CANDIPLAS H Cream (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Candiplas H 2%w/w / 1%w/w cream.
2. Qualitative and quantitative composition
Each 1 g of cream contains miconazole nitrate 2% w/w, equivalent to 20 mg, and hydrocortisone 1% w/w, equivalent to 10 mg. <u>Excipients with known effect:</u> Cetostearyl alcohol. Each 1 g of Candiplas ...
3. Pharmaceutical form
Cream. White, soft, homogeneous, smooth, odourless cream.
4.1. Therapeutic indications
For the topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation co-exist, e.g. intertrigo and infected eczema. Moist or dry eczema or dermatitis including atopic ...
4.2. Posology and method of administration
Posology The properties of Candiplas H cream indicate it particularly for the initial stages of treatment. Because of its corticosteroid content avoid long-term treatment with Candiplas H cream. Once the ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 True hypersensitivity to other imidazole derivatives, hydrocortisone. Tubercular or viral infections of the skin ...
4.4. Special warnings and precautions for use
When Candiplas H cream is used by patients taking oral anticoagulants, the anticoagulant effect should be carefully monitored. Severe hypersensitivity reactions, including anaphylaxis and angioedema, have ...
4.5. Interaction with other medicinal products and other forms of interaction
Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application (see section 5.2), clinically relevant interactions are rare. However, ...
4.6. Pregnancy and lactation
Pregnancy Clinical data on the use of miconazole nitrate and hydrocortisone cream in pregnancy are limited. In animals, corticosteroids are known to cross the placenta and consequently can affect the foetus ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
The safety of miconazole nitrate and hydrocortisone cream was evaluated in 480 patients who participated in 13 clinical trials (six double-blind and seven open-label trials) of miconazole nitrate and hydrocortisone ...
4.9. Overdose
Symptoms Prolonged and excessive use can result in skin irritation, which usually disappears after discontinuation of therapy. Topically applied corticosteroids can be absorbed in sufficient amounts to ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Imidazole and triazole derivatives, combinations <b>ATC code:</b> D01AC20 Miconazole nitrate is active against dermatophytes and pathogenic yeasts, and many Gram-positive ...
5.2. 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 ...
5.3. Preclinical safety data
Preclinical data on the drug product (miconazole nitrate + hydrocortisone) revealed no special hazard for humans based on conventional studies of ocular irritation, dermal sensitization, single dose oral ...
6.1. List of excipients
<u>Candiplas H cream also contains:</u> Purified water Chlorocresol Cetomacrogol 1000 Cetostearyl alcohol White petrolatum Liquid paraffin
6.2. Incompatibilities
Contact should be avoided between latex products such as contraceptive diaphragms or condoms and Candiplas H cream since the constituents of Candiplas H cream may damage the latex.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C in the original package, in order to protect from light and moisture.
6.5. Nature and contents of container
Lacquered collapsible aluminium tubes, crimped at bottom and sealed with a polypropylene screw cap containing 15 g and 30g of cream packed in a carton box. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
12705
9. Date of first authorization / renewal of the authorization
Date of first authorization: 13/03/1990 Date of latest renewal: 18/09/2007
10. Date of revision of the text
09/2017
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