:For the treatment of

i. All dermatomycoses due to moulds and other fungi (e.g. Trichophyton species)

ii. All dermatomycoses due to yeasts (Candida species). These include ringworm (tinea) infections (e.g. athlete's foot), paronychia, pityriasis versicolor, erythrasma and intertrigo

iii. Skin diseases showing secondary infection with these fungi

iv. Candidal nappy rash, vulvitis and balanitis

Posology

There is no separate dosage schedule for the young or elderly

Method of administration

The cream should be applied thinly and evenly to the affected area 2 – 3 times daily and rubbed in gently. A strip of cream (½ cm long) is enough to treat an area of about the size of the hand

If the feet are infected, they should be thoroughly washed and dried, especially between the toes, before applying the cream

Treatment should be continued for at least one month for dermatophyte infections, or for at least two weeks for candidal infections

(This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis

Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently, the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product

:Pregnancy

There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses (see section 5.3). At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole can be used during pregnancy but only under the supervision of a physician or midwife

:Lactation

Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk after intravenous administration (see section 5.3). A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from clotrimazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman

Fertility

No human studies of the effects of clotrimazole on fertility have been performed; however, animal studies have not demonstrated any effects of the drug on fertility

Clotrimazole cream has no or negligible influence on the ability to drive or use machines

As the listed undesirable effects are based on spontaneous reports, assigning an accurate frequency of occurrence for each is not possible

Immune system disorders: allergic reaction (syncope, hypotension, dyspnoea, urticaria)

Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, erythema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote

However, in the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately

Pharmacotherapeutic group: Antifungals for topical use – imidazole and triazole derivatives

ATC code: A01AB18; D01AC01; G01AF02

Mechanism of Action

Dermatin Cream acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane.

Pharmacodynamic Effects

Dermatin Cream has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc. Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062-8.0 µg/ml substrate

The mode of action of clotrimazole is primarily fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive

(In addition to its antimycotic action, clotrimazole also acts on gram-positive microorganisms (Streptococci / Staphylococci / Gardnerella vaginalis), and gram-negative microorganisms (Bacteroides

In vitro clotrimazole inhibits the multiplication of Corynebacteria and gram-positive cocci - with the exception of Enterococci - in concentrations of 0.5-10 µg/ml substrate

Primarily resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions

Pharmacokinetic investigations after dermal application have shown that clotrimazole is minimally absorbed from the intact or inflamed skin into the human blood circulation. The resulting peak serum concentrations of clotrimazole were below the detection limit of 0.001 mcg/ml, suggesting that clotrimazole applied topically is unlikely to lead to measurable systemic effects or side effects

Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity and carcinogenicity

Dermatin Cream was not teratogenic in reproductive toxicity studies in mice, rats and rabbits. In rats high oral doses were associated with maternal toxicity, embryotoxicity, reduced fetal weights and decreased pup survival

In rats clotrimazole and/or its metabolites were secreted into milk at levels higher than in plasma by a factor of 10 to 20 at 4 hrs after administration, followed by a decline to a factor of 0.4 by 24 hrs

Cetomacrogol 1000, Cetostearyl Alcohol, Glycerin, Liquid Paraffin, Methylparaben, Propylparaben, Propylene glycol, White soft paraffin and Purified Water

Not applicable

Store below 30⁰C

Carton box contains Aluminium tube of 12 g with plastic cap with leaflet

No special requirements