Active ingredients: Triamcinolone, Chlortetracycline
AUREOCORT® ointment
Indications Why is Aureocort used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antibiotic - anti-inflammatory for dermatological use.
THERAPEUTIC INDICATIONS
AUREOCORT Ointment for topical use is indicated for: dermatitis sensitive to corticosteroids for topical use accompanied by bacterial superinfection sensitive to chlortetracycline and bacterial dermatitis from germs sensitive to chlortetracycline accompanied by evident inflammatory reaction.
Contraindications When Aureocort should not be used
Known hypersensitivity to tetracyclines or corticosteroids; cutaneous tuberculosis, herpes, chicken pox, fungal and viral diseases of the skin to be treated. Acne rosacea. Skin ulcers.
Do not use with the occlusive dressing technique.
The product is not for ophthalmic use.
Precautions for use What you need to know before taking Aureocort
Locally applied cortisones can reduce skin resistance to bacteria, viruses and fungi and mask a hypersensitivity reaction to chlortetracycline. If concomitant antibiotic treatment is inappropriate, due to the anti-inflammatory effect of the steroids. If the conditions do not respond promptly and effectively to the combined treatment this will have to be suspended and the infection treated adequately with other measures.
In pregnant women and in very early childhood, use only in case of real need and under direct medical supervision.
Prolonged or repeated use of the product may give rise to sensitization phenomena or the development of bacterial or fungal infections not sensitive to chlortetracycline.
Should this occur, the treatment must be interrupted and the attending physician should be consulted. In children, skin folds and nappies can act as an occlusive dressing.
Interactions Which drugs or foods may change the effect of Aureocort
In the event that the patient is suffering from other diseases or is taking other medicines, he or she may ask his / her Doctor for the necessary information.
Warnings It is important to know that:
Excessive use of the product such as in the case of treatment of large areas or for prolonged therapies beyond the limit may cause general phenomena of systemic absorption (Cushing's syndrome, inhibition of the pituitary-adrenal axis), especially in subjects with renal insufficiency.
This medicine can cause local skin reactions (e.g. contact dermatitis).
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDRENDose, Method and Time of Administration How to use Aureocort: Posology
The AUREOCORT Ointment for topical use must be applied 2 or 3 times a day on the affected area, directly or spread with sterile gauze for no more than a consecutive week.
Overdose What to do if you have taken too much Aureocort
METHOD OF INTERVENTION IN CASE OF EXCESSIVE DOSES
In case of accidental overdose it is advisable to wash the part with soap and water, then contact your doctor.
CONDUCT TO FOLLOW IN CASE OF OMISSION OF DOSES
If the patient forgets to apply the ointment at the scheduled time, he can apply it as soon as possible
POSSIBLE RISK OF WITHDRAWAL SYNDROME
None described.
Side Effects What are the side effects of Aureocort
Locally signs of hypersensitivity such as hyperemia, edema, itching and desquamation; for treatments prolonged beyond the limit it is possible the appearance of skin atrophy, hypertrichosis, acneiform eruptions, capillary fragility, purpura.
The phenomena of excess corticosteroids are represented by asthenia, adynamy, arterial hypertension, heart rhythm disturbances, hypokalaemia, metabolic alkalosis
THE PATIENT MUST REPORT ANY UNDESIRABLE EFFECT NOT DESCRIBED IN THIS PACKAGE LEAFLET TO HIS PHYSICIAN.
Expiry and Retention
Warning: do not use the medicine after the expiry date indicated on the package
COMPOSITION
100 g of ointment contain:
Active ingredient: Chlortetracycline hydrochloride g 3.0, Triamcinolone acetonide g 0.1.
Excipients: Anhydrous Lanolin, White Vaseline.
PHARMACEUTICAL FORM AND CONTENTS BY WEIGHT
Ointment for dermatological use, tube of 30 g.
Content by weight: see paragraph "Composition".
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
AUREOCORT
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of ointment contain:
Active ingredients: Chlortetracycline hydrochloride g 3.00 -Triamcinolone acetonide (9 o-fluoro-11B, 21 dihydroxy-16 o, 17 o isopripylidioxy - pregna - 1,4 diene - 3,20 dione) g 0,10
03.0 PHARMACEUTICAL FORM
Ointment.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
AUREOCORT Ointment for topical use allows to exploit both the anti-inflammatory action of triamcinolone acetonide and the antibiotic action of chlortetracycline.
