SIRTURO

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Unit dalam paket:

DUS, 1 BOTOL PLASTIK @ 60 TABLET

Tanggal Otorisasi:

2022-09-24

Karakteristik produk

Page 1
SIRTURO®
BEDAQUILINE FUMARATE
DOSAGE FORMS AND STRENGTHS
SIRTURO 20 MG TABLET
Each tablet contains 20 mg of bedaquiline free base (present as
fumarate salt).
Oral tablet: uncoated, white to almost white oblong tablet with score
line on both sides, debossed with “2” and
“0” on one side and plain on other side.
For excipients, see _List of Excipients._
CLINICAL INFORMATION
INDICATIONS
ADULT AND PEDIATRIC PATIENTS (5 YEARS TO LESS THAN 18 YEARS OF AGE)
SIRTURO is indicated in adult (≥ 18 years) and pediatric patients (5
years to less than 18 years of age and
weighing at least 15 kg) as part of combination therapy of pulmonary
tuberculosis (TB) due to multi-drug
resistant _Mycobacterium tuberculosis_.
DOSAGE AND ADMINISTRATION
SIRTURO should only be administered as part of a multi-drug resistant
tuberculosis (MDR-TB) regimen. It is
recommended that SIRTURO is administered by directly observed therapy
(DOT). MDR-TB is defined as _in vitro_
resistance of the patient’s isolate to at least isoniazid and
rifampin.
The prescribing physician should refer to
international (e.g. WHO guidelines) and
national/local TB treatment
guidelines for direction on selection and duration of use of companion
drugs with SIRTURO. SIRTURO should
only be used in combination with at least 3 drugs to which the
patient’s isolate has been shown to be susceptible
_in vitro_. If _in vitro_ drug susceptibility testing results are
unavailable, treatment may be initiated with SIRTURO in
combination with at least 4 other drugs to which the patient's isolate
is likely to be susceptible.
Throughout treatment with, and following the last intake of SIRTURO,
patients should continue to take their
companion drugs in accordance with international, national/local TB
treatment guidelines and local MDR-TB
treatment practice. Refer to the prescribing information of the drugs
used in combination with SIRTURO for their
specific dosing recommendations.
DOSAGE – ADULTS (≥ 18 YEARS)
The recommended dosage of SIRTURO in adult patients is:
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