Daktarin Cream

White homogeneous cream for topical use. Each gram contains 20 mg of the active substance miconazole nitrate.
Excipients/Inactive Ingredients: The cream formulation consists of benzoic acid, butylated hydroxyanisole, liquid paraffin, oleoyl macrogolglycerides, PEG-6 (and) PEG-32 (and) glycol stearate, purified water.

Pharmacotherapeutic Group: Antifungals for dermatological/topical use; imidazole derivative. ATC Code: D01A C02.
Pharmacology: Pharmacodynamics: Mechanism of action: Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis.
Pharmacodynamic effects: Usually, miconazole acts very rapidly on pruritus, which frequently accompanies dermatophyte and yeast infections. This symptomatic improvement is seen before the first signs of healing are observed.
Miconazole has also been proven to be effective in secondarily infected mycoses.
Pharmacokinetics: Absorption: Miconazole remains in the skin after topical application for up to 4 days. Systemic absorption of miconazole is limited, with a bioavailability of less than 1% following topical 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%).
Metabolism and 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.
Toxicology: Non-Clinical Information: 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.
Microbiology: Miconazole combines an antifungal activity against the common dermatophytes, yeasts and various other fungi with an antibacterial activity against certain gram-positive bacilli and cocci.

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).

Apply some cream to the lesions twice daily.
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.
Administration: For topical use.
Rub the cream into the skin with finger until it has fully penetrated the skin.

Symptoms and Signs: Topical use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.
Treatment: Accidental ingestion: DAKTARIN are intended for topical use, not for oral use. Should accidental oral ingestion of large quantities of these products occur, use appropriate supportive care.

DAKTARIN is contraindicated in individuals with a known hypersensitivity to miconazole, another ingredient of the formulation or other imidazole derivatives.

In patients on warfarin, caution should be exercised and the anticoagulant effect should be monitored (see Interactions).
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with DAKTARIN and with other miconazole topical formulations (see Adverse Reactions). If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued.
DAKTARIN must not come into contact with the eyes.
Effects on Ability to Drive and Use Machines: Not applicable.

Pregnancy: DAKTARIN 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 during pregnancy should always be weighed against the expected therapeutic benefits.
Breast-feeding: 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.

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of miconazole nitrate/miconazole based on the comprehensive