COLCHICINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Colchicine capsules are indicated for prophylaxis of gout flares in adults. Limitations of use: The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes. Patients with renal or hepatic impairment should not be given colchicine capsules with drugs that inhibit both P-glycoprotein and CYP3A4 inhibitors [see Drug Interactions (7)] . Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not be given colchicine capsules.  There are no adequate and well-controlled studies with colchicine capsules in pregnant women. Colchicine crosses the human placenta. Developmental studies in animals were not conducted with colchicine capsules, however published animal reproduction and development studies with colchicine demonstrated embryofetal toxicity, teratogenicity, and altered postnatal development at exposures within or above the clinical therapeutic range. Colchicine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The effect of colchicine on labor and delivery is unknown. Colchicine is excreted into human milk. Limited information suggests that infants exclusively breastfed receive less than 10 percent of the maternal weight-adjusted dose. While there are no published reports of adverse effects in breast-feeding infants of mothers taking colchicine, colchicine can affect gastrointestinal cell renewal and permeability. Caution should be exercised and breastfeeding infants should be observed for adverse effects when colchicine capsules is administered to a nursing woman.   Gout is rare in pediatric patients; the safety and effectiveness of colchicine capsules in pediatric patients has not been evaluated in controlled studies. Because of the increased incidence of decreased renal function in the elderly population, and the higher incidence of other co-morbid conditions in the elderly population requiring the use of other medications, reducing the dosage of colchicine when elderly patients are treated with colchicine should be carefully considered. No dedicated pharmacokinetic study has been conducted using colchicine capsules in patients with varying degrees of renal impairment.  Colchicine is known to be excreted in urine in humans and the presence of severe renal impairment has been associated with colchicine toxicity. Urinary clearance of colchicine and its metabolites may be decreased in patients with impaired renal function. Dose reduction or alternatives should be considered for the prophylaxis of gout flares in patients with severe renal impairment. Colchicine is not effectively removed by hemodialysis. Patients who are undergoing hemodialysis should be monitored carefully for colchicine toxicity. No dedicated pharmacokinetic study using colchicine capsules has been conducted in patients with varying degrees of hepatic impairment. Colchicine is known to be metabolized in humans and the presence of severe hepatic impairment has been associated with colchicine toxicity. Hepatic clearance of colchicine may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment. Dose reduction or alternatives should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment. Tolerance, abuse, or dependence from colchicine has not been reported.

Product summary:

Product: 50090-3465 NDC: 50090-3465-0 4 CAPSULE in a BOTTLE NDC: 50090-3465-1 90 CAPSULE in a BOTTLE

Authorization status:

New Drug Application

Patient Information leaflet

A-S Medication Solutions
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MEDICATION GUIDE
Medication Guide
Colchicine (kol' chi seen) Capsules
What is the most important information I should know about colchicine
capsules?
Colchicine capsules can cause serious side effects or death if levels
of colchicine are too high in your
body.
•
Taking certain medicines with colchicine capsules 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 capsules may need to be
changed.
•
Even medicines that you take for a short period of time, such as
antibiotics, can interact with
colchicine capsules and cause serious side effects or death.
What are colchicine capsules?
Colchicine capsules are a prescription medication used to prevent gout
flares in adults.
It is not known if colchicine capsules are safe and effective for the
treatment of:
•
acute gout flares
Colchicine capsules are not a pain medicine and it should not be taken
to treat pain related to other
conditions unless specifically for those conditions.
It is not known if colchicine capsules are safe and effective in
children.
Who should not take colchicine capsules?
Do not take colchicine capsules if you have liver and kidney problems
and you take certain other
medicines. Serious side effects, including death, have been reported
in these people even when taken as
directed. See “What is the most important information I should know
about colchicine capsules?”
What should I tell my healthcare provider before taking colchicine
capsules?
Before you take colchicine capsules, tell your healthcare provider:
•
about all of your medical conditions
•
if you have kidney or liver problems
•
if you are pregnant or plan to become pregnant. It is not known if
colchicine capsules can harm
your unborn baby. Talk to your healthcare provider if you are pregnant
or plan to become pregnant.
•
if you are breastfeeding or plan to

Summary of Product characteristics

COLCHICINE- COLCHICINE CAPSULE
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COLCHICINE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
COLCHICINE
CAPSULES.
COLCHICINE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1961
INDICATIONS AND USAGE
Colchicine capsules are indicated for prophylaxis of gout flares in
adults (1).
Limitations of use:
The safety and effectiveness of colchicine capsules for acute
treatment of gout flares during prophylaxis
has not been studied.
Colchicine capsules are not an analgesic medication and should not be
used to treat pain from other
causes.
DOSAGE AND ADMINISTRATION
•
Colchicine capsules are administered orally, without regard to meals
(2).
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
The most commonly reported adverse reactions with colchicine are
gastrointestinal symptoms, including
diarrhea, nausea, vomiting, and abdominal pain (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA PHARMACEUTICALS
USA INC. AT 1-
800-962-8364 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
0.6 mg (one capsule) once or twice daily (2). Maximum dose 1.2 mg/day.
0.6 mg Capsules (3).
Patients with renal or hepatic impairment should not be given
colchicine capsules in conjunction with
drugs that inhibit both P-gp and CYP3A4 (4).
Patients with both renal and hepatic impairment should not be given
colchicine capsules (4).
_Fatal overdoses_ have been reported with colchicine in adults and
children. Keep colchicine capsules
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 with dual P-gp and CYP3A4 inhibitors:_
Co-admin