Clotrimazole BP 10 mg (1% w/w), in a cream base q.s.
Pharmacotherapeutic group: Antifungals for topical use - Imidazole and Triazole derivatives.
Pharmacology: Mechanism of Action: Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and function impairment of the cytoplasmic membrane.
Pharmacodynamics: Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeast, moulds, etc. Under appropriate test conditions, the MIC values for these types of fungi area in the region of less than 0.062 - 8.0 μg/mL.
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 vaginitis), 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 the therapeutic conditions.
Pharmacokinetics: 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.
For the treatment of: All dermatomycoses due to moulds and other fungi (e.g. Trichophyton species).
All dermatomycoses due to yeasts (Candida species). These include ringworm (tinea) infections (e.g. athlete's foot), paronychia, pityriasis versicolor, erythrasma and intertrigo.
Skin diseases showing secondary infection with these fungi.
Candidal nappy rash, vulvitis and balanitis.
The cream should be applied thinly and evenly to the affected area 2-3 times daily and rubbed in gently. A strip of cream (1/2 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. Or as prescribed by the physician.
No risk of acute intoxication is seen as it unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favorable to absorption) or inadvertent oral ingestion. There is no specific antidote.
Hypersensitivity to the active substance or to any of the excipients.
Do not use the cream to treat nail and scalp infections.
This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
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. 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. A risk to the sucking 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 women.
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:
Blister, discomfort/pain, oedema, erythema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning.
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.
Store at temperatures not exceeding 30°C.
Protect from light.
Puncture nozzle seal of the tube with piercing point of cap. Keep the tube tightly closed.
D01AC01 - clotrimazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Clotritas cream 10 mg (1% w/w)
15 g x 1's;20 g x 1's