Colchicine

What is Colchicine?

• Colchicine is an alkaloid used for treatment of gout. It is also indicated in the treatment of Familial Mediterranean fever (FMF) in adults and children 4 years or older.

Colchicine structure

Colchicine-3D-balls

Colchicine3Dan

What are the uses of this medicine?

Colchicine Tablets, USP are a prescription medicine used to:

• prevent and treat gout flares in adults
• treat familial Mediterranean fever (FMF) in adults and children age 4 or older
• Colchicine Tablets, USP are not a pain medicine, and should not be taken to treat pain related to other conditions unless specifically prescribed for those conditions.

How does this medicine work?

• Colchicine (kol' chi seen) is an ancient medication that has been used for the treatment of gout for centuries.
• Colchicine is a plant alkaloid derived from several members of the lily family, including meadow saffron or autumn crocus (originally found in the district of Colchis and called colchicum).
• Colchicine inhibits microtubule and spindle formation and is believed to act by interference with leukocyte migration to the site of uric acid crystal formation, thereby reducing production of inflammatory mediators.
• Colchicine does not lower serum and tissue uric acid levels, but is effective in relieving the pain and swelling of acute gout.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have liver or kidney problems and you take P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir)

What drug interactions can this medicine cause?

• Coadministration of P-gp and/or CYP3A4 inhibitors (e.g., clarithromycin or cyclosporine) have been demonstrated to alter the concentration of colchicine.
• Using Colchicine Tablets, USP with certain other medicines, such as cholesterol-lowering medications and digoxin, can affect each other, causing serious side effects.

Especially tell your healthcare provider if you take:

• atazanavir sulfate (Reyataz)
• cyclosporine (Neoral, Gengraf, Sandimmune)
• fosamprenavir (Lexiva) with ritonavir
• indinavir (Crixivan)
• ketoconazole (Nizoral)
• nefazodone (Serzone)
• ritonavir (Norvir)
• telithromycin (Ketek)
• clarithromycin (Biaxin)
• darunavir (Prezista)
• fosamprenavir (Lexiva)
• itraconazole (Sporanox)
• lopinavir/ritonavir (Kaletra)
• nelfinavir mesylate (Viracept)
• saquinavir mesylate (Invirase)
• tipranavir (Aptivus)

Is this medicine FDA approved?

• Colchicine was officially approved for use in the United States in 1961 and it is still widely used with several million prescriptions filled yearly.
• Current indications include therapy of acute attacks of gout and as maintenance therapy in combination with other agents to prevent attacks.

How should this medicine be used?

Recommended dosage: Gout Flares: Prophylaxis of Gout Flares:

• 0.6 mg once or twice daily in adults and adolescents older than 16 years of age.
• Maximum dose 1.2 mg/day.

Treatment of Gout Flares:

• 1.2 mg (two tablets) at the first sign of a gout flare followed by 0.6 mg (one tablet) one hour later.

FMF:

• Adults and children older than 12 years 1.2 – 2.4 mg; children 6 to 12 years 0.9 – 1.8 mg; children 4 to 6 years 0.3 – 1.8 mg.
• Give total daily dose in one or two divided doses.
• Increase or decrease the dose as indicated and as tolerated in increments of 0.3 mg/day, not to exceed the maximum recommended daily dose.

Administration:

• Colchicine Tablets, USP can be taken with or without food.
• If you take too many Colchicine Tablets, USP go to the nearest hospital emergency room right away.
• Do not stop taking Colchicine Tablets, USP even if you start to feel better, unless your healthcare provider tells you.
• Your healthcare provider may do blood tests while you take Colchicine Tablets, USP.
• If you take Colchicine Tablets, USP daily and you miss a dose, then take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.
• If you have a gout flare while taking Colchicine Tablets, USP daily, report this to your healthcare provider.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 0.6 mg tablets

This medicine is available in fallowing brand namesː

• COLCRYS

What side effects can this medication cause?

• The most common side effect of Colchicine Tablets, USP in people who have gout flares is diarrhea.
• The most common side effects of Colchicine Tablets, USP in people who have FMF are abdominal pain, diarrhea, nausea and vomiting.
• Colchicine Tablets, USP can cause serious side effects or even cause death.

Get medical help right away if you have:

• Muscle weakness or pain
• Numbness or tingling in your fingers or toes
• Unusual bleeding or bruising
• Increased infections
• Feel weak or tired
• Pale or gray color to your lips, tongue or palms of your hands
• Severe diarrhea or vomiting

What special precautions should I follow?

• Avoid eating grapefruit or drinking grapefruit juice while taking Colchicine Tablets, USP. It can increase your chances of getting serious side effects.
• Fatal overdoses have been reported with colchicine in adults and children. Keep Colchicine Tablets, USP out of the reach of children.
• Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia and aplastic anemia have been reported with colchicine used in therapeutic doses. Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.
• Coadministration of colchicine with P-gp and/or strong CYP3A4 inhibitors has resulted in life-threatening interactions and death. Use of Colchicine Tablets, USP in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir) is contraindicated in patients with renal or hepatic impairment.
• Myotoxicity including rhabdomyolysis may occur, especially in combination with other drugs known to cause this effect. Consider temporary interruption or discontinuation of Colchicine Tablets, USP.
• Colchicine has not been associated with acute liver injury or liver test abnormalities except with serious overdoses.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• myelosuppression
• gastrointestinal symptoms such as abdominal pain, nausea, vomiting, diarrhea and significant fluid loss, leading to volume depletion
• Peripheral leukocytosis
• multiorgan failure
• Death is usually a result of respiratory depression and cardiovascular collapse
• Colchicine has not been associated with acute liver injury or liver test abnormalities except with serious overdoses.

Treatment of overdosage:

• Treatment of colchicine poisoning should begin with gastric lavage and measures to prevent shock.
• Otherwise, treatment is symptomatic and supportive. No specific antidote is known.
• Colchicine is not effectively removed by dialysis.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies with colchicine in pregnant women.
• Colchicine crosses the human placenta.

Can this medicine be used in children?

• The safety and efficacy of colchicine in children of all ages with FMF has been evaluated in uncontrolled studies.
• Colchicine Tablets, USP should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Gout is rare in pediatric patients; safety and effectiveness of colchicine in pediatric patients has not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: colchicine
• 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.

Who manufactures and distributes this medicine?

Distributed by:

• American Health Packaging
• Columbus, OH

What should I know about storage and disposal of this medication?

• Store Colchicine Tablets, USP at room temperature between 68°F and 77°F (20°C and 25°C).
• Keep Colchicine Tablets, USP out of the light.

The following drugs are considered antigout medications:

• Allopurinol
• Benzbromarone
• Colchicine
• Febuxostat
• Lesinurad
• Pegloticase
• Probenecid
• Rasburicase

• Dailymed label info on Colchicine
• FDA Colchicine