PRIFTIN- rifapentine tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

RIFAPENTINE (UNII: XJM390A33U) (RIFAPENTINE - UNII:XJM390A33U)

Tillgänglig från:

sanofi-aventis U.S. LLC

INN (International namn):

rifapentine

Sammansättning:

rifapentine 150 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

PRIFTIN® (rifapentine) is indicated in adults and children 12 years and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis . PRIFTIN must always be used in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible [see Dosage and Administration (2.1) and Clinical Studies (14.1)] . Limitations of Use Do not use PRIFTIN monotherapy in either the initial or the continuation phases of active antituberculous treatment. PRIFTIN should not be used once weekly in the continuation phase regimen in combination with isoniazid (INH) in HIV-infected patients with active pulmonary tuberculosis because of a higher rate of failure and/or relapse with rifampin (RIF)-resistant organisms [see Warnings and Precautions (5.4) and Clinical Studies (14.1)] . PRIFTIN has not been studied as part of the initial phase treatment regimen in HIV-infected patients with active pulmonary tuberculosis. PRIFTIN is indicated in adults and children 2 years

Produktsammanfattning:

How Supplied PRIFTIN is supplied as 150 mg round normal convex dark-pink film-coated tablets debossed "F" on one side of tablet packaged in aluminum formable foil blister strips. Carton of 24 tablets (3 strips of 8 tablets) NDC 0088-2102-24 Storage Store at 25°C (77°F); excursions permitted 15–30°C (59–86°F) (see USP Controlled Room Temperature). Protect from excessive heat and humidity.

Bemyndigande status:

New Drug Application

Bipacksedel

sanofi-aventis U.S. LLC
----------
Medication Guide
PRIFTIN (prif - tin)
(rifapentine)
Tablets
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: June 2020
Read this Medication Guide before you start taking PRIFTIN and each
time you get a refill. There may
be new information. This information does not take the place of
talking with your doctor about your
medical condition or your treatment.
What is the most important information I should know about PRIFTIN?
PRIFTIN may cause serious side effects, including:
•
Liver problems. PRIFTIN may cause serious liver problems. Your doctor
may do a blood test to
check your liver function before and while you take PRIFTIN. Stop
taking PRIFTIN and call
your doctor right away if you have any of the following signs and
symptoms of liver problems:
•
nausea
•
stomach pain
•
tiredness, yellowing skin
or whites of your eyes
•
vomiting
•
loss of appetite
•
dark urine
•
Allergic reactions and flu-like symptoms. Allergic reactions and
flu-like symptoms have
happened in some people taking PRIFTIN. Signs and symptoms of an
allergic reaction may
include:
•
low blood pressure
(hypotension)
•
hives
•
cough with wheezing
•
difficulty breathing
•
red eyes (conjunctivitis)
•
lower blood platelet levels
Signs and symptoms of a flu-like reaction may include:
•
weakness
•
nausea and vomiting
•
chills
•
itching
•
shortness of breath
•
fainting
•
tiredness
•
headache
•
aches
•
sweats
•
chest pain
•
fast heartbeat
•
muscle pain
•
fever
•
rash
•
dizziness
•
cough
•
Severe skin reactions. Serious skin reactions such as Stevens-Johnson
syndrome (SJS) and drug
reaction with eosinophilia and systemic symptoms (DRESS) syndrome have
happened in some
Medication Guide
PRIFTIN (prif - tin)
(rifapentine)
Tablets
people taking PRIFTIN.
Stop taking PRIFTIN right away and call your doctor or get emergency
help if you have any of
the following symptoms:
•
rash
•
red and painful skin
•
peeling or bleeding
s

Produktens egenskaper

PRIFTIN- RIFAPENTINE TABLET, FILM COATED
SANOFI-AVENTIS U.S. LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRIFTIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRIFTIN.
PRIFTIN (RIFAPENTINE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12
years of age and older for the
treatment of active pulmonary tuberculosis (TB) caused by
_Mycobacterium tuberculosis_ in combination
with one or more antituberculosis (anti-TB) drugs to which the isolate
is susceptible. (1.1)
PRIFTIN is indicated for the treatment of latent tuberculosis
infection (LTBI) caused by _M. tuberculosis _in
combination with isoniazid in patients 2 years of age and older at
high risk of progression to TB disease.
(1.2)
See Full Prescribing Information for Limitations of Use. (1.1, 1.2)
DOSAGE AND ADMINISTRATION
ACTIVE PULMONARY TUBERCULOSIS: PRIFTIN should be used in regimens
consisting of an initial 2 month
phase followed by a 4 month continuation phase. (2.1)
INITIAL PHASE (2 MONTHS): 600 mg twice weekly for two months as
directly observed therapy (DOT),
with no less than 72 hours between doses, in combination with other
antituberculosis drugs. (2.1)
CONTINUATION PHASE (4 MONTHS): 600 mg once weekly for 4 months as
directly observed therapy
with isoniazid or another appropriate antituberculosis agent. (2.1)
LATENT TUBERCULOSIS INFECTION: PRIFTIN should be administered in
combination with isoniazid once
weekly for 12 weeks as directly observed therapy. (2.2)
ADULTS AND CHILDREN ≥12 YEARS: PRIFTIN (based on weight, see table
below) and isoniazid 15 mg/kg
(900 mg maximum). (2.2)
CHILDREN 2 TO 11 YEARS: PRIFTIN (based on weight, see table below) and
isoniazid 25 mg/kg (900 mg
maximum). (2.2)
WEIGHT RANGE
PRIFTIN DOSE
NUMBER OF PRIFTIN TABLETS
10–14 kg
300 mg
2
14.1–25 kg
450 mg
3
25.1–32 kg
600 mg
4
32.1–50 kg
750 mg
5
>50 kg
900 mg
6
For Latent Tuberculosis Infect