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Daktarin

 

INTERNATIONAL NON-PROPRIETARY NAMES

DAKTARIN Cream Miconazole nitrate 20 mg/g topical cream.

DAKTARIN Powder Miconazole nitrate 20 mg/g topical powder.

DAKTARIN Tincture Miconazole 20 mg/mL topical tincture.

 

QUALITATIVE AND QUANTITATIVE COMPOSITION

DAKTARIN Cream: Each gram contains 20 mg of the active substance miconazole nitrate.

DAKTARIN Powder: Each gram contains 20 mg of the active substance miconazole nitrate.

DAKTARIN Tincture: Each milliliter contains 20 mg of the active substance miconazole.

For excipients, see List of Excipients.

 

PHARMACEUTICAL FORM

DAKTARIN Cream: White homogeneous cream for topical use.

DAKTARIN Powder: White powder for topical use.

DAKTARIN Tincture: Clear, colorless solution for topical application to the nail.

 

CLINICAL PARTICULARS

Therapeutic Indications

DAKTARIN Cream

Skin infections due to dermatophytes or yeasts, and other fungi such as: Tinea capitis, corporis, manuum, barbae, cruris, pedis (athlete's foot).

 

Since DAKTARIN has an antibacterial effect on gram-positive bacteria, it may be used in mycoses secondarily infected with such bacteria (e.g., in napkin dermatitis).

 

DAKTARIN Powder

Usually in combination with cream:

  - napkin dermatitis.

  - treatment of inguinal and/or interdigital infections caused by dermatophytes or yeasts.

 

The powder can be used prophylactically in socks and shoes.

 

DAKTARIN Tincture

Nail and nailbed infections caused by dermatophytes or yeasts.

 

Adjuvant topical medication for the treatment of onychomycosis.

 

Since DAKTARIN has an antibacterial effect on certain gram-positive bacteria, it may be used in mycoses secondarily infected with such bacteria.

 

Posology and Method of Administration

DAKTARIN Cream

Apply some cream to the lesions twice daily. Rub the cream into the skin with your finger until it has fully penetrated.

 

If the powder is used with the cream, a once daily application of both formulations is recommended.

 

The duration of therapy varies from 2 to 6 weeks depending on the localization and the severity of the lesion.

 

Treatment should be continued at least one week after disappearance of all signs and symptoms.

 

DAKTARIN Powder

Apply some powder to the lesions twice daily.

 

If the powder is used with the cream, a once daily application of both formulations is recommended.

 

A once daily prophylactic use of the powder in shoes and socks is sufficient.

 

The duration of therapy varies from 2 to 6 weeks depending on the localization and the severity of the lesion.

 

Treatment should be continued at least one week after disappearance of all signs and symptoms.

 

DAKTARIN Tincture

The infected nails should be cut as short as possible. Twice daily, a thick layer of tincture should be applied with a brush to the infected nail and the surrounding area and allowed to dry to an occlusive film. It is recommended to clean the nail and the surrounding area with acetone before every new application of the tincture.

 

The treatment should be continued without interruption, until a new nail has started to grow and definite cure can be observed (rarely less than 3 months).

 

Contraindications

DAKTARIN Cream, Powder and Tincture are contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient of the formulation.

 

Special Warnings and Special Precautions for Use

If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued.

 

DAKTARIN Cream, Powder and Tincture must not come into contact with the eyes.

 

Because the tincture is an alcoholic solution, it cannot be applied to open lesions, into the eyes or on mucous membranes.

 

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 Medicinal Products and Other Forms of Interaction

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application (see Pharmacokinetic Properties), 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 coadministered with miconazole, can be increased and caution should be exercised.

 

Pregnancy and Lactation

Pregnancy

DAKTARIN Cream, Powder and Tincture applied topically are minimally absorbed into the systemic circulation (bioavailability < 1%). Although there is no evidence that miconazole is embryotoxic or teratogenic in animals, potential hazards of prescribing DAKTARIN Cream, Powder or Tincture during pregnancy should always be weighed against the expected therapeutic benefits.

 

Lactation

Topically applied miconazole is minimally absorbed into the systemic circulation, and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied miconazole products during lactation. (See Interactions with Other Medicinal Products and Other Forms of Interaction.)

 

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