COLCHICINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

COLCHICINE (UNII: SML2Y3J35T) (COLCHICINE - UNII:SML2Y3J35T)

Available from:

Granules Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Colchicine tablets 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 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. 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 outcomes (see Data). Colchicine crosses the human placenta. Although animal reproductive and developmental studies were not conducted with colchicine, published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratogenicity and altered postnatal development at exposures within or above the clinical th

Product summary:

Colchicine tablets, USP 0.6 mg are purple, film-coated, capsule-shaped tablets debossed with "G 02" on one side and scored on the other side. Bottles of 30 NDC 70010-002-03 Bottles of 100 NDC 70010-002-01 Bottles of 1000 NDC 70010-002-10 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

COLCHICINE- COLCHICINE TABLET, FILM COATED
Granules Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Colchicine (KOL-chi-seen) Tablets, 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 a

Summary of Product characteristics

COLCHICINE- COLCHICINE TABLET, FILM COATED
GRANULES PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
COLCHICINE TABLETS USP, 0.6 MG
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COLCHICINE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR COLCHICINE TABLETS.
COLCHICINE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1961
INDICATIONS AND USAGE
Colchicine is an alkaloid indicated for:
• Familial Mediterranean fever (FMF) in adults and children 4 years
or older _(1.2)._
DOSAGE AND ADMINISTRATION
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).
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 ( 2.2).
Colchicine tablets 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: 0.6mg colchicine ( 3)
CONTRAINDICATIONS
Patients with renal or hepatic impairment should not be given
colchicine 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 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 wit