Hydroxychloroquine (Oral route)
Physicians should completely familiarize themselves with the contents of this leaflet before prescribing hydroxychloroquine .
Uses of This Medicine:
Hydroxychloroquine belongs to the family of medicines called antiprotozoals. Protozoa are tiny, one-celled animals. Some are parasites that can cause many different kinds of infections in the body.
This medicine is used to prevent and to treat malaria and to treat some conditions such as liver disease caused by protozoa. It is also used in the treatment of arthritis to help relieve inflammation, swelling, stiffness, and joint pain and to help control the symptoms of lupus erythematosus (lupus; SLE).
This medicine may be given alone or with one or more other medicines. It may also be used for other conditions as determined by your doctor.
Hydroxychloroquine is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, hydroxychloroquine is used in certain patients with the following medical conditions:
- Arthritis, juvenile
- Hypercalcemia, sarcoid-associated
- Polymorphous light eruption
- Porphyria cutanea tarda
- Urticaria, solar
- Vasculitis, chronic cutaneous
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:
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 are especially sensitive to the effects of hydroxychloroquine. This may increase the chance of side effects during treatment. Overdose is especially dangerous in children. Taking as few as 3 or 4 tablets (250-milligrams [mg] strength) of chloroquine has resulted in death in small children. Because hydroxychloroquine is so similar to chloroquine, it is probably just as toxic.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of hydroxychloroquine in the elderly with use in other age groups.
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
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.
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.
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:
- Blood disease (severe)—Hydroxychloroquine may cause blood disorders
- Eye or vision problems—Hydroxychloroquine may cause serious eye side effects, especially in high doses
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency—Hydroxychloroquine may cause serious blood side effects in patients with this deficiency
- Kidney disease—There may be an increased chance of side effects in patients with kidney disease
- Liver disease—May decrease the removal of hydroxychloroquine from the blood, increasing the chance of side effects
- Nerve or brain disease (severe), including convulsions (seizures)—Hydroxychloroquine may cause muscle weakness and, in high doses, seizures
- Porphyria—Hydroxychloroquine may worsen the symptoms of porphyria
- Psoriasis—Hydroxychloroquine may bring on severe attacks of psoriasis
- Stomach or intestinal disease (severe)—Hydroxychloroquine may cause stomach irritation
Proper Use of This Medicine:
Take this medicine with meals or milk to lessen possible stomach upset, unless otherwise directed by your doctor.
Keep this medicine out of the reach of children. Children are especially sensitive to the effects of hydroxychloroquine and overdose is especially dangerous in children. Taking as few as 3 or 4 tablets (250-mg strength) of chloroquine has resulted in death in small children. Hydroxychloroquine is probably just as dangerous.
It is very important that you take this medicine only as directed. 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 of serious side effects.
If you are taking this medicine to help keep you from getting malaria, keep taking it for the full time of treatment. If you already have malaria, you should still keep taking this medicine for the full time of treatment even if you begin to feel better after a few days. This will help to clear up your infection completely. If you stop taking this medicine too soon, your symptoms may return.
Hydroxychloroquine works best when you take it on a regular schedule. For example, if you are to take it once a week to prevent malaria, it is best to take it on the same day each week. Or if you are to take 2 doses a day, 1 dose may be taken with breakfast and the other with the evening meal. Make sure that you do not miss any doses. If you have any questions about this, check with your health care professional.
For patients taking hydroxychloroquine to prevent malaria:
- Your doctor may want you to start taking this medicine 1 to 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 to 6 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.
For patients taking hydroxychloroquine for arthritis or lupus:
- This medicine must be taken regularly as ordered by your doctor in order for it to help you. It may take up to several weeks before you begin to feel better. It may take up to 6 months before you feel the full benefit of this medicine.
For patients unable to swallow hydroxychloroquine tablets:
- Your pharmacist can crush the tablets and put each dose in a capsule. Contents of the capsules may then be mixed with a teaspoonful of jam, jelly, or jello. Be sure you take all the food in order to get the full dose of medicine.
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 tablets dosage form:
- For prevention of malaria:
- Adults—400 milligrams (mg) once every seven days.
- Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.4 mg per kilogram (kg) (2.9 mg per pound) of body weight once every seven days.
- For treatment of malaria:
- Adults—800 mg as a single dose. This may sometimes be followed by a dose of 400 mg six to eight hours after the first dose, then 400 mg once a day on the second and third days.
- Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 32 mg per kg (14.5 mg per pound) of body weight taken over a period of three days.
- For treatment of arthritis:
- Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.5 mg per kg (2.9 mg per pound) of body weight per day.
- For prevention of malaria:
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.
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.
Precautions While Using This Medicine:
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after long-term treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
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.
Hydroxychloroquine may cause blurred vision, difficulty in reading, or other change in vision. It may also cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well. If these reactions are especially bothersome, check with your doctor.
Malaria is spread by 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, sleep under mosquito netting to avoid being bitten by malaria-carrying 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 mosquito repellent to uncovered areas of the skin from dusk through dawn when mosquitoes are out.
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. When this medicine is used for short periods of time, side effects usually are rare. However, when it is used for a long time and/or in high doses, side effects are more likely to occur and may be serious.
- Less common
- Blurred vision or any other change in vision—this side effect may also occur or get worse after you stop taking this medicine
- Convulsions (seizures)
- increased muscle weakness
- mood or other mental changes
- ringing or buzzing in ears or any loss of hearing
- sore throat and fever
- unusual bleeding or bruising
- unusual tiredness
- Symptoms of overdose
- increased excitability
Check with your doctor immediately if any of the following side effects occur:
- More common
- difficulty in seeing to read
- itching (more common in black patients)
- loss of appetite
- nausea or vomiting
- stomach cramps or pain
- Less common
- Bleaching of hair or increased hair loss
- blue-black discoloration of skin, fingernails, or inside of mouth
- dizziness or lightheadedness
- nervousness or restlessness
- skin rash
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:
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.
Last Updated: 11/4/2014