Quinine Capsules is used to treat malaria, a disease caused by parasites. Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.
Quinine Capsules will not treat severe forms of malaria, and it should not be taken to prevent malaria. Quinine Capsules also should not be taken to treat or prevent night-time leg cramps.
Using this medication improperly or without the advice of a doctor can result in serious side effects or death. Quinine Capsules is approved for use only in treating malaria. Some people have used Quinine Capsules to treat leg cramps, but this is not an FDA-approved use.
The U.S. Food and Drug Administration has banned the sale of all non-approved brands of Quinine Capsules. As of December 2006, Quinine Capsules is the only brand of Quinine Capsules that is approved by the FDA.
Quinine Capsules may also be used for purposes not listed in this medication guide.
Quinine Capsules indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Oral
Malaria
Adult: As sulfate: 648 mg 8 hrly for 7 days.
Child: As sulfate: ≥8 yr10 mg/kg 8 hrly for 7 days.
Renal impairment: Severe: Initially, 648 mg followed after 12 hr by maintenance doses of 324 mg 12 hrly.
Hepatic impairment: Mild to moderate (Child-Pugh class A and B): No dosage adjustment needed.
Reconstitution: Dilute in NaCl 0.9% to a concentration of diHCl 60-100 mg/mL.
Intravenous
Malaria
Adult: As diHCl: Initially, 20 mg/kg to max 1.4 g over 4 hr w/ maintenance infusion started after 8 hr. Maintenance infusions: 10 mg/kg to max 700 mg over 4 hr 8 hrly. Loading dose should not be given if patient received Quinine Capsules, quinidine, halofantrine or mefloquine during the previous 12 hr.
Child: ≤5 mg/kg/hr by slow IV infusion.
Renal impairment: Severe: Reduce maintenance dose to 5-7 mg/kg of Quinine Capsules salt 8 hrly.
Hepatic impairment: Mild to moderate (Child-Pugh class A and B): No dosage adjustment needed. Severe: Reduce maintenance dose to 5-7 mg/kg of Quinine Capsules salt 8 hrly.
Reconstitution: Dilute in NaCl 0.9% to a concentration of diHCl 60-100 mg/mL.
How should I use Quinine Capsules?
Use Quinine Capsules capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Quinine Capsules capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Do not take an antacid that has aluminum in it within 1 hour before or 2 hours after you take Quinine Capsules capsules.
Do not eat grapefruit or drink grapefruit juice while you use Quinine Capsules capsules.
Continue taking Quinine Capsules capsules for the full course of treatment even if you feel better in a few days.
Do not miss any doses. If you miss a dose of Quinine Capsules capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Quinine Capsules capsules.
Uses of Quinine Capsules in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Malaria, uncomplicated, due to Plasmodium falciparum (treatment): Treatment of uncomplicated chloroquine-resistant P. falciparum malaria, in combination with other antimalarial agents
Off Label Uses
Babesiosis
Clinical experience suggests the utility of Quinine Capsules (in combination with clindamycin) for the treatment of Babesia microti infection.
Based on the Infectious Diseases Society of America (IDSA) guidelines for the Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis, Quinine Capsules (in combination with clindamycin) is an effective and recommended initial therapy in the treatment of babesiosis.
Malaria, uncomplicated, due to Plasmodium vivax (treatment)
Based on the Centers for Disease Control and Prevention (CDC) Guidelines for Treatment of Malaria in the United States, Quinine Capsules (in combination with other antimalarial agents) is effective and recommended in the treatment of uncomplicated chloroquine-resistant P. vivax malaria.
Quinine Capsules description
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An alkaloid derived from the bark of the cinchona tree. It is used as an antimalarial drug, and is the active ingredient in extracts of the cinchona that have been used for that purpose since before 1633. Coco-Quinine Capsules is also a mild antipyretic and analgesic and has been used in common cold preparations for that purpose. It was used commonly and as a bitter and flavoring agent, and is still useful for the treatment of babesiosis. Coco-Quinine Capsules is also useful in some muscular disorders, especially nocturnal leg cramps and myotonia congenita, because of its direct effects on muscle membrane and sodium channels. The mechanisms of its antimalarial effects are not well understood.
