DAKTARIN 2% Cream (Miconazole Nitrate)

DAKTARIN 2% Cream (Miconazole Nitrate)

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DAKTARIN 2% Cream (Miconazole Nitrate)

DAKTARIN Cream is a medicine used for treating athlete’s foot, tinea, ringworm and thrush infections of the skin caused by fungi, including yeast.

DAKTARIN Cream contains 20 milligrams of miconazole nitrate in each gram. It also contains apricot kernel oil PEG-6 esters, ethylene glycol, liquid paraffin, tefose 63, benzoic acid, butylated hydroxyanisole and purified water.

Miconazole is 1-[2,4-dichloro-beta-(2,4-dichlorobenzyloxy) phenethyl] imidazole derivative and is a synthetic 1-phenethylimidazole derivative.
Miconazole nitrate is 1-[2,4-dichloro-beta-(2,4-dichlorobenzyloxy) phenethyl] imidazole nitrate, and is a synthetic 1-phenethylimidazole derivative.

Therapeutic Indications

Daktarin Cream, Lotion, Powder and Spray Powder are indicated for the topical treatment of the following fungal infections:

  • cutaneous candidiasis (moniliasis), caused by Candida albicans;
    tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum;
  • tinea versicolour caused by Pityrosporum orbicular (Malassezia furfur).

Daktarin Tincture is indicated for the topical treatment of tinea unguium caused by Candida albicans, Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum.

Mechanism of action.

Miconazole exhibits antifungal activity against Candida albicans, the dermatophytes –Trichophyton rubrum, T. mentagrophytes, Epidermophyton floccosum and Pityrosporum orbicular (Malassezia furfur). Miconazole penetrates the fungal cell wall, alters cellular membranes, and interferes with intracellular enzymes and biosynthesis of ergosterol.

Pharmacokinetics

Absorption

Systemic absorption of miconazole is limited, with a bioavailability of less than 1% following application of miconazole. Plasma concentrations of miconazole and/or its metabolites were measurable 24 and 48 hours after application.
Systemic absorption has also been demonstrated after repeated application of miconazole to infants with diaper dermatitis. Plasma levels of miconazole were undetectable or low in all infants.

Distribution.

Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).

Excretion.

The small amount of miconazole that is absorbed is eliminated predominantly in feces as both unchanged drug and metabolites over a four-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in urine.

Dose and Method of Administration

A thin layer of Daktarin Cream sufficient to cover the affected area should be applied and rubbed well into the skin. In patients with tinea pedis, tinea cruris, tinea corporis and cutaneous candidiasis, the cream or lotion should be applied twice daily, and in patients with tinea versicolour, once daily.

Daktarin Powder should be applied directly to the lesions and also dusted inside articles of clothing in contact with the affected areas. This should be carried out twice daily.
The Daktarin Spray Powder can must be well shaken before use. It should be held about 15 cm from the area to be treated and a thin layer is applied twice daily.
Treatment must be continued, without interruption until the lesions have completely healed. Candida infections should be treated for 2 weeks and dermatophyte infections for one month.

Nail infections.

Before treatment commences, the nail should be cut as short as possible. A thin layer of Daktarin Tincture should be applied to the affected nail, the area around it and if possible under it twice daily. After the infected nail has come off, the treatment should be continued without interruption until a new nail has grown and the lesions are completely cured (usually for at least 2 months). If the nail falls off during the course of treatment, this is due to the infection not to Daktarin Tincture. Before reapplying the product, clean the nail of any product buildup with acetone based nail polish remover.

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Note.

To improve the therapeutic results of treatment, certain hygienic measures must be taken such as washing the infected regions every day, disinfecting and frequently changing stockings and shoes.

Side Effects

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects.

DAKTARIN Cream is usually well tolerated. However, it may sometimes cause a skin reaction such as a rash, redness, swelling, itching or a burning sensation.

Do not be alarmed by this list of side effects. You may not experience any of them.

If severe irritation or other signs of allergic reaction occur, discontinue treatment and consult your doctor or pharmacist.

Do not hesitate to report any other side effects to your doctor or pharmacist.

Contraindications

Daktarin Cream, Powder, Spray Powder and Tincture are contraindicated in the following situations:

  • Patients with known hypersensitivity to the active ingredient and/or any of the other excipients in these presentations.
  • Patients with known hypersensitivity to similar antifungal agents such as ketoconazole.

Special Warnings and Precautions for Use

Not all strains of a particular organism may be susceptible to miconazole.
As with other drugs of this class, prolonged use may result in overgrowth of non-susceptible micro-organisms.

Intractable candidiasis may be the presenting symptom of unrecognised diabetes. Appropriate tests should therefore be performed in patients not responding to treatment.
Discontinue Daktarin if sensitisation or irritation is reported during use.
Daktarin must not come into contact with the eyes.
Tincture is an alcoholic solution and should not be applied to open lesions.
Avoid spraying Daktarin Spray Powder in the eyes.

Daktarin powder contains talc. Avoid inhalation of the powder to prevent irritation of airways, In particular, when treating infants and children, careful application should be used to prevent inhalation by the child.

Interactions with Other Medicines and Other Forms of Interactions

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions occur very rarely. In patients on oral anticoagulants, such as warfarin, caution should be exercised and the anticoagulant effect should be monitored. The effects and side effects of some other drugs (e.g. oral hypoglycemics and phenytoin), when co-administered with miconazole, can be increased and caution should be exercised.

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