ALTARGO retapamulin 1% w/w ointment tube

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

Retapamulin

Dostupné z:

GlaxoSmithKline Australia Pty Ltd

INN (Medzinárodný Name):

Retapamulin

Príbalový leták

ALTARGO
®
_retapamulin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Altargo. It does not
contain all the available information.
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 using Altargo against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ALTARGO IS USED
FOR
Altargo ointment contains the
antibiotic retapamulin as the active
ingredient. It also contains the
inactive ingredient soft white paraffin
and may contain traces of the
antioxidant, butylated
hydroxytoluene.
The active ingredient is derived from
the antibiotic pleuromutilin. It works
by inhibiting bacterial protein
synthesis.
Altargo is used to treat the following
skin infections caused by bacteria in
adults and children aged nine months
and older:
•
primary impetigo
•
secondarily infected traumatic
lesions e.g. small lacerations,
abrasions, sutured wounds
•
secondarily infected dermatoses
including infected psoriasis,
infected atopic dermatitis and
infected contact dermatitis
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
There is not enough information to
recommend the use of this medicine
for children under the age of nine
months.
BEFORE YOU USE
ALTARGO
_WHEN YOU MUST NOT USE IT_
DO NOT USE ALTARGO IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
retapamulin
•
soft white paraffin
•
butylated hydroxytoluene
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other par

Súhrn charakteristických

1
ALTARGO
®
PRODUCT INFORMATION
NAME OF THE MEDICINE
Retapamulin
STRUCTURE:
CAS NUMBER: 224452-66-8
DESCRIPTION
Retapamulin is a white to pale yellow solid with a molecular weight of
517.78. The partition
coefficient (log D) of retapamulin in octanol and water is +1.89.
Altargo is an off-white, smooth ointment for topical use which
contains the active
ingredient retapamulin 1% w/w. Altargo also contains the inactive
ingredient soft white
paraffin and may contain traces of the antioxidant, butylated
hydroxytoluene._ _
PHARMACOLOGY
PHARMACODYNAMICS:
_Mechanism of Action _
_ _
Retapamulin is a semisynthetic derivative of the compound
pleuromutilin, which is isolated
through fermentation from _Clitopilus passeckerianus_.
Retapamulin selectively inhibits bacterial protein synthesis by
interacting with the 50S
subunit of the bacterial ribosome in a way that is distinct from that
of other non-
pleuromutilin antibiotics that interact with the ribosome.
Data indicate that the binding site involves ribosomal protein L3 and
is in the region of the
ribosomal
P
site
and peptidyl
transferase
centre.
By
virtue
of
binding
to this
site,
pleuromutilins inhibit peptidyl transfer, partially block P-site
interactions, and prevent
normal formation
of
active 50S
ribosomal
subunits,
and therefore appear
to inhibit
bacterial protein synthesis by multiple mechanisms.
Due
to
this
distinct
mode
of
action,
_in _
_vitro_
target-specific
cross-resistance
with
retapamulin and other classes of antibiotics is rare.
2
_Pharmacodynamic Effects _
_ _
Retapamulin is active against most isolates of the common skin and
skin structure
pathogens _ Staphylococcus aureus_ and _ Streptococcus pyogenes_, both
_ in vitro_ and in
clinical studies. However, retapamulin has limited activity against
some MRSA strains in
the clinical setting (see _Clinical Trials_).
It
also
has
_in _
_vitro_
activity
against
some
other
Gram-positive,
Gram-negative
and
anaerobic bacteria.
Retapamulin is predominantly bacteriostatic against _ S. aureus_ and _
S. pyogenes_. The
mini