Colchicine .6 mg Tablet, Film Coated, 90-count — NDC 62135-789-90 (Billing 62135-0789-90)
This is a package of 90 tablets of Colchicine .6 mg Tablet, Film Coated from Chartwell RX, LLC, marketed since Mar 2023 and currently FDA-listed; retail pharmacies pay about $0.1221 per tablet (NADAC).
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 008334
- GCN: 35674
- GPI-14 (Medi-Span): 68000020000310
- HICL (First Databank): 003717
- AHFS class code: 24:44.00.00
- RxCUI (RxNorm): 197541
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Alkaloid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It depends on the product. Most colchicine products — tablets, capsules, and the liquid Gloperba — are used to prevent gout flares in adults. Colcrys tablets and generic colchicine...
- Diarrhea is the most common side effect and it's a real nuisance for many people. Colchicine affects the lining of the gut, and nausea, cramping, and loose stools often come with i...
- Why does colchicine cause so much diarrhea?
- This is one of the most important questions you can ask. Colchicine has some serious drug interactions that have caused deaths — not just discomfort. Certain antibiotics (like clar...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Colchicine — tap one for details:
Colchicine may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.122 | $10.99 / 90 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.3755 | $33.80 / 90 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 62135-0789-30 62135-789-30 Main listing | 30 TABLET, FILM COATED in 1 BOTTLE | $0.1221 / ea | $3.66 | 2023-10-27 | — | Active |
| 62135-0789-90 You're viewing this | 90 TABLET, FILM COATED in 1 BOTTLE | $0.1221 / ea | $10.99 | 2023-10-27 | — | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.1221 NADAC).
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 62135-0789-30?
What NDC number is used to bill for this package of Colchicine .6 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Colchicine .6 mg 00904-7120-04 | Major | 1 tablet | $0.122 | AB | Availability likely | — |
| Colchicine .6 mg 16714-0039-01 | Northstar | 30 tablets | $0.122 | — | Availability likely | — |
| Colchicine .6 mg 23155-0855-01 | Heritage | 100 tablets | $0.122 | AB | Discontinued | — |
| Colchicine .6 mg 31722-0899-01 | Camber | 100 tablets | $0.122 | AB | Availability likely | — |
| colchicine .6 mg 43598-0372-01 | Dr.Reddys | 100 tablets | $0.122 | AB | Availability likely | — |
| Colchicine .6 mg 49884-0171-01 | Par | 100 tablets | $0.122 | AB | Availability likely | — |
| Colchicine .6 mg 50268-0187-15 | AvPAK | 50 tablets | $0.122 | AB | Availability likely | — |
| Colchicine .6 mg 59651-0455-01 | Aurobindo | 100 tablets | $0.122 | AB | Availability likely | — |
| Colchicine .6 mg 60687-0727-21 | American | 1 tablet | $0.122 | AB | Availability likely | — |
| Colchicine .6 mgthis 62135-0789-90 | Chartwell | 90 tablets | $0.122 | AB | Availability likely | — |
| Colchicine .6 mg 65162-0710-03 | Amneal | 30 tablets | $0.122 | AB | Availability likely | — |
| colchicine .6 mg 67877-0589-01 | Ascend | 100 tablets | $0.122 | AB | Availability likely | — |
| Colchicine .6 mg 70010-0002-01 | Granules | 100 tablets | $0.122 | AB | Availability likely | — |
| Colchicine .6 mg 70710-1351-01 | Zydus | 100 tablets | $0.122 | — | Availability likely | — |
| Colchicine .6 mg 64380-0796-04 | Strides | 30 tablets | $0.134 | AB | Discontinued | +9% |
| Colchicine .6 mg 00378-1086-01 | Mylan | 100 tablets | $0.287 | AB | FDA listed | +135% |
| Colchicine .6 mg 33342-0341-07 | Macleods | 30 tablets | — | AB | FDA listed | — |
| Colchicine .6 mg 50090-7205-07 | A-S | 4 tablets | — | — | FDA listed | — |
| Colchicine .6 mg 51407-0082-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| colchicine .6 mg 60760-0839-10 | ST. | 10 tablets | — | AB | FDA listed | — |
| Colcrys .6 mg 63187-0292-03 | Proficient | 3 tablets | — | — | FDA listed | — |
| Colchicine .6 mg 63629-2166-01 | Bryant | 100 tablets | — | — | FDA listed | — |
| Colchicine .6 mg 63629-2167-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| colchicine .6 mg 63629-8362-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| colchicine .6 mg 63629-8766-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| colchicine .6 mg 68071-2567-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Colchicine .6 mg 70518-3851-00 | REMEDYREPACK | 9 tablets | — | AB | Discontinued | — |
