HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
colchicine safely and effectively. See full prescribing information for
COLCRYS
TM
.
COLCRYS
TM
(colchicine, USP) tablets for Oral use
Initial U.S. Approval: 1961
---------------------------- INDICATIONS AND USAGE --------------------------
COLCRYS (colchicine, USP) tablets are an alkaloid indicated for
• gout flares (1.1)
• Familial Mediterranean fever (FMF) in adults and children 4 years or
older (1.2).
COLCRYS is not an analgesic medication and should not be used to treat pain
from other causes.
----------------------- DOSAGE AND ADMINISTRATION ----------------------
• Gout Flares: 1.2 mg (2 tablets) at the first sign of a gout flare followed
by 0.6 mg (1 tablet) one hour later (2.1).
• FMF: Adults and Children older than 12 years 1.2 – 2.4 mg; Children 6
to 12 years 0.9 – 1.8 mg; Children 4 to 6 years 0.3 – 1.8 mg. (2.2, 2.3).
o Give total daily dose in one or two divided doses (2.2).
o 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 (2.4).
• See full prescribing information for dose adjustment regarding patients
with impaired renal function (2.5) or hepatic function (2.6).
--------------------- DOSAGE FORMS AND STRENGTHS ---------------------
• 0.6 mg tablets (3).
----------------------------- CONTRAINDICATIONS ------------------------------
Patients with renal or hepatic impairment should not be given COLCRYS 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 therapeutic doses (7).
---------------------- WARNINGS AND PRECAUTIONS ------------------------
• Fatal overdoses have been reported with colchicine in adults and children.
Keep COLCRYS out of the reach of children (5.1, 10).
• Blood dyscrasias: myelosuppression, leukopenia, granulocytopenia,
thrombocytopenia, and aplastic anemia have been reported.
• 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: Coadministration 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 COLCRYS. (5.4, 7).
----------------------------- ADVERSE REACTIONS -------------------------------
Gout Flares: Most common adverse reaction is diarrhea (23%) and
pharyngolaryngeal pain (3%). (6).
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 Mutual
Pharmaceutical Company, Inc. at 1-888-351-3786 or
or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
------------------------------ DRUG INTERACTIONS ------------------------------
Coadministration of P-gp and/or CYP3A4 inhibitors (e.g., clarithromycin or
cyclosporine) have been demonstrated to alter the concentration of
COLCRYS. The potential for drug-drug interactions must be considered prior
to and during therapy. See full prescribing information for a complete list of
reported and potential interactions (2.4, 5.3, 7).
---------------------- USE IN SPECIFIC POPULATIONS -----------------------
• In patients with severe hepatic or renal impairment, close monitoring is
recommended in both gout flares and FMF patients; a dose reduction may
not be needed in gout flares but should be considered in FMF patients,
based on the patient’s estimated creatinine clearance. (2.5, 2.6, 8.6, 8.7)
• In the presence of renal impairment, dosing for gout flares should be
repeated no more than once every two weeks, whereas dosing for FMF
should be continued but adjusted based upon the patients estimated
creatinine clearance. (2.5, 8.6).
• For patients undergoing dialysis, the total recommended dose for gout flares
should be reduced to 0.6 mg (1 tablet) x 1 dose, whereas for FMF patients
the starting dose should be 0.3 mg per day. For gout flares, a treatment
course should be repeated no more than once every 2 weeks with no
increase in dosage but for FMF patients, dosing can be increased with close
monitoring. (2.5, 8.6)
• Pregnancy: Use only if the potential benefit justifies the potential risk to the
fetus (8.1).
• Nursing Mothers: Caution should be exercised when administered to a
nursing woman (8.3).
• Geriatric Use: The recommended dose of colchicine should be based on
renal function (2.5, 8.5).
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
Revised: 7/2009
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 Labor and Delivery
8.3 Nursing Mothers
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
17.1 Dosing Instructions
17.2 Blood Dyscrasias
17.3 Drug and Food Interactions
17.4 Neuromuscular Toxicity
17.5 Medication Guide
*Sections or subsections omitted from the full prescribing information are not
listed