Pronunciation:

KWYE-nine

Brand Names:

• Qualaquin
• Quinamm
• Quiphile

Dosage Forms:

• Capsule

Warnings:

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 .

Classifications:

Therapeutic—

Musculoskeletal Agent

Chemical—

Cinchona Alkaloid

Uses of This Medicine:

Quinine is used to treat malaria caused by Plasmodium falciparum. Plasmodium falciparum is a parasite that gets into the red blood cells in the body and causes malaria. Quinine works by killing the parasite or preventing it from growing. This medicine may be used alone or given together with one or more medicines for malaria.

Quinine should not be used to treat or prevent night time leg cramps. This medicine may cause very serious unwanted effects and should only be used for patients with malaria.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of quinine in children younger than 16 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of quinine in the elderly.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Astemizole
• Aurothioglucose
• Bepridil
• Cisapride
• Colchicine
• Dronedarone
• Fluconazole
• Ketoconazole
• Lefamulin
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Alfuzosin
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Amphetamine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asciminib
• Asenapine
• Atazanavir
• Avacopan
• Azithromycin
• Bedaquiline
• Benzphetamine
• Berotralstat
• Buprenorphine
• Buserelin
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Codeine
• Conivaptan
• Crizotinib
• Cyclosporine
• Dabigatran Etexilate
• Dabrafenib
• Daridorexant
• Dasatinib
• Degarelix
• Delamanid
• Desflurane
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Dextroamphetamine
• Digoxin
• Dihydrocodeine
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Disopyramide
• Dolasetron
• Domperidone
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Efavirenz
• Enasidenib
• Encorafenib
• Ensartinib
• Entrectinib
• Enzalutamide
• Erythromycin
• Escitalopram
• Etrasimod
• Fexinidazole
• Fingolimod
• Fluoxetine
• Formoterol
• Foscarnet
• Fostemsavir
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Givinostat
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroxyamphetamine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Isoflurane
• Itraconazole
• Ivabradine
• Ivosidenib
• Lacosamide
• Lanreotide
• Lapatinib
• Lazertinib
• Lenvatinib
• Letermovir
• Leuprolide
• Levofloxacin
• Lisdexamfetamine
• Lofexidine
• Lonafarnib
• Lumefantrine
• Macimorelin
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Trisilicate
• Mavorixafor
• Mefloquine
• Methadone
• Methamphetamine
• Metronidazole
• Mifepristone
• Mirtazapine
• Mitotane
• Mobocertinib
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nebivolol
• Nelfinavir
• Nevirapine
• Nilotinib
• Nirogacestat
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Ozanimod
• Pacritinib
• Palbociclib
• Paliperidone
• Pancuronium
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Phenobarbital
• Pimavanserin
• Pitolisant
• Ponesimod
• Primidone
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quizartinib
• Ranolazine
• Relugolix
• Repotrectinib
• Revumenib
• Ribociclib
• Rifampin
• Rilpivirine
• Ritonavir
• Selpercatinib
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sotorasib
• Succinylcholine
• Sulpiride
• Sunitinib
• Suzetrigine
• Tacrolimus
• Tamoxifen
• Taurursodiol
• Tazemetostat
• Telavancin
• Telithromycin
• Tenofovir Alafenamide
• Tetrabenazine
• Tocilizumab
• Toremifene
• Tovorafenib
• Tramadol
• Trazodone
• Treosulfan
• Triclabendazole
• Trifluoperazine
• Trimipramine
• Triptorelin
• Troleandomycin
• Tubocurarine
• Tucatinib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venetoclax
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Vonoprazan
• Vorasidenib
• Voriconazole
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atorvastatin
• Fosphenytoin
• Mavacamten
• Phenytoin
• Rifapentine
• Tetracycline

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Atrial fibrillation or flutter (abnormal heart rhythms) or
• Bradycardia (slow heartbeat) or
• Heart disease (eg, myocardial ischemia) or
• Hypokalemia (low potassium in the blood), uncorrected or
• Sick sinus syndrome (type of abnormal heart rhythm)—Use with caution. May cause side effects to become worse.

• Blackwater fever (blood disorder) or
• Hemolytic uremic syndrome (blood disorder causing serious kidney problems) or
• Idiopathic thrombocytopenia purpura (bleeding disorder) or
• Thrombocytopenia (low number of platelets) or
• Thrombotic thrombocytopenic purpura (blood disorder)—Should not be used in patients who have had these serious side effects to quinine.