| colchicine .6 mg 70518-4000-01 | REMEDYREPACK | 9 tablets | — | AB | FDA listed | — |
| colchicine .6 mg 71205-0687-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| colchicine .6 mg 71335-1738-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Colchicine .6 mg 71335-1802-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| Colchicine .6 mg 71335-2791-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Colchicine .6 mg 71610-0494-03 | Aphena | 9 tablets | — | AB | FDA listed | — |
| colchicine .6 mg 72162-1855-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Colchicine .6 mg 72189-0249-03 | direct | 3 tablets | — | — | FDA listed | — |
| Colchicine .6 mg 72189-0331-03 | Direct | 3 tablets | — | AB | FDA listed | — |
| Colchicine .6 mg 72789-0572-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| colchicine .6 mg 50090-8014-07 | A-S | 4 tablets | — | AB | FDA listed | — |
| Colchicine .6 mg 72189-0687-03 | Direct_Rx | 3 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ( 1.2 ).
1.1Gout Flares Colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. Prophylaxis of Gout Flares: Colchicine tablets is 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.
1.2Familial Mediterranean Fever (FMF) Colchicine tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).
⏱️ Dosage and Administration ▾
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 Dosage and Administration ( 2.4 , 2.5 , 2.6 )].
Colchicine tablets are administered orally without regard to meals. Colchicine tablets is 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 ( 2.1 ).
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 ( 2.1 ). 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.
( 2.2 , 2.3 ). Give total daily dose in one or two divided doses ( 2.2 ). 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 ( 2.2 ).
Colchicine tablets are administered orally without regard to meals. See full prescribing information (FPI) for dose adjustment regarding patients with impaired renal function ( 2.5 ), impaired hepatic function ( 2.6 ), the patient's age ( 2.3 , 8.5 ) or use of coadministered drugs ( 2.4 ).
2.1Gout Flares Prophylaxis of Gout Flares The recommended dosage of colchicine tablets for prophylaxis of gout flares for adults and adolescents older than 16 years of age is 0.6 mg once or twice daily. The maximum recommended dose for prophylaxis of gout flares is 1.2 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 is 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. Treatment of Gout Flares The recommended dose of colchicine tablets for treatment of a gout flare is 1.2 mg (two tablets) at the first sign of the flare followed by 0.6 mg (one tablet) one hour later.
Higher doses have not been found to be more effective. The maximum recommended dose for treatment of gout flares is 1.8 mg over a 1-hour period. Colchicine tablets may be administered for treatment of a gout flare during prophylaxis at doses not to exceed 1.2 mg (two tablets) at the first sign of the flare followed by 0.6 mg (one tablet) one hour later.
Wait 12 hours and then resume the prophylactic dose.
2.2FMF The recommended dosage of Colchicine tablets for FMF in adults is 1.2 mg to 2.4 mg daily. Colchicine tablets should be increased as needed to control disease and as tolerated in increments of 0.3 mg/day to a maximum recommended daily dose. If intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day. The total daily Colchicine tablets dose may be administered in one to two divided doses.
2.3Recommended Pediatric Dosage Prophylaxis and Treatment of Gout Flares Colchicine tablets is 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. The following daily doses may be given as a single or divided dose twice daily: Children 4 to 6 years: 0.3 mg to 1.8 mg daily Children 6 to 12 years: 0.9 mg to 1.8 mg daily Adolescents older than 12 years: 1.2 mg to 2.4 mg daily
2.4Dose Modification for Coadministration of Interacting Drugs Concomitant Therapy Coadminist… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablets: 0.6 mg colchicine - purple colored film-coated, capsule-shaped tablets, debossed with 'C' on one side and scored on the other side. Tablets: 0.6 mg colchicine ( 3 )
⛔ Contraindications ▾
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 ( 5.3 ).
