Colchicine .6 mg Capsule, 1,000-count — NDC 31722-099-10 (Billing 31722-0099-10)
This is a package of 1,000 capsules of Colchicine .6 mg Capsule from Camber Pharmaceuticals, Inc., marketed since Apr 2024 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 31722-099-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 31722 labeler · 099 product · 10 package
- Package marketed since
- Apr 29, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0331722099011, 0331722099103, 0331722099301
- FDA record last changed
- Jul 24, 2026
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): 072896
- GCN: 37202
- GPI-14 (Medi-Span): 68000020000120
- HICL (First Databank): 003717
- AHFS class code: 24:44.00.00
- RxCUI (RxNorm): 1550940
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| 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 | $3.22 | $3,219.30 / 1000 capsules |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 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 |
|---|---|---|---|---|---|---|
| 31722-0099-01 31722-099-01 Main listing | 100 CAPSULE in 1 BOTTLE | $1.75 / ea | $175.28 | 2024-04-29 | — | Active |
| 31722-0099-10 You're viewing this | 1000 CAPSULE in 1 BOTTLE | — | — | 2024-04-29 | — | Active |
| 31722-0099-30 31722-099-30 | 30 CAPSULE in 1 BOTTLE | $1.75 / ea | $52.58 | 2024-04-29 | — | Active |
You're viewing the largest of 3 pack sizes for this product.
This pack shows little to no recent Medicaid volume — the 100 capsules pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 31722-0099-30?
What NDC number is used to bill for this package of Colchicine .6 mg Capsule?
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 00143-3018-01 | Hikma | 100 capsules | $1.753 | AB | Availability likely | — |
| Colchicine .6 mg 00254-0460-01 | Par | 100 capsules | $1.753 | AB | Availability likely | — |
| Colchicine .6 mg 00904-6732-04 | Major | 30 capsules | $1.753 | AB | Availability likely | — |
| Colchicine .6 mg 42571-0341-01 | Micro | 100 capsules | $1.753 | AB | Availability likely | — |
| Colchicine .6 mg 59651-0446-01 | Aurobindo | 100 capsules | $1.753 | — | Availability likely | — |
| Colchicine .6 mg 60687-0358-25 | American | 30 capsules | $1.753 | AB | Availability likely | — |
| Colchicine .6 mg 70010-0001-01 | Granules | 100 capsules | $1.753 | AB | Availability likely | — |
| Mitigare .6 mg 59467-0318-01 | Hikma | 100 capsules | $6.029 | AB | Availability likely | — |
| Colchicine .6 mgthis 31722-0099-10 | Camber | 1000 capsules | — | AB | FDA listed | — |
| Colchicine .6 mg 50090-3465-00 | A-S | 4 capsules | — | AB | FDA listed | — |
| Colchicine .6 mg 67046-0889-03 | Coupler | 30 capsules | — | AB | FDA listed | — |
| Colchicine .6 mg 67046-1634-03 | Coupler | 30 capsules | — | AB | FDA listed | — |
| Colchicine .6 mg 71335-2703-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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 Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 8, 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.
🧪 Avoiding an ingredient? See Colchicine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
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 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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
More NDCs from Camber Pharmaceuticals, Inc. labeler code 31722
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- Sodium sulfate, potassium sulfate and magnesium 17.5 g/177mL; 3.13 g/177mL; 1.6 g/177mL Solution NDC 31722-098-31
- Nitazoxanide 500 mg Tablet, Film Coated NDC 31722-100-30
- Cinacalcet 30 mg Tablet, Film Coated NDC 31722-103-30
- Cinacalcet 60 mg Tablet, Film Coated NDC 31722-104-30
- Cinacalcet 90 mg Tablet, Film Coated NDC 31722-105-30
- Oseltamivir phosphate 6 mg/mL Powder, For Suspension NDC 31722-108-60
- Lidocaine hydrochloride 10 mg/mL Injection, Solution NDC 31722-116-31
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Colchicine capsules are indicated for prophylaxis of gout flares in adults. Limitations of Use: The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.
Colchicine is an alkaloid indicated for prophylaxis of gout flares in adults ( 1 ). Limitations of Use: The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended dosage is 0.6 mg (one capsule) once or twice daily ( 2 ). Maximum dose 1.2 mg/day. Colchicine capsules are administered orally, without regard to meals ( 2 ).
