MYCOBUTIN Rifabutin 150mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rifabutin, Quantity: 150 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: microcrystalline cellulose; sodium lauryl sulfate; magnesium stearate; silicon dioxide; iron oxide red; titanium dioxide; Gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; Shellac; sulfuric acid; povidone; tert-butyl alcohol; sodium hydroxide

Administration route:

Oral

Units in package:

30 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MYCOBUTIN is indicated for: The prophylaxis of M.avium-intracellulare complex (MAC) infections in patients with advanced HIV infection (CD4 counts lower than 200/uL); The treatment of infections caused by MAC and other atypical mycobacteria, including in immunocompromised patients; The treatment of chronic multi-drug resistant pulmonary tuberculosis in the presence of rifampicin resistant, rifabutin-sensitive M.tuberculosis strains; The treatment of newly diagnosed pulmonary tuberculosis in the presence of rifampicin resistant, rifabutin sensitive M.tuberculosis strains. In accordance with the commonly accepted criteria for the treatment of mycobacterial infections, Mycobutin should always be given in combination with other anti-mycobacterial drugs not belonging to the family of rifamycins.

Product summary:

Visual Identification: Red-brown, self-locking hard gelatin capsule, Size 0 with the radial imprints "Pharmacia & Upjohn" and "Mycobutin", in white ink.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2000-05-02

Patient Information leaflet

MYCOBUTIN
®
CAPSULES
_Rifabutin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before taking Mycobutin. This leaflet
answers some common questions
about Mycobutin. It does not contain
all the available information and it
does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Mycobutin
against the expected benefits it will
have for you.
Ask your doctor if you have any
concerns about taking this medicine.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT MYCOBUTIN IS
USED FOR
Mycobutin contains the active
ingredient, rifabutin. It is an
antibiotic, an agent used to kill
certain types of germs, known as
mycobacteria.
Mycobutin is used in combination
with other medicines to treat
mycobacterial infections e.g.
tuberculosis (TB) or Mycobacteria
avium-intracellulare complex
(MAC). It may also be used to
prevent infections in patients with
HIV disease.
Your doctor, however, may prescribe
Mycobutin for another purpose. Ask
your doctor if you have any questions
about why Mycobutin has been
prescribed for you.
Mycobutin can only be obtained on
prescription from a doctor.
BEFORE TAKING
MYCOBUTIN
Some information is provided below.
However, always talk to your doctor
if you have concerns or questions
about your treatment.
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE MYCOBUTIN AND TALK TO
YOUR DOCTOR OR PHARMACIST IF:
•
you are allergic to rifabutin or
other rifamycin antibiotics (e.g.
rifampicin)
•
you are allergic to any of the
other ingredients listed at the end
of this leaflet
•
the packaging is torn or shows
signs of tampering
Do not take Mycobutin capsules after
the expiry date printed on the pack
has passed.
Do not give Mycobutin to children.
_BEFORE YOU TAKE MYCOBUTIN_
YOU SHOULD TELL YOUR DOCTOR IF YOU:
•
have or have had problems with
your liver or kidneys
•
are or may become pregnant
during the time in which you are
taking Mycobutin.
•
are breastf

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
MYCOBUTIN (RIFABUTIN)
1.
NAME OF THE MEDICINE
Rifabutin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mycobutin (rifabutin) is a wide spectrum, semi-synthetic ansamycin
antibiotic particularly
active on acid-fast bacilli, including atypical and
multidrug-resistant mycobacteria.
Each Mycobutin capsule for oral administration contains 150 mg of
rifabutin.
3.
PHARMACEUTICAL FORM
The hard gelatin capsules are opaque and red-brown in colour with the
words "Pharmacia &
Upjohn" and "Mycobutin" imprinted on the capsule in white ink.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mycobutin is indicated for:
The prophylaxis of
_M. avium-intracellulare_
complex (MAC) infections in patients with
advanced HIV infection (CD4 counts lower than 200/μL).
The treatment of infections caused by MAC and other atypical
mycobacteria, including in
immunocompromised patients.
The treatment of chronic multidrug-resistant pulmonary tuberculosis in
the presence of
rifampicin resistant, rifabutin-sensitive
_M. tuberculosis_
strains.
The treatment of newly diagnosed pulmonary tuberculosis in the
presence of rifampicin
resistant, rifabutin-sensitive
_M. tuberculosis_
strains.
In accordance with the commonly accepted criteria for the treatment of
mycobacterial
infections, Mycobutin should always be given in combination with other
anti-mycobacterial
drugs not belonging to the family of rifamycins.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Mycobutin can be administered as a single, daily, oral dose at any
time independently of meals.
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Caution should be applied when rifabutin is coadministered with any of
the other drugs listed
in Section 4.5 Interactions with other medicines and other forms of
interactions. Dosages of
either drug may need to be adjusted on a case-by-case basis.
ADULTS
Mycobutin as a single agent:
‒
prophylaxis of MAC infection in immunodepressed patients: 300 mg (2