Colchicine

Colchicine tablets are an alkaloid indicated for: • Prophylaxis and treatment of gout flares in adults ( 1.1 ). • Familial Mediterranean fever (FMF) in adults and children 4 years or older ( Error! Hyperlink reference not valid. ). 1.1 Gout Flares Colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. • Prophylaxis of Gout Flares: Colchicine tablets are indicated for prophylaxis of gout flares. • Treatment of Gout Flares: Colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. …

• The long-term use of colchicine is established for FMF and the prophylaxis of gout flares, but the safety and efficacy of repeat treatment for gout flares has not been evaluated
• The dosing regimens for colchicine tablets are different for each indication and must be individualized
• The recommended dosage of colchicine tablets depends on the patient’s age, renal function, hepatic function and use of coadministered drugs [see Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ]
• Colchicine tablets are administered orally without regard to meals
• Colchicine tablets are not an analgesic medication and should not be used to treat pain from other causes. • Gout Flares: Prophylaxis of Gout Flares: 0.6 mg once or twice daily
• In adults and adolescents older than 16 years of age ( Error! Hyperlink reference not valid. )
• 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 ( Error! Hyperlink reference not valid. ). • 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 ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ). o Give total daily dose in one or two divided doses ( Error! Hyperlink reference not valid. ). o 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 ( Error! Hyperlink reference not valid. ). …

Colchicine Tablets USP, 0.6 mg — purple color, film-coated, capsule shaped tablets debossed with ‘ 372’ on one side and score line on the other side of the tablet. • Tablets: 0.6 mg colchicine ( Error! Hyperlink reference not valid. ). logo

• The safety and efficacy of colchicine in children of all ages with FMF has been evaluated in uncontrolled studies
• There does not appear to be an adverse effect on growth in children with FMF treated long-term with colchicine
• Safety and effectiveness of colchicine
• In pediatric patients with gout has not been established

Clinical studies with colchicine for prophylaxis and treatment of gout flares and for treatment of FMF did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. …

• Advise the patient to read the FDA-approved patient labeling ( Error! Hyperlink reference not valid. )
• Dosing Instructions: Patients should be advised to take colchicine tablets as prescribed, even if they are feeling better
• Patients should not alter the dose or discontinue treatment without consulting with their doctor
• If a dose of colchicine tablets is missed: • For treatment of a gout flare when the patient is not being dosed for prophylaxis, take the missed dose as soon as possible. • For treatment of a gout flare during prophylaxis, take the missed dose immediately, wait 12 hours, then resume the previous dosing schedule. …

• Patients with renal or hepatic impairment should not be given colchicine tablets in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir)
• In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses
• Patients with renal or hepatic impairment should not be given colchicine tablets in conjunction with P-gp or strong CYP3A4 inhibitors ( Error! Hyperlink reference not valid. …

Colchicine is a substrate of the efflux transporter P-glycoprotein (P-gp). Of the cytochrome P450 enzymes tested, CYP3A4 was mainly involved in the metabolism of colchicine. If colchicine tablets are administered with drugs that inhibit P-gp, most of which also inhibit CYP3A4, increased concentrations of colchicine are likely. Fatal drug interactions have been reported. Physicians should ensure that patients are suitable candidates for treatment with colchicine tablets and remain alert for signs and symptoms of toxicities related to increased colchicine exposure as a result of a drug interaction. …

• Fatal overdoses have been reported with colchicine in adults and children. Keep colchicine tablets out of the reach of children ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ). • Blood dyscrasias: myelosuppression, leukopenia, granulocytopenia, thrombocytopenia and aplastic anemia have been reported ( Error! Hyperlink reference not valid. ). • Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ). …

Prophylaxis of Gout Flares: The most commonly reported adverse reaction in clinical trials of colchicine for the prophylaxis of gout was diarrhea. Treatment of Gout Flares: The most common adverse reactions reported in the clinical trial with colchicine tablets for treatment of gout flares were diarrhea (23%) and pharyngolaryngeal pain (3%). FMF: Gastrointestinal tract adverse effects are the most frequent side effects in patients initiating colchicine tablets, usually presenting within 24 hours, and occurring in up to 20% of patients given therapeutic doses. Typical symptoms include cramping, nausea, diarrhea, abdominal pain and vomiting. …

8.1 Pregnancy Risk Summary Available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Error! Hyperlink reference not valid. ). Colchicine crosses the human placenta. …

The exact dose of colchicine that produces significant toxicity is unknown. Fatalities have occurred after ingestion of a dose as low as 7 mg over a four day period, while other patients have survived after ingesting more than 60 mg. A review of 150 patients who overdosed on colchicine found that those who ingested less than 0.5 mg/kg survived and tended to have milder toxicities such as gastrointestinal symptoms, whereas those who took 0.5 to 0.8 mg/kg had more severe reactions such as myelosuppression. There was 100% mortality in those who ingested more than 0.8 mg/kg. …

Tolerance, abuse or dependence with colchicine has not been reported.

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