COLCHICINE tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
COLCHICINE (UNII: SML2Y3J35T) (COLCHICINE - UNII:SML2Y3J35T)
Available from:
Amneal Pharmaceuticals LLC
INN (International Name):
COLCHICINE
Composition:
COLCHICINE 0.6 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Colchicine tablets, USP are indicated for prophylaxis and the treatment of acute gout flares. - Prophylaxis of Gout Flares: Colchicine tablets, USP are indicated for prophylaxis of gout flares. - Treatment of Gout Flares: Colchicine tablets, USP are indicated for treatment of acute gout flares when taken at the first sign of a flare. Colchicine tablets, USP are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF). Patients with renal or hepatic impairment should not be given colchicine, USP in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir). In these patients, life-threatening and fatal colchicine, USP toxicity has been reported with colchicine, USP taken in therapeutic doses. 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 adverse maternal or fetal ou
Product summary:
Colchicine tablets, USP, 0.6 mg, are purple, capsule-shaped, film-coated tablets, scored on one side and debossed with ”A10” on the other side. They are available as: Bottles of 30:              NDC 65162-710-03 Bottles of 90:              NDC 65162-710-09 Bottles of 1,000:         NDC 65162-710-11 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Authorization status:
Abbreviated New Drug Application
Authorization number:
65162-710-03, 65162-710-09, 65162-710-11

Amneal Pharmaceuticals LLC

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MEDICATION GUIDE

Colchicine (kol’ chi seen) Tablets, USP 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)

clarithromycin (Biaxin)

cyclosporine (Neoral, Gengraf, Sandimmune)

darunavir (Prezista)

fosamprenavir (Lexiva) with ritonavir

fosamprenavir (Lexiva)

indinavir (Crixivan)

itraconazole (Sporanox)

ketoconazole (Nizoral)

lopinavir/ritonavir (Kaletra)

nefazodone (Serzone)

nelfinavir mesylate (Viracept)

ritonavir (Norvir)

saquinavir mesylate (Invirase)

telithromycin (Ketek)

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 in your child.

Tell your healthcare provider about all the medicines you take, including ones that you may only be taking

for a short time, such as antibiotics. See “What is the most important information that I should know about

colchicine tablets?” Do not start a new medicine without talking to your healthcare provider.

Using colchicine tablets with certain other medicines, such as cholesterol-lowering medications and digoxin,

can affect each other, causing serious side effects. Your healthcare provider may need to change your dose

of colchicine tablets. Talk to your healthcare provider about whether the medications you are taking might

interact with colchicine tablets and what side effects to look for.

How should I take colchicine tablets?

Take colchicine tablets exactly as your healthcare provider tells you to take it. If you are not sure

about your dosing, call your healthcare provider.

Colchicine tablets can be taken with or without food.

If you take too much colchicine tablets, go to the nearest hospital emergency room right away.

Do not stop taking colchicine tablets even if you start to feel better, unless your healthcare provider

tells you.

Your healthcare provider may do blood tests while you take colchicine tablets.

If you take colchicine tablets daily and you miss a dose, then take it as soon as you remember. If it is

almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do

not take 2 doses at the same time.

If you have a gout flare while taking colchicine tablets daily, report this to your healthcare provider.

What should I avoid while taking colchicine tablets?

Avoid eating grapefruit or drinking grapefruit juice while taking colchicine tablets. It can increase

your chances of getting serious side effects.

What are the possible side effects of colchicine tablets?

Colchicine tablets can cause serious side effects or even cause death. See “What is the most important

information that I should know about colchicine tablets?”

Get medical help right away if you have:

Muscle weakness or pain

Numbness or tingling in your fingers or toes

Unusual bleeding or bruising

Increased infections

Feel weak or tired

Pale or gray color to your lips, tongue or palms of your hands

Severe diarrhea or vomiting

Gout Flares: The most common side effect of colchicine tablets in people who have gout flares is diarrhea.

FMF: The most common side effects of colchicine tablets in people who have FMF are abdominal pain,

diarrhea, nausea and vomiting.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of colchicine tablets. For more information, ask your healthcare

provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-

1088.

How should I store colchicine tablets?

Store colchicine tablets at room temperature between 68°F and 77°F (20°C to 25°C).

Keep colchicine tablets in a tightly closed container.

Keep colchicine tablets out of the light.

Keep colchicine tablets and all medicines out of the reach of children.