• Heart rhythm problems (eg, prolonged QT interval) or
• Liver disease, severe or
• Myasthenia gravis (severe muscle weakness) or
• Optic neuritis (swelling of a nerve in the eye)—Should not be used in patients with these conditions.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (blood disorder) or
• Hypoglycemia (low blood sugar)—Use with caution. May make this condition worse.

• Kidney disease, severe or
• Liver disease, mild to moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Quinine may be given together with one or more medicines for malaria. Make sure you take all of the medicines your doctor ordered. If you have any questions about this, talk to your doctor.

Take this medicine with food to lessen stomach upset, unless otherwise directed by your doctor. If you are taking this medicine at bedtime, take it with a snack, water, milk, or other beverage.

To help clear up the malaria completely, keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For treatment of malaria:
    • Adults and children 16 years of age and older—648 milligrams (mg) (2 capsules) every 8 hours for 7 days.
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If it has been more than 4 hours since you missed a dose, skip the missed dose and take your next dose at the regular time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress after you finish using the medicine. This is to make sure the malaria is cleared up completely. Blood and urine tests may be needed to check for unwanted effects.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

Be extra careful to avoid injuries. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Gently brush and floss your teeth. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause hemolytic anemia (blood disorder). Check with your doctor right away if you have back, leg, or stomach pains, bleeding gums, chills, dark urine, difficulty breathing, fever, swelling, headache, loss of appetite, nausea, vomiting, nosebleeds, pale skin, sore throat, or yellowing of the eyes or skin.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, lightheadedness, dizziness, or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you use this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

Quinine may cause hypoglycemia (low blood sugar). If your blood sugar gets too low, you may feel weak, drowsy, confused, anxious, or very hungry. You may also sweat, shake, or have blurred vision, a fast heartbeat, or a headache that will not go away. Tell your doctor right away if you have any of these symptoms.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blurred vision

change in color vision

changes in behavior

confusion

diarrhea

hearing loss

nausea

ringing in the ears

stomach cramps or pain

vomiting

Less common

Anxiety

behavior change, similar to drunkenness

black, tarry stools

bloody urine

blurred vision or change in vision

chills

cold sweats

confusion

cool pale skin

cough

difficulty concentrating

drowsiness

excessive hunger

fast heartbeat

fever

headache

hoarseness

loss of consciousness

lower back or side pain

nervousness

nightmares

painful or difficult urination

pinpoint red spots on the skin

restless sleep

seizures

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, inside of the nose, fingers, feet, or lower legs

Incidence not known

Back, leg, or stomach pains

bleeding gums

bleeding under the skin

blindness

blistering, peeling, or loosening of the skin

bloody nose

blue-yellow color blindness

change in mental status

chest pain

cold sweats

confusion

cool, pale skin

cough

dark urine

decreased frequency or amount of urine

decreased vision

depression

diarrhea

difficulty breathing

difficulty in moving

difficulty speaking

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

eye pain

fainting

fast, pounding, or irregular heartbeat or pulse

general body swelling

general feeling of discomfort, illness, or weakness

hoarseness

heavier menstrual periods

hoarseness

increased hunger

increased or decreased urination

increased sensitivity of the skin to sunlight

increased thirst

irregular heartbeat, recurrent

irritation

itching, skin rash

joint pain, stiffness, or swelling

light-colored stools

loss of appetite

muscle cramps, weakness, or stiffness

nervousness

nightmares

nosebleeds

painful or difficult urination

pale color of the skin

pale skin

red skin lesions, often with a purple center

red, irritated eyes

redness or other discoloration of the skin

severe

sunburn

sores, ulcers, or white spots in the mouth or on the lips

tightness in the chest

troubled swallowing

upper right abdominal pain

weakness

weight gain

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of an overdose

Blindness

blurred vision or change in vision

chest pain

dizziness

double vision

fainting

lightheadedness

rapid or irregular heartbeat

sleepiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Feeling of warmth

heartburn

lack or loss of strength

pain or burning in the throat

problems with speech or speaking

restlessness

thoughts or attempts of killing oneself tremors

unsteadiness, trembling, or other problems with muscle control or coordination

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.