ALACARE 5-aminolevulinic acid hydrochloride 8 mg dermal patch sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aminolevulinic acid hydrochloride, Quantity: 10.2 mg (Equivalent: aminolevulinic acid, Qty 8 mg)

Available from:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (International Name):

Aminolevulinic acid hydrochloride

Pharmaceutical form:

Patch, dermal

Composition:

Excipient Ingredients: polyethylene terephthalate; polyethylene; aluminium; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane

Administration route:

Topical

Units in package:

4 patches, 8 patches

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of mild to moderate actinic keratoses (AK) lesions on the face and scalp (hairless areas).

Product summary:

Visual Identification: Square (4 sq cm) skin coloured self-adhesive patches with rounded corners; Container Type: Sachet; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-03-19

Patient Information leaflet

ALACARE
®
_5-aminolevulinic acid (as hydrochloride) _
_ _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet
carefully before you use
Alacare.
This leaflet answers some
common questions about
Alacare. 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
taking Alacare 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 ALACARE IS USED
FOR
The name of your medicine is
Alacare. It contains the active
ingredient 5-aminolevulinic
acid (as hydrochloride).
Alacare is used to treat mild to
moderate skin abnormalities
on the head or face, called
solar keratosis. These are
small, rough spots which
develop on the skin. They are
caused by a lot of exposure to
the sun over many years.
They are also called actinic
keratosis.
Your doctor, however, may
prescribe Alacare for another
purpose. ASK YOUR DOCTOR IF
YOU HAVE ANY QUESTIONS
ABOUT WHY ALACARE HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription
and is to be administered by a
trained health care
professional.
BEFORE YOU USE
ALACARE
_WHEN YOU MUST NOT USE IT _
DO NOT USE ALACARE IF YOU:
•
are allergic
(hypersensitive) to 5-
aminolevulinic acid, acrylic
pressure sensitive
adhesive or any of the
other ingredients of
Alacare.
•
suffer from a certain
disease of blood
metabolism known as
porphyria.
•
were undergoing similar
therapy with 5-
aminolevulinic acid-
containing preparations
and it was unsuccessful.
•
have other skin conditions
caused by or made worse
by exposure to light.
ASK YOUR DOCTOR OR
PHARMACIST IF YOU ARE NOT
SURE IF THIS APPLIES TO YOU.
TREATMENT WITH ALACARE MAY
BE LESS SUCCESSFUL IF YOUR
SKIN IS AFFECTED BY:
•
inflammation
•
infection
•
psoriasis
•
eczema
•
cancer
•
tatt

Summary of Product characteristics

PRODUCT INFORMATION
ALACARE
®
NAME OF THE MEDICINE
Alacare 5-aminolevulinic acid (as hydrochloride) 8 mg dermal patch.
The chemical structure of aminolevulinic acid is:
*HCl
Chemical name: 5-Amino-4-oxo-
pentanoic acid hydrochloride
The molecular formula of aminolevulinic acid hydrochloride is C
5
H
9
NO
3
* HCl and its molecular
weight is 167.61. The CAS number is 5451-09-2. The white to off-white
crystalline powder is
freely soluble in water and slightly soluble in ethanol and methanol.
DESCRIPTION
Alacare
®
is a dermal patch consisting of a skin tone backing foil and a
self-adhesive matrix,
covered by a release liner.
Each dermal patch of 4 cm
2
contains 8 mg 5-aminolevulinic acid (as hydrochloride), 2 mg per cm
2
as part of a pressure sensitive adhesive patch (Durotak 387-2353, ARTG
PI no: 2261), pigmented
backing film (Scotchpak 1109, ARTG PI no: 11913) and polyethylene
terephthalate film release
liner which is removed prior to application.
PHARMACOLOGY
PHARMACODYNAMICS
Pharmacotherapeutic group:
Sensitisers used in Photodynamic/Radiation therapy, ATC Code: L01XD04
Mechanism of action:
After
topical
application
of
aminolevulinic
acid
hydrochloride,
protoporphyrin
IX
(PPIX)
accumulates intracellularly in the treated AK lesion. The
intracellular PPIX is a photoactive,
fluorescing compound and, upon light activation in the presence of
oxygen, singlet oxygen is
formed which causes damage to cellular compartments of the
light-exposed target cells, in
particular the mitochondria.
PHARMACOKINETICS
Pharmacokinetic data from a clinical trial in patients with mild to
moderate actinic keratoses on
the head and/or face, who had 8 Alacare patches applied for 4h, showed
a baseline corrected Cmax
Alacare® Product Information - 16 February 2016
Page 1 of 7
of 16.4 µg/l and an AUC
0-24
of 101.4 µg*h/l of systemic exogenous 5-aminolevulinic acid Tmax
was at 4 hours. The excretion of 5-ALA in urine during the first 12
hours after application was
low. The maximum excretion was 2.06% of the total dose, the median was
1.39%.