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Colchicine is a brand name for Colchicine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE 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…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION 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. 6 mg once or twice daily in adults and adolescents older than 16 years of age ( Error!
Hyperlink reference not valid. ). 2 mg/day. 6 mg (one tablet) one hour later ( Error! Hyperlink reference not valid. ). 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. ). 3 mg/day, not to exceed the maximum recommended daily dose ( Error! Hyperlink reference not valid. ). • Colchicine tablets are administered orally without regard to meals. • See full prescribing information (FPI) for dose adjustment regarding patients with impaired renal function ( Error!
Hyperlink reference not valid. ), impaired hepatic function ( Error! Hyperlink reference not valid. ), the patient’s age ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) or use of coadministered drugs ( Error!
Hyperlink reference not valid. ). 6 mg once or twice daily. 2 mg/day. An increase in gout flares may occur after initiation of uric acid-lowering therapy, including pegloticase, febuxostat and allopurinol, due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits.
Colchicine tablets are recommended upon initiation of gout flare prophylaxis with uric acid-lowering therapy. Prophylactic therapy may be beneficial for at least the first six months of uric acid-lowering therapy. 6 mg (one tablet) one hour later.
Higher doses have not been found to be more effective. 8 mg over a 1-hour period. 6 mg (one tablet) one hour later. Wait 12 hours and then resume the prophylactic dose. 4 mg daily. 3 mg/day to a maximum recommended daily dose. 3 mg/day. The total daily colchicine tablets dose may be administered in one to two divided doses.
6 ADVERSE REACTIONS 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.
These events should be viewed as dose-limiting if severe, as they can herald the onset of more significant toxicity. • Prophylaxis of Gout Flares: The most commonly reported adverse reaction in clinical trials for the prophylaxis of gout was diarrhea.
• Treatment of Gout Flares: The most common adverse reactions reported in the clinical trial for gout were diarrhea (23%) and pharyngolaryngeal pain (3%). • FMF: Most common adverse reactions (up to 20%) are abdominal pain, diarrhea, nausea and vomiting.
These effects are usually mild, transient and reversible upon lowering the dose ( Error! Hyperlink reference not valid. ). To report SUSPECTED ADVERSE REACTIONS, contact Dr. gov/medwatch. 1 Clinical Trials Experience in Gout Because clinical studies are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice.
5 WARNINGS AND PRECAUTIONS • 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. ). • Drug interaction P-gp and/or CYP3A4 inhibitors: Coadministration of colchicine with P-gp and/or strong CYP3A4 inhibitors has resulted in life-threatening interactions and death ( Error!
Hyperlink reference not valid. , Error! Hyperlink reference not valid. ). • Neuromuscular toxicity: Myotoxicity including rhabdomyolysis may occur, especially in combination with other drugs known to cause this effect. Consider temporary interruption or discontinuation of colchicine tablets ( Error!
Hyperlink reference not valid. , Error! Hyperlink reference not valid. ). 1 Fatal Overdose Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine [see Error! Hyperlink reference not valid.
] . Colchicine tablets should be kept out of the reach of children. 2 Blood Dyscrasias Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia and aplastic anemia have been reported with colchicine used in therapeutic doses.
3 Drug Interactions Colchicine is a P-gp and CYP3A4 substrate. Life-threatening and fatal drug interactions have been reported in patients treated with colchicine given with P-gp and strong CYP3A4 inhibitors. If treatment with a P-gp or strong CYP3A4 inhibitor is required in patients with normal renal and hepatic function, the patient’s dose of colchicine may need to be reduced or interrupted [see Error!
4 CONTRAINDICATIONS 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. ). In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses ( Error!
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3 Recommended Pediatric Dosage Prophylaxis and Treatment of Gout Flares Colchicine tablets are not recommended for pediatric use in prophylaxis or treatment of gout flares. FMF The recommended dosage of colchicine tablets for FMF in pediatric patients 4 years of age and older is based on age.
4 Dose Modification for Coadministration of Interacting Drugs Concomitant Therapy Coadministration of colchicine tablets with drugs known to inhibit CYP3A4 and/or P-glycoprotein (P-gp) increases the risk of colchicine-induced toxic effects (Table 1) .
If patients are taking or have recently completed treatment with drugs listed in Table 1 within the prior 14 days, the dose adjustments are as shown in the table below [see Error! Hyperlink reference not valid. ] . Table 1. Colchicine Tablets Dose Adjustment for Coadministration with Interacting Drugs if No Alternative Available For magnitude of effect on colchicine plasma concentrations [see Error!