General Information about Colchicine Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use

colchicine tablets for a condition for which it was not prescribed. Do not give colchicine tablets to other

people, even if they have the same symptoms that you have. It may harm them. This Medication Guide

summarizes the most important information about colchicine tablets. If you would like more information,

talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information

about colchicine tablets that is written for healthcare professionals.

What are the ingredients in colchicine tablets?

Active Ingredient: colchicine

Inactive Ingredients: ethanol, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, macrogol,

magnesium stearate, microcrystalline cellulose, polydextrose, pregelatinized starch (corn), purified water,

sodium starch glycolate, titanium dioxide and triacetin.

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 05-2020-02

Trademarks are the property of their respective owners.

For more information, go to www.amneal.com or call 1-877-835-5472.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 5/2020

Document Id: 46365914-b211-41af-902c-be344f6ad6b1

34391-3

Set id: 7daef7e2-888d-4116-81a9-2c02b9ef97ef

Version: 13

Effective Time: 20200520

Amneal Pharmaceuticals LLC

COLCHICINE- colchicine tablet

Amneal Pharmaceuticals LLC

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use COLCHICINE TABLETS safely and

effectively. See full prescribing information for COLCHICINE TABLETS.

COLCHICINE tablets, for oral use

Initial U.S. Approval: 1961

INDICATIONS AND USAGE

Colchicine tablets, USP 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).

DOSAGE AND ADMINISTRATION

Gout Flares:

Prophylaxis of Gout Flares: 0.6 mg once or twice daily in adults and adolescents older than 16 years of age (2.1).

Maximum dose 1.2 mg/day.

Treatment of Gout Flares: 1.2 mg (two tablets) at the first sign of a gout flare followed by 0.6 mg (one tablet) one hour

later (2.1).

FMF: Adults and children older than 12 years 1.2 to 2.4 mg; children 6 to 12 years 0.9 to 1.8 mg; children 4 to 6 years

0.3 to 1.8 mg (2.2, 2.3).

Give total daily dose in one or two divided doses (2.2).

Increase or decrease the dose as indicated and as tolerated in increments of 0.3 mg/day, not to exceed the

maximum recommended daily dose (2.2).

Colchicine tablets, USP are administered orally without regard to meals.

See full prescribing information (FPI) for dose adjustment regarding patients with impaired renal function (2.5),

impaired hepatic function (2.6), the patient’s age (2.3, 8.5) or use of co-administered drugs (2.4).

DOSAGE FORMS AND STRENGTHS

Tablets: 0.6 mg colchicine (3).

CONTRAINDICATIONS

Patients with renal or hepatic impairment should not be given colchicine, USP in conjunction with P-gp or strong CYP3A4

inhibitors (5.3).

In these patients, life-threatening and fatal colchicine, USP toxicity has been reported with colchicine, USP taken in

therapeutic doses (7).

WARNINGS AND PRECAUTIONS

Fatal overdoses have been reported with colchicine in adults and children. Keep colchicine 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 P-gp and/or CYP3A4 inhibitors: Co-administration of colchicine with P-gp and/or strong 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 (5.4, 7).

ADVERSE REACTIONS

Prophylaxis of Gout Flares: The most commonly reported adverse reaction in clinical trials for the prophylaxis of

gout was diarrhea.

Treatment of Gout Flares: The most common adverse reactions reported in the clinical trial for gout were diarrhea

(23%) and pharyngolaryngeal pain (3%).

FMF: Most common adverse reactions (up to 20%) are abdominal pain, diarrhea, nausea and vomiting. These effects

are usually mild, transient and reversible upon lowering the dose (6).

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at

1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Co-administration of P-gp and/or CYP3A4 inhibitors (e.g., clarithromycin or cyclosporine) have been demonstrated to alter

the concentration of colchicine. The potential for drug-drug interactions must be considered prior to and during therapy.

See FPI for a complete list of reported and potential interactions (2.4, 5.3, 7).

USE IN SPECIFIC POPULATIONS

In the presence of mild to moderate renal or hepatic impairment, adjustment of dosing is not required for treatment of

gout flare, prophylaxis of gout flare and FMF, but patients should be monitored closely (8.6).

In patients with severe renal impairment for prophylaxis of gout flares, the starting dose should be 0.3 mg/day for gout

flares, no dose adjustment is required, but a treatment course should be repeated no more than once every two weeks.