In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses ( 7 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Fatal overdoses have been reported with colchicine in adults and children. Keep colchicine tablets out of the reach of children ( 5.1 , 10 ). Blood dyscrasias: myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia have been reported.
( 5.2 ) Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine (5.2 , 5.3 , 5.4 , 6 , 10 ). 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 ( 5.3 , 7 ). 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 ( 5.4 , 7 ).
5.1Fatal Overdose Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine [see Overdosage (10) ]. Colchicine tablets should be kept out of the reach of children.
5.2Blood Dyscrasias Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia have been reported with colchicine used in therapeutic doses.
5.3Drug 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 Drug Interactions (7) ].
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 Contraindications (4) ].
5.4Neuromuscular 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 may potentiate the development of myopathy [see Drug Interactions (7) ] .
Once colchicine is stopped, the symptoms generally resolve within one week to several months.
🤒 Adverse Reactions ▾
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 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 ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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. In a randomized, double-blind, placebo-controlled trial in patients with a gout flare, gastrointestinal adverse reactions occurred in 26% of patients using the recommended dose (1.8 mg over one hour) of colchicine compared to 77% of patients taking a nonrecommended high dose (4.8 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 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 regimen. Table 3. Number (%) of Patients with at Least One Drug-Related Treatment-Emergent Adverse Event with an Incidence of ≥ 2% of Patients in Any Treatment Group MedDRA System Organ Class MedDRA Preferred Term Colchicine Dose Placebo (N=59) n (%) High (N=52) n (%) Low (N=74) n (%) Number of Patients with at Least One Drug-Related TEAE 40 (77) 27 (37) 16 (27) Gastrointestinal Disorders 40 (77) 19 (26) 12 (20) Diarrhea 40 (77) 17 (23) 8 (14) Nausea 9 (17) 3 (4) 3 (5) Vomiting 9 (17) 0 0 Abdominal Discomfort 0 0 2 (3) General Disorders and Administration Site Conditions 4 (8) 1 (1) 1 (2) Fatigue 2 (4) 1 (1) 1 (2) Metabolic and Nutrition Disorders 0 3 (4) 2 (3) Gout 0 3 (4) 1 (2) Nervous System Disorders 1 (2) 1 (1.4) 2 (3) Headache 1 (2) 1 (1) 2 (3) Respiratory Thoracic Mediastinal Disorders 1 (2) 2 (3) 0 Pharyngolaryngeal Pain 1 (2) 2 (3) 0
6.2Postmarketing 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 Overdosage (10) ]. 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 poss… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS 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 tablet is 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. Signs and symptoms of colchicine tablets toxicity should be evaluated promptly and, if toxicity is suspected, colchicine tablets should be discontinued immediately.
Table 4 provides recommendations as a result of other potentially significant drug interactions. Table 1 provides recommendations for strong and moderate CYP3A4 inhibitors and P-gp inhibitors. Table 4.
Other Potentially Significant Drug Interactions Concomitant Drug Class or Food Noted or Anticipated Outcome Clinical Comment HMG-Co A Reductase Inhibitors: atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin Pharmacokinetic and/or pharmacodynamic interaction: the addition of one drug to a stable long-term regimen of the other has resulted in myopathy and rhabdomyolysis (including a fatality) Weigh the potential benefits and risks and carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during initial therapy; monitoring CPK (creatine phosphokinase) will not necessarily prevent the occurrence of severe myopathy.
Other Lipid-Lowering Drugs: fibrates, gemfibrozil Digitalis Glycosides: digoxin P-gp substrate; rhabdomyolysis has been reported Coadministration of P-gp and/or CYP3A4 inhibitors (e.g., clarithromycin or cyclosporine) have been demonstrated to alter the concentration of colchicine. The potential for drug-drug interactions must be considered prior to and during therapy. See FPI for a complete list of reported and potential interactions ( 2.4 , 5.3 , 7 ).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS In the presence of mild to moderate renal or hepatic impairment, adjustment of dosing is not required for treatment of gout flare, prophylaxis of gout flare and FMF, but patients should be monitored closely (8.6). In patients with severe renal impairment for prophylaxis of gout flares, the starting dose should be 0.3 mg/day for gout flares, no dose adjustment is required, but a treatment course should be repeated no more than once every two weeks. In FMF patients, start with 0.3 mg/day, and any increase in dose should be done with close monitoring ( 8.6 ).