Hyperlink reference not valid. ] Strong CYP3A4 Inhibitors Patients with renal or hepatic impairment should not be given colchicine tablets in conjunction with strong CYP3A4 or P-gp inhibitors [see Error! Hyperlink reference not valid.
] Gout Flares Noted or Anticipated Outcome Prophylaxis of Gout Flares Treatment of Gout Flares FMF Drug Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Atazanavir Clarithromycin Darunavir/ Ritonavir When used in combination with Ritonavir, see dosing recommendations for strong CYP3A4 inhibitors [see Error!
Hyperlink reference not valid. ] Indinavir Itraconazole Ketoconazole Lopinavir/ Ritonavir Nefazodone Nelfinavir Ritonavir Saquinavir Telithromycin Tipranavir/ Ritonavir Significant increase in colchicine plasma levels; fatal colchicine toxicity has been reported with clarithromycin, a strong CYP3A4 inhibitor.
6 mg (1 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. 3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. 3 mg twice a day) Moderate CYP3A4 Inhibitors Gout Flares Note or Anticipated Outcome Prophylaxis of Gout Flares Treatment of Gout Flares FMF Drug Original Intended Dosage Adjusted Dosage Original Intended Dosage Adjusted Dosage Original Intended Dosage Adjusted Dosage Amprenavir Aprepitant Diltiazem Erythromycin Fluconazole Fosamprenavir (prodrug of Amprenavir) Grapefruit juice Verapamil Significant increase in colchicine plasma concentration is anticipated.
Neuromuscular toxicity has been reported with diltiazem and verapamil interactions. 6 mg (1 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. 2 mg (2 tablets) x 1 dose. Dose to be repeated no earlier than 3 days. 6 mg twice a day) P-gp Inhibitors Gout Flares Note or Anticipated Outcome Prophylaxis of Gout Flares Treatment of Gout Flares FMF Drug Original Intended Dosage Adjusted Dosage Original Intended Dosage Adjusted Dosage Original Intended Dosage Adjusted Dosage Cyclosporine Ranolazine Significant increase in colchicine plasma levels; fatal colchicine toxicity has been reported with cyclosporine, a P-gp inhibitor.
Similarly, significant increase in colchicine plasma levels is anticipated with other P-gp inhibitors. 6 mg (1 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. 6 mg (1 tablet) x 1 dose. Dose to be repeated no earlier than 3 days.
3 mg twice a day) Table 2. Colchicine Tablets Dose Adjustment for Coadministration with Protease Inhibitors Protease Inhibitor Clinical Comment w/ Colchicine - Prophylaxis of Gout Flares w/o Colchicine – Treatment of Gout Flares w/Colchicine – Treatment of FMF Atazanavir sulfate (Reyataz) Patients with renal or hepatic impairment should not be given colchicine with Reyataz.
3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. 3 mg once every other day Darunavir (Prezista) Patients with renal or hepatic impairment should not be given colchicine with Prezista/ritonavir. 3 mg (1/2 tablet) 1 hour later.
Dose to be repeated no earlier than 3 days. 3 mg once every other day Fosamprenavir (Lexiva) with Ritonavir Patients with renal or hepatic impairment should not be given colchicine with Lexiva/ritonavir. 3 mg (1/2 tablet) 1 hour later.
Dose to be repeated no earlier than 3 days. 2 mg (2 tablets) x 1 dose. Dose to be repeated no earlier than 3 days. 3 mg once a day Indinavir (Crixivan) Patients with renal or hepatic impairment should not be given colchicine with Crixivan.
3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. 3 mg once every other day Lopinavir/ Ritonavir (Kaletra) Patients with renal or hepatic impairment should not be given colchicine with Kaletra. 3 mg (1/2 tablet) 1 hour later.
Dose to be repeated no earlier than 3 days. 3 mg once every other day Nelfinavir mesylate (Viracept) Patients with renal or hepatic impairment should not be given colchicine with Viracept. 3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days.
3 mg once every other day Ritonavir (Norvir) Patients with renal or hepatic impairment should not be given colchicine with Norvir. 3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. 3 mg once every other day Saquinavir mesylate (Invirase) Patients with renal or hepatic impairment should not be given colchicine with Invirase/ritonavir.
3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. 3 mg once every other day Tipranavir (Aptivus) Patients with renal or hepatic impairment should not be given colchicine with Aptivus/ritonavir. 3 mg (1/2 tablet) 1 hour later.
Dose to be repeated no earlier than 3 days. 3 mg once every other day Treatment of gout flares with colchicine tablets is not recommended in patients receiving prophylactic dose of colchicine tablets and CYP3A4 inhibitors. 5 Dose Modification in Renal Impairment Colchicine dosing must be individualized according to the patient's renal function [see Error!