In FMF patients, start with 0.3 mg/day and any increase in dose should be done with close monitoring (8.6).

In patients with severe hepatic impairment, a dose reduction may be needed in prophylaxis of gout flares and FMF

patients; while a dose reduction may not be needed in gout flares, a treatment course should be repeated no more than

once every two weeks (8.6, 8.7).

For patients undergoing dialysis, the total recommended dose for prophylaxis of gout flares should be 0.3 mg given

twice a week with close monitoring. For treatment of gout flares, the total recommended dose should be reduced to 0.6

mg (one tablet) x 1 dose and the treatment course should not be repeated more than once every two weeks. For FMF

patients, the starting dose should be 0.3 mg/day and dosing can be increased with close monitoring (8.6).

Females and Males of Reproductive Potential: Advise males that colchicine may transiently impair fertility (8.3).

Geriatric Use: The recommended dose of colchicine should be based on renal function (8.5).

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 5/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Gout Flares

1.2 Familial Mediterranean Fever (FMF)

2 DOSAGE AND ADMINISTRATION

2.1 Gout Flares

2.2 FMF

2.3 Recommended Pediatric Dosage

2.4 Dose Modification for Co-administration of Interacting Drugs

2.5 Dose Modification in Renal Impairment

2.6 Dose Modification in Hepatic Impairment

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Fatal Overdose

5.2 Blood Dyscrasias

5.3 Drug Interactions

5.4 Neuromuscular Toxicity

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience in Gout

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

9 DRUG ABUSE AND DEPENDENCE

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 Gout Flares

Colchicine tablets, USP are indicated for prophylaxis and the treatment of acute gout flares.

Prophylaxis of Gout Flares:

Colchicine tablets, USP are indicated for prophylaxis of gout flares.

Treatment of Gout Flares:

Colchicine tablets, USP 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, USP are indicated in adults and children four years or older for treatment of familial

Mediterranean fever (FMF).

2 DOSAGE AND ADMINISTRATION

The long-term use of colchicine, USP 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, USP are different for each indication and must be individualized.

The recommended dosage of colchicine tablets, USP depends on the patient’s age, renal function,

hepatic function and use of co-administered drugs [see Dosage and Administration (2.4, 2.5, 2.6)].

Colchicine tablets, USP are administered orally without regard to meals.

Colchicine tablets, USP are not an analgesic medication and should not be used to treat pain from other

causes.

2.1 Gout Flares

Prophylaxis of Gout Flares

Sections or subsections omitted from the full prescribing information are not listed.

The recommended dosage of colchicine tablets, USP 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, USP 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, USP 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, USP 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.

2.2 FMF

The recommended dosage of colchicine tablets, USP for FMF in adults is 1.2 mg to 2.4 mg daily.

Colchicine tablets, USP 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, USP dose may be

administered in one to two divided doses.

2.3 Recommended Pediatric Dosage

Prophylaxis and Treatment of Gout Flares

Colchicine tablets, USP are not recommended for pediatric use in prophylaxis or treatment of gout

flares.

The recommended dosage of colchicine tablets, USP 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

2.4 Dose Modification for Co-administration of Interacting Drugs

Concomitant Therapy

Co-administration of colchicine tablets, USP 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, USP Dose Adjustment for Co-administration with Interacting Drugs

if No Alternative Available

Strong CYP3A4 Inhibitors

Drug

Noted or

Anticipated

Gout Flares

FMF

Prophylaxis of Gout

Flares

Treatment of Gout

Flares

Original

Original

Original

*

Outcome

Original

Intended

Dos age

Adjus ted

Dos e

Original

Intended

Dos age

Adjus ted

Dos e

Original

Intended

Dos age

Adjus ted

Dos e

Atazanavir

Clarithromycin

Darunavir/

Ritonavir

Indinavir

Itraconazole

Ketoconazole

Lopinavir/

Ritonavir

Nefazodone

Nelfinavir

Ritonavir

Saquinavir

Telithromycin

T ipranavir/

Ritonavir

Significant

increase in

colchicine, USP

plasma levels ;

fatal colchicine,

USP toxicity has

been reported

with

clarithromycin, a

strong CYP3A4

inhibitor.

Similarly,

significant

increase in

colchicine, USP

plasma levels is

anticipated with

other strong

CYP3A4

inhibitors.

0.6 mg

twice a

0.6 mg

once a day

0.3 mg

once a day

0.3 mg

once every

other day

1.2 mg (2

tablets)

followed

by 0.6 mg

(1 tablet) 1

hour later.

