"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(chloroquine phosphate) Tablets for Oral Administration, USP
ARALEN, chloroquine phosphate, USP, is a 4-aminoquinoline compound for oral administration. It is a white, odorless, bitter tasting, crystalline substance, freely soluble in water.
ARALEN is an antimalarial and amebicidal drug.
Chemically, it is 7-chloro-4-[[4-(diethylamino)-1-methylbutyl]amino] quinoline phosphate (1:2) and has the following structural formula:
Each tablet contains 500 mg of chloroquine phosphate USP, equivalent to 300 mg chloroquine base.
Inactive Ingredients: Carnauba Wax, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Hydroxypropyl Methylcellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid, Titanium Dioxide.
What are the possible side effects of chloroquine (Aralen Phosphate)?
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 chloroquine 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; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using chloroquine and call your doctor at once if you have a serious...
What are the precautions when taking chloroquine (Aralen)?
Before taking chloroquine, tell your doctor or pharmacist if you are allergic to it; or to hydroxychloroquine; 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain enzyme problem (glucose-6-phosphate dehydrogenase deficiency-G6PD), vision/eye problems, hearing problems, kidney disease, liver disease, regular alcohol use/abuse, psoriasis, a certain blood disorder (porphyria), seizures.
This drug may cause blurred vision or rarely make you dizzy. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you...
Last reviewed on RxList: 11/21/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Aralen Information
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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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