ORACORT E

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

LIDOCAINE HYDROCHLORIDE MONOHYDRATE; TRIAMCINOLONE ACETONIDE

Disponibil de la:

TARO PHARMACEUTICAL INDUSTRIES LTD

Codul ATC:

A01AC01

Forma farmaceutică:

PASTE

Compoziție:

LIDOCAINE HYDROCHLORIDE MONOHYDRATE 3 G / 100 G; TRIAMCINOLONE ACETONIDE 0.1 G / 100 G

Calea de administrare:

LOCAL ORAL

Tip de prescriptie medicala:

Not required

Produs de:

TARO PHARMACEUTICAL INDUSTRIES LTD

Grupul Terapeutică:

TRIAMCINOLONE

Zonă Terapeutică:

TRIAMCINOLONE

Indicații terapeutice:

Adjunctive treatment and temporary relief of pain and symptoms associated with oral inflammatory and ulcerative lesions.

Data de autorizare:

2014-05-31

Prospect

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is to be dispensed
without a doctor’s prescription
ORACORT E
ORAL PASTE
ACTIVE INGREDIENTS - 1 gram of the preparation contains:
Triamcinolone acetonide 1 mg
Lidocaine hydrochloride monohydrate 30 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 according to the instructions in the section about
dose in this leaflet. 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 E is indicated as an adjunctive treatment and for the
temporary relief of symptoms and pain
associated with oral inflammatory and ulcerative lesions.
THERAPEUTIC GROUP:
Triamcinolone acetonide: synthetic corticosteroid for local treatment,
with anti-inflammatory, antipruritic,
and vasoconstrictive properties.
Lidocaine: local anesthetic.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:

You are sensitive (allergic) to the active ingredients or to any of
the additional ingredients this
medicine contains (see section 6).

You are sensitive (allergic) to other amino amide local anesthetics.

There exists a viral (such as herpes), fungal and/or bacterial
infection 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
requires medical supervision.
•
If you are sensitive t

Caracteristicilor produsului

Oracort E SPC – 08.2022
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
_ _
ORACORT E
_ _
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Triamcinolone Acetonide 1 mg
Lidocaine Hydrochloride monohydrate 30 mg
Topical Oral Paste
_ _
EXCIPIENTS:
Paraffin liquid, gelatin, pectin, sodium carboxymethylcellulose,
polyethylene.
INDICATIONS AND USAGE
Oracort E is indicated for adjunctive treatment and temporary relief
of pain
and symptoms associated with oral inflammatory and ulcerative lesions.
DESCRIPTION
Oracort E, 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:
Oracort E SPC – 08.2022
Each gram of Oracort E contains 1 mg triamcinolone acetonide and 30 mg
lidocaine hydrochloride monohydrate in an emollient dental paste.
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.
Lidocaine reversibly prevents opening of Na+ channels and thus the
development of an action potential. The active substance binds to a
specific receptor on the Na+ channel of the nerve, thereby preventing
the
transport of ions through the pores and thus the development of an
action
potential.
This leads to suppression of conduction loca