Dose to

repeated

no earlier

than 3

days.

0.6 mg (1

tablet) x 1

dose,

followed

by 0.3 mg

(1/2 tablet)

1 hour

later.

Dose to be

repeated

no earlier

than 3

days.

Maximum

daily dose

of 1.2 to

2.4 mg

Maximum

daily dose

of 0.6 mg

(may be

given as

0.3 mg

twice a

day)

Moderate CYP3A4 Inhibitors

Drug

Noted or

Anticipated

Outcome

Gout Flares

FMF

Prophylaxis of Gout

Flares

Treatment of Gout

Flares

Original

Intended

Dos age

Adjus ted

Dos e

Original

Intended

Dos age

Adjus ted

Dos e

Original

Intended

Dos age

Adjus ted

Dos e

Amprenavir

Aprepitant

Diltiazem

Erythromycin

Fluconazole

Fosamprenavir

(prodrug of

Amprenavir)

Grapefruit juice

Verapamil

Significant

increase in

colchicine, USP

plasma

concentration is

anticipated.

Neuromuscular

toxicity has been

reported with

diltiazem and

verapamil

interactions.

0.6 mg

twice a

0.6 mg

once a day

0.3 mg

twice a day

or 0.6 mg

once a day

0.3 mg

once a day

1.2 mg (2

tablets)

followed

by 0.6 mg

(1 tablet) 1

hour later.

Dose to

repeated

no earlier

than 3

days.

1.2 mg (2

tablets) x 1

dose.

Dose to be

repeated

no earlier

than 3

days.

Maximum

daily dose

of 1.2 to

2.4 mg

Maximum

daily dose

of 1.2 mg

(may be

given as

0.6 mg

twice a

day)

P-gp Inhibitors

Drug

Noted or

Anticipated

Outcome

FMF

Prophylaxis of Gout

Flares

Treatment of Gout

Flares

Original

Intended

Dos age

Adjus ted

Dos e

Original

Intended

Dos age

Adjus ted

Dos e

Original

Intended

Dos age

Adjus ted

Dos e

Significant

increase in

colchicine, USP

plasma levels ;

1.2 mg (2

Cyclosporine

Ranolazine

fatal colchicine,

USP toxicity has

been reported

with

cyclosporine, a

P-gp inhibitor.

Similarly,

significant

increase in

colchicine, USP

plasma levels is

anticipated with

other P-gp

inhibitors.

0.6 mg

twice a

0.6 mg

once a day

0.3 mg

once a day

0.3 mg

once every

other day

tablets)

followed

by 0.6 mg

(1 tablet) 1

hour later.

Dose to

repeated

no earlier

than 3

days.

0.6 mg (1

tablet) x 1

dose.

Dose to be

repeated

no earlier

than 3

days.

Maximum

daily dose

of 1.2 to

2.4 mg

Maximum

daily dose

of 0.6 mg

(may be

given as

0.3 mg

twice a

day)

For magnitude of effect on colchicine, USP plasma concentrations [see Clinical Pharmacology (12.3)]

Patients with renal or hepatic impairment should not be given colchicine tablets, USP 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)].

Table 2. Colchicine Tablets, USP Dose Adjustment for Co-administration with Protease

Inhibitors

Protease Inhibitor

Clinical Comment

w/Colchicine -

Prophylaxis

of Gout Flares

w/Colchicine –

Treatment of

Gout Flares

w/Colchicine –

Treatment of

FMF

Atazanavir sulfate

(Reyataz)

Patients with renal or

hepatic impairment

should not be given

colchicine, USP with

Reyataz.

Original

Dos e

Adjus ted

Dos e

0.6 mg (1 tablet)

x 1 dose,

followed by 0.3

mg (1/2 tablet) 1

hour later. Dose

to be repeated

no earlier than 3

days.

Maximum daily

dose of 0.6 mg

(may be given as

0.3 mg twice a

day)

0.6 mg

twice a

0.6 mg

once a day

0.3 mg

once a day

0.3 mg

once every

other day

Darunavir (Prezista)

Patients with renal or

hepatic impairment

should not be given

colchicine, USP with

Prezista/ritonavir.

Original

Dos e

Adjus ted

Dos e

0.6 mg (1 tablet)

x 1 dose,

followed by 0.3

mg (1/2 tablet) 1

hour later. Dose

to be repeated

no earlier than 3

days.

