Generic equivalent of colchicine
2 SKUs available · Available to order · NABP accredited · DSCSA compliant
Colchicine is the generic equivalent of the brand-name drug colchicine. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Colchicine through Premier Pharma with same-day fulfillment on in-stock SKUs.
1 INDICATIONS AND USAGE Colchicine tablets are an alkaloid indicated for: • Prophylaxis and treatment of gout flares in adults ( 1.1 ). • Familial Mediterranean fever (FMF) in adults and children 4 years or older ( 1.2 ). 1.1 Gout 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. 1.2 Familial Mediterranean Fever (FMF) Colchicine tablets are indicated in adults and children four years or older for treatment of familial…
12.1 Mechanism of Action The mechanism by which colchicine tablets exert 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 thought to mediate some gout symptoms.
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The mechanism by which colchicine tablets exert 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 thought to mediate some gout symptoms. 12.3 Pharmacokinetics Absorption In healthy adults, colchicine tablets are absorbed…
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 ther…
6 ADVERSE REACTIONS Prophylaxis of Gout Flares: The most commonly reported adverse reaction in clinical trials of colchicine for the prophylaxis of gout was diarrhea. Treatment of Gout Flares: The most common adverse reactions reported in the clinical trial with colchicine tablets for treatment of gout flares were diarrhea (23%) and pharyngolaryngeal pain (3%). FMF: Gastrointestinal tract adverse effects are the most frequent side effects in patients initiating colchicine tablets, usually presen…
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 tablets are 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 tablets and re…
2 DOSAGE AND ADMINISTRATION 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)…
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 tablets 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 tablets is missed: • For treatment of a gout flare when the patient is not being dosed for prophylaxis, take the missed dose as soon as possible. • For treatment of a gout flare during prophylaxis, take the missed dose immediately, wait 1…
Source: FDA. For professional use only. Not a substitute for prescribing information.
| Name | Status |
|---|---|
| COLCHICINE 0.6MG 100 TAB | 2-Day |
| COLCHICINE 0.6MG 30 TAB | 2-Day |
Premier Pharma stocks 2 Colchicine SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Colchicine is the generic equivalent of colchicine. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Colchicine in .6 mg/1 and TABLET.
Colchicine carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
12.1 Mechanism of Action The mechanism by which colchicine tablets exert 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 thought to mediate some gout symptoms.
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