Colchicine .6 mg Tablet, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Alkaloid class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Colchicine is used to prevent gout attacks (sudden, severe pain in one or more joints caused by abnormally high levels of a substance called uric acid in the blood) in adults. Colchicine is also used to relieve the pain of gout attacks when they occur. Colchicine is also used to treat familial Mediterranean fever (FMF; an inborn condition that causes episodes of fever, pain, and swelling of the stomach area, lungs, and joints) in adults and children 4 years of age and older. Colchicine (Lodoco®) is used to reduce the risk of heart attack, stroke, cardiovascular death, and needing certain ty...
Read the full MedlinePlus article ↗- 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.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII 0VUT3PMY82
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
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UNII 1IVH67816N
Hypromellose 2910 is a plant-derived cellulose compound used as a thickener and film-former in medicines. It helps control how quickly the medication dissolves and creates protective coatings on tablets or capsules.
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UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
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Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
14 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 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 | $0.118 | $3.55 / 30 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 | $11.27 / 30 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Colchicine .6 mg 00904-7120-04 | Major | 1 tablet | $0.118 | AB | Availability likely | — |
| Colchicine .6 mg 16714-0039-01 | Northstar | 30 tablets | $0.118 | — | Availability likely | — |
| Colchicine .6 mg 23155-0855-01 | Heritage | 100 tablets | $0.118 | AB | Discontinued | — |
| Colchicine .6 mg 31722-0899-01 | Camber | 100 tablets | $0.118 | AB | Availability likely | — |
| colchicine .6 mg 43598-0372-01 | Dr.Reddys | 100 tablets | $0.118 | AB | Availability likely | — |
| Colchicine .6 mg 49884-0171-01 | Par | 100 tablets | $0.118 | AB | Availability likely | — |
| Colchicine .6 mg 50268-0187-15 | AvPAK | 50 tablets | $0.118 | AB | Availability likely | — |
| Colchicine .6 mgthis 59651-0455-30 | Aurobindo | 30 tablets | $0.118 | AB | Availability likely | — |
| Colchicine .6 mg 60687-0727-21 | American | 1 tablet | $0.118 | AB | Availability likely | — |
| Colchicine .6 mg 62135-0789-30 | Chartwell | 30 tablets | $0.118 | AB | Availability likely | — |
| Colchicine .6 mg 65162-0710-03 | Amneal | 30 tablets | $0.118 | AB | Availability likely | — |
| colchicine .6 mg 67877-0589-01 | Ascend | 100 tablets | $0.118 | AB | Availability likely | — |
| Colchicine .6 mg 70010-0002-01 | Granules | 100 tablets | $0.118 | AB | Availability likely | — |
| Colchicine .6 mg 70710-1351-01 | Zydus | 100 tablets | $0.118 | — | Availability likely | — |
| Colchicine .6 mg 64380-0796-04 | Strides | 30 tablets | $0.134 | AB | Discontinued | +13% |
| Colchicine .6 mg 00378-1086-01 | Mylan | 100 tablets | $0.287 | AB | FDA listed | +143% |
| 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?
⏳ 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?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 59651-0455-01 | 100 TABLET in 1 BOTTLE (59651-455-01) | $0.1182 / ea | $11.82 | 2022-03-22 | Active |
| 59651-0455-30 You're viewing this | 30 TABLET in 1 BOTTLE (59651-455-30) | $0.1182 / ea | $3.55 | 2022-03-22 | Active |
| 59651-0455-91 | 100000 TABLET in 1 BAG (59651-455-91) | — | — | — | Active |
You're viewing the smallest of 3 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.1182 NADAC).
This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 59651-0455-30?
What is the difference between NDC 59651-0455-30 and NDC 59651-0455-01?
What NDC number is used to bill for this package of Colchicine .6 mg Tablet?
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.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Colchicine is an alkaloid indicated for: Familial Mediterranean fever (FMF) in adults and children 4 years or older ( 1.2 ).
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 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 are not an analgesic medication and should not be used to treat pain from other causes.
FMF: Adults and children older than 12 years 1.2 to 2.4 mg; children 6 to 12 years 0.9 to 1.8 mg; children 4 to 6 years 0.3 to 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 ).
2.2FMF 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 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 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 Drug Interactions (7) ]. Table 1.
Colchicine Tablets Dose Adjustment for Coadministration with Interacting Drugs if No Alternative Available* Strong CYP3A4 Inhibitors † Drug Noted or Anticipated Outcome FMF Original Intended Dosage Adjusted Dose Atazanavir Clarithromycin Darunavir/ Ritonavir ‡ Indinavir Itraconazole Ketoconazole Lopinavir/ Ritonavir ‡ Nefazodone Nelfinavir Ritonavir Saquinavir Telithromycin Tipranavir/ Ritonavir ‡ Significant increasein colchicine plasma levels*; fatal colchicine toxicity has beenreported with clarithromycin, a strong CYP3A4 inhibitor.
Similarly, significant increasein colchicine plasma levelsisanticipatedwithother strong CYP3A4 inhibitors. Maximum daily dose of1.2 to 2.4mg Maximum daily dose of0.6mg (maybe givenas 0.3mg twice a day) Moderate CYP3A4 Inhibitors Drug Noted or Anticipated Outcome FMF Original Intended Dosage Adjusted Dose Amprenavir ‡ Aprepitant Diltiazem Erythromycin Fluconazole Fosamprenavir ‡ (prodrugof Amprenavir) Grapefruit juice Verapamil Significant increasein colchicine plasma concentrationisanticipated.Neuromuscular toxicity has beenreported withdiltiazemand verapamil interactions.