Maximum daily

dose of 0.6 mg

(may be given as

0.3 mg twice a

day)

0.6 mg

twice a

0.6 mg

once a day

0.3 mg

once a day

0.3 mg

once every

other day

Fosamprenavir

(Lexiva) with Ritonavir

Patients with renal

or hepatic

impairment should

not be given

colchicine, USP

with

Lexiva/ritonavir.

Original

Dos e

Adjus ted

Dos e

0.6 mg (1 tablet)

x 1 dose,

followed by 0.3

mg (1/2 tablet) 1

hour later. Dose

to be repeated

no earlier than 3

days.

Maximum daily

dose

of 0.6 mg (may

given as 0.3 mg

twice

a day)

0.6 mg

twice a

0.6 mg

once a day

0.3 mg

once a day

0.3 mg

once every

other day

Patients with renal

or hepatic

Original

Dos e

Adjus ted

Dos e

1.2 mg (2 tablets)

Maximum daily

dose

Fosamprenavir

(Lexiva)

or hepatic

impairment should

not be given

colchicine, USP

with

Lexiva/ritonavir.

0.6 mg

twice a

0.6 mg

once a day

0.3 mg

twice a day

or 0.6 mg

once a day

0.3 mg

once a day

1.2 mg (2 tablets)

x 1 dose. Dose

to be repeated

no earlier than 3

days.

dose

of 1.2 mg (may

given as 0.6 mg

twice

a day)

Indinavir (Crixivan)

Patients with renal

or hepatic

impairment should

not be given

colchicine, USP

with Crixivan

Original

Dos e

Adjus ted

Dos e

0.6 mg (1 tablet)

x 1 dose,

followed by 0.3

mg (1/2 tablet) 1

hour later. Dose

to be repeated

no earlier than 3

days.

Maximum daily

dose

of 0.6 mg (may

given as 0.3 mg

twice

a day)

0.6 mg

twice a

0.6 mg

once a day

0.3 mg

once a day

0.3 mg

once every

other day

Lopinavir/Ritonavir

(Kaletra)

Patients with renal

or hepatic

impairment should

not be given

colchicine, USP

with Kaletra

Original

Dos e

Adjus ted

Dos e

0.6 mg (1 tablet)

x 1 dose,

followed by 0.3

mg (1/2 tablet) 1

hour later. Dose

to be repeated

no earlier than 3

days.

Maximum daily

dose

of 0.6 mg (may

given as 0.3 mg

twice

a day)

0.6 mg

twice a

0.6 mg

once a day

0.3 mg

once a day

0.3 mg

once every

other day

Nelfinavir mesylate

(Viracept)

Patients with renal

or hepatic

impairment should

not be given

colchicine, USP

with Viracept

Original

Dos e

Adjus ted

Dos e

0.6 mg (1 tablet)

x 1 dose,

followed by 0.3

mg (1/2 tablet) 1

hour later. Dose

to be repeated

no earlier than 3

days.

Maximum daily

dose

of 0.6 mg (may

given as 0.3 mg

twice

a day)

0.6 mg

twice a

0.6 mg

once a day

0.3 mg

once a day

0.3 mg

once every

other day

Ritonavir (Norvir)

Patients with renal

or hepatic

impairment should

not be given

colchicine, USP

with Norvir

Original

Dos e

Adjus ted

Dos e

0.6 mg (1 tablet)

x 1 dose,

followed by 0.3

mg (1/2 tablet) 1

hour later. Dose

to be repeated

no earlier than 3

days.

Maximum daily

dose

of 0.6 mg (may

given as 0.3 mg

twice

a day)

0.6 mg

twice a

0.6 mg

once a day

0.3 mg

once a day

0.3 mg

once every

other day

Saquinavir mesylate

(Invirase)

Patients with renal or

hepatic

impairment should not

be given colchicine,

USP with

Invirase/ritonavir

Original

Dos e

Adjus ted

Dos e

0.6 mg (1 tablet)

x 1 dose,

followed by 0.3

mg (1/2 tablet) 1

hour later. Dose

to be repeated

no earlier than 3

days.

