Colchicine

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Colchicine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

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Overview

Colchicine is an alkaloid that is FDA approved for the {{{indicationType}}} of gout flares in adults, familial mediterranean fever (FMF) in adults and children 4 years or older. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Gout Flares
  • Dosing Information
  • Prophylaxis of Gout Flares:
  • The recommended dosage of COLCRYS 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.
  • Treatment of Gout Flares:
  • The recommended dose of COLCRYS for treatment of a gout flare is 1.2 mg (2 tablets) at the first sign of the flare followed by 0.6 mg (1 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. COLCRYS may be administered for treatment of a gout flare during prophylaxis at doses not to exceed 1.2 mg (2 tablets) at the first sign of the flare followed by 0.6 mg (1 tablet) one hour later. Wait 12 hours and then resume the prophylactic dose.
Familial Mediterranean fever (FMF)
  • Dosing Information
  • The recommended dosage of COLCRYS for FMF in adults is 1.2 mg to 2.4 mg daily.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Colchicine in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Colchicine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Familial Mediterranean fever (FMF)
  • Dosing Information
  • The recommended dosage of COLCRYS 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 – 6 years: 0.3 mg to 1.8 mg daily
    • Children 6 – 12 years: 0.9 mg to 1.8 mg daily
    • Adolescents older than 12 years: 1.2 mg to 2.4 mg daily

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Colchicine in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Colchicine in pediatric patients.

Contraindications

  • Patients with renal or hepatic impairment should not be given COLCRYS 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.

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Colchicine in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Colchicine in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Colchicine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Colchicine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Colchicine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Colchicine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Colchicine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Colchicine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Colchicine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Colchicine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Colchicine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Colchicine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Colchicine in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Colchicine in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Colchicine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Colchicine in the drug label.

Pharmacology

There is limited information regarding Colchicine Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Colchicine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Colchicine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Colchicine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Colchicine in the drug label.

How Supplied

Storage

There is limited information regarding Colchicine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Colchicine in the drug label.

Precautions with Alcohol

  • Alcohol-Colchicine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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  2. ↑ "http://www.ismp.org". External link in |title= (help)


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