ORACORT

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

TRIAMCINOLONE ACETONIDE

Disponible desde:

TARO INTERNATIONAL LTD, ISRAEL

Código ATC:

A01AC01

formulario farmacéutico:

PASTE

Composición:

TRIAMCINOLONE ACETONIDE 0.1 %

Vía de administración:

TOPICAL

tipo de receta:

Not required

Fabricado por:

TARO PHARMACEUTICALS INC., CANADA

Grupo terapéutico:

TRIAMCINOLONE

Área terapéutica:

TRIAMCINOLONE

indicaciones terapéuticas:

Indicated for the adjunctive treatment and the temporary relief of symptoms associated with oral inflammatory and ulcerative lesions.

Fecha de autorización:

2020-05-31

Información para el usuario

PK-3021-4
1216-4 DOR-13559-1216-02
PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This medicine is to be dispensed without a
doctor’s prescription
ORACORT
ORAL PASTE
ACTIVE INGREDIENT - 1 gram of the preparation
contains:
Triamcinolone Acetonide 1 mg
Inactive ingredients and allergens: See section 6 -
“Additional Information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE
MEDICINE. This leaflet contains concise information
about the medicine. If you have further questions,
refer to the doctor or pharmacist.
The medicine is not usually recommended for
infants
and
children
under
two
years
of
age.
Under this age, contact a doctor.
Use this medicine correctly. Consult a pharmacist
if you need further information. Contact a doctor
if the signs of your illness (symptoms) get worse
or do not improve after 7 days.
1. WHAT IS THE MEDICINE INTENDED FOR?
Oracort is indicated as an adjunctive treatment and
for the temporary relief of symptoms associated
with oral inflammatory and ulcerative lesions.
THERAPEUTIC GROUP:
Synthetic
corticosteroids
for
local
treatment,
with
anti-inflammatory,
antipruritic,
and
vasoconstrictive properties.
2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF:
·
You
are
sensitive
(allergic)
to
the
active
ingredient
or
to
any
of
the
additional
ingredients this medicine contains.
·
There exist viral (such as herpes simplex), fungal
and/or bacterial infections of the mouth and/
or throat or tuberculosis of the skin, especially
during prolonged use of the preparation. SPECIAL WARNINGS ABOUT USING THE MEDICINE
•
Do not use this medicine frequently, or for a
long period, without consulting the doctor.
•
Special
caution
is
required
when
using
in
children. Use in children and adolescents must
be carried out under medical supervision.
Caution recommended when using in elderly
patients.
•
If you are sensitive to any food or medication,
inform the doctor before taking the medicine.
•
If local irritation develops, stop treatment and
ref

Ficha técnica

Oracort SPC – 12.2020
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
_ _
ORACORT
_ _
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Triamcinolone Acetonide Topical Paste, 0.1%
_ _
EXCIPIENTS:
Mineral oil, fine gelatin powder, pectin, sodium
carboxymethylcellulose,
polyethylene.
INDICATIONS AND USAGE
Oracort (triamcinolone acetonide topical paste, 0.1%) is indicated for
adjunctive treatment and the temporary relief of symptoms associated
with
oral inflammatory and ulcerative lesions.
DESCRIPTION
Oracort (triamcinolone acetonide topical paste, 0.1%), contains the
corticosteroid triamcinolone acetonide in an adhesive vehicle suitable
for
application to oral tissues. Triamcinolone acetonide is designated
chemically as 9-fluoro-11
β
, 16
α
, 17, 21-tetrahydroxypregna-1, 4-diene-3,
20- dione cyclic 16, 17-acetal with acetone. The structural formula of
triamcinolone acetonide is as follows:
Each gram of Oracort contains 1 mg triamcinolone acetonide in an
emollient dental paste containing gelatin, pectin, and
carboxymethylcellulose sodium in a plasticized hydrocarbon gel (a
Oracort SPC – 12.2020
polyethylene and mineral oil gel base).
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, triamcinolone acetonide has anti-
inflammatory, antipruritic, and vasoconstrictive properties. The
mechanism
of the anti-inflammatory activity of the topical steroids, in general,
is
unclear. However, corticosteroids are thought to act by the induction
of
phospholipase A inhibitory proteins, collectively called lipocortins.
It is
postulated that these proteins control the biosynthesis of potent
mediators
of inflammation such as prostaglandins and leukotrienes by inhibiting
the
release of their common precursor, arachidonic acid. Arachidonic acid
is
released from membrane phospholipids by phospholipase A.
PHARMACOKINETICS
The extent of absorption through the oral mucosa is determined by
multiple
factors including the vehicle, the integrity of the mucosal barrier,
the
duration of therapy, and the presence of infla