Yunzhi Colchicine Tablets

1. Indications and Usage
Acute Flares of Gout:
Indicated for the treatment of acute flares of gouty arthritis.
Prophylaxis of Gout Flares:
Indicated for the prophylaxis of flares in patients with gout.
Familial Mediterranean Fever (FMF):
Indicated for the treatment of FMF in adults and pediatric patients (1 year of age and older).
2. Dosage and Administration
Acute Gout:
Dose: 1.2 mg orally at the first sign of a flare, followed by 0.6 mg one hour later (“1.2/0.6 mg regimen”).
Limit: Maximum dose within a 1-hour period is 1.8 mg. No repeat dosing for at least 3 days.
Prophylaxis of Gout Flares:
Dose: 0.6 mg once or twice daily.
FMF:
Dose: 1.0 mg to 3.0 mg daily as a single dose or in two divided doses.
3. Mechanism of Action
Microtubule Polymerization Inhibition:
Colchicine binds to tubulin, inhibiting microtubule polymerization and assembly.
Physiological Effect:
This inhibition disrupts the cytoskeleton and interferes with multiple inflammatory pathways, including the inhibition of neutrophil chemotaxis, degranulation, and the activation of the NLRP3 inflammasome.
4. Safety and Warnings
Bone Marrow Suppression:
Fatalities have occurred due to bone marrow suppression (aplastic anemia, thrombocytopenia, neutropenia). Monitor blood counts periodically.
Neuromyopathy:
Neuromyopathy (muscle weakness and elevated creatine phosphokinase) may occur, especially in patients with renal or hepatic impairment.
Hematologic and Renal Impairment:
Contraindicated in patients with renal or hepatic impairment when used with P-gp or strong CYP3A4 inhibitors.
5. Adverse Reactions
Most Common:
Diarrhea, nausea, vomiting, and abdominal pain.
6. Drug Interactions
Strong CYP3A4 or P-gp Inhibitors:
Concomitant use can cause fatal colchicine toxicity, particularly in patients with renal or hepatic impairment.
Examples: Clarithromycin, ritonavir, ketoconazole, cyclosporine.
Statin/Fibrates:
Caution advised when used with HMG-CoA reductase inhibitors or fibrates due to increased risk of myopathy/rhabdomyolysis.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Colchicine.
Storage:
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).