Plaquenil

Hydroxychloroquine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dizziness
• loss of appetite
• nausea
• diarrhea
• stomach pain
• vomiting
• skin rash

If you experience any of the following symptoms, call your doctor immediately:

• reading or seeing difficulties (words, letters, or parts of objects missing)
• sensitivity to light
• blurred distance vision
• seeing light flashes or streaks
• difficulty hearing
• ringing in ears
• muscle weakness
• bleeding or bruising of the skin
• bleaching or loss of hair
• mood or mental changes
• irregular heartbeat
• drowsiness
• convulsions

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Hydroxychloroquine is classified as an anti-malarial drug. It is similar to chloroquine (Aralen) and is useful in treating several forms of malaria as well as lupus erythematosus and rheumatoid arthritis. Its mechanism of action is unknown. Malarial parasites invade human red blood cells. Hydroxychloroquine may prevent malarial parasites from breaking down (metabolizing) hemoglobin in human red blood cells. Hydroxychloroquine is effective against the malarial parasites Plasmodium vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. Hydroxychloroquine prevents inflammation caused by lupus erythematosus and rheumatoid arthritis. The FDA approved hydroxychloroquine in April, 1955.

Plaquenil

Common Side Effects of Plaquenil

Tell your doctor if any of the following side effects, as they may be indications of a more serious reaction:

• Headache
• Loss of appetite
• Dizziness
• Nausea
• Diarrhea, vomiting, or stomach pain
• Skin rash

Serious Side Effects of Plaquenil

If you are taking Plaquenil long-term, such as for an autoimmune condition, your doctor should regularly check you for potential serious side effects.

Call your doctor immediately or get emergency medical help if you experience any of the following serious side effects:

• Any vision problems, such as reading difficulties, sensitivity to light, seeing light flashes or streaks, blurred distance vision, or other issues
• Hearing problems, such as ringing or ticking in the ears, or hearing changes (Plaquenil may have toxic effects on your inner ear)
• Loss of balance, coordination, room spinning, or other vertigo symptoms
• Muscle weakness
• Bleeding or bruising of the skin
• Irregular heartbeat
• Mood or mental changes, such as confusion or other changes in thinking, feelings, or behavior
• Bleaching or loss of hair
• Drowsiness
• Convulsions

Your pharmacist can provide more information about hydroxychloroquine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Serious side effects have been reported with Plaquenil including the following:

• Heart failure. Plaquenil can cause weakening of the heart muscle, resulting in heart failure.Tell your healthcare provider right away if you have some or all of the following symptoms of heart failure.
  • breathlessness
  • swelling of the legs
  • irregular heart beat
  • fatigue
  • dizziness
• Retinal damage. Plaquenil may cause irreversible damage to the retina (the back of the eye where vision is created). You are required to have an eye exam before taking Plaquenil, then a follow-up as often as needed while taking Plaquenil. Tell your healthcare provider right away if you have some or all of the following symptoms.
  • blurred vision
  • seeing halos around lights (especially at night)
  • seeing light flashes and streaks
  • visual field loss
  • change in eye color
  • difficulty focusing eye
  • difficulty reading (skipped words)
  • night blindness
• Hypoglycemia (low blood sugar). Tell your healthcare provider right away if you have some or all of the following symptoms.
  • sweating
  • shakiness
  • weakness
  • dizziness
  • fast heartbeat
• Muscular weakness. All patients on long term therapy should be questioned and examined periodically, including the examination of skeletal muscle function and tendon reflexes, testing of knee and ankle reflexes, to detect any evidence of muscular weakness. If weakness occurs, your doctor may need to discontinue the drug.
• Low blood counts. Your doctor will monitor your blood counts and may have to discontinue medication depending on the results.

Plaquenil can cause blurred vision and dizziness. Do not drive or operate heavy machinery until you know how Plaquenil affects you.

Do not take Plaquenil if you:

• are allergic to Plaquenil or to any of its ingredients
• pre-existing retinopathy of the eye
• use in children below 6 years of age (200 mg tablets not adapted for weight < 35kg)

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Take Plaquenil exactly as prescribed.