In patients with severe hepatic impairment, a dose reduction may be needed in prophylaxis of gout flares and FMF patients; while a dose reduction may not be needed in gout flares, a treatment course should be repeated no more than once every two weeks ( 8.6 , 8.7 ). For patients undergoing dialysis, the total recommended dose for prophylaxis of gout flares should be 0.3 mg given twice a week with close monitoring. For treatment of gout flares, the total recommended dose should be reduced to 0.6 mg (one tablet) × 1 dose and the treatment course should not be repeated more than once every two weeks.
For FMF patients, the starting dose should be 0.3 mg/day and dosing can be increased with close monitoring ( 8.6 ). Females and Males of Reproductive Potential: Advise males that colchicine may transiently impair fertility ( 8.3 ). Geriatric Use: The recommended dose of colchicine should be based on renal function ( 8.5 ).
8.1Pregnancy 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 Data) . Colchicine crosses the human placenta. Although animal reproductive and developmental studies were not conducted with Colchicine, published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratogenicity and altered postnatal development at exposures within or above the clinical therapeutic range.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Human Data Available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects or miscarriage in pregnant women with rheumatic diseases (such as rheumatoid arthritis, Behcet's disease, or familial Mediterranean fever (FMF) treated with colchicine at therapeutic doses during pregnancy. Limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications.
8.2Lactation Risk Summary Colchicine is present in human milk (see Data). Adverse events in breastfed infants have not been reported in the published literature after administration of colchicine to lactating women. There are no data on the effects of colchicine on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for colchicine and any potential adverse effects on the breastfed child from colchicine or from the underlying maternal condition. Data Limited published data from case reports and a small lactation study demonstrate that colchicine is present in breastmilk. A systematic review of literature reported no adverse effects in 149 breastfed children.
In a prospective observational cohort study, no gastrointestinal or other symptoms were reported in 38 colchicine-exposed breastfed infants.
8.3Females and Males of Reproductive Potent… [Excerpted — this section continues on DailyMed.]
🆘 Overdosage ▾
10 OVERDOSAGE 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. The first stage of acute colchicine toxicity typically begins within 24 hours of ingestion and includes gastrointestinal symptoms such as abdominal pain, nausea, vomiting, diarrhea, and significant fluid loss, leading to volume depletion. Peripheral leukocytosis may also be seen.
Life-threatening complications occur during the second stage, which occurs 24 to 72 hours after drug administration, attributed to multiorgan failure and its consequences. Death is usually a result of respiratory depression and cardiovascular collapse. If the patient survives, recovery of multiorgan injury may be accompanied by rebound leukocytosis and alopecia starting about one week after the initial ingestion.
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 [see Clinical Pharmacology (12.3) ].
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism by which colchicine tablets exerts its beneficial effect in patients with FMF has not been fully elucidated; however, evidence suggests that colchicine may interfere with the intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediates activation of interleukin-1β. Additionally, colchicine disrupts cytoskeletal functions through inhibition of β-tubulin polymerization into microtubules, and consequently prevents the activation, degranulation, and migration of neutrophils thought to mediate some gout symptoms.
12.3Pharmacokinetics Absorption In healthy adults, colchicine tablets is absorbed when given orally, reaching a mean C max of 2.5 ng/mL (range 1.1 to 4.4 ng/mL) in one to two hours (range 0.5 to 3 hours) after a single dose administered under fasting conditions. Following oral administration of colchicine tablets given as 1.8 mg colchicine over one hour to healthy, young adults under fasting conditions, colchicine appears to be readily absorbed, reaching mean maximum plasma concentrations of 6.2 ng/mL at a median 1.81 hours (range: 1.0 to 2.5 hours).
Following administration of the nonrecommended high-dose regimen (4.8 mg over six hours), mean maximal plasma concentrations were 6.8 ng/mL, at a median 4.47 hours (range: 3.1 to 7.5 hours). After ten days on a regimen of 0.6 mg twice daily, peak concentrations are 3.1 to 3.6 ng/mL (range 1.6 to 6.0 ng/mL), occurring 1.3 to 1.4 hours postdose (range 0.5 to 3.0 hours). Mean pharmacokinetic parameter values in healthy adults are shown in Table 5.