Quinine Capsules dosage
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule,
Oral, as sulfate:
Quinine Capsules: 324 mg
Generic: 324 mg
Dosing: Adult
Note: Dosage expressed in terms of the salt; 1 capsule Quinine Capsules = 324 mg of Quinine Capsules sulfate = 269 mg of base; Canadian products contain 200 mg of Quinine Capsules sulfate = 167 mg of base or 300 mg of Quinine Capsules sulfate = 250 mg of base.
Malaria, uncomplicated, due to chloroquine-resistant P. falciparum (treatment):
Oral:
CDC guidelines: 648 mg every 8 hours, in combination with doxycycline, tetracycline, or clindamycin (preferred in pregnancy). Note: Administer Quinine Capsules for 3 days unless the infection was acquired in Southeast Asia, in which case Quinine Capsules duration of therapy is 7 days. Duration of concomitant agent is 7 days, regardless of geographic region (CDC 2013).
Canadian product: 600 mg every 8 hours for 3 to 7 days. Note: Use in combination with tetracycline, doxycycline, or clindamycin.
Malaria, uncomplicated, due to chloroquine-resistant P. vivax (treatment) (off-label use):
Oral: 648 mg every 8 hours, in combination with doxycycline or tetracycline plus primaquine. Note: Quinine Capsules in combination with clindamycin is an alternative regimen for pregnant patients. Administer Quinine Capsules for 3 days unless the infection was acquired in Southeast Asia, in which case Quinine Capsules duration of therapy is 7 days. Duration of concomitant agent is 7 days (doxycycline, tetracycline, clindamycin) or 14 days (primaquine), regardless of geographic region (CDC 2013).
Babesiosis (off-label use):
Oral: 650 mg every 6 to 8 hours for at least 7 to 10 days with clindamycin (Vannier 2012; Wormser 2006). Relapsing infection may require at least 6 weeks of therapy (Vannier 2012). Note: US manufactured Quinine Capsules sulfate capsule is 324 mg; 2 capsules (648 mg Quinine Capsules sulfate) should be sufficient for adult dosing.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Note: Dosage expressed in terms of the Quinine Capsules sulfate salt; 324 mg capsule Quinine Capsules sulfate = 269 mg of base. Canadian products: 200 mg capsule of Quinine Capsules sulfate = 167 mg of base or 300 mg capsule of Quinine Capsules sulfate = 250 mg of base.
Malaria: Children and Adolescents; regardless of HIV status (HHS [OI pediatric 2013]): Limited data available in ages <16 years: Note: Duration of Quinine Capsules treatment for malaria dependent upon the geographic region or pathogen. Lack of an appropriate Quinine Capsules dosage form may restrict use in some smaller patients.
P. falciparum (chloroquine resistant), uncomplicated; treatment:
Oral: 10 mg/kg/dose Quinine Capsules sulfate every 8 hours for 3 to 7 days depending on region; maximum dose: 650 mg/dose; use in combination with tetracycline, doxycycline, or clindamycin (dependent upon patient age) (CDC 2013)
P. vivax (chloroquine resistant), uncomplicated; treatment:
Oral: 10 mg/kg/dose Quinine Capsules sulfate every 8 hours for 3 to 7 days depending on region; maximum dose: 650 mg/dose; use in combination with primaquine and tetracycline or doxycycline (dependent upon patient age) (CDC 2013)
Severe malaria:
Oral Quinine Capsules, using the regimens previously described (dose and duration), may be used following IV quinidine including antimicrobial regimen once parasite density is <1% and patient is able to tolerate oral medications (CDC 2013)
Babesiosis: Limited data available: Children and Adolescents:
Oral: 10 mg/kg/dose Quinine Capsules sulfate every 8 hours for 7 to 10 days; maximum dose: 650 mg/dose (Red Book [AAP 2015]; Wittner 1982); use in combination with clindamycin as a first-line treatment option (IDSA [Wormser 2006])
Effects Of Drugs And Other Substances On Quinine Capsules Pharmacokinetics
Quinine Capsules is a P-gp substrate and is primarily metabolized by CYP3A4. Other enzymes, including CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1 may contribute to the metabolism of Quinine Capsules.
Antacids
Antacids containing aluminum and/or magnesium may delay or decrease absorption of Quinine Capsules. Concomitant administration of these antacids with Quinine Capsules should be avoided.