Maximum daily

dose of 0.6 mg

(may be given as

0.3 mg twice a

day)

0.6 mg

twice a

0.6 mg

once a day

0.3 mg

once a day

0.3 mg

once every

other day

Tipranavir (Aptivus)

Patients with renal or

hepatic

impairment should not

be given colchicine,

USP with

Original

Dos e

Adjus ted

Dos e

0.6 mg (1 tablet)

x 1 dose,

followed by 0.3

mg (1/2 tablet) 1

hour later. Dose

to be repeated

Maximum daily

dose of 0.6 mg

(may be given as

0.3 mg twice a

day)

0.6 mg

twice a

0.6 mg

0.3 mg

once a day

0.3 mg

once every

Aptivus/ritonavir

0.6 mg

once a day

once every

other day

no earlier than 3

days.

day)

Treatment of gout flares with colchicine tablets, USP is not recommended in patients receiving

prophylactic dose of colchicine tablets, USP and CYP3A4 inhibitors.

2.5 Dose Modification in Renal Impairment

Colchicine, USP dosing must be individualized according to the patient's renal function [see Use in

Specific Populations (8.6)].

in mL/minute may be estimated from serum creatinine (mg/dL) determination using the following

formula:

[140-age (years) × weight (kg)]

= ---------------------------------------- × 0.85 for female patients

72 × serum creatinine (mg/dL)

Gout Flares

Prophylaxis of Gout Flares

For prophylaxis of gout flares in patients with mild (estimated creatinine clearance [Cl

] 50 to 80

mL/min) to moderate (Cl

30 to 50 mL/min) renal function impairment, adjustment of the recommended

dose is not required, but patients should be monitored closely for adverse effects of colchicine.

However, in patients with severe impairment, the starting dose should be 0.3 mg/day and any increase in

dose should be done with close monitoring. For the prophylaxis of gout flares in patients undergoing

dialysis, the starting doses should be 0.3 mg given twice a week with close monitoring [see Clinical

Pharmacology (12.3), Use in Specific Populations (8.6)].

Treatment of Gout Flares

For treatment of gout flares in patients with mild (Cl

50 to 80 mL/min) to moderate (Cl

30 to 50

mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients

should be monitored closely for adverse effects of colchicine. However, in patients with severe

impairment, while the dose does not need to be adjusted for the treatment of gout flares, a treatment

course should be repeated no more than once every two weeks. For patients with gout flares requiring

repeated courses, consideration should be given to alternate therapy. For patients undergoing dialysis,

the total recommended dose for the treatment of gout flares should be reduced to a single dose of 0.6

mg (one tablet). For these patients, the treatment course should not be repeated more than once every

two weeks [see Clinical Pharmacology (12.3), Use in Specific Populations (8.6)].

Treatment of gout flares with colchicine tablets, USP is not recommended in patients with renal

impairment who are receiving colchicine tablets, USP for prophylaxis.

FMF

Caution should be taken in dosing patients with moderate and severe renal impairment and in patients

undergoing dialysis. For these patients, the dosage should be reduced [see Clinical Pharmacology

(12.3)]. Patients with mild (Cl

50 to 80 mL/min) and moderate (Cl

30 to 50 mL/min) renal impairment

should be monitored closely for adverse effects of colchicine tablets, USP. Dose reduction may be

necessary. For patients with severe renal failure (Cl

less than 30 mL/min), start with 0.3 mg/day; any

increase in dose should be done with adequate monitoring of the patient for adverse effects of

colchicine [see Use in Specific Populations (8.6)]. For patients undergoing dialysis, the total

recommended starting dose should be 0.3 mg (half tablet) per day. Dosing can be increased with close

monitoring. Any increase in dose should be done with adequate monitoring of the patient for adverse

effects of colchicine [see Clinical Pharmacology (12.3), Use in Specific Populations (8.6)].

2.6 Dose Modification in Hepatic Impairment

Gout Flares

Prophylaxis of Gout Flares

For prophylaxis of gout flares in patients with mild to moderate hepatic function impairment, adjustment

of the recommended dose is not required, but patients should be monitored closely for adverse effects

of colchicine. Dose reduction should be considered for the prophylaxis of gout flares in patients with

severe hepatic impairment [see Use in Specific Populations (8.7)].

Treatment of Gout Flares

For treatment of gout flares in patients with mild to moderate hepatic function impairment, adjustment of

the recommended dose is not required, but patients should be monitored closely for adverse effects of

colchicine. However, for the treatment of gout flares in patients with severe impairment, while the dose

does not need to be adjusted, a treatment course should be repeated no more than once every two weeks.

