Colcrys

DRUG DESCRIPTION

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.

Colcrys (colchicine) structural formula illustration

Colchicine occurs as a pale yellow powder that is soluble in water.

COLCRYS™ (colchicine tablets) (colchicine USP) tablets is supplied for oral administration as purple, film-coated, capsule-shaped tablets (0.1575” ?? 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; difficulty 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...

Read All Potential Side Effects and See Pictures of Colcrys »

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...

Read All Potential Precautions of Colcrys »


Colcrys Consumer (continued)

SIDE EFFECTS: Diarrhea, nausea, cramping, abdominal pain, and vomiting may occur. If any of these effects persist or worsen, tell 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.

Stop taking this medication and seek immediate medical attention if any of these rare but serious side effects occur: unusual bleeding/bruising, severe diarrhea or vomiting, muscle weakness or pain, numbness/tingling in your fingers or toes, pale or gray color of the lips/tongue/palms of hands, signs of infection (such as fever, persistent sore throat), unusual weakness/tiredness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe 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 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 drugs, nonprescription drugs, and herbal products).

Colchicine can decrease sperm production, which may affect the ability of a male to father a child. Consult your doctor for more information.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding. Your doctor may recommend that you separate the time(s) you take your medication apart from breast-feeding.


Colcrys Patient Information Including Side Effects

Brand Names: Colcrys

Generic Name: colchicine (Pronunciation: KOL chi seen)

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

What is colchicine (Colcrys)?

Colchicine affects the way the body responds to uric acid crystals, which reduces swelling and pain.

Because colchicine was developed prior to federal regulations requiring FDA review of all marketed drug products, not all uses for colchicine have been approved by the FDA. As of 2009, Colcrys is the only brand of colchicine that has been approved by the FDA.

The Colcrys brand of colchicine is FDA-approved to treat gout in adults, and to treat a genetic condition called Familial Mediterranean Fever in adults and children who are at least 4 years old.

Generic forms of colchicine have been used to treat or prevent attacks of gout, or to treat symptoms of Behcets syndrome (such as swelling, redness, warmth, and pain).

Colchicine is not a cure for gouty arthritis or Behcets syndrome, and it will not prevent these diseases from progressing. Colchicine should not be used as a routine pain medication for other conditions.

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

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; difficulty 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 than usual or not at all.

Less serious side effects may include:

  • mild nausea or stomach pain; or
  • mild diarrhea.

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 colchicine (Colcrys)?

Because colchicine was developed prior to federal regulations requiring FDA review of all marketed drug products, not all uses for colchicine have been approved by the FDA. As of 2009, Colcrys is the only brand of colchicine that has been approved by the FDA.

You should not use this medication if you are allergic to colchicine. Do not take colchicine if you have liver or kidney disease and are also taking any of the medications listed below under "What other drugs can affect colchicine."

Before taking colchicine, tell your doctor if yo have liver or kidney disease, heart disease, a stomach ulcer, ulcerative colitis, Crohn's disease, intestinal bleeding, or any other severe gastrointestinal disorder.

If you take colchicine over a long period of time, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

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, severe vomiting or diarrhea, easy bruising or bleeding, feeling weak or tired, flu symptoms, blood in your urine, urinating less than usual or not at all, or a pale or gray appearance of your lips, tongue, or hands.

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