Plaquenil

DRUG DESCRIPTION

Hydroxychloroquine sulfate is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1).

PLAQUENIL (hydroxychloroquine sulfate) tablets contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration.

Inactive Ingredients: Dibasic Calcium Phosphate, Hydroxypropyl Methylcellulose, Magnesium Stearate, Polyethylene glycol 400, Polysorbate 80, Starch, Titanium Dioxide.

What are the possible side effects of hydroxychloroquine (Plaquenil Sulfate)?

Some people taking this medication over long periods of time or at high doses have developed irreversible damage to the retina of the eye. Stop taking hydroxychloroquine 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.

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

Call your doctor at...

Read All Potential Side Effects and See Pictures of Plaquenil

What are the precautions when taking hydroxychloroquine (Plaquenil)?

Before taking hydroxychloroquine, tell your doctor or pharmacist if you are allergic to it; or to other aminoquinolines (e.g., chloroquine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain eye problems (retinal or visual field problems from other aminoquinolines such as chloroquine).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol dependency, certain blood disorder (porphyria), certain genetic problem (G-6-PD deficiency), kidney...

Read All Potential Precautions of Plaquenil


Plaquenil Consumer (continued)

SIDE EFFECTS: Nausea, stomach cramps, loss of appetite, diarrhea, dizziness, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: arm/leg/back pain, fast heartbeat, hair loss/color change, mental/mood changes (e.g., anxiety, depression, hallucinations), ringing in the ears/hearing loss, worsening of skin conditions (e.g., psoriasis).

This medication may infrequently cause serious (sometimes permanent) eye problems or muscle damage, especially if you take it for a long time. Seek immediate medical attention if any of these unlikely but very serious side effects occur: sensitivity to light, vision changes (e.g., blurred vision, seeing light flashes/streaks/halos, missing/blacked-out areas of vision), muscle weakness.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, severe nausea/vomiting, easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), seizures, shortness of breath, swelling ankles/feet, extreme tiredness, dark urine, yellowing eyes/skin.

A very serious allergic reaction is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking hydroxychloroquine, tell your doctor or pharmacist if you are allergic to it; or to other aminoquinolines (e.g., chloroquine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain eye problems (retinal or visual field problems from other aminoquinolines such as chloroquine).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol dependency, certain blood disorder (porphyria), certain genetic problem (G-6-PD deficiency), kidney disease, liver disease, certain skin problems (e.g., atopic dermatitis, psoriasis).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages because they may increase your risk of liver problems while you are taking this drug.

Caution is advised when using this drug in children because they may be more sensitive to the side effects of the drug. This medication is not recommended for long-term use in children. If a child accidentally takes this medication, even a small amount can be very harmful (possibly fatal). Be sure to keep this drug out of the reach of children.

This medication should be used only when clearly needed during pregnancy. This medication is not recommended for use in treating rheumatoid arthritis during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.


Plaquenil Patient Information Including Side Effects

Brand Names: Plaquenil Sulfate

Generic Name: hydroxychloroquine (Pronunciation: hye drox ee KLOR oh kwin)

  • What is hydroxychloroquine (Plaquenil)?
  • What are the possible side effects of hydroxychloroquine (Plaquenil)?
  • What is the most important information I should know about hydroxychloroquine (Plaquenil)?
  • What should I discuss with my health care provider before taking hydroxychloroquine (Plaquenil)?
  • How should I take hydroxychloroquine (Plaquenil)?
  • What happens if I miss a dose (Plaquenil)?
  • What happens if I overdose (Plaquenil)?
  • What should I avoid while taking hydroxychloroquine (Plaquenil)?
  • What other drugs will affect hydroxychloroquine (Plaquenil)?
  • Where can I get more information?

What is hydroxychloroquine (Plaquenil)?

Hydroxychloroquine is used to treat or prevent malaria, a disease caused by parasites. Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.

Hydroxychloroquine is also used to treat symptoms of rheumatoid arthritis and discoid or systemic lupus erythematosus.

Hydroxychloroquine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of hydroxychloroquine (Plaquenil)?

Some people taking this medication over long periods of time or at high doses have developed irreversible damage to the retina of the eye. Stop taking hydroxychloroquine 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.

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

Call your doctor at once if you have any of these serious side effects:

  • muscle weakness, twitching, or uncontrolled movement;
  • loss of balance or coordination;
  • blurred vision, light sensitivity, seeing halos around lights;
  • pale skin, easy bruising or bleeding;
  • confusion, unusual thoughts or behavior; or
  • seizure (convulsions).

Less serious side effects may include:

  • headache, ringing in your ears;
  • spinning sensation;
  • 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.

What is the most important information I should know about hydroxychloroquine (Plaquenil)?

You should not use this medication if you are allergic to hydroxychloroquine, or if you have a history of vision changes or damage to your retina caused by hydroxychloroquine or similar anti-malaria medications.

Before using hydroxychloroquine, tell your doctor if you are allergic to any drugs, or if you have psoriasis, porphyria, liver disease, alcoholism, or glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.

Call a poison control center at once and then seek emergency medical attention if you think you have used too much of this medicine. An overdose of hydroxychloroquine can be fatal, especially in children.

Take this medicine for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Contact 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.

When treating lupus or arthritis, tell your doctor if your symptoms do not improve after 6 months of treatment.

If you take hydroxychloroquine long-term, your doctor may need to check your knee and ankle reflexes and also do blood tests on a regular basis to check for harmful side effects. Your vision may also need to be tested every 3 months. Do not miss any scheduled appointments.

Hydroxychloroquine should not be used for long-term treatment in children.

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