Quiphile (Oral)

Quinine is used to treat malaria caused by Plasmodium falciparum. Plasmodium falciparum is a parasite that enters the red blood cells in the body and causes malaria. Quinine works by killing the parasite or stopping it from growing. This medicine may be used by itself or along with one or more other medicines for malaria.

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

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

It is very important that your doctor checks your or your child's progress after finishing this medicine. This is to ensure the malaria is completely gone. Blood and urine tests may be needed to check for any unwanted effects.

Contact your doctor immediately if you notice any changes in your heart rhythm. You might feel dizzy or faint, or you might experience a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm issue, such as QT prolongation.

Check with your doctor right away if you experience any unusual bleeding or bruising, black or tarry stools, blood in your urine or stools, headache, dizziness, weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or 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 situations where you could get 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 (a 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 your 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 using 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 your skin, or fever or chills while using this medicine.

Quinine may cause hypoglycemia (low blood sugar). If your blood sugar drops 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 won’t go away. Inform your doctor immediately if you have any of these symptoms.

Before having any medical tests, inform 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 your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use this medicine, you and your doctor need to think about the risks versus the benefits. Here are some important points to consider:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There have not been enough studies on how quinine affects children younger than 16 years old, so safety and effectiveness have not been established.

Geriatric

Current studies have not shown specific problems in older adults that would limit the usefulness of quinine.

Breast Feeding

Research in women suggests that this medicine poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if an interaction might happen. In these cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The interactions listed are significant and are not all-inclusive.

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

• 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

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

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both medicines might be necessary for your treatment. If both are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Atorvastatin
• Cyclosporine
• Fosphenytoin
• Phenytoin
• Rifapentine
• Tetracycline

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or near the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to inform your doctor if you have any other medical problems, especially:

• Atrial fibrillation or flutter (abnormal heart rhythms) or
• Bradycardia (slow heartbeat) or
• Heart disease (e.g., myocardial ischemia) or
• Uncorrected hypokalemia (low potassium in the blood) or
• Sick sinus syndrome (a type of abnormal heart rhythm)—Use with caution. May worsen side effects.

• Blackwater fever (a blood disorder) or
• Hemolytic uremic syndrome (a serious kidney problem) or
• Idiopathic thrombocytopenia purpura (a bleeding disorder) or
• Thrombocytopenia (low platelet count) or
• Thrombotic thrombocytopenic purpura (a blood disorder)—Should not be used in patients who have experienced these serious side effects from quinine.

• Heart rhythm problems (e.g., prolonged QT interval) or
• Severe liver disease 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 (a blood disorder) or
• Hypoglycemia (low blood sugar)—Use with caution. May worsen this condition.

• Severe kidney disease or
• Mild to moderate liver disease—Use with caution. The effects may be stronger because the body removes the medicine more slowly.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might 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
• Reddish 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
• 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.

In the U.S.

• Qualaquin
• Quinamm
• Quiphile

Available Dosage Forms:

• Capsule

Therapeutic Class: Musculoskeletal Agent

Chemical Class: Cinchona Alkaloid

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.