2.1Recommended Dosage for Gout Prophylaxis For prophylaxis of gout flares, the recommended dosage of colchicine capsules is 0.6 mg once or twice daily. The maximum dose is 1.2 mg per day. Colchicine capsules are administered orally, without regard to meals.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 0.6 mg capsules - Size '4' hard gelatin capsules with green opaque cap imprinted with “V1” in white color and light green opaque body imprinted with “85" in white color filled with white to off white colored granular powder. • 0.6 mg capsules ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS Patients with renal or hepatic impairment should not be given colchicine capsules with drugs that inhibit both P-glycoprotein and CYP3A4 inhibitors [see Drug Interactions ( 7 )] . Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not be given colchicine capsules. • Patients with renal or hepatic impairment should not be given colchicine capsules in conjunction with drugs that inhibit both P-gp and CYP3A4 ( 4 ). • Patients with both renal and hepatic impairment should not be given colchicine capsules ( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Fatal overdoses have been reported with colchicine in adults and children. Keep colchicine capsules 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 with dual P-gp and CYP3A4 inhibitors: Co-administration of colchicine with dual P-gp and 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 capsules ( 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 capsules 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.
5.3Interactions with CYP3A4 and P-gp Inhibitors Because colchicine is a substrate for both the CYP3A4 metabolizing enzyme and the P-glycoprotein efflux transporter, inhibition of either of these pathways may lead to colchicine-related toxicity. Inhibition of both CYP3A4 and P-gp by dual inhibitors such as clarithromycin has been reported to produce life-threatening or fatal colchicine toxicity due to significant increases in systemic colchicine levels. Therefore, concomitant use of colchicine capsules and inhibitors of CYP3A4 or P-glycoprotein should be avoided [see Drug Interactions ( 7 )] .
If avoidance is not possible, reduced daily dose should be considered and the patient should be monitored closely for colchicine toxicity. Use of colchicine capsules in conjunction with drugs that inhibit both P-gp and CYP3A4 is contraindicated in patients with renal or hepatic impairment [see Contraindications ( 4 )] .
5.4Neuromuscular Toxicity Neuromuscular toxicity and rhabdomyolysis have been reported from chronic treatment with colchicine in therapeutic doses, especially in combination with other drugs known to cause this effect. Patients with impaired renal function and elderly patients (even those with normal renal and hepatic function) are at increased risk. Once colchicine treatment is ceased, the symptoms generally resolve within 1 week to several months.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Gastrointestinal disorders are the most common adverse reactions with colchicine. They are often the first signs of toxicity and may indicate that the colchicine dosage needs to be reduced or therapy stopped. These include diarrhea, nausea, vomiting, and abdominal pain.
Colchicine has been reported to cause neuromuscular toxicity, which may present as muscle pain or weakness [see Warnings and Precautions ( 5.4 )] . Toxic manifestations associated with colchicine include myelosuppression, disseminated intravascular coagulation, and injury to cells in the renal, hepatic, circulatory, and central nervous system. These most often occur with excessive accumulation or overdosage [see Overdosage ( 10 )] .
The following reactions have been reported with colchicine. These have been generally reversible by interrupting treatment or lowering the dose of colchicine: Digestive: abdominal cramping, abdominal pain, diarrhea, lactose intolerance, nausea, vomiting Neurological: sensory motor neuropathy Dermatological: alopecia, maculopapular rash, purpura, rash 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 The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Colchicine is a substrate of the efflux transporter P-glycoprotein (P-gp), and the CYP3A4 metabolizing enzyme. Fatal drug interactions have been reported when colchicine is administered with clarithromycin, a dual inhibitor of CYP3A4 and P-glycoprotein. Toxicities have also been reported when colchicine is administered with inhibitors of CYP3A4 that may not be potent inhibitors of P-gp (e.g., grapefruit juice, erythromycin, verapamil), or inhibitors of P-gp that may not be potent inhibitors of CYP3A4 (e.g., cyclosporine).
Patients with renal or hepatic impairment should not be given colchicine capsules with drugs that inhibit both P-glycoprotein and CYP3A4 [see Contraindications ( 4 )] . Combining these dual inhibitors with colchicine capsules in patients with renal and hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. Physicians should ensure that patients are suitable candidates for treatment with colchicine capsules and remain alert for signs and symptoms of toxic reactions associated with increased colchicine exposure due to drug interactions.
Signs and symptoms of colchicine toxicity should be evaluated promptly and, if toxicity is suspected, colchicine capsules should be discontinued immediately. • Co-administration of P-gp or CYP3A4 inhibitors or inhibitors of both P-gp and CYP3A4 (e.g., clarithromycin or cyclosporine) have been reported to lead to colchicine toxicity. The potential for drug-drug interactions must be considered prior to and during therapy. • Concomitant use of colchicine capsules and inhibitors of CYP3A4 or P-gp should be avoided if possible.
If co-administration of colchicine capsules and an inhibitor of CYP3A4 or P-gp is necessary, the dose of colchicine capsules should be reduced and the patient should be monitored carefully for colchicine toxicity ( 7 , 12.3 ).
7.1CYP3A4 The concomitant use of colchicine capsules and CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole, grapefruit juice, erythromycin, verapamil, etc.) should be avoided due to the potential for serious and life-threatening toxicity [see Warnings and Precautions ( 5.3 ) and Clinical Pharmacology ( 12 )] . If co-administration of colchicine capsules and a CYP3A4 inhibitor is necessary, the dose of colchicine capsules should be adjusted by either reducing the daily dose or reducing the dose frequency, and the patient should be monitored carefully for colchicine toxicity [see Clinical Pharmacology ( 12 )] .
7.2P-glycoprotein The concomitant use of colchicine capsules and inhibitors of P-glycoprotein (e.g. clarithromycin, ketoconazole, cyclosporine, etc.) should be avoided due to the potential for serious and life-threatening toxicity [see Warnings and Precautions ( 5.3 ) and Clinical Pharmacology ( 12 )] . If co-administration of colchicine capsules and a P-gp inhibitor is necessary, the dose of colchicine capsules should be adjusted by either reducing the daily dose or reducing the dose frequency, and the patient should be monitored carefully for colchicine toxicity [see Clinical Pharmacology ( 12 )] .
7.3HMG-CoA Reductase Inhibitors and Fibrates Some drugs such as HMG-CoA reductase inhibitors and fibrates may increase the risk of myopathy when combined with colchicine capsules. Complaints of muscle pain or weakness could be an indication to check serum creatinine kinase levels for signs of myopathy.
7.4Drug-Drug Interaction Studies Four pharmacokinetic studies evaluated the effects of co-administration of voriconazole (200 mg BID), fluconazole (200 mg QD), cimetidine (800 mg BID), and propafenone (225 mg BID) on systemic levels of colchicine. Colchicine can be administered with these drugs at the tested doses without a need for dose adjustment. However, these results should not be extrapolated to other co-administered drugs [ see Drug-Drug Interactions ( 7.1 , 7.2 ) and Pharmacokinetics ( 12.3 ) ].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • In the presence of renal or hepatic impairment, patients should be monitored closely and dose adjustment should be considered as necessary ( 8.6 , 8.7 ). • Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus ( 8.1 ). • Lactation: Caution should be exercised when administered to a breastfeeding woman ( 8.2 ). • Females and Males of Reproductive Potential: Advise males that colchicine may rarely and transiently impair fertility ( 8.3 ) • Geriatric Use: The recommended dosage of colchicine should be based on renal/hepatic 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 other 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 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 Human 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.
8.4Pediatric Use Gout is rare in pediatric patients; the safety and effectiveness of colchicine capsules in pediatric patients has not been evaluated in controlled studies.
8.5Geriatric Use Because of the increased incidence of decreased renal function in the elderly population, and the higher incidence of other co-morbid conditions in the elderly population requiring the use of other medications, reducing the dosage of colchicine when elderly patients are treated with colchicine should be carefully considered.
8.6Renal Impairment No dedicated pharmacokinetic study has been conducted using colchicine capsules in patients with varying degrees of renal impairment. Colchicine is known to be excreted in urine in humans and… [Excerpted — this section continues on DailyMed.]
🤰 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 other 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 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 Gout is rare in pediatric patients; the safety and effectiveness of colchicine capsules in pediatric patients has not been evaluated in controlled studies.
🧓 Geriatric Use ▾
8.5Geriatric Use Because of the increased incidence of decreased renal function in the elderly population, and the higher incidence of other co-morbid conditions in the elderly population requiring the use of other medications, reducing the dosage of colchicine when elderly patients are treated with colchicine should be carefully considered.
🆘 Overdosage ▾
10 OVERDOSAGE The dose of colchicine that would induce significant toxicity for an individual is unknown. Fatalities have been reported in patients after ingesting a dose as low as 7 mg over a 4-day period, while other patients have reportedly 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 adverse reactions, such as gastrointestinal symptoms, whereas those who ingested from 0.5 to 0.8 mg/kg had more severe adverse reactions, including myelosuppression.
There was 100% mortality among patients 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 multi-organ failure and its associated consequences.
Death usually results from respiratory depression and cardiovascular collapse. If the patient survives, recovery of multi-organ injury may be accompanied by rebound leukocytosis and alopecia starting about 1 week after the initial ingestion. • Treatment of colchicine overdose 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 hemodialysis [see Pharmacokinetics ( 12.3 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Colchicine’s effectiveness as a treatment for gout has been postulated to be due to its ability to block neutrophil-mediated inflammatory responses induced by monosodium urate crystals in synovial fluid. Colchicine disrupts the polymerization of β-tubulin into microtubules, thereby preventing the activation, degranulation, and migration of neutrophils to sites of inflammation. Colchicine also interferes with the inflammasome complex found in neutrophils and monocytes that mediates interleukin-1β (IL-1β) activation.
12.3Pharmacokinetics Absorption In healthy adults, colchicine capsules when given orally reached a mean C max of 3 ng/mL in 1.3 h (range 0.7 to 2.5 h) after 0.6 mg single dose administration. Absolute bioavailability is reported to be approximately 45%. Administration with food has no effect on the rate or extent of colchicine absorption.
Colchicine is not effectively removed by hemodialysis. Distribution Colchicine has a mean apparent volume of distribution in healthy young volunteers of approximately 5 to 8 L/kg. Colchicine binding to serum protein is about 39%, primarily to albumin.
Colchicine crosses the placenta and distributes into breast milk [see Pregnancy ( 8.1 ) and Lactation ( 8. 2)] . Metabolism A published in vitro human liver microsome study showed that about 16% of colchicine is metabolized to 2-O-demethylcolchicine and 3-O-demethylcolchicine (2- and 3-DMC, respectively) by CYP3A4.
Glucuronidation is also believed to be a metabolic pathway for colchicine. Excretion In a published study in healthy volunteers, 40 to 65% of the total absorbed dose of colchicine (1 mg administered orally) was recovered unchanged in urine. Enterohepatic recirculation and biliary excretion are also believed to play a role in colchicine elimination.
Colchicine is a substrate of P-gp and P-gp efflux is postulated to play an important role in colchicine disposition. Elimination half-life in humans was found to be 31 h (range 21.7 to 49.9 h). Special Populations There is no difference between men and women in the pharmacokinetic disposition of colchicine.
Pediatric Patients: Pharmacokinetics of colchicine was not evaluated in pediatric patients. Elderly: Pharmacokinetics of colchicine have not been determined in elderly patients. A published report described the pharmacokinetics of 1 mg oral colchicine tablet in four elderly women compared to six young healthy males.
The mean age of the four elderly women was 83 years (range 75 to 93), mean weight was 47 kg (38 to 61 kg) and mean creatinine clearance was 46 mL/min (range 25 to 75 mL/min). Mean peak plasma levels and AUC of colchicine were two times higher in elderly subjects compared to young healthy males. It is possible that the higher exposure in the elderly subjects was due to decreased renal function.
Renal impairment: Pharmacokinetics of colchicine in patients with mild and moderate renal impairment is not known. A published report described the disposition of colchicine (1 mg) in young adult men and women patients who had end-stage renal disease requiring dialysis compared to patients with normal renal function. Patients with end-stage renal disease had 75% lower colchicine clearance (0.17 vs.
0.73L/hr/kg) and prolonged plasma elimination half-life (18.8 hrs vs. 4.4 hrs) as compared to subjects with normal renal function [see Renal Impairment ( 8.6 )] . Hepatic impairment: Published reports on the pharmacokinetics of intravenous colchicine in patients with severe chronic liver disease, as well as those with alcoholic or primary biliary cirrhosis, and normal renal function suggest wide inter-patient variability.
In some subjects with mild to moderate cirrhosis, the clearance of colchicine is significantly reduced and plasma half-life prolonged compared to healthy subjects. In subjects with primary biliary cirrhosis, no consistent trends were noted [see Hepatic Impairment ( 8.7 )] . No pharmacokinetic data are available f… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Colchicine’s effectiveness as a treatment for gout has been postulated to be due to its ability to block neutrophil-mediated inflammatory responses induced by monosodium urate crystals in synovial fluid. Colchicine disrupts the polymerization of β-tubulin into microtubules, thereby preventing the activation, degranulation, and migration of neutrophils to sites of inflammation. Colchicine also interferes with the inflammasome complex found in neutrophils and monocytes that mediates interleukin-1β (IL-1β) activation.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Colchicine capsules, 0.6 mg are Size '4' hard gelatin capsules with Green opaque Cap imprinted with “V1” in white color and light green opaque Body imprinted with “85" in white color filled with white to off white colored granular powder. Bottle of 30 Capsules NDC 31722-099-30 Bottle of 100 Capsules NDC 31722-099-01 Bottle of 1000 Capsules NDC 31722-099-10
16.2Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.
📋 Description ▾
11 DESCRIPTION Colchicine, USP is an alkaloid obtained from the plant colchicum autumnale. The chemical name for colchicine, USP is (N-[(7 S )-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[a]heptalen-7yl] acetamide with a molecular formula of C 22 H 25 NO 6 and a molecular weight of 399.44. The structural formula of colchicine is represented below: Colchicine, USP consists of pale yellow to pale greenish-yellow crystalline powder; is odorless or nearly so, and darkens on exposure to light.
Colchicine is freely soluble in alcohol, in chloroform and soluble in water. Colchicine capsules, USP are supplied for oral administration. Each capsule contains 0.6 mg colchicine, USP and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
The capsule shell contains FD&C blue No. 1, FD&C yellow No. 6, gelatin, iron oxide yellow and titanium dioxide.
The capsules are imprinted with white ink containing ammonia solution, potassium hydroxide, propylene glycol, shellac and titanium dioxide. colchicinecapsstructure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Dosing Instructions If a dose of colchicine capsules is missed, advise the patient to 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 Advise the patient that fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Colchicine capsules should be kept out of the reach of children. Blood Dyscrasias Advise patients that bone marrow depression with agranulocytosis, aplastic anemia, and thrombocytopenia may occur with colchicine capsules.
Drug and Food Interactions Advise patients that many drugs or other substances may interact with colchicine capsules 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, including short-term medications such as antibiotics. Patients should also be advised to report the use of non-prescription medication or herbal products.
Grapefruit and grapefruit juice may also interact and should not be consumed during treatment with colchicine capsules. Neuromuscular Toxicity Advise patients that muscle pain or weakness, tingling or numbness in fingers or toes may occur with colchicine capsules alone or when it is used with certain other drugs. Patients developing any of these signs or symptoms must discontinue colchicine capsules and seek medical evaluation immediately.
Infertility Advise males of reproductive potential that colchicine capsules may rarely and transiently impair fertility [see Use in Specific Populations ( 8.3 )]. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854.
By: Annora Pharma Pvt. Ltd. Sangareddy - 502313, Telangana, India.
Revised: 07/2024 Camber-logo
🍼 Nursing Mothers ▾
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.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption In healthy adults, colchicine capsules when given orally reached a mean C max of 3 ng/mL in 1.3 h (range 0.7 to 2.5 h) after 0.6 mg single dose administration. Absolute bioavailability is reported to be approximately 45%. Administration with food has no effect on the rate or extent of colchicine absorption.
Colchicine is not effectively removed by hemodialysis. Distribution Colchicine has a mean apparent volume of distribution in healthy young volunteers of approximately 5 to 8 L/kg. Colchicine binding to serum protein is about 39%, primarily to albumin.
Colchicine crosses the placenta and distributes into breast milk [see Pregnancy ( 8.1 ) and Lactation ( 8. 2)] . Metabolism A published in vitro human liver microsome study showed that about 16% of colchicine is metabolized to 2-O-demethylcolchicine and 3-O-demethylcolchicine (2- and 3-DMC, respectively) by CYP3A4.
Glucuronidation is also believed to be a metabolic pathway for colchicine. Excretion In a published study in healthy volunteers, 40 to 65% of the total absorbed dose of colchicine (1 mg administered orally) was recovered unchanged in urine. Enterohepatic recirculation and biliary excretion are also believed to play a role in colchicine elimination.
Colchicine is a substrate of P-gp and P-gp efflux is postulated to play an important role in colchicine disposition. Elimination half-life in humans was found to be 31 h (range 21.7 to 49.9 h). Special Populations There is no difference between men and women in the pharmacokinetic disposition of colchicine.
Pediatric Patients: Pharmacokinetics of colchicine was not evaluated in pediatric patients. Elderly: Pharmacokinetics of colchicine have not been determined in elderly patients. A published report described the pharmacokinetics of 1 mg oral colchicine tablet in four elderly women compared to six young healthy males.
