MicoCortisone 20mg/g+10mg/g cream

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

miconazole (miconazole nitrate), hydrocortisone

Disponible des:

Orion Pharma Ltd.

Codi ATC:

D01AC52

Designació comuna internacional (DCI):

miconazole (miconazole nitrate), hydrocortisone

Dosis:

20mg/g+10mg/g

formulario farmacéutico:

cream

Unidades en paquete:

10g aluminium tube

tipo de receta:

Prescription

Estat d'Autorització:

Registered

Data d'autorització:

2015-10-21

Informació per a l'usuari

MICOCORTISONE
CREAM
Miconazole Nitrate 2.0%, Hydrocortisone 1.0%
_PATIENT INFORMATION LEAFLET _
NAME OF THE MEDICINAL PRODUCT: MicoCortisone
INTERNATIONAL NONPROPRIETARY NAME: Miconazole Nitrate & Hydrocortisone
COMPOSITION:
Each gram of cream contains:
_ACTIVE INGREDIENT: _
Miconazole Nitrate 20 mg
Hydrocortisone 10 mg.
_EXCIPIENTS:_ Cetyl Ester Wax, Cetostearyl Alcohol, Sorbitan
Monostearate, Liquid Paraffin (heavy), Polysorbate 60, Glycerin,
Benzyl Alcohol, Purified Water
PHARMACEUTICAL FORM: Cream
PHARMACOLOGICAL GROUP: Antifungal
ANATOMICAL THERAPEUTIC CHEMICAL CODE (ATC): A01AB09, D07AA02
DESCRIPTION: MicoCortisone is a combination of Miconazole Nitrate &
Hydrocortisone. Miconazole Nitrate is an imidazole
antifungal agent and possesses antibacterial activity. At low
concentrations, it interacts with fungal cytochrome p450 which
results in inhibition of a demethylation step in the biosynthesis of
ergosterol. At high concentrations, Miconazole interacts with
membrane lipids causes direct membrane damage which results in leakage
of fungus cell constituents. It appears that
fungistatic effects result from the inhibition of membrane sterol
synthesis and fungicidal effects from impairment of the barrier
function of the membrane. Hydrocortisone is a naturally occurring
glucocorticoid that is now prepared by chemical synthesis
and its main action is to reduce the response of the skin to injury
(i.e. anti-inflammatory). It also has immunosuppressant and
antimitotic actions. The anti-inflammatory activity of Hydrocortisone
is its main therapeutic property.
PHARMACOKINETIC PROPERTIES: Absorption: Miconazole remains in the skin
after topical application for up to 4 days. Systemic
absorption of miconazole is limited, with a bioavailability of less
than 1% following topical application of miconazole. Plasma
concentrations of miconazole and/or its metabolites were measurable 24
and 48 hours after application. Approximately 3% of
the dose of hydrocortisone is absorbed after application on the skin.
DISTRIBUTION: Absorbed m

Fitxa tècnica

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_ _
Orion Pharma Limited
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PRODUCT REGISTRATION DOSSIER FOR ARMENIA (MICOCORTISONE CREAM)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT: MicoCortisone
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains:
Active ingredients:
Miconazole Nitrate 20 mg
Hydrocortisone 10 mg.
For excipients, see 5.1
2.
PHARMACEUTICAL FORM
Cream, Topical Preparation
White, homogeneous, odourless cream
3.
CLINICAL PARTICULARS
3.1.
THERAPEUTIC INDICATIONS
Athlete's foot and candidal intertrigo where there are co-existing
symptoms of inflammation.
Organisms which are susceptible to miconazole are dermatophytes and
pathogenic yeasts (e.g., _Candida_ spp.).
Also many Gram-positive bacteria including most strains of
_Streptococcus_ and _Staphylococcus_.
The properties of MicoCortisone Cream indicate it particularly for the
initial stages of treatment.
3.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration
Apply the cream twice a day to the affected area, rubbing in gently
until the cream has been absorbed by the
skin. The maximum period of treatment is 7 days
3.3.
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients. Tubercular or viral
infections of the skin or those caused by Gram-
negative bacteria. MicoCortisone Cream should not be used in the
following conditions:
• If the skin is broken
• On large areas of skin
• Used for longer than 7 days
• To treat cold sores and acne
• Use on the face, eyes and mucous membranes
• Children under 10 years of age, unless prescribed by a doctor
• On the ano-genital region unless prescribed by a doctor
• To treat ringworm unless prescribed by a doctor
• To treat secondary infected conditions unless prescribed by a
doctor
3.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
When MicoCortisone Cream is used by patients taking oral
anticoagulants, the anticoagulant effect should be
carefully monitored.
Severe hypersensitivity reactions, including anaphylaxis and
angioedema, have been reported during treatment
with miconazole