Antiepileptics (AEDs) (carbamazepine, phenobarbital, and phenytoin)
Carbamazepine, phenobarbital, and phenytoin are CYP3A4 inducers and may decrease Quinine Capsules plasma concentrations if used concurrently with Quinine Capsules.
Cholestyramine
In 8 healthy subjects who received Quinine Capsules sulfate 600 mg with or without 8 grams of cholestyramine resin, no significant difference in Quinine Capsules pharmacokinetic parameters was seen.
Cigarette Smoking (CYP1A2 inducer)
In healthy male heavy smokers, the mean Quinine Capsules AUC following a single 600 mg dose was 44% lower, the mean Cmax was 18% lower, and the elimination half-life was shorter (7.5 hours versus 12 hours) than in their non-smoking counterparts. However, in malaria patients who received the full 7-day course of Quinine Capsules therapy, cigarette smoking produced only a 25% decrease in median Quinine Capsules AUC and a 16.5% decrease in median Cmax, suggesting that the already reduced clearance of Quinine Capsules in acute malaria could have diminished the metabolic induction effect of smoking. Because smoking did not appear to influence the therapeutic outcome in malaria patients, it is not necessary to increase the dose of Quinine Capsules in the treatment of acute malaria in heavy cigarette smokers.
Grapefruit juice (P-gp/CYP3A4 inhibitor)
In a pharmacokinetic study involving 10 healthy subjects, the administration of a single 600 mg dose of Quinine Capsules sulfate with grapefruit juice (full-strength or half-strength) did not significantly alter the pharmacokinetic parameters of Quinine Capsules. Quinine Capsules may be taken with grapefruit juice.
In healthy subjects who were given a single oral 600 mg dose of Quinine Capsules sulfate after pretreatment with cimetidine (200 mg three times daily and 400 mg at bedtime for 7 days) or ranitidine (150 mg twice daily for 7 days), the apparent oral clearance of Quinine Capsules decreased and the mean elimination half-life increased significantly when given with cimetidine but not with ranitidine. Compared to untreated controls, the mean AUC of Quinine Capsules increased by 20% with ranitidine and by 42% with cimetidine (p < 0.05) without a significant change in mean Quinine Capsules Cmax. When Quinine Capsules 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 Capsules, patients should be monitored closely for adverse events associated with Quinine Capsules.
Isoniazid
Isoniazid 300 mg/day pretreatment for 1 week did not significantly alter the pharmacokinetic parameter values of Quinine Capsules. Adjustment of Quinine Capsules dosage is not necessary when isoniazid is given concomitantly.
Ketoconazole (CYP3A4 inhibitor)
In a crossover study, healthy subjects (N=9) who received a single oral dose of Quinine Capsules hydrochloride (500 mg) concomitantly with ketoconazole (100 mg twice daily for 3 days) had a mean Quinine Capsules AUC that was higher by 45% and a mean oral clearance of Quinine Capsules that was 31% lower than after receiving Quinine Capsules alone. Although no change in the Quinine Capsules dosage regimen is necessary with concomitant ketoconazole, patients should be monitored closely for adverse reactions associated with Quinine Capsules.
In a crossover study (N=10), healthy subjects who received a single oral 600 mg dose of Quinine Capsules sulfate with the macrolide antibiotic, troleandomycin (500 mg every 8 hours) exhibited a 87% higher mean Quinine Capsules AUC, a 45% lower mean oral clearance of Quinine Capsules, and a 81% lower formation clearance of the main metabolite, 3-hydroxyquinine, than when Quinine Capsules was given alone.
Erythromycin was shown to inhibit the in vitro metabolism of Quinine Capsules in human liver microsomes, an observation confirmed by an in vivo interaction study. In a crossover study (N=10), healthy subjects who received a single oral 500 mg dose of Quinine Capsules sulfate with erythromycin (600 mg every 8 hours for four days) showed a decrease in Quinine Capsules oral clearance (CL/F), an increase in half-life, and a decreased metabolite (3hydroxyquinine) to Quinine Capsules AUC ratio, as compared to when Quinine Capsules was given with placebo.
Therefore, concomitant administration of macrolide antibiotics such as erythromycin or troleandomycin with Quinine Capsules should be avoided.
