Colchicine

Colcrys treats acute gout flares at the first sign and prevents gout flares; it also treats FMF in adults and children ≥4 years. The reviewed June 2026 generic/repackaged tablet label is FMF-only: do not confer Colcrys gout approval on that package. Gout pediatric efficacy/safety is unestablished; Colcrys prophylaxis dose text includes adolescents older than 16 while section 2.3 says pediatric gout use is not recommended, requiring product/prescriber reconciliation.

Mitigare capsules prevent gout flares in adults; acute flare treatment during prophylaxis is unstudied, and FMF/CV dosing is not inferred. LoDoCo reduces risk of MI, stroke, coronary revascularization and CV death in adults with established atherosclerotic disease or multiple CV risk factors. Its 0.5 mg regimen is not a gout rescue course or a substitute for comprehensive CV prevention. Gloperba ready-to-use oral solution is labeled for adult gout prophylaxis; acute flare treatment during prophylaxis is unstudied, and FMF/CV regimens are not inferred.

Mild/moderate hepatic impairment: gout regimens generally need no automatic change but close monitoring; FMF requires close monitoring. Severe disease: consider reduction for prophylaxis/FMF; acute course need not be reduced, but repeat no more than every 2 weeks and consider alternative for repeated courses. Flare treatment while already on prophylaxis is not recommended with hepatic impairment. Interaction contraindications still apply; this is not permission for an inhibitor combination.

Colcrys section 2.4 has indication-specific adjustment tables for current or recent (prior 14 days) CYP3A4/P-gp inhibitors, only when an alternative is unavailable and organ-function restrictions permit. A pharmacist must select exact table, drug, indication and repeat interval; normal doses above do not apply automatically. LoDoCo’s strong-inhibitor contraindications cannot be bypassed by using Colcrys dose reductions.

• Colcrys and selected FMF tablet: renal OR hepatic impairment together with P-gp or strong CYP3A4 inhibitors is contraindicated; label includes protease inhibitors except unboosted fosamprenavir wording, not permission for ritonavir combinations.
• Mitigare and Gloperba: contraindicated with BOTH renal and hepatic impairment; also renal OR hepatic impairment with drugs inhibiting BOTH CYP3A4 and P-gp. Its avoidance warnings extend beyond this shorter formal list.
• LoDoCo: any concurrent strong CYP3A4 inhibitor or P-gp inhibitor, CrCl <15 mL/min, severe hepatic impairment, pre-existing blood dyscrasias, or product hypersensitivity. Section 4 says P-gp inhibitors without a strength qualifier; do not narrow it to strong-only based on a table comment.

Selected Colcrys, FMF tablet, Mitigare LoDoCo and Gloperba labels contain no boxed warning. Fatal toxicity and product-specific contraindications remain prominent full-label warnings.

Diarrhea, nausea, vomiting, cramping/abdominal pain and muscle pain are reported; severe symptoms require toxicity assessment. Other reports include neuropathy, alopecia/rash, liver-enzyme abnormalities, cytopenias and reproductive effects; postmarketing frequency is uncertain. Any excess/accidental ingestion needs immediate emergency/Poison Help (1-800-222-1222), even before symptoms. No established safe overdose threshold or specific antidote; systemic poisoning may progress to multiorgan failure. Hemodialysis does not effectively remove colchicine; no home decontamination instructions.

Examples include clarithromycin, azole antifungals and ritonavir combinations (CYP3A4), and cyclosporine/ranolazine (P-gp); combinations can be fatal. Colcrys/FMF tablet contraindications apply with renal/hepatic impairment; otherwise reduced/interrupted dosing may be necessary, using full section 2.4 tables. Mitigare advises avoiding CYP3A4 or P-gp inhibitors, with reduced dose/frequency and monitoring if unavoidable; dual-inhibitor plus organ impairment is prohibited. LoDoCo prohibits strong CYP3A4 or any P-gp inhibitor regardless of organ function. Gloperba likewise advises avoiding CYP3A4 or P-gp inhibitors, with product-specific reduced dosing/frequency if necessary; its dual-inhibitor/organ-impairment combinations are prohibited. Its selected section 7.4 posaconazole exception requires pharmacist review and is not a LoDoCo permission.

Verapamil, diltiazem, erythromycin or fluconazole can increase exposure; review exact product. LoDoCo: monitor moderate inhibitors, avoid with existing renal/hepatic impairment. Mitigare studies at specified doses do not establish safety for every inhibitor or patient. Avoid grapefruit/grapefruit juice; mechanistic or volunteer-study findings do not override label warning. Gloperba section 7.4 specifies 0.24 mg (2 mL) with posaconazole but supplies no explicit dosing frequency in that exception; do not infer a regimen from this isolated statement. Formal contraindications still govern, and full prescription/pharmacy clarification is required before use.