Plaquenil comes in tablet form. It is taken once or twice a day, unless it is used for the prevention of malaria, in which case it is taken once a week beginning 1 to 2 weeks prior to traveling to an area where malaria is common. Take this medication with a meal or a glass of milk to prevent stomach upset.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Plaquenil at the same time.

Store Plaquenil at room temperature (15°C-30°C).

Keep in a safe place out of reach of children.

WARNING

PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF PRODUCT LABELING BEFORE PRESCRIBING PLAQUENIL.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Hydroxychloroquine is sometimes given only once per week. Choose the same day each week to take this medicine if you are on a weekly dosing schedule.

Take hydroxychloroquine with a meal or a glass of milk.

To prevent malaria: Start taking the medicine 2 weeks before entering an area where malaria is common. Continue taking the medicine regularly during your stay and for at least 8 weeks after you leave the area.

To treat malaria: Your doctor may recommend a single dose, or a high starting dose followed by a smaller dose during the last 2 days of treatment. Follow your doctor's instructions.

Take this medicine for the full prescribed length of time for malaria. Your symptoms may improve before the infection is completely cleared.

Use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

Call your doctor as soon as possible if you have been exposed to malaria, or if you have fever or other symptoms of illness during or after a stay in an area where malaria is common.

No medication is 100% effective in treating or preventing all types of malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

When treating lupus or arthritis, hydroxychloroquine is usually given daily for several weeks or months. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 months of treatment.

While using hydroxychloroquine, you may need frequent blood tests and vision exams.

Store at room temperature away from moisture, heat, and light.

Storage

Oral

Room temperature ≤30°C in tight, light-resistant container.109

• If you have an allergy to hydroxychloroquine or any other part of Plaquenil (hydroxychloroquine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have had any eye changes or changes in eyesight due to this medicine or drugs like this one.
• If you have psoriasis.
• If you have porphyria.
• If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.

This is not a list of all drugs or health problems that interact with Plaquenil.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
• Any unexplained bruising or bleeding.
• Seizures.
• Mood changes.
• If you are planning to harm yourself or the want to harm yourself gets worse.
• Bad dreams.
• Change in hearing.
• Ringing in ears.
• Hearing loss.
• Change in balance.
• Fever or chills.
• Sore throat.
• Feeling very tired or weak.
• Muscle weakness.
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• Not able to control eye movements.
• Call your doctor right away if you have any changes in eyesight. Rarely, this may not go away.
• Heart problems like heart failure and a certain abnormal heartbeat (prolonged QT interval) have happened with Plaquenil. Sometimes, these heart problems have been deadly. Call your doctor right away if you have a fast or abnormal heartbeat; very bad dizziness or passing out; or shortness of breath, a big weight gain, or swelling in the arms or legs.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

The 4-aminoquinoline compounds are very rapidly and completely absorbed after ingestion, and in accidental overdosage, or rarely with lower doses in hypersensitive patients, toxic symptoms may occur within 30 minutes. The symptoms of overdosage may include headache, drowsiness, visual disturbances, cardiovascular collapse, convulsions, hypokalemia, rhythm and conduction disorders including QT prolongation, torsades de pointes, ventricular tachycardia and ventricular fibrillation, followed by sudden potentially fatal respiratory and cardiac arrest. Treatment is symptomatic and must be prompt. Immediate gastric lavage until the stomach is completely emptied is indicated. After lavage, activated charcoal is introduced by the stomach tube within 30 minutes of ingestion of the drug may inhibit further intestinal absorption. To be effective, the dose of activated charcoal should be at least five times the estimated dose of hydroxychloroquine ingested.

Consideration should be given to administering diazepam parenterally since studies suggest that it may be beneficial in reversing chloroquine and hydroxychloroquine cardiotoxicity.

Respiratory support and shock management should be instituted as necessary.

Exchange transfusions are used to reduce the level of 4-aminoquinoline drug in the blood.

