Pronunciation:

hye-drox-ee-KLOR-oh-kwin SUL-fate

Brand Names:

• Plaquenil

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antimalarial

Chemical—

Hydroxychloroquine

Uses of This Medicine:

Hydroxychloroquine is used to treat malaria. It is also used to prevent malaria infection in areas or regions where there is no known medicine (eg, chloroquine) resistance.

Using this medicine alone or with other medicines (eg, azithromycin) may increase your risk of heart rhythm problems (eg, QT prolongation, ventricular fibrillation, ventricular tachycardia). Do not take any medicine that contains hydroxychloroquine unless prescribed by your doctor.

Hydroxychloroquine belongs to a group of medicines known as antimalarials. It works by preventing or treating malaria, a red blood cell infection transmitted by the bite of a mosquito. However, this medicine is not used to treat severe or complicated malaria.

Hydroxychloroquine is used to treat discoid lupus erythematosus (DLE) or systemic lupus erythematosus (SLE or lupus). It is also used to treat acute and chronic rheumatoid arthritis.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydroxychloroquine to prevent and treat malaria in children. However, use is not recommended in children weighing less than 31 kilograms (kg). Safety and efficacy of hydroxychloroquine to treat lupus and arthritis have not been established in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydroxychloroquine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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.

• Aurothioglucose
• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• 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.

• Acarbose
• Adagrasib
• Albiglutide
• Alfuzosin
• Alogliptin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buprenorphine
• Bupropion
• Buserelin
• Canagliflozin
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Chlorpropamide
• Cimetidine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Dabrafenib
• Dapagliflozin
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Dulaglutide
• Ebastine
• Efavirenz
• Empagliflozin
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Exenatide
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glimepiride
• Glipizide
• Glyburide
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Linagliptin
• Liraglutide
• Lixisenatide
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Metformin
• Methadone
• Methotrexate
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Miglitol
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nafarelin
• Nateglinide
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Pimavanserin
• Pioglitazone
• Pipamperone
• Pitolisant
• Ponesimod
• Posaconazole
• Pramlintide
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Remdesivir
• Repaglinide
• Ribociclib
• Rifampin
• Rilpivirine
• Risperidone
• Ritonavir
• Rosiglitazone
• Saxagliptin
• Selpercatinib
• Semaglutide
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sitagliptin
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tolazamide
• Tolbutamide
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vildagliptin
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zotepine
• 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.

• Ampicillin
• Digoxin

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:

• Allergy to 4-aminoquinoline compounds (eg, chloroquine)—Should not be used in patients with this condition.

• Blood or bone marrow problems or
• Diabetes or
• Eye or vision problems or
• Muscle problems or
• Nerve problems or
• Porphyria (blood disorder) or
• Psoriasis (skin disease) or
• Stomach or bowel problems–Use with caution. May make these conditions worse.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency—May cause hemolytic anemia in patients with this condition.

• Heart disease (eg, heart attack, heart failure) or
• Heart rhythm problems (eg, bradycardia, ventricular dysrhythmia), or history of or
• Hypokalemia (low potassium in the blood), uncorrected or
• Hypomagnesemia (low magnesium in the blood), uncorrected—Use with caution. May prolong the QT interval.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of the 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.

Swallow the tablet whole. Do not crush, break, or chew it. Take this medicine with meals or milk to lessen stomach upset, unless otherwise directed by your doctor.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

For patients taking hydroxychloroquine to prevent malaria:

• Your doctor may want you to start taking this medicine 2 weeks before you travel to an area where there is a chance of getting malaria. This will help you to see how you react to the medicine. Also, it will allow time for your doctor to change to another medicine if you have a reaction to this medicine.
• Also, you should keep taking this medicine while you are in the area and for 4 weeks after you leave the area. No medicine will protect you completely from malaria. However, to protect you as completely as possible, it is important to keep taking this medicine for the full time your doctor ordered. Also, if fever develops during your travels or within 2 months after you leave the area, check with your doctor immediately.

If you are also taking kaolin or antacids, take them at least 4 hours before or after using hydroxychloroquine.