Statins and fibrates can add myopathy/rhabdomyolysis risk; digoxin also has reported rhabdomyolysis interactions. Weigh benefit/risk and monitor clinical muscle symptoms; normal CK or routine CK testing does not guarantee prevention. These risks do not amount to a universal ban on every statin.

See separate dose tables and contraindications. Colchicine clearance falls with kidney/liver dysfunction; older patients require cautious selection and medicine review even with apparently normal function. LoDoCo has stricter CrCl <15/severe liver contraindications; Mitigare/Gloperba combined kidney/liver impairment is prohibited. Indexed eGFR is not silently substituted for label CrCl in mL/min.

Selected tablets support FMF ≥4; overlapping age-6 bands need specialist resolution. No tablet gout dose is inferred for children from an FMF schedule. Colcrys prophylaxis older-than-16 wording conflicts with broader pediatric-gout caution; do not present an adolescent treatment recommendation. Mitigare, Gloperba and LoDoCo lack established pediatric dosing for their indications.

Current manufacturer Colcrys, Mitigare, selected FMF tablet LoDoCo and Gloperba summaries report observational human data without identified major pregnancy-risk signals, with study limitations and animal developmental toxicity; colchicine crosses placenta. Balance disease-treatment benefit/risk, not a claim of proved zero risk. Present in milk; assess maternal need and feeding benefits/risks, evaluate infant diarrhea/other symptoms. Rare male infertility may be reversible; untreated FMF also has reproductive consequences.

Binding tubulin inhibits microtubule assembly and neutrophil activation/migration; inflammasome/IL-1β pathways may contribute. Exact FMF benefit mechanism is incompletely understood. CV labeling describes anti-inflammatory effects rather than cholesterol reduction; no urate-lowering or universal pain-relief effect inferred.

Oral absorption, CYP3A4 metabolism, P-gp transport and renal/biliary elimination shape exposure; enterohepatic recirculation can occur. Repeated 0.6 mg tablet doses in healthy volunteers had mean half-life roughly 27–31 hours; this is not every patient/product’s value. Organ impairment and inhibitors prolong/increase exposure; hemodialysis is ineffective for removal. Food is not a clinically required restriction for reviewed oral regimens.

Check product, indication, renal/hepatic function and medicine list before treatment and each change. Assess GI tolerance, muscle/nerve symptoms, infection or bleeding; targeted CBC, renal/liver studies and CK can evaluate suspected toxicity. No label-backed universal monitoring frequency or safe CK threshold asserted. Follow FMF disease control, gout flare prevention and CV-risk care according to the prescriber plan.

Take the exact prescribed regimen; 0.5 and 0.6 mg products are not automatically interchangeable. Acute Colcrys dose is a short limited course, not repeated until diarrhea. Avoid grapefruit and unreviewed new medicines. Stop and seek assessment for toxicity symptoms; call immediately for any overdose. Keep secure and never share. No off-label pericarditis, Behçet or other specialist dose algorithm supplied.

Tablet

0.6 mg purple, capsule-shaped film-coated tablet; AR 374 and score.

Manufacturer package

Takeda label lists NDC 64764-119-01 (100) and 64764-119-07 (30); verify actual package.

Status

Prescription oral product; manufacturer PDF clinical revision May 2020, currently retrieved, not proof of stock.

Tablets

Colcrys and selected FMF generic 0.6 mg scored tablets; generic G 02 appearance differs.

Capsules

Mitigare 0.6 mg dark/light-blue hard capsule, West-ward 118; do not infer tablet splitting.

CV tablet

LoDoCo 0.5 mg white to slightly yellow round biconvex L1 tablet; selected 30-tablet blister NDC 82867-001-01.

Solution

Gloperba ready-to-use 0.6 mg/5 mL (0.12 mg/mL), red/cherry odor; 150 mL bottle NDC 69557-222-01.

Scope

Selected U.S. oral tablet, capsule and solution products; no IV or non-U.S. regimen.

Selected products generally store at 20–25°C. Colcrys/FMF tablets: tight light-resistant container; Mitigare protect light/moisture. LoDoCo keep original light-protective package, excursions 15–30°C permitted. Retain exact package instructions; keep all colchicine securely out of children’s reach. Gloperba solution: 20–25°C, excursions 15–30°C; no unsupported after-opening discard interval or compounded concentration.