LOTRIDERM Cream (2021)
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Περιεχόμενα
1. Name of the medicinal product
LOTRIDERM 0.05% w/w /1.0% w/w Cream.
2. Qualitative and quantitative composition
Betamethasone dipropionate 0.064% w/w* (* equivalent to 0.05% betamethasone) Clotrimazole 1.0% w/w <u>Excipients with known effect:</u> Cetostearyl alcohol, Propylene glycol, 100mg/g of cream Benzyl alcohol, ...
3. Pharmaceutical form
Cream. Smooth, uniform, white to off-white cream.
4.1. Therapeutic indications
Short-term topical treatment of tinea infections due to Trichophyton rubrum; T.mentagrophytes; Epidermophyton floccusum and Microsporum canis; candidiasis due to Candida albicans.
4.2. Posology and method of administration
Posology Adults and children over the age of 12 years. Topical administration twice daily for two weeks (tinea cruris, tinea corporis and candidiasis) or for four weeks (tinea pedis). Paediatric population ...
4.3. Contraindications
Lotriderm is contraindicated in those patients with a history of sensitivity to any of its components or to other corticosteroids or imidazoles. If irritation or sensitisation develops with the use of ...
4.4. Special warnings and precautions for use
Local and systemic toxicity is common especially following long continued use on large areas of damaged skin and in flexures. If used on the face, courses should be limited to 5 days. LOTRIDERM CREAM SHOULD ...
4.5. Interaction with other medicinal products and other forms of interaction
There are no known interactions.
4.6. Fertility, pregnancy and lactation
Pregnancy There is inadequate evidence of safety in pregnancy. Clotrimazole has shown no teratogenic effect in animals but is foetotoxic at high oral doses. Topical administration of corticosteroids to ...
4.7. Effects on ability to drive and use machines
Lotriderm cream has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Adverse reactions reported for Lotriderm include: burning and stinging, maculopapular rash, oedema, paraesthesia and secondary infection. Reported reactions to clotrimazole include erythema, stinging, ...
4.9. Overdose
Acute overdosage with topical application of Lotriderm cream is unlikely and would not be expected to lead to a life-threatening situation; however topically applied corticosteroids can be absorbed in ...
5.1. Pharmacodynamic properties
Lotriderm Cream contains the dipropionate ester of betamethasone, a glucocorticoid exhibiting the general properties of corticosteroids, and clotrimazole which is an imidazole antifungal agent. Topical ...
5.2. Pharmacokinetic properties
Lotriderm is intended for treatment of skin conditions and is applied topically. Thus there are minimal pharmacokinetic aspects related to bioavailability at the site of action. Clotrimazole penetrates ...
5.3. Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of this SmPC.
6.1. List of excipients
Liquid paraffin White soft paraffin Cetostearyl alcohol Macrogol cetostearyl ether Benzyl alcohol Sodium dihydrogen phosphate dihydrate Phosphoric acid concentrated Sodium hydroxide Propylene glycol (E ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
The product will be marketed in standard epoxy-lined aluminium tubes with low density polyethylene caps. Tubes will contain 2g or 5g (Professional Sample Packs), 15g, 30g or 50g. Not all pack sizes may ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
Organon Pharma (UK) Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
8. Marketing authorization number(s)
PL 00025/0568
9. Date of first authorization / renewal of the authorization
October 1992 / July 2007
10. Date of revision of the text
03 March 2021
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