Hyperlink reference not valid. ] . Cl cr in mL/minute may be estimated from serum creatinine (mg/dL) determination using the following formula: Gout Flares Prophylaxis of Gout Flares For prophylaxis of gout flares in patients with mild (estimated creatinine clearance [Cl cr ] 50 to 80 mL/min) to moderate (Cl cr 30 to 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine.
3 mg/day and any increase in dose should be done with close monitoring. 3 mg given twice a week with close monitoring [see Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ] . Treatment of Gout Flares For treatment of gout flares in patients with mild (Cl cr 50 to 80 mL/min) to moderate (Cl cr 30 to 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine.
However, in patients with severe impairment, while the dose does not need to be adjusted for the treatment of gout flares, a treatment course should be repeated no more than once every two weeks. For patients with gout flares requiring repeated courses, consideration should be given to alternate therapy.
6 mg (one tablet). For these patients, the treatment course should not be repeated more than once every two weeks [see Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ] . Treatment of gout flares with colchicine tablets is not recommended in patients with renal impairment who are receiving colchicine tablets for prophylaxis.
FMF Caution should be taken in dosing patients with moderate and severe renal impairment and in patients undergoing dialysis. For these patients, the dosage should be reduced [see Error! Hyperlink reference not valid. ] . Patients with mild (Cl cr 50 to 80 mL/min) and moderate (Cl cr 30 to 50 mL/min) renal impairment should be monitored closely for adverse effects of colchicine tablets.
Dose reduction may be necessary. 3 mg/day; any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine [see Error! Hyperlink reference not valid. ] . 3 mg (half tablet) per day. Dosing can be increased with close monitoring.
Any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine [see Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ] . 6 Dose Modification in Hepatic Impairment Gout Flares Prophylaxis of Gout Flares For prophylaxis of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine.
Dose reduction should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment [see Error! Hyperlink reference not valid. ] . Treatment of Gout Flares For treatment of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine.
However, for the treatment of gout flares in patients with severe impairment, while the dose does not need to be adjusted, a treatment course should be repeated no more than once every two weeks. For these patients, requiring repeated courses for the treatment of gout flares, consideration should be given to alternate therapy [see Error!
Hyperlink reference not valid. ] . Treatment of gout flares with colchicine tablets is not recommended in patients with hepatic impairment who are receiving colchicine tablets for prophylaxis. FMF Patients with mild to moderate hepatic impairment should be monitored closely for adverse effects of colchicine.
Dose reduction should be considered in patients with severe hepatic impairment [see Error! Hyperlink reference not valid. ] .
8 mg over six hours) of colchicine and 20% of patients taking placebo. Diarrhea was the most commonly reported drug-related gastrointestinal adverse event. As shown in Table 3, diarrhea is associated with colchicine tablets treatment.
Diarrhea was more likely to occur in patients taking the high-dose regimen than the low-dose regimen. Severe diarrhea occurred in 19% and vomiting occurred in 17% of patients taking the nonrecommended high-dose colchicine regimen but did not occur in the recommended low-dose colchicine tablets regimen.
Table 3. 2 Postmarketing Experience Serious toxic manifestations associated with colchicine include myelosuppression, disseminated intravascular coagulation and injury to cells in the renal, hepatic, circulatory and central nervous systems.
These most often occur with excessive accumulation or overdosage [see Error! Hyperlink reference not valid. ] . The following adverse reactions have been identified with colchicine. These have been generally reversible upon temporarily interrupting treatment or lowering the dose of colchicine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Neurological: sensory motor neuropathy Dermatological: alopecia, maculopapular rash, purpura, rash Digestive: abdominal cramping, abdominal pain, diarrhea, lactose intolerance, nausea, vomiting Hematological: leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia Hepatobiliary: elevated AST, elevated ALT Musculoskeletal: myopathy, elevated CPK, myotonia, muscle weakness, muscle pain, rhabdomyolysis Reproductive: azoospermia, oligospermia
Hyperlink reference not valid. ] . Use of colchicine tablets 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 [see Error!
Hyperlink reference not valid. ]. 4 Neuromuscular Toxicity Colchicine-induced neuromuscular toxicity and rhabdomyolysis have been reported with chronic treatment in therapeutic doses. Patients with renal dysfunction and elderly patients, even those with normal renal and hepatic function, are at increased risk.
Concomitant use of atorvastatin, simvastatin, pravastatin, fluvastatin, lovastatin, gemfibrozil, fenofibrate, fenofibric acid or benzafibrate (themselves associated with myotoxicity) or cyclosporine with colchicine tablets may potentiate the development of myopathy [see Error!
Hyperlink reference not valid. ] . Once colchicine is stopped, the symptoms generally resolve within one week to several months.