Oral Contraceptives (estrogen, progestin)
In 7 healthy females who were using single-ingredient progestin or combination estrogen-containing oral contraceptives, the pharmacokinetic parameters of a single 600 mg dose of Quinine Capsules sulfate were not altered in comparison to those observed in 7 age-matched female control subjects not using oral contraceptives.
Rifampin (CYP3A4 inducer)
In patients with uncomplicated P. falciparum malaria who received Quinine Capsules sulfate 10 mg/kg concomitantly with rifampin 15 mg/kg/day for 7 days (N=29), the median AUC of Quinine Capsules between days 3 and 7 of therapy was 75% lower as compared to those who received Quinine Capsules monotherapy. In healthy subjects (N=9) who received a single oral 600 mg dose of Quinine Capsules sulfate after 2 weeks of pretreatment with rifampin 600 mg/day, the mean Quinine Capsules AUC and Cmax decreased by 85% and 55%, respectively. Therefore, the concomitant administration of rifampin with Quinine Capsules should be avoided.
Ritonavir
In healthy subjects who received a single oral 600 mg dose of Quinine Capsules sulfate with the 15 dose of ritonavir (200 mg every 12 hours for 9 days), the mean ritonavir AUC, Cmax, and elimination half-life were slightly but not significantly increased compared to when ritonavir was given alone. However, due to the significant effect of ritonavir on Quinine Capsules pharmacokinetics, the concomitant administration of Quinine Capsules capsules with ritonavir should be avoided.
Theophylline Or Aminophylline (CYP1A2 substrate)
In 19 healthy subjects who received multiple doses of Quinine Capsules 648 mg every 8 hours x 7 days with a single 300 mg oral dose of theophylline, the mean theophylline AUC was 10% lower than when theophylline was given alone. There was no significant effect on mean theophylline Cmax. Therefore, if Quinine Capsules is co-administered to patients receiving theophylline or aminophylline, plasma theophylline concentrations should be monitored frequently to ensure therapeutic concentrations.
Warfarin And
Oral Anticoagulants
Cinchona alkaloids, including Quinine Capsules, may have the potential to depress hepatic enzyme synthesis of vitamin K-dependent coagulation pathway proteins and may enhance the action of warfarin and other oral anticoagulants. Quinine Capsules may also interfere with the anticoagulant effect of heparin. Thus, in patients receiving these anticoagulants, the prothrombin time (PT), partial thromboplastin time (PTT), or international normalization ratio (INR) should be closely monitored as appropriate, during concurrent therapy with Quinine Capsules.
Drug/Laboratory Interactions
Quinine Capsules may produce an elevated value for urinary 17-ketogenic steroids when the Zimmerman method is used.
Quinine Capsules may interfere with urine qualitative dipstick protein assays as well as quantitative methods (e.g., pyrogallol red-molybdate).
As well as its needed effects, Quinine Capsules (the active ingredient contained in Quinine Capsules) may cause unwanted side effects that require medical attention.
Major Side Effects
If any of the following side effects occur while taking Quinine Capsules, check with your doctor immediately:
More common:
Diarrhea
nausea
stomach cramps or pain
vomiting
Less common:
Anxiety
behavior change, similar to drunkenness
black, tarry stools
blood in the urine or stools
blurred vision or change in vision
cold sweats
confusion
convulsions (seizures) or coma
cool pale skin
cough or hoarseness
difficulty concentrating
drowsiness
excessive hunger
fast heartbeat
fever or chills
headache
lower back or side pain
nervousness
nightmares
painful or difficult urination
pinpoint red spots on the skin
restless sleep
shakiness
slurred speech
sore throat
unusual bleeding or bruising
unusual tiredness or weakness
Rare
Difficulty breathing or swallowing
disturbed color perception
double vision
hives
increased sweating
muscle aches
night blindness
reddening of the skin, especially around ears
ringing or buzzing in the ears
swelling of the eyes, face, or inside of the nose
If any of the following symptoms of overdose occur while taking Quinine Capsules, get emergency help immediately:
Quinine Capsules Sulfate Capsules are contraindicated in patients with the following:
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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 Capsules sulfate intravenously for P. falciparum malaria.
DailyMed. "QUININE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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