Mycoderm-C

Mycoderm-C

clotrimazole

Manufacturer:

FDC

Distributor:

Unimed
Full Prescribing Info
Contents
Clotrimazole.
Description
White to off-white powder with pleasant perfume.
Composition: Clotrimazole BP 1% w/w, Maize Starch BP and Purified Talc BP q.s.
Action
Pharmacology: Pharmacodynamics: Clotrimazole is an imidazole derivative with a broad spectrum of antimycotic activity.
Mechanism of Action: Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane.
Pharmacodynamic Effects: Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.
The mode of action of clotrimazole is 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.
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.
Pharmacokinetics: Pharmacokinetic investigations after dermal application have shown that clotrimazole is practically not 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 μg/ml, reflecting that clotrimazole applied topically does not lead to measurable systemic effects or side effects.
Indications/Uses
Mycoderm is indicated for all dermatomycoses due to dermatophytes (eg, tinea cruris, tinea pedis, tinea corporis), yeasts (cutaneous candidiasis), molds and other fungi, skin diseases showing secondary infection with these fungi.
Examples of previously mentioned dermatomycoses are interdigital mycoses (eg. athlete's foot), paronychias (associated with nail mycoses); mycoses in skin folds, pityriasis versicolor, erythrasma.
Dosage/Direction for Use
Recommended Dose: The powder should be sprinkled on to the affected areas 2 to 3 times daily. The powder may also be dusted inside articles of clothing and footwear which are in contact with the infected area.
Mode of Administration: For external use only.
Overdosage
Symptoms and Treatment of Overdose: Accidental oral Ingestion: In the event, routing measures such as gastric lavage should be performed as soon as possible after ingestion.
Contraindications
The preparation is contraindicated in patients with hypersensitivity to clotrimazole or to any ingredient in the preparation.
Special Precautions
None.
Use In Pregnancy & Lactation
Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife. Data on a large number of exposed pregnancies indicate no adverse effects of Clotrimazole on pregnancy or on the health of the foetus/newborn child.
To date, no relevant epidemiological data are available.
Side Effects
Rarely patients may experience a mild burning or irritation after application of the preparation.
Drug Interactions
None.
Storage
Store in a dry place below 30°C, and protect from light.
Shelf life: 36 Months from date of Manufacture.
MIMS Class
Topical Antifungals & Antiparasites
ATC Classification
D01AC01 - clotrimazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Presentation/Packing
Form
Mycoderm-C topical powd 1% w/w
Packing/Price
75 g x 1's
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