and Bangladesh, and quinine may not be as effective in those areas. 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 P. falciparum malaria is limited, and these shorter course combination regimens may not be as effective as the longer regimens.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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 Drosophila , the in vivo 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).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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 Drosophila , the in vivo 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).
📚 References ▾
15 REFERENCES Looareesuwan S et al (1985). Quinine and severe falciparum malaria in late pregnancy. Lancet.
2(8445):4-8. Kovacs SD et al (2015). Treating severe malaria in pregnancy: a review of the evidence.
Drug Saf. 38(2):165-81. Clark RL (2017).
Animal embryotoxicity studies of key non-artemisinin antimalarials and use in women in the first trimester. Birth Defects Res. 109(14):1075-1126.
Tanimura T (1972). The use of non-human primates in research on human reproduction. WHO research and Training Centre on Human Reproduction.
Karolinska Institutet (Symposium), Stockholm, 293-308. Ejebe DE et al. (2008).
Effects of anti-malarial alkaloids on the sperm properties and blood levels of reproductive hormones of adult men. Afr J Biotech. 7: 3395-3400.
📄 Package Label / Principal Display Panel ▾
Package/Label Display Panel NDC 0093-3002-56 Quinine Sulfate Capsules, USP 324 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 30 Capsules 30s
Medicaid utilization by pack size
Medicare Part D spend CMS · PART D · 2026 (Q1)
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |