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COLCHICINE .6 mg Tablet, 3-count — NDC 72189-0331-03 package photo

COLCHICINE .6 mg Tablet, 3-count

by Direct Rx · 3 TABLET in 1 BOTTLE (72189-331-03)
NDC 72189-0331-03
🏷️ FDA NDC (as labeled) 72189-331-03 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 72189-331-03
Product NDC 72189-331
11-digit billing NDC 72189033103
NCPDP billing unit EA — each (per item)
RxCUI 197541
UNII SML2Y3J35T
Application # ANDA209876
SPL Set ID d92b7189-78fd-693d-e053-2a95a90a7c73
Established class (EPC) Alkaloid
Chemical class Alkaloids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-03-01
Route ORAL
Dosage form TABLET
Substance COLCHICINE
GPI-14 68000020000310
GPI class Colchicine
GCN Seq No 008334
GCN 35674
HICL code 003717
Ingredient (HICL) Colchicine
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2A
Therapeutic class — specific (HIC3) Colchicine
AHFS code 24:44.00.00
AHFS class Cardiovascular Drugs, Nsaid Anti-Infl
FDB label name COLCHICINE 0.6 MG TABLET
FDB brand name Colchicine
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72189-331-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72189-0331-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Alkaloid class.

Pharmacologic class Alkaloid
Drug family (ATC) Preparations with no effect on uric acid metabolism
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerDirect Rx
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA209876 (ANDA)
Labeler code72189
First marketedMar 2022
Product typeHuman Prescription Drug
Portfolio204 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name COLCHICINE 0.6 MG TABLET Ingredient Colchicine
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Colchicine guide →
2
Nutrient depletion considerations

Colchicine may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Colchicine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

  • 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.
  • 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.
  • 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.
  • UNII B1QE5P712K
    Hypromellose 2208 is a plant-derived thickening agent that dissolves in water. It's used as a binder to help hold tablet ingredients together and as a coating on pills to control how quickly the medicine releases in your body.
  • UNII EWQ57Q8I5X
    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.
  • 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.
  • UNII VH2XOU12IE
    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.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII AG9B65PV6B
    A starch derivative made from corn that helps tablets and capsules break apart quickly when swallowed. It acts as a disintegrant, allowing the medicine to dissolve and be absorbed in your stomach and intestines.
  • 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.
  • 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.
  • 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.

12 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eachPer 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 $0.3755 $1.13 / 3 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 mg 59651-0455-01 Aurobindo 100 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 —
Colchicine .6 mg 00378-1086-01 Mylan 100 tablets $0.287 AB FDA listed —
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 mgthis 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Colchicine — the program that covers self-administered drugs. 15 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Colchicine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$13.12M
Claims incl. refills
405.6K
Beneficiaries
294.4K
Spend / beneficiary
$44.59
Spend / claim
$32.35
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72189-0331-03 You're viewing this 3 TABLET in 1 BOTTLE (72189-331-03) 2022-03-01 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
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) ✓ 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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72189-331-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72189-0331-03, written without dashes as 72189033103. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72189-0331-03, the first segment (72189) is the labeler code FDA assigned to Direct Rx; the middle segment (0331) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Direct Rx. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Direct Rx is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications 📦 How Supplied / Storage and Handling 💬 Medication Guide
🎯 Indications and Usage 78 words ▾

1.1Gout Flares Colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. • Prophylaxis of Gout Flares: Colchicine tablets are indicated for prophylaxis of gout flares. • Treatment of Gout Flares: Colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare.

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 ~3 min read ▾

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 are not an analgesic medication and should not be used to treat pain from other causes.

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 are recommended upon initiation of gout flare prophylaxis with uric acid-lowering therapy. Prophylactic therapy may be beneficial for at least the first six months of uric acid-lowering therapy. 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 are not recommended for pediatric use in prophylaxis or treatment of gout flares. FMF The recommended dosage of colchicine tablets for FMF in pediatric patients 4 years of age and older is based on age. 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* * For magnitude of effect on colchicine plasma concentrations [see CLINICAL PHARMACOLOGY (12.3)] † Patients with renal or hepatic impairment should not be given colchicine tablets in conjunction with strong CYP3A4 or P-gp inhibitors [see CONTRAINDICATIONS (4)] ‡ When used in combination with Ritonavir, see dosing recommendations for strong CYP3A4 inhibitors [see CONTRAINDICATIONS (4)] Strong CYP3A4 Inhibitors† Gout Flares Noted or Anticipated Outcome Prophylaxis of Gout Flares Treat…

💊 Dosage Forms and Strengths 30 words ▾

Colchicine Tablets USP, 0.6 mg — purple color, film-coated, capsule shaped tablets debossed with ‘ [logo] 372’ on one side and score line on the other side of the tablet.

⛔ Contraindications 44 words ▾

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.

📦 How Supplied / Storage and Handling 71 words ▾

16.1How Supplied Colchicine Tablets USP, 0.6 mg are purple colored, film-coated, capsule shaped tablets debossed with ‘Stylized Y 372’ on one side and score line on the other side of the tablet. Bottles of 30 NDC 43598-372-30 Bottles of 100 NDC 43598-372-01 Bottles of 1,000 NDC 43598-372-10

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.

💬 Medication Guide ~3 min read ▾

Colchicine Tablets, USP (KOL-chi-seen) 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 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 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) • 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 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: • 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…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72189-0330-80 · Direct 72189-0332-60 · Direct →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.