For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only

Composition

Each gram contains:

Oxiconazole … 10 mg (as Oxiconazole Nitrate)

Benzoic Acid IP … 2 mg (as preservative)

In cream base … q.s.

Dosage Form

Cream

Pharmacology

Pharmacodynamics

Oxiconazole is a broad-spectrum imidazole derivative whose antifungal activity is derived primarily from the inhibition of ergosterol biosynthesis, which is critical for cellular membrane integrity. It has fungicidal or fungistatic activity in vitro against a number of pathogenic fungi, including the following dermatophytes and yeasts: T. rubrum, T. mentagrophytes, T. tonsurans, T. violaceum, E. floccosum, M. canis, M. audouini, M. gypseum, C. albicans, and M. furfur.

Oxiconazole inhibits ergosterol biosynthesis, which is required for cytoplasmic membrane integrity of fungi. It acts to destabilise the fungal cyctochrome P450 51 enzyme (also known as lanosterol 14-alpha demethylase). This is vital in the cell membrance structure of the fungus. Its inhibition leads to cell lysis. Oxiconazole has also been shown in inhibit DNA synthesis and suppress intracellular concentrations of ATP. Like other imidazole antifungals, oxiconazole can increase membrane permeability to zinc, augmenting its cytotoxicity.

Pharmacokinetics

The penetration of oxiconazole nitrate into different layers of the skin was assessed using an in vitro permeation technique with human skin. At 5 hours after application of 2.5 mg/cm² of oxiconazole nitrate cream onto human skin, the concentration of oxiconazole nitrate was demonstrated to be 16.2 ?mol in the epidermis, 3.64 ?mol in the upper corium, and 1.29 ?mol in the deeper corium. Systemic absorption of oxiconazole nitrate is low. Using radiolabelled drug, less than 0.3% of the applied dose of oxiconazole nitrate was recovered in the urine of volunteer subjects up to 5 days after application of the cream formulation.

Indications

AUXERG Cream is indicated for topical treatment of superficial fungal infections of the skin.

Dosage and Administration

AUXERG Cream should be applied to the affected and immediately surrounding areas once to twice daily in case of tinea pedis, tinea corporis or tinea cruris. AUXERG Cream should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris and tinea (pityriasis) versicolor should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed.

Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk that may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalisation of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea (pityriasis) versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.

Contraindications

AUXERG Cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Warnings and Precautions

AUXERG Cream is not for ophthalmic or intravaginal use.

AUXERG Cream is for external dermal use only. If a reaction suggesting sensitivity or chemical irritation should occur with the use of AUXERG Cream, treatment should be discontinued and appropriate therapy instituted. If signs of epidermal irritation should occur, use of AUXERG Cream should be discontinued.

Drug Interactions

Potential drug interactions between oxiconazole nitrate cream and other drugs have not been systematically evaluated.

Pregnancy

Pregnancy Category B

Reproduction studies have been performed in rabbits, rats and mice at oral doses up to 100, 150 and 200 mg/kg/day (57, 40 and 27 times the human dose based on mg/m²), respectively, and revealed no evidence of harm to the foetus due to oxiconazole nitrate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, AUXERG Cream should be used during pregnancy only if clearly needed.

Lactation

Because oxiconazole is excreted in human milk, caution should be exercised when AUXERG Cream is administered to a nursing mother.

Paediatric Use

Paediatric experience with oxiconazole nitrate cream is limited.

Geriatric Use

A limited number of patients aged 60 years or older (n ~ 396) have been treated with oxiconazole nitrate cream in US and non-US clinical trials, and a limited number (n=43) have been treated with oxiconazole lotion in US clinical trials. The number of patients is too small to permit separate analyses of efficacy and safety. No adverse events were reported with oxiconazole lotion in geriatric patients, and the adverse reactions reported with oxiconazole nitrate cream in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of oxiconazole nitrate cream and lotion in geriatric patients is warranted.

Undesirable Effects

During clinical trials, of 955 patients treated with oxiconazole nitrate cream, 1%, 41 (4.3%) reported adverse reactions thought to be related to drug therapy. These reactions included pruritus (1.6%); burning (1.4%); irritation and allergic contact dermatitis (0.4% each); folliculitis (0.3%); erythema (0.2%); and papules, fissure, maceration, rash, stinging, and nodules (0.1% each).

If you experience any side effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the national Pharmacovigilance Programme of India by calling on 1800 180 3024 or you can report to Cipla Ltd. on 18002677779. By reporting side effects, you can help provide more information on the safety of this product

Overdosage

When oxiconazole nitrate cream, 5%, (5 times the concentration of the marketed product) was applied at a rate of 1 g/kg to approximately 10% of body surface area of a group of 40 male and female rats for 35 days, three deaths and severe dermal inflammation were reported. No overdoses in humans have been reported with the use of oxiconazole nitrate cream.

Shelf-Life

See on pack

Storage and Handling Instructions

Store at a temperature not exceeding 25°C. Do not freeze. Protect from light.

Keep all medication out of the reach and sight of children.

Packaging Information

Available in 30 g and 50 g tube

Information for Patients

1. Use oxiconazole nitrate cream as directed by the physician. The hands should be washed after applying the medication to the affected area(s). Avoid contact with the eyes, nose, mouth, and other mucous membranes. Oxiconazole nitrate cream is for external use only.
2. Use the medication for the full treatment time recommended by the physician, even though symptoms may have improved. Notify the physician if there is no improvement after 2 to 4 weeks, or sooner if the condition worsens (see below).
3. Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing.
4. Avoid the use of occlusive dressings unless otherwise directed by the physician.
5. Do not use this medication for any disorder other than that for which it was prescribed.

Last Updated: Nov 2018

Last Reviewed: Jan 2020