COLCHICINE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

Colchicine (UNII: SML2Y3J35T) (Colchicine - UNII:SML2Y3J35T)

Disponible des:

Proficient Rx LP

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. 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 tablets 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. 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 tablets, published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratoge

Resumen del producto:

Colchicine Tablets USP, 0.6 mg are purple colored, film-coated, capsule shaped tablets debossed with ‘372’ on one side and score line on the other side of the tablet. Bottles of 10 NDC 71205-687-10 Bottles of 30 NDC 71205-687-30 Bottles of 60 NDC 71205-687-60 Bottles of 90 NDC 71205-687-90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Proficient Rx LP
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MEDICATION GUIDE
Colchicine Tablets, USP
(KOL-chi-seen)
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)
•
cyclosporine (Neoral, Gengraf, Sandimmune)
•
fosamprenavir (Lexiva) with ritonavir
•
indinavir (Crixivan)
•
ketoconazole (Nizoral)
•
nefazodone (Serzone)
•
clarithromycin (Biaxin)
•
darunavir (Prezista)
•
fosamprenavir (Lexiva)
•
itraconazole (Sporanox)
•
lopinavir/ritonavir (Kaletra)
•
nelfinavir mesylate (Viracept)
•
ritonavir (Norvir)
•
telithromycin (Ketek)
•
saquinavir mesylate (Invirase)
•
tipranavir (Aptivus)
Ask your healthcare provider or pharmacist if you are not sure if you
take any of the medici

Fitxa tècnica

COLCHICINE- COLCHICINE TABLET
PROFICIENT RX LP
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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 are an alkaloid indicated for:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Patients with renal or hepatic impairment should not be given
colchicine tablets 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
•
•
•
•
•
ADVERSE REACTIONS
•
•
Prophylaxis and treatment of gout flares in adults (1.1).
Familial Mediterranean fever (FMF) in adults and children 4 years or
older (1.2).
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 - 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
o
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 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 coadministered
drugs (2.4).
Tablets: 0.6 mg colchicine (3).
_Fatal overdoses _have been reported with colchicine in adults and
children. Keep colchicine tablets out
of the reach