McNeil Healthcare (Ireland) Ltd

Daktarin 2% w/w Cutaneous Powder

Contains miconazole nitrate 2% w/w (20mg/g).

Each gram of cutaneous powder contains 20 mg miconazole nitrate.

For a full list of excipients, see section 6.1.

Cutaneous powder.

White free-flowing powder.

For the topical treatment of fungal infections of the skin and secondary infections due to Gram-positive bacteria. The powder may be applied separately or with the cream to skin lesions.

For cutaneous administration.

Apply powder once or twice daily to affected areas until the lesions have completely healed.

Daktarin Powder is contra-indicated in individuals who have shown hypersensitivity to miconazole or another ingredient of Daktarin Powder.

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

Avoid the introduction of Daktarin Powder into 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.

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after cutaneous application (See Section 5.2 Pharmacokinetic properties), clinically relevant interactions are unlikely to occur. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

The effects and side effects of some other drugs (e.g. oral hypoglycaemics and phenytoin), when co-administered with miconazole, can be increased and caution should be exercised.

Pregnancy

Daktarin Powder applied topically is minimally absorbed into the circulation (bioavailability < 1%). Although there is no evidence that miconazole is embryotoxic or teratogenic in animals, potential hazards of prescribing Daktarin Powder 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.

Not applicable.

Adverse drug reactions from spontaneous reports during the worldwide postmarketing experience with Daktarin that meet threshold criteria are included. The adverse drug reactions are ranked by frequency, using the following convention:

Very common 1/10

Common 1/100 and < 1/10

Uncommon 1/1,000 and <1/100

Rare 1/10,000, <1/1,000

Very rare <1/10,000, including isolated reports

The frequencies provided below reflect reporting rates for adverse drug reactions from spontaneous reports, and do not represent more precise estimates of incidence that might be obtained in clinical or epidemiological studies.

Immune system disorders

Very rare: anaphylactic reaction, hypersensitivity, angioneurotic edema

Skin and subcutaneous tissue disorders

Very rare: urticaria, contact dermatitis, rash, erythema, pruritus, skin burning sensation

General disorders and administration site conditions

Very rare: application site reactions, including application site irritation

Symptoms

Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.

Treatment

Daktarin Powder is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered necessary.

Accidental inhalation of talc-containing powder: Massive accidental aspiration of Daktarin powder may cause impaction blockage of airways. Respiratory arrest should be treated with intensive supportive therapy and oxygen. If respiration is compromised, endotracheal intubation, removal of impacted material, and assisted breathing should be considered.

Pharmacotherapeutic classification: (Antifungals for dermatological/topical use; imidazole derivative) ATC code: D01A C02.

Miconazole is an imidazole antifungal agent and may act by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial activity.

Absorption: Miconazole remains in the skin after cutaneous application for up to 4 days. Systemic absorption of miconazole is limited, with a bioavailability of less than 1% following cutaneous 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 nappy rash. 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%).

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

Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

Talc (E553b)

Zinc oxide

Silica, colloidal anhydrous

Not applicable.

3 years.

This medicinal product does not require any special storage conditions.

White polyethylene bottle containing 20 g of powder, with white polypropylene dredging applicator and cap. Not all pack sizes may be marketed.

No special requirements.

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/59/2

Date of first authorisation: 01 April 1977

Date of renewal of authorisation: 31 March 2003.

August 2009