Maximum daily dose of1.2 to2.4mg Maximum daily dose of1.2mg (maybe givenas 0.6mg twice a day) P-gp Inhibitors † Drug Noted or Anticipated Outcome FMF Original Intended Dosage Adjusted Dose Cyclosporine Ranolazine Significant increaseincolchicine plasma levels*;fatal colchicine toxicity has beenreportedwithcyclosporine, a P-gpinhibitor.Similarly, significant increaseincolchicine plasma levelsisanticipatedwithotherP-gpinhibitors. Maximum dailydoseof1.2 to 2.4mg Maximum daily doseof0.6mg (maybe givenas 0…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Colchicine Tablets USP, 0.6 mg are light purple to purple capsule-shaped, biconvex film-coated tablets debossed with "CO 6" on one side and scored on 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 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 ( 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 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 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 FMF Gastrointestinal tract adverse effects are the most frequent side effects in patients initiating colchicine, 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.
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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 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
🔄 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 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 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 toxicity should be evaluated promptly and, if toxicity is suspected, colchicine 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 orAnticipated Outcome Clinical Comment HMG-Co A ReductaseInhibitors: atorvastatin,fluvastatin,lovastatin,pravastatin,simvastatin Pharmacokineticand/orpharmacodynamicinteraction: the additionofonedrug to a stablelong-term regimen of the otherhasresultedinmyopathy andrhabdomyolysis(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 FMF, but patients should be monitored closely ( 8.6 ). In patients with severe renal impairment for 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 FMF patients ( 8.6 , 8.7 ).
For patients undergoing dialysis, 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 Potential Infertility Case reports and epidemiology studies in human male subjects on colchicine therapy indicated that infertility from colchicine is rare and may be reversible. A case report indicated that azoospermia was reversed when therapy was stopped. Case reports and epidemiology studies in female subjects on colchicine therapy have not established a clear relationship between colchicine use and female infertility.
However, since the progression of FMF without treatment may result in infertility, the use of colchicine needs to be weighed against the potential risks [see Nonclinical Toxicology (13.1) ] .
8.4 Pediatric Use The safety and efficacy of colchicine in children of all ages with FMF…
🤰 Pregnancy ▾
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.
🧒 Pediatric Use ▾
8.4Pediatric Use 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.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies with colchicine 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. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased renal function, concomitant disease or other drug therapy [see Dosage and Administration (2.4) , Clinical Pharmacology (12.3) ] .
🆘 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 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.
12.3Pharmacokinetics Absorption In healthy adults, colchicine 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 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 C max (Colchicine ng/mL) T max * (h) Vd/F (L) CL/F (L/hr) t 1/2 (h) Colchicine 0.6 mg Single Dose (N=13) 2.5 (28.7) 1.5 (1.0 to 3.0) 341.5 (54.4) 54.1 (31.0) -- Colchicine 0.6 mg TwiceDaily x 10 Days(N=13) 3.6 (23.7) 1.3 (0.5 to 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 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. Colchicine is a substrate of P-gp.
Extracorporeal Elimination Colchicine is not removed by hemodialysis.…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism by which colchicine 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Colchicine Tablets USP, 0.6 mg are light purple to purple capsule-shaped, biconvex film-coated tablets debossed with "CO 6" on one side and scored on other side. They are supplied as follows: Bottles of 30 NDC 59651-455-30 Bottles of 100 NDC 59651-455-01
16.2Storage Store at 20° to 25°C (68° 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 to pale greenish-yellow amorphous scales or powder or crystalline powder that is soluble in water, freely soluble in alcohol and in chloroform; slightly soluble in ether.
Colchicine Tablets USP are supplied for oral administration as light purple to purple capsule-shaped, biconvex film-coated tablets (0.1591” x 0.3039”), debossed with "CO 6" on one side and scored on other side, containing 0.6 mg of the active ingredient colchicine USP. Inactive ingredients: FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide and triacetin.
Chemical Structure
💬 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 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 is missed: For 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 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. Drug and Food Interactions Patients should be advised that many drugs or other substances may interact with colchicine 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 treatment.
Neuromuscular Toxicity Patients should be informed that muscle pain or weakness, tingling or numbness in fingers or toes may occur with colchicine alone or when it is used with certain other drugs. Patients developing any of these signs or symptoms must discontinue colchicine and seek medical evaluation immediately. Infertility Advise males of reproductive potential that colchicine may rarely and transiently impair fertility [see Use in Specific Populations (8.3) ].
Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 032, India
💬 Medication Guide ▾
MEDICATION GUIDE Colchicine (KOL chi seen) Tablets, for oral use 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 tablets are too high in your body.
Taking certain medicines with colchicine tablets can cause your level of colchicine tablets 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 tablets 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) • clarithromycin (Biaxin) • cyclosporine (Neoral, Gengraf, • darunavir (Prezista) Sandimmune) • fosamprenavir (Lexiva) with ritonavir • fosamprenavir (Lexiva) • indinavir (Crixivan) • itraconazole (Sporanox) • ketoconazole (Nizoral) • lopinavir/ritonavir (Kaletra) • nefazodone (Serzone) • nelfinavir mesylate (Viracept) • ritonavir (Norvir) • saquinavir mesylate (Invirase) • telithromycin (Ketek) • 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 tablets. 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: 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 p…