For these patients, requiring repeated courses for the treatment of gout flares, consideration should be

given to alternate therapy [see Use in Specific Populations (8.7)].

Treatment of gout flares with colchicine tablets, USP is not recommended in patients with hepatic

impairment who are receiving colchicine tablets, USP for prophylaxis.

FMF

Patients with mild to moderate hepatic impairment should be monitored closely for adverse effects of

colchicine. Dose reduction should be considered in patients with severe hepatic impairment [see Use in

Specific Populations (8.7)].

3 DOSAGE FORMS AND STRENGTHS

Tablets: 0.6 mg colchicine - purple capsule-shaped, film-coated tablets, scored on one side and

debossed with “A10” on the other side.

4 CONTRAINDICATIONS

Patients with renal or hepatic impairment should not be given colchicine, USP in conjunction with P-gp

or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir). In these

patients, life-threatening and fatal colchicine, USP toxicity has been reported with colchicine, USP

taken in therapeutic doses.

5 WARNINGS AND PRECAUTIONS

5.1 Fatal Overdose

Fatal overdoses, both accidental and intentional, have been reported in adults and children who have

ingested colchicine [see Overdosage (10)]. Colchicine should be kept out of the reach of children.

5.2 Blood Dyscrasias

Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia and aplastic anemia

have been reported with colchicine used in therapeutic doses.

5.3 Drug Interactions

Colchicine is a P-gp and CYP3A4 substrate. Life-threatening and fatal drug interactions have been

reported in patients treated with colchicine given with P-gp and strong CYP3A4 inhibitors. If treatment

with a P-gp or strong CYP3A4 inhibitor is required in patients with normal renal and hepatic function,

the patient’s dose of colchicine may need to be reduced or interrupted [see Drug Interactions (7)]. Use

of colchicine in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease

inhibitors except fosamprenavir) is contraindicated in patients with renal or hepatic impairment

[see Contraindications (4)].

5.4 Neuromuscular Toxicity

Colchicine-induced neuromuscular toxicity and rhabdomyolysis have been reported with chronic

treatment in therapeutic doses. Patients with renal dysfunction and elderly patients, even those with

normal renal and hepatic function, are at increased risk. Concomitant use of atorvastatin, simvastatin,

pravastatin, fluvastatin, lovastatin, gemfibrozil, fenofibrate, fenofibric acid or benzafibrate (themselves

associated with myotoxicity) or cyclosporine with colchicine may potentiate the development of

myopathy [see Drug Interactions (7)]. Once colchicine is stopped, the symptoms generally resolve

within one week to several months.

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 for treatment of gout

flares were diarrhea (23%) and pharyngolaryngeal pain (3%).

Gastrointestinal tract adverse effects are the most frequent side effects in patients initiating colchicine,

usually presenting within 24 hours, and occurring in up to 20% of patients given therapeutic doses.

Typical symptoms include cramping, nausea, diarrhea, abdominal pain and vomiting. These events

should be viewed as dose-limiting if severe, as they can herald the onset of more significant toxicity.

6.1 Clinical Trials Experience in Gout

Because clinical studies are conducted under widely varying and controlled conditions, adverse

reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical

studies of another drug and may not predict the rates observed in a broader patient population in clinical

practice.

In a randomized, double-blind, placebo-controlled trial in patients with a gout flare, gastrointestinal

adverse reactions occurred in 26% of patients using the recommended dose (1.8 mg over one hour) of

colchicine compared to 77% of patients taking a non-recommended high dose (4.8 mg over six hours)

of colchicine and 20% of patients taking placebo. Diarrhea was the most commonly reported drug-

related gastrointestinal adverse event. As shown in Table 3, diarrhea is associated with colchicine

treatment. Diarrhea was more likely to occur in patients taking the high-dose regimen than the low-dose

regimen. Severe diarrhea occurred in 19% and vomiting occurred in 17% of patients taking the non-

recommended high-dose colchicine regimen but did not occur in the recommended low-dose

colchicine regimen.

Table 3. Number (%) of Patients with at Least One Drug-Related Treatment-Emergent Adverse

Event with an Incidence of ≥2% of Patients in Any Treatment Group

MedDRA System Organ Class

MedDRA Preferred Term

Colchicine Dose

Placebo

(N=59)

n (%)

High (N=52)

n (%)

Low (N=74)

n (%)

Number of Patients with at Least One Drug-

Related TEAE

40 (77)

27 (37)

16 (27)

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