Table 5. Mean (%CV) Pharmacokinetic Parameters in Healthy Adults Given Colchicine Tablets C max (Colchicine ng/mL) T max * (h) Vd/F (L) CL/F (L/hr) t 1/2 (h) Colchicine Tablets 0.6 mg Single Dose (N=13) 2.5 (28.7) 1.5 (1.0 – 3.0) 341.5 (54.4) 54.1 (31.0) -- Colchicine Tablets 0.6 mg Twice Daily × 10 Days (N=13) 3.6 (23.7) 1.3 (0.5 – 3.0) 1150 (18.7) 30.3 (19.0) 26.6 (16.3) *T max mean (range) CL = Dose/AUC 0-t (calculated from mean values) Vd = CL/Ke (calculated from mean values) In some subjects, secondary colchicine peaks are seen, occurring between three and 36 hours postdose and ranging from 39 to 155% of the height of the initial peak.
These observations are attributed to intestinal secretion and reabsorption and/or biliary recirculation. Absolute bioavailability is reported to be approximately 45%. Administration of colchicine tablets with food has no effect on the rate of colchicine absorption but does decrease the extent of colchicine by approximately 15%.
This is without clinical significance. Distribution The mean apparent volume of distribution in healthy young volunteers is approximately 5 to 8 L/kg. Colchicine binding to serum protein is low, 39 ± 5%, primarily to albumin regardless of concentration.
Colchicine crosses the placenta (plasma levels in the fetus are reported to be approximately 15% of the maternal concentration). Colchicine also distributes into breast milk at concentrations similar to those found in the maternal serum. [see Use in Specific Populations ( 8.1 , 8.2 )]. Metabolism Colchicine is demethylated to two primary metabolites, 2-O-demethylcolchicine and 3-O-demethylcolchicine (2- and 3-DMC, respectively) and one minor metabolite, 10-O-demethylcolchicine (also known as colchiceine).
In vitro studies using human liver microsomes have shown that CYP3A4 is involved in the metabolism of colchicine to 2- and 3-DMC. Plasma levels of these metabolites are minimal (less than 5% of parent drug). Elimination/Excretion In healthy volunteers (n=12), 40 to 65% of 1 mg orally administered colchicine was recovered unchanged in urine.
Enterohepatic recirculation and biliary excretion are also postulated to play a role in colchicine elimination. Following multiple oral doses (0.6 mg twice daily), the mean elimination half-lives in young healthy volunteers (mean age 25 to 28 years of age) is 26.6 to 31.2 hours. Colchic… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Colchicine Tablets, USP 0.6 mg are supplied as purple-colored film-coated capsule-shaped tablets, debossed with 'C' on one side and scored on the other side and are supplied as follows: Bottles of 30 Tablets NDC 62135-789-30 Bottles of 90 Tablets NDC 62135-789-90
16.2Storage Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Protect from light. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
📋 Description ▾
11 DESCRIPTION Colchicine, USP 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 C 22 H 25 NO 6 and a molecular weight of 399.4. The structural formula of colchicine is given below. Colchicine, USP occurs as a pale yellow powder that is soluble in water.
Colchicine Tablets, USP are supplied for oral administration as purple colored, film coated, capsule shaped tablets, debossed with 'C' on one side and scored on the other side, containing 0.6 mg of the active ingredient Colchicine, USP. Inactive ingredients: carnauba wax, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and Opadry-II purple [40L500004] (consisting of Polydextrose NF, HPMC 2910/Hypromellose USP 6mpas, HPMC 2910/Hypromellose USP 3mpas, Triacetin, HPMC 2910/Hypromellose USP 50 mpas, FD& C Blue #2/Indigo carmine Al 3 %-5 %, FD & C Red#40/Allura Red AC Aluminium Lake 15-17 %, Macrogol, Titanium Dioxide). "Image Description"
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide) 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. For prophylaxis without treatment for a gout flare, or FMF, take the dose as soon as possible and then return to the normal dosing schedule. However, if a dose is skipped the patient should not double the next dose.
Fatal Overdose Instruct patient that fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Colchicine tablets should be kept out of the reach of children. Blood Dyscrasias Patients should be informed that bone marrow depression with agranulocytosis, aplastic anemia, and thrombocytopenia may occur with colchicine tablets.