A patient who survives the acute phase and is asymptomatic should be closely observed for at least six hours. Fluids may be forced and sufficient ammonium chloride (8 g daily in divided doses for adults) may be administered for a few days to acidify the urine. This will promote urinary excretion in cases of both overdosage and sensitivity. However, caution must be exercised in patients with impaired renal function and/or metabolic acidosis.

Plaquenil (hydroxychloroquine) belongs to a group of medicines called quinolines.

Plaquenil is used to treat or prevent malaria, a disease caused by parasites that enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia. This medicine is not effective against all strains of malaria.

Plaquenil is also an antirheumatic medicine and is used to treat symptoms of rheumatoid arthritis and discoid or systemic lupus erythematosus.

Take Plaquenil exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Plaquenil is sometimes given only once per week. Choose the same day each week to take this medicine if you are on a weekly dosing schedule.

Take Plaquenil with a meal or a glass of milk.

To prevent malaria: Start taking Plaquenil 2 weeks before entering an area where malaria is common. Continue taking the medicine regularly during your stay and for at least 8 weeks after you leave the area.

To treat malaria: Your doctor may recommend a single dose, or a high starting dose followed by a smaller dose during the last 2 days of treatment. Follow your doctor's instructions.

Take Plaquenil for the full prescribed length of time for malaria. Your symptoms may improve before the infection is completely cleared.

Use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

Call your doctor as soon as possible if you have been exposed to malaria, or if you have fever or other symptoms of illness during or after a stay in an area where malaria is common.

No medication is 100% effective in treating or preventing all types of malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

When treating lupus or arthritis, Plaquenil is usually given daily for several weeks or months. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 months of treatment.

While using Plaquenil, you may need frequent blood tests and vision exams.

Store at room temperature away from moisture, heat, and light.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Avoid taking an antacid or Kaopectate (kaolin-pectin) within 4 hours before or after you take hydroxychloroquine. Some antacids can make it harder for your body to absorb hydroxychloroquine.

Get emergency medical help if you have signs of an allergic reaction to Plaquenil: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Taking Plaquenil long-term or at high doses may cause irreversible damage to the retina of your eye. Stop taking Plaquenil and call your doctor at once if you have trouble focusing, if you see light streaks or flashes in your vision, or if you notice any swelling or color changes in your eyes.

Call your doctor at once if you have:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• very slow heart rate, weak pulse;

• muscle weakness, numbness or tingling;

• low blood sugar - headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky; or

• low blood cell counts - fever, chills, sore throat, weakness or ill feeling, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed.

Common Plaquenil side effects may include:

• headache, dizziness, ringing in your ears;

• nausea, vomiting, stomach pain;

• loss of appetite, weight loss;

• mood changes, feeling nervous or irritable;

• skin rash or itching; or

• hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to hydroxychloroquine: oral tablet

Along with its needed effects, hydroxychloroquine (the active ingredient contained in Plaquenil) 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 while taking hydroxychloroquine:

• Blistering, peeling, loosening of the skin
• blurred vision or other vision changes
• chest discomfort, pain, or tightness
• cough or hoarseness
• dark urine
• decreased urination
• defective color vision
• diarrhea
• difficulty breathing
• difficulty seeing at night
• 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 with or without chills
• general feeling of tiredness or weakness
• headache
• inability to move the eyes
• increased blinking or spasms of the eyelid
• 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
• noisy breathing
• painful or difficult urination
• red irritated eyes
• red skin lesions, often with a purple center
• severe mood or mental changes
• sore throat sores, ulcers, or white spots on the lips or in the mouth
• sticking out of the tongue
• stomach pain
• swelling of the 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
• yellow eyes or skin

• 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 of hydroxychloroquine 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:

• Continuing ringing or buzzing or other unexplained noise in the ears
• feeling of constant movement of self or surroundings
• irritability
• nausea
• nervousness
• nightmares
• sensation of spinning
• shakiness and unsteady walk
• uncontrolled eye movements
• unsteadiness, trembling, or other problems with muscle control or coordination
• vomiting