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 (tablets):
  • For prevention of malaria:
    • Adults—400 mg once a week on the same day of each week starting 2 weeks before traveling to an area where malaria occurs, and continued for 4 weeks after leaving the area.
    • Children weighing 31 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. At first, 6.5 mg per kilogram (kg) of body weight, not to exceed 400 mg, once weekly on the same day of the week starting 2 weeks before traveling to an area where malaria occurs, and continued for 4 weeks after leaving the area.
    • Children weighing less than 31 kg—Use is not recommended.
  • For treatment of malaria:
    • Adults—At first, 800 milligrams (mg) (4 tablets) taken as a single dose. Then, 400 mg taken 6 hours, 24 hours, and 48 hours after the first dose.
    • Children weighing 31 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. At first, 13 mg per kg of body weight taken as a single dose. Then, 6.5 mg per kg of body weight taken 6 hours, 24 hours, and 48 hours after the first dose. However, dose is usually not more than 800 mg for the first dose and not more than 400 mg for the next doses.
    • Children weighing less than 31 kg—Use is not recommended.
  • For treatment of arthritis:
    • Adults—At first, 400 to 600 milligrams (mg) taken as a single dose or in two divided doses per day. Then, 200 mg once a day or 400 mg taken as a single dose or in two divided doses per day. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of lupus:
    • Adults—200 milligrams (mg) once a day or 400 mg taken once a day or in two divided doses.
    • Children—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.

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 progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

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 had a heart rhythm problem, including QT prolongation.

This medicine may cause muscle and nerve problems. Check with your doctor right away if you have muscle weakness, pain, or tenderness while using this medicine.

Hydroxychloroquine may cause some people to be agitated, irritable, or display other abnormal behaviors within the first month after the start of treatment. It may also cause some people to have suicidal thoughts and tendencies, or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Check with your doctor immediately if you think you are getting an infection or if you get a fever, chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis can occur during treatment with this medicine. Check with your doctor right away if you or your child have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, severe acne or skin rash, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness while you are using this medicine.

If your symptoms do not improve within a few days (or a few weeks or months for arthritis), or if they become worse, check with your doctor.

Malaria is spread by the bites of certain kinds of infected female mosquitoes. If you are living in or will be traveling to an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:

• If possible, avoid going out between dusk and dawn because it is at these times that mosquitoes most commonly bite.
• Remain in air-conditioned or well-screened rooms to reduce contact with mosquitoes.
• Wear long-sleeved shirts or blouses and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are out.
• Apply insect repellant, preferably one containing DEET, to uncovered areas of the skin from dusk through dawn when mosquitoes are out.
• If possible, sleep in a screened or air-conditioned room or under mosquito netting preferably netting coated or soaked with pyrethrum, to avoid being bitten by malaria-carrying mosquitoes.
• Use mosquito coils or sprays to kill mosquitoes in living and sleeping quarters during evening and nighttime hours.

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:

Incidence not known

Anxiety

black, tarry stools

bleeding gums

blindness

blistering, peeling, loosening of the skin

blood in the urine or stools

blurred vision or other vision changes

change in how colors look

chest discomfort, pain, or tightness

chills

cold sweats

confusion

cough or hoarseness

dark urine

decreased urination

defective color vision

diarrhea

difficulty seeing at night

dilated neck veins

dizziness or fainting

fast, pounding, uneven heartbeat

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

feeling, seeing, or hearing things that are not there

fever

headache

inability to move the eyes

increased blinking or spasms of the eyelid

increased hunger

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, and sex organs

loss of hearing

lower back or side pain

nervousness

nightmares

noisy breathing

painful or difficult urination

pale skin

palpitations

pinpoint red spots on the skin

red irritated eyes

red skin lesions, often with a purple center

seizures

severe mood or mental changes

shakiness

slurred speech

sore throat

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

sticking out of the tongue

stomach pain

swelling of the eye

swelling of the face, fingers, feet, or lower legs

swollen or painful glands

trouble with breathing, speaking, or swallowing

uncontrolled twisting movements of the neck, trunk, arms, or legs

unusual behavior

unusual bleeding or bruising

unusual facial expressions

unusual tiredness or weakness

weight gain

yellow eyes or skin

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

Symptoms of overdose

Drowsiness

dry mouth

increased thirst

loss of appetite

mood changes

no pulse or blood pressure

numbness or tingling in the hands, feet, or lips

unconsciousness

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

Continuing ringing or buzzing or other unexplained noise in the ears

darkening of the skin

feeling of constant movement of self or surroundings

hair loss or thinning of the hair

increased sensitivity of the skin to sunlight

irritability

loss of appetite

nausea

redness or other discoloration of the skin

sensation of spinning

severe sunburn

shakiness and unsteady walk

uncontrolled eye movements

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

vomiting

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.