Drug and Food Interactions Patients should be advised that many drugs or other substances may interact with colchicine tablets and some interactions could be fatal. Therefore, patients should report to their healthcare provider all of the current medications they are taking, and check with their healthcare provider before starting any new medications, particularly antibiotics. Patients should also be advised to report the use of nonprescription medication or herbal products.
Grapefruit and grapefruit juice may also interact and should not be consumed during colchicine tablets treatment. Neuromuscular Toxicity Patients should be informed that muscle pain or weakness, tingling or numbness in fingers or toes may occur with colchicine tablets alone or when it is used with certain other drugs. Patients developing any of these signs or symptoms must discontinue colchicine tablets and seek medical evaluation immediately.
Infertility Advise males of reproductive potential that colchicine tablets may rarely and transiently impair fertility [see Use in Specific Populations (8.3) ]. Manufactured by: Strides Pharma Science Ltd. Bengaluru-562106, India Manufactured for: Chartwell RX, LLC.
Congers, NY 10920 Rev: 10/2023 L71772 Print Medication Guides at: www.chartwellpharma.com/medguides Print Medication Guides at: www.chartwellpharma.com/medguides
💬 Medication Guide ▾
MEDICATION GUIDE Colchicine tablets (KOL-chi-seen) Read the Medication Guide that comes with colchicine tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
You and your healthcare provider should talk about colchicine tablets when you start taking it and at regular checkups. What is the most important information that I should know about colchicine tablets? Colchicine tablets can cause serious side effects or death if levels of colchicine are too high in your body.
Taking certain medicines with colchicine tablets can cause your level of colchicine to be too high, especially if you have kidney or liver problems. Tell your healthcare provider about all your medical conditions, including if you have kidney or liver problems. Your dose of colchicine tablets may need to be changed.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Even medicines that you take for a short period of time, such as antibiotics, can interact with colchicine and cause serious side effects or death. Talk to your healthcare provider or pharmacist before taking any new medicine.
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) Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above.
This is not a complete list of all the medicines that can interact with colchicine. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
Keep colchicine tablets out of the reach of children. What are Colchicine tablets? Colchicine tablets 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 are not a pain medicine, and it should not be taken to treat pain related to other conditions unless specifically prescribed for those conditions.
Who should not take colchicine tablets? Do not take Colchicine Tablets if you have liver or kidney problems and you take certain other medicines. Serious side effects, including death, have been reported in these patients even when taken as directed.
See "What is the most important information that I should know about colchicine tablets?" What should I tell my healthcare provider before starting colchicine tablets? See "What is the most important information that I should know about colchicine tablets?" Before you take colchicine tablets, tell your healthcare provider about all your medical conditions, including if you: have liver or kidney problems. are pregnant or plan to become pregnant. It is not known if colchicine tablets will harm your unborn baby.
Talk to your healthcare provider if you are pregnant or plan to become pregnant. are a male with a female partner who can become pregnant. Receiving treatment with colchicine tablets may be related to infertility in some men that is reversible when treatment is stopped. are breastfeeding or plan to breastfeed. Colchicine passes into your breast milk.
You and your healthcare provider should decide if you will take colchicine tablets while breastfeeding. If you take colchicine tablets and breastfeed, you should talk to your child's healthcare provider about how to watch for side effects in your child. Tell your healthcare provider about all the medicines you take… [Excerpted — this section continues on DailyMed.]
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The evidence for the efficacy of colchicine in patients with chronic gout is derived from the published literature. Two randomized clinical trials assessed the efficacy of colchicine 0.6 mg twice a day for the prophylaxis of gout flares in patients with gout initiating treatment with urate-lowering therapy. In both trials, treatment with colchicine decreased the frequency of gout flares.
The efficacy of a low-dosage regimen of oral colchicine (Colchicine tablets total dose 1.8 mg over one hour) for treatment of gout flares was assessed in a multicenter, randomized, double-blind, placebo-controlled, parallel group, one-week, dose-comparison study. Patients meeting American College of Rheumatology criteria for gout were randomly assigned to three groups: high-dose colchicine (1.2 mg, then 0.6 mg hourly × 6 hours [4.8 mg total]); low-dose colchicine (1.2 mg, then 0.6 mg in one hour [1.8 mg total] followed by five placebo doses hourly); or placebo (two capsules, then one capsule hourly × six hours).
