Description and Brand Names

US Brand Name

1. Qualaquin
2. Quinamm
3. Quiphile

Descriptions

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.

This product is available in the following dosage forms:

• Capsule

Before Using

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.

Pediatric
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.

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

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

Drug Interactions
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
Dronedarone
Eliglustat
Fluconazole
Ketoconazole
Levoketoconazole
Mesoridazine
Nelfinavir
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
Crizotinib
Cyclosporine
Dabigatran Etexilate
Dabrafenib
Daridorexant
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Deutetrabenazine
Dexmedetomidine
Dextroamphetamine
Digoxin
Dihydrocodeine
Dihydroxyaluminum Aminoacetate
Dihydroxyaluminum Sodium Carbonate
Disopyramide
Dolasetron
Domperidone
Donepezil
Droperidol
Efavirenz
Enasidenib
Encorafenib
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
Itraconazole
Ivabradine
Ivosidenib
Lacosamide
Lanreotide
Lapatinib
Lefamulin
Lenvatinib
Leuprolide
Levofloxacin
Lisdexamfetamine
Lofexidine
Lonafarnib
Lumefantrine
Macimorelin
Magaldrate
Magnesium Carbonate
Magnesium Hydroxide
Magnesium Trisilicate
Mavacamten
Mavorixafor
Mefloquine
Methadone
Methamphetamine
Metronidazole
Mifepristone
Mirtazapine
Mitotane
Mobocertinib
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Nafarelin
Nebivolol
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
Ribociclib
Rifampin
Rilpivirine
Ritonavir
Selpercatinib
Sertraline
Sevoflurane
Siponimod
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
Sotorasib
Succinylcholine
Sulpiride
Sunitinib
Tacrolimus
Tamoxifen
Taurursodiol
Telavancin
Telithromycin
Tenofovir Alafenamide
Tetrabenazine
Tocilizumab
Toremifene
Tovorafenib
Tramadol
Trazodone
Triclabendazole
Trifluoperazine
Trimipramine
Triptorelin
Troleandomycin
Tubocurarine
Tucatinib
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Vilanterol
Vinflunine
Voclosporin
Vonoprazan
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
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

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

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

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

1. Blurred vision
2. change in color vision
3. changes in behavior
4. confusion
5. diarrhea
6. hearing loss
7. nausea
8. ringing in the ears
9. stomach cramps or pain
10. vomiting

Less common

1. Anxiety
2. behavior change, similar to drunkenness
3. black, tarry stools
4. bloody urine
5. blurred vision or change in vision
6. chills
7. cold sweats
8. confusion
9. cool pale skin
10. cough
11. difficulty concentrating
12. drowsiness
13. excessive hunger
14. fast heartbeat
15. fever
16. headache
17. hoarseness
18. loss of consciousness
19. lower back or side pain
20. nervousness
21. nightmares
22. painful or difficult urination
23. pinpoint red spots on the skin
24. restless sleep
25. seizures
26. shakiness
27. slurred speech
28. sore throat
29. unusual bleeding or bruising
30. unusual tiredness or weakness

Rare

1. Difficulty breathing or swallowing
2. disturbed color perception
3. double vision
4. hives
5. increased sweating
6. muscle aches
7. night blindness
8. reddening of the skin, especially around ears
9. ringing or buzzing in the ears
10. swelling of the eyes, face, inside of the nose, fingers, feet, or lower legs

Incidence not known

1. Back, leg, or stomach pains
2. bleeding gums
3. bleeding under the skin
4. blindness
5. blistering, peeling, or loosening of the skin
6. bloody nose
7. blue-yellow color blindness
8. change in mental status
9. chest pain
10. cold sweats
11. confusion
12. cool, pale skin
13. cough
14. dark urine
15. decreased frequency or amount of urine
16. decreased vision
17. depression
18. diarrhea
19. difficulty breathing
20. difficulty in moving
21. difficulty speaking
22. dizziness
23. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
24. eye pain
25. fainting
26. fast, pounding, or irregular heartbeat or pulse
27. general body swelling
28. general feeling of discomfort, illness, or weakness
29. hoarseness
30. heavier menstrual periods
31. hoarseness
32. increased hunger
33. increased or decreased urination
34. increased sensitivity of the skin to sunlight
35. increased thirst
36. irregular heartbeat, recurrent
37. irritation
38. itching, skin rash
39. joint pain, stiffness, or swelling
40. light-colored stools
41. loss of appetite
42. muscle cramps, weakness, or stiffness
43. nervousness
44. nightmares
45. nosebleeds
46. painful or difficult urination
47. pale color of the skin
48. pale skin
49. red skin lesions, often with a purple center
50. red, irritated eyes
51. redness or other discoloration of the skin
52. severe
53. sunburn
54. sores, ulcers, or white spots in the mouth or on the lips
55. tightness in the chest
56. troubled swallowing
57. upper right abdominal pain
58. weakness
59. weight gain
60. yellow eyes or skin

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

Symptoms of an overdose

1. Blindness
2. blurred vision or change in vision
3. chest pain
4. dizziness
5. double vision
6. fainting
7. lightheadedness
8. rapid or irregular heartbeat
9. 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

1. Feeling of warmth
2. heartburn
3. lack or loss of strength
4. pain or burning in the throat
5. problems with speech or speaking
6. restlessness
7. thoughts or attempts of killing oneself tremors
8. unsteadiness, trembling, or other problems with muscle control or coordination
9. 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.

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