"The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout f"...
(colchicine) Tablets, USP
Colchicine is an alkaloid chemically described as (S)N- (5,6,7,9-tetrahydro- 1,2,3, 10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide with a molecular formula of C22H25NO6 and a molecular weight of 399.4. The structural formula of colchicine is given below.
Colchicine occurs as a pale yellow powder that is soluble in water.
COLCRYS (colchicine, USP) tablets are supplied for oral administration as purple, filmcoated, capsule-shaped tablets (0.1575” x 0.3030”), debossed with “AR 374” on one side and scored on the other, containing 0.6 mg of the active ingredient colchicine USP. Inactive ingredients: carnauba wax, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide and triacetin.
What are the possible side effects of colchicine (Colcrys)?
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.
Call your doctor at once if you have a serious side effect such as:
- muscle pain or weakness;
- numbness or tingly feeling in your fingers or toes;
- pale or gray appearance of your lips, tongue, or hands;
- severe vomiting or diarrhea;
- easy bruising or bleeding, feeling weak or tired;
- fever, chills, body aches, flu symptoms;
- blood in your urine; or
- urinating less...
What are the precautions when taking colchicine tablets (Colcrys)?
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; 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: kidney problems, liver problems (such as cirrhosis).
Alcohol can decrease this drug's effectiveness. Limit alcohol while taking this drug.
This medication can affect how well your body absorbs some foods and nutrients (such as vitamin B12). Consult your doctor or pharmacist for more details.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription...
Last reviewed on RxList: 1/5/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Colcrys Information
Colcrys - User Reviews
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Report Problems to the Food and Drug Administration
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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