The mean age of the four elderly women was 83 years (range 75 to 93), mean weight was 47 kg (38 to 61 kg) and mean creatinine clearance was 46 mL/min (range 25 to 75 mL/min). Mean peak plasma levels and AUC of colchicine were two times higher in elderly subjects compared to young healthy males. It is possible that the higher exposure in the elderly subjects was due to decreased renal function.
Renal impairment: Pharmacokinetics of colchicine in patients with mild and moderate renal impairment is not known. A published report described the disposition of colchicine (1 mg) in young adult men and women patients who had end-stage renal disease requiring dialysis compared to patients with normal renal function. Patients with end-stage renal disease had 75% lower colchicine clearance (0.17 vs.
0.73L/hr/kg) and prolonged plasma elimination half-life (18.8 hrs vs. 4.4 hrs) as compared to subjects with normal renal function [see Renal Impairment ( 8.6 )] . Hepatic impairment: Published reports on the pharmacokinetics of intravenous colchicine in patients with severe chronic liver disease, as well as those with alcoholic or primary biliary cirrhosis, and normal renal function suggest wide inter-patient variability.
In some subjects with mild to moderate cirrhosis, the clearance of colchicine is significantly reduced and plasma half-life prolonged compared to healthy subjects. In subjects with primary biliary cirrhosis, no consistent trends were noted [see Hepatic Impairment ( 8.7 )] . No pharmacokinetic data are available for patients with severe hepatic impairment (Child-Pugh C).
Drug Interactions Pharmacokinetic studies evaluating changes in systemic levels of colchicine when co-administered with CYP3A4 inhibitors in healthy volunteers have been conducted with colchicine capsules. While voriconazole 200 mg BID for 5 days (considered a strong CYP3A4 inhibitor) and cimetidine 800 mg BID for 5 days (considered a weak CYP3A4 inhibitor) did not cause any changes in colchicine systemic levels, fluconazole 200 mg QD for 4 days with a 400 mg loading dose (considered a moderate CYP3A4 inhib… [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.
🔒 Drug Abuse and Dependence ▾
9 DRUG ABUSE AND DEPENDENCE Tolerance, abuse, or dependence from colchicine has not been reported.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies of colchicine have not been conducted. Due to the potential for colchicine to produce aneuploid cells (cells with an unequal number of chromosomes), colchicine presents a theoretical increased risk of malignancy. Mutagenesis Published studies demonstrated that colchicine was negative for mutagenicity in the bacterial reverse mutation assay.
However, in vitro chromosomal aberration assays demonstrated the formation of micronuclei following colchicine treatment. Because published studies demonstrated that colchicine induces aneuploidy through the process of mitotic nondisjunction without structural DNA changes, colchicine is not considered clastogenic, although micronuclei are formed. Impairment of Fertility There were no studies of the effects of colchicine capsules on fertility.
However, published nonclinical studies have demonstrated that colchicine-induced disruption of microtubule formation affects meiosis and mitosis. Published reproductive studies with colchicine reported abnormal sperm morphology and reduced sperm counts in males, and interference with sperm penetration, second meiotic division, and normal cleavage in females. Case reports and epidemiology studies in human male subjects on colchicine therapy indicate that infertility from colchicine is rare.
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.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies of colchicine have not been conducted. Due to the potential for colchicine to produce aneuploid cells (cells with an unequal number of chromosomes), colchicine presents a theoretical increased risk of malignancy. Mutagenesis Published studies demonstrated that colchicine was negative for mutagenicity in the bacterial reverse mutation assay.
However, in vitro chromosomal aberration assays demonstrated the formation of micronuclei following colchicine treatment. Because published studies demonstrated that colchicine induces aneuploidy through the process of mitotic nondisjunction without structural DNA changes, colchicine is not considered clastogenic, although micronuclei are formed. Impairment of Fertility There were no studies of the effects of colchicine capsules on fertility.
However, published nonclinical studies have demonstrated that colchicine-induced disruption of microtubule formation affects meiosis and mitosis. Published reproductive studies with colchicine reported abnormal sperm morphology and reduced sperm counts in males, and interference with sperm penetration, second meiotic division, and normal cleavage in females. Case reports and epidemiology studies in human male subjects on colchicine therapy indicate that infertility from colchicine is rare.
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.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Colchicine Capsules 0.6 mg - 30' s count container label Colchicine Capsules 0.6 mg - 100' s count container label Colchicine Capsules 0.6 mg - 1000' s count container label 30capsules 100capsules 1000capsules
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |