"March 9, 2011 -- The FDA has approved Benlysta, the first new lupus treatment in 50 years.
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HYDROXYCHLOROQUINE SULFATE, USP
- Patient Information:
Details with Side Effects
PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING HYDROXYCHLOROQUINE.
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 once if you have a serious side effect...
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...
Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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