This makes it possible to use it in: dermatitis sensitive to corticosteroids for topical use accompanied by bacterial superinfection sensitive to chlortetracycline; bacterial dermatitis caused by germs sensitive to chlortetracycline accompanied by evident inflammatory reactions.
04.2 Posology and method of administration
AUREOCORT Ointment for topical use should be applied two or three times a day on the affected area, directly or spread on sterile gauze.
04.3 Contraindications
Known hypersensitivity to the components; cutaneous tuberculosis, herpes, chicken pox and other fungal and viral skin diseases to be treated.
Acne rosacea.
Skin ulcers.
Do not use with the occlusive dressing technique.
The product is not for ophthalmic use.
04.4 Special warnings and appropriate precautions for use
Locally applied cortisones can reduce skin resistance to bacteria, viruses and fungi and mask a hypersensitivity reaction to chlortetracycline.
If concomitant antibiotic treatment is inappropriate, due to the anti-inflammatory effect of steroids, only an apparent improvement in the clinical situation may occur. Therefore, if the conditions do not respond promptly and effectively to the combined treatment, this must be suspended and the infection treated adequately. with other measures. However, it is necessary not to exceed a week of therapy, then moving on to the component deemed necessary. Excessive use of the product such as in the case of treatment of large areas or for prolonged therapies beyond the limit may cause general phenomena of systemic absorption (Cushing's syndrome, inhibition of the pituitary-adrenal axis) especially in subjects with renal insufficiency. In children, skin folds and nappies can act as an occlusive dressing. Prolonged or repeated use of the product can give rise to sensitization phenomena or the development of bacterial or fungal infections that are not sensitive to chlortetracycline. If this should occur, the treatment must be interrupted and the treating doctor consulted.
In pregnant women and in very early childhood use only in case of real need and under direct medical supervision.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known drug interactions with other drugs.
04.6 Pregnancy and lactation
In pregnant women, the product should be administered only in cases of real need, under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
The AUREOCORT does not interfere with the ability to drive and use machines.
04.8 Undesirable effects
Locally signs of hypersensitivity such as hyperemia, edema, itching and desquamation; for treatments prolonged beyond the limit it is possible the appearance of skin atrophy, hypertrichosis, acneiform eruptions, capillary fragility, purpura.
The phenomena of excess corticosteroids are represented by asthenia, adynamy, arterial hypertension, heart rhythm disturbances, hypokalaemia, metabolic alkalosis.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
AUREOCORT is a combination consisting of a corticosteroid, triamcinolone acetonide, and a broad spectrum antibiotic, chlortetracycline hydrochloride.
Triamcinolone acetonide is a corticosteroid with a singular affinity for the skin, given its particular physicochemical characteristics which enhance its penetration and activity.
Therefore, due to its high anti-inflammatory and antipruginous power, triamcinolone acetonide exerts a particularly effective action in the most varied skin conditions.
Chlortetracycline hydrochloride (AUREOMYCIN) also has a broad spectrum of action for topical use, being effective on gram-positive (streptococci, staphylococci, diplococci) and gram-negative (coliaerogenes group) microorganisms.
In addition to its effectiveness, this antibiotic is particularly suitable for topical use due to its stability and because it is well tolerated.
05.2 "Pharmacokinetic properties
In pharmacology studies, AUREOCORT has been shown to be effective in reducing the inflammatory edema of the rat paw and the experimentally induced skin inflammatory reaction in humans.
05.3 Preclinical safety data
Topical application of AUREOCORT in rats does not produce systemic side effects.
In rats and rabbits, the administration of AUREOCORT mitigates the irritating effects induced by the repeated application of formalin.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Anhydrous lanolin, white petroleum jelly.
06.2 Incompatibility
None.
06.3 Period of validity
Shelf life: 3 years.
The expiry date indicated refers to the product in intact packaging, correctly stored.
06.4 Special precautions for storage
None.
06.5 Nature of the immediate packaging and contents of the package
30 g tube.
06.6 Instructions for use and handling
07.0 MARKETING AUTHORIZATION HOLDER
Teofarma S.r.l. via F.lli Cervi, 8 - Salimbene Valley (PV)
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C. 020867026
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
June 1967 / June 2010
10.0 DATE OF REVISION OF THE TEXT
June 2010
