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Indications/Uses
Sertaconazole nitrate cream 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by: Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum [see Pharmacology: Clinical Studies under Actions].
Dosage/Direction for Use
In the treatment of interdigital tinea pedis, Sertaconazole nitrate cream, 2%, should be applied twice daily for 4 weeks. Sufficient amount of Sertaconazole nitrate cream, 2%, should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin of patients with interdigital tinea pedis.
Not for opthalmic, oral, or intravaginal use.
Not for opthalmic, oral, or intravaginal use.
Overdosage
Overdosage with Sertaconazole nitrate cream 2%, has not been reported to date. Sertaconazole nitrate cream 2% is intended for topical dermatological use only. It is not for oral, ophthalmic, or intravaginal use.
Contraindications
Sertaconazole nitrate cream 2%, is contraindicated in patients who have a known or suspected sensitivity to sertaconazole nitrate or any of its components or to other imidazoles.
Special Precautions
Local Adverse Reactions: If irritation develops, treatment should be discontinued and appropriate therapy instituted. Physicians should exercise caution when prescribing Sertaconazole nitrate cream, 2%, to patients known to be sensitive to azole antifungals, since cross-reactivity may occur.
Use in Children: The efficacy and safety of Sertaconazole nitrate cream, 2%, have not been established in pediatric patients below the age of 12 years.
Use in the Elderly: Clinical studies of Sertaconazole nitrate cream, 2%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Use in Children: The efficacy and safety of Sertaconazole nitrate cream, 2%, have not been established in pediatric patients below the age of 12 years.
Use in the Elderly: Clinical studies of Sertaconazole nitrate cream, 2%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Use In Pregnancy & Lactation
Pregnancy: Pregnancy Category C.
There are no adequate and well-controlled studies conducted with Sertaconazole nitrate cream in pregnant women. Sertaconazole nitrate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Reproduction studies have not been performed with Sertaconazole nitrate cream. Sertaconazole nitrate did not produce any evidence of maternal toxicity, embryotoxicity or teratogenicity in rats and rabbits at an oral dose of 160 mg/kg/day (40 times (rats) and 80 times (rabbits) the maximum recommended human dose based on a body surface area comparison). A reduction in live birth indices and an increase in the number of still-born pups were seen at doses of 80 and 160 mg/kg/day sertaconazole nitrate in an oral peri- and post-natal development study in rats.
Nursing Mothers: It is not known if sertaconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when prescribing Sertaconazole nitrate cream, 2%, to a nursing woman.
There are no adequate and well-controlled studies conducted with Sertaconazole nitrate cream in pregnant women. Sertaconazole nitrate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Reproduction studies have not been performed with Sertaconazole nitrate cream. Sertaconazole nitrate did not produce any evidence of maternal toxicity, embryotoxicity or teratogenicity in rats and rabbits at an oral dose of 160 mg/kg/day (40 times (rats) and 80 times (rabbits) the maximum recommended human dose based on a body surface area comparison). A reduction in live birth indices and an increase in the number of still-born pups were seen at doses of 80 and 160 mg/kg/day sertaconazole nitrate in an oral peri- and post-natal development study in rats.
Nursing Mothers: It is not known if sertaconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when prescribing Sertaconazole nitrate cream, 2%, to a nursing woman.
Adverse Reactions
Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.
In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving Sertaconazole nitrate cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, application site skin tenderness.
In a dermal sensitization trial, 8 of 202 evaluable subjects tested with Sertaconazole nitrate cream, 2%, and 4 of 202 evaluable subjects tested with vehicle, exhibited a slight erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers.
Post-marketing Experience: The following adverse reactions have been identified during post-approval use of Sertaconazole nitrate cream, 2%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
In post-marketing surveillance for Sertaconazole nitrate cream, 2%, the following were reported: Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.
In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving Sertaconazole nitrate cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, application site skin tenderness.
In a dermal sensitization trial, 8 of 202 evaluable subjects tested with Sertaconazole nitrate cream, 2%, and 4 of 202 evaluable subjects tested with vehicle, exhibited a slight erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers.
Post-marketing Experience: The following adverse reactions have been identified during post-approval use of Sertaconazole nitrate cream, 2%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
In post-marketing surveillance for Sertaconazole nitrate cream, 2%, the following were reported: Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Mechanism of Action: Sertaconazole nitrate cream is an azole antifungal (see Microbiology as follows)
Pharmacokinetics: In a multiple dose pharmacokinetic trial that included 5 male subjects with interdigital tinea pedis (range of diseased area, 42-140 cm2; mean, 93 cm2), Sertaconazole nitrate cream, 2%, was topically applied every 12 hours for a total of 13 doses to the diseased skin (0.5 grams sertaconazole nitrate per 100 cm2). Sertaconazole concentrations in plasma measured by serial blood sampling for 72 hours after the thirteenth dose were below the limit of quantitation (2.5 ng/mL) of the analytical method used.
Nonclinical Toxicology: Carcinogenesis. Mutagenesis, Impairment of Fertility: In a rat dermal carcinogenicity study, topical administration of sertaconazole nitrate cream for up to 102 weeks did not increase the number of neoplastic lesions compared to control animals, at sertaconazole nitrate doses of up to 800 mg/kg/day (approximately 200 times the maximum recommended human dose based on a body surface area comparison).
No clastogenic potential was observed in a mouse micronucleus test. Sertaconazole nitrate was considered nonclastogenic in the in vivo mouse sister chromatid exchange assay. There was no evidence that sertaconazole nitrate induced unscheduled DNA synthesis in primary rat hepatocyte cultures.
At oral doses up to 60 mg/kg/day (16 times the maximum recommended human dose based on a body surface area comparison), sertaconazole nitrate exhibited no toxicity or adverse effects on reproductive performance or fertility in male or female rats.
Clinical Studies: In two randomized, double-blind, clinical trials, subjects 12 years and older with interdigital tinea pedis applied Sertaconazole nitrate cream, 2%, or vehicle, twice daily for four weeks. Subjects with moccasin-type (plantar) tinea pedis and/or onychomycosis were excluded from the trial. Two weeks after completion of therapy (six weeks after beginning therapy), subjects were evaluated for signs and symptoms related to interdigital tinea pedis. (See table.)
Pharmacokinetics: In a multiple dose pharmacokinetic trial that included 5 male subjects with interdigital tinea pedis (range of diseased area, 42-140 cm2; mean, 93 cm2), Sertaconazole nitrate cream, 2%, was topically applied every 12 hours for a total of 13 doses to the diseased skin (0.5 grams sertaconazole nitrate per 100 cm2). Sertaconazole concentrations in plasma measured by serial blood sampling for 72 hours after the thirteenth dose were below the limit of quantitation (2.5 ng/mL) of the analytical method used.
Nonclinical Toxicology: Carcinogenesis. Mutagenesis, Impairment of Fertility: In a rat dermal carcinogenicity study, topical administration of sertaconazole nitrate cream for up to 102 weeks did not increase the number of neoplastic lesions compared to control animals, at sertaconazole nitrate doses of up to 800 mg/kg/day (approximately 200 times the maximum recommended human dose based on a body surface area comparison).
No clastogenic potential was observed in a mouse micronucleus test. Sertaconazole nitrate was considered nonclastogenic in the in vivo mouse sister chromatid exchange assay. There was no evidence that sertaconazole nitrate induced unscheduled DNA synthesis in primary rat hepatocyte cultures.
At oral doses up to 60 mg/kg/day (16 times the maximum recommended human dose based on a body surface area comparison), sertaconazole nitrate exhibited no toxicity or adverse effects on reproductive performance or fertility in male or female rats.
Clinical Studies: In two randomized, double-blind, clinical trials, subjects 12 years and older with interdigital tinea pedis applied Sertaconazole nitrate cream, 2%, or vehicle, twice daily for four weeks. Subjects with moccasin-type (plantar) tinea pedis and/or onychomycosis were excluded from the trial. Two weeks after completion of therapy (six weeks after beginning therapy), subjects were evaluated for signs and symptoms related to interdigital tinea pedis. (See table.)
In clinical trials, complete cure in sertaconazole treated subjects was achieved in 32 of 160 (20%) subjects with Trichophyton rubrum, in 7 of 28 (25%) subjects with Trichophyton mentagrophytes and in 1 of 13 (15%) subjects with Epidermophyton floccosum.
Microbiology: Mechanism of Action: Sertaconazole, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. Ergosterol is a key component of fungal cell membranes and lack of this component leads to fungal cell injury by leakage of key constituents in the cytoplasm from the cell.
Activity In Vitro and in Clinical Infections: Sertaconazole nitrate has been shown to be active against isolates of the following microorganisms in clinical infections (see Indications): Trichophyton rubrum; Trichophyton mentagrophytes; Epidermophyton floccosum.
Microbiology: Mechanism of Action: Sertaconazole, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. Ergosterol is a key component of fungal cell membranes and lack of this component leads to fungal cell injury by leakage of key constituents in the cytoplasm from the cell.
Activity In Vitro and in Clinical Infections: Sertaconazole nitrate has been shown to be active against isolates of the following microorganisms in clinical infections (see Indications): Trichophyton rubrum; Trichophyton mentagrophytes; Epidermophyton floccosum.
MedsGo Class
Topical Antifungals & Antiparasites
Features
Dosage
20mg /g (2% w/w)
Ingredients
- Sertaconazole Nitrate
Packaging
Cream 20g
Generic Name
Sertaconazole Nitrate
Registration Number
DR-XY43288
Classification
Prescription Drug (RX)
Product Questions
Questions
