COLCHICINE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Amneal Pharmaceuticals LLC

INN (Internationale Bezeichnung):

COLCHICINE

Zusammensetzung:

COLCHICINE 0.6 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Colchicine tablets, USP are indicated for prophylaxis and the treatment of acute gout flares. - Prophylaxis of Gout Flares: Colchicine tablets, USP are indicated for prophylaxis of gout flares. - Treatment of Gout Flares: Colchicine tablets, USP are indicated for treatment of acute gout flares when taken at the first sign of a flare. Colchicine tablets, USP 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, USP in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir). In these patients, life-threatening and fatal colchicine, USP toxicity has been reported with colchicine, USP 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 ou

Produktbesonderheiten:

Colchicine tablets, USP, 0.6 mg, are purple, capsule-shaped, film-coated tablets, scored on one side and debossed with ”A10” on the other side. They are available as: Bottles of 30:              NDC 65162-710-03 Bottles of 90:              NDC 65162-710-09 Bottles of 1,000:         NDC 65162-710-11 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

Amneal Pharmaceuticals LLC
----------
MEDICATION GUIDE
Colchicine (kol’ chi seen) Tablets, USP 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

Fachinformation

COLCHICINE- COLCHICINE TABLET
AMNEAL PHARMACEUTICALS LLC
----------
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, USP are an alkaloid indicated for:
Prophylaxis and treatment of gout flares in adults (1.1).
Familial Mediterranean fever (FMF) in adults and children 4 years or
older (1.2).
DOSAGE AND ADMINISTRATION
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 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).
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, USP 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: 0.6 mg colchicine (3).
CONTRAINDICATIONS
Patients with renal or hepatic impairment should not be given
colchicine, USP in conjunction with P-gp or
strong CYP3A4 inhibitors (5.3).
In these patients, life-threatening and fatal colchicine, USP toxicity
has been reported with colchicine, USP
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:_ myelosuppre