Patients took the first dose within 12 hours of the onset of the flare and recorded pain intensity (11-point Likert scale) and adverse events over 72 hours. The efficacy of colchicine was measured based on response to treatment in the target joint, using patient self-assessment of pain at 24 hours following the time of first dose as recorded in the diary. A responder was one who achieved at least a 50% reduction in pain score at the 24-hour postdose assessment relative to the pretreatment score and did not use rescue medication prior to the actual time of 24-hour postdose assessment.
Rates of response were similar for the recommended low-dose treatment group (38%) and the nonrecommended high-dose group (33%) but were higher as compared to the placebo group (16%) as shown in Table 8. Table 8. Number (%) of Responders Based on Target Joint Pain Score at 24 Hours Post First Dose Colchicine Dose Responders n (%) Placebo n (%) (n=58) % Differences in Proportion Low-Dose (n=74) High-Dose (n=52) Low-Dose vs Placebo (95% CI) High-Dose vs Placebo (95% CI) 28 (38%) 17 (33%) 9 (16%) 22 (8, 37) 17 (1, 33) Figure 1 shows the percentage of patients achieving varying degrees of improvement in pain from baseline at 24 hours.
Figure 1 Pain Relief on Low and High Doses of Colchicine and Placebo (Cumulative) The evidence for the efficacy of colchicine in patients with FMF is derived from the published literature. Three randomized, placebo-controlled studies were identified. The three placebo-controlled studies randomized a total of 48 adult patients diagnosed with FMF and reported similar efficacy endpoints as well as inclusion and exclusion criteria.
One of the studies randomized 15 patients with FMF to a six month crossover study during which five patients discontinued due to study noncompliance. The ten patients completing the study experienced five attacks over the course of 90 days while treated with colchicine compared to 59 attacks over the course of 90 days while treated with placebo. Similarly, the second study randomized 22 patients with FMF to a four-month crossover study during which nine patients discontinued due to lack of efficacy while receiving placebo or study noncompliance.
The 13 patients completing the study experienced 18 attacks over the course of 60 days while treated with colchicine compared to 68 attacks over the course of 60 days while treated with placebo. The third study was discontinued after an interim analysis of six of the 11 patients enrolled had completed the study; results could not be confirmed. Open-label experience with colchicine in adults and children with FMF is consistent with the randomized, controlled trial experience and was utilized to support information on the safety profile of colchicine and for dosing recommendations. image description
🔒 Drug Abuse and Dependence ▾
9 DRUG ABUSE AND DEPENDENCE Tolerance, abuse, or dependence with colchicine has not been reported.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Two-year studies were conducted in mice and rats to assess the carcinogenic potential of colchicine. No evidence of colchicine-related tumorigenicity was observed in mice or rats at colchicine oral doses up to 3 and 2 mg/kg/day, respectively (approximately six and eight times, respectively, the maximum recommended human dose of 2.4 mg on a mg/m 2 basis). Mutagenesis Colchicine was negative for mutagenicity in the bacterial reverse mutation assay.
In a chromosomal aberration assay in cultured human white blood cells, colchicine treatment resulted in the formation of micronuclei. Since published studies demonstrated that colchicine induces aneuploidy from the process of mitotic nondisjunction without structural DNA changes, colchicine is not considered clastogenic, although micronuclei are formed. Impairment of Fertility No studies of colchicine effects on fertility were conducted with colchicine tablets.
However, published nonclinical studies demonstrated that colchicine-induced disruption of microtubule formation affects meiosis and mitosis. Reproductive studies also reported abnormal sperm morphology and reduced sperm counts in males, and interference with sperm penetration, second meiotic division, and normal cleavage in females when exposed to colchicine. Colchicine administered to pregnant animals resulted in fetal death and teratogenicity.
These effects were dose-dependent, with the timing of exposure critical for the effects on embryofetal development. The nonclinical doses evaluated were generally higher than an equivalent human therapeutic dose, but safety margins for reproductive and developmental toxicity could not be determined.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Colchicine Tablets, USP - 0.6 mg - NDC - 62135-789-30 - 30's - Bottle Label Colchicine Tablets, USP - 0.6 mg - NDC - 62135-789-90 - 90's - Bottle Label image description image description