Palavale 1%

Uses

Palavale 1% Cream: All fungal skin infections due to dermatophytes, yeasts, moulds and other fungi. These include Vulvo-vaginal candidiasis, Candidial napkin rash, and other candidial infection, Ringworm (tinea) infections, Athlete's foot, Paronychia, Pityriasis versicolor and Balanitis.

Palavale 1%-G Cream: Vulvo-vaginal candidiasis or any other fungal infection of vagina.

Palavale 1% VT: Vulvo-vaginal candidiasis or any other fungal infection of vagina.

For the treatment of onychomycosis, local therapy with Palavale 1% cream, combined with an oral antimycotic, is recommended.

Palavale 1% is also used to associated treatment for these conditions: Allergy Skin, Balanitis candida, Dermatitis, Fungal infectious disorders of the Beard, Fungal skin infection, Herpes Zoster, Intertrigo, Mycotic Eczema, Pityriasis versicolor, Ringworm, Skin candida, Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea pedis of the interdigital, Vulvovaginal mycotic infection, Cutaneous candidiasis, Cutaneous dermatophyte infection

How Palavale 1% works

Palavale 1% interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert lanosterol to ergosterol. As ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Palavale 1% may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and impair triglyceride and/or phospholipid biosynthesis.

Dosage

Palavale 1% dosage

Palavale 1% Cream is applied to the affected skin areas once or twice daily, in the morning and/or in the evening and gently rubbed in with the clean finger.

For mycoses of the hands, application is recommended following each washing of the hands. For the treatment of onychomycosis, occlusive dressings are recommended.

Palavale 1%-G Cream is applied with the applicator par vaginally once or twice daily.

Palavale 1% VT is applied with the applicator par vaginally one tablet once or twice daily.

In order to prevent relapse, treatment should be continued for 2 weeks after clinical cure.

Side Effects

Rarely, transient local mild irritation, itching & redness may occur immediately after application. Palavale 1% has minimal allergic effect. It is well tolerated, even by delicate skin. Local irritations are not likely to occur, except in rare cases, e.g., in eczematous skin areas. In such cases, anti-eczematous treatment is recommended for several days before therapy with Palavale 1% is initiated.

Toxicity

Overdosage of econazole in humans has not been reported to date. In mice, rats guinea pigs and dogs, the oral LD 50 values were found to be 462, 668, 272, and > 160 mg/kg, respectively.

Precaution

Hypersensitivity has rarely been recorded. If something like this occur, administration of the product should be discontinued. The infected area should be kept clean and dry during treatment.

Interaction

Although not studied, based on the chemical similarity of enconazole with other imidazole compounds, a theoretical potential for competitive interaction with compounds metabolized by CYP3A4/2C9 exists. Due to the limited systemic availability after vaginal application (see Pharmacokinetics under Actions), clinically relevant interactions are unlikely to occur, in patients on oral anticoagulants eg, warfarin and acenocoumarol, caution should be exercised and monitoring of the anticoagulant effect should be considered.

Food Interaction

Elimination Route

After topical application to the skin of normal subjects, systemic absorption of econazole nitrate is extremely low. Although most of the applied drug remains on the skin surface, drug concentrations were found in the stratum corneum which, by far, exceeded the minimum inhibitory concentration for dermatophytes.

Pregnancy & Breastfeeding use

During pregnancy: There is no information of any abnormality or adverse event in neonates while Palavale 1% Cream / VT had been used during pregnancy.

During lactation: As the systemic absorption of Palavale 1% Nitrate cream is extremely low after topical/vaginal use, excretion in breast milk is likely to be negligible. So, it can be used topically/vaginally during lactation if needed.

Contraindication

Hypersensitivity to any component of Palavale 1%.

Acute Overdose

Palavale 1% Cream / VT is intended for topical and vaginal use. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered desirable.

Innovators Monograph

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