COLCHICINE tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Proficient Rx LP

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Colchicine Tablets, USP are indicated for prophylaxis and the treatment of acute gout flares. 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 Tablets, 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 toxicity has been reported with colchicine taken in therapeutic doses. Pregnancy Category C There are no adequate and well-controlled studies with colchicine in pregnant women. Colchicine crosses the human placenta. While not studied in the treatment of gout flares, data from a limited number of published studies found no evidence of an increased risk of miscarriage, stillbirth or teratogenic effects among pregnant women using colchicine to treat familial Mediterranean fever (FMF). Although animal reproductive and developmental stud

Ürün özeti:

Colchicine Tablets, USP 0.6 mg are purple, film-coated, capsule-shaped tablets debossed with "AR 374" on one side and scored on the other side. Bottles of 30 71205-310-30 Bottles of 60 71205-310-60 Bottles of 90 71205-310-90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Yetkilendirme durumu:

New Drug Application Authorized Generic

Bilgilendirme broşürü

Proficient Rx LP
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MEDICATION GUIDE
COLCHICINE TABLETS, USP
Read the Medication Guide that comes with Colchicine Tablets, USP
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, USP when you start taking it and at
regular checkups.
What is the most important information that I should know about
Colchicine Tablets, USP?
Colchicine Tablets, USP can cause serious side effects or death if
levels of colchicine are too high in your
body.
•
Taking certain medicines with Colchicine Tablets, USP 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, USP 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, USP 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)
saquinavir mesylate (Invirase)
ritonavir (Norvir)
telithromycin (Ketek)
tipranavir (Aptivus)
Ask your healthcare provider or pharmacist if you are not sure if you
take any of the medicines listed above.
This is not a complete list of all the

Ürün özellikleri

COLCHICINE- COLCHICINE TABLET, FILM COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COLCHICINE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR COLCHICINE TABLETS,
USP.
COLCHICINE TABLETS, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1961
INDICATIONS AND USAGE
Colchicine Tablets, USP are an alkaloid indicated for:
•
•
Colchicine Tablets, USP are not an analgesic medication and should not
be used to treat pain from other
causes.
DOSAGE AND ADMINISTRATION
•
•
Colchicine Tablets, USP are administered orally without regard to
meals.
See full prescribing information 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).
DOSAGE FORMS AND STRENGTHS
0.6 mg tablets (3).
CONTRAINDICATIONS
Patients with renal or hepatic impairment should not be given
Colchicine Tablets, USP 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 OF GOUT FLARES: The most commonly reported adverse
reaction in clinical trials for the
prophylaxis of gout was diarrhea.
TREATMENT OF GOUT FLARES: The most common adverse reactions reported
in the clinical trial for gout
were diarrhea (23%) and pharyngolaryngeal pain (3%).
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 TAKEDA PHARMACEUTICALS
AT 1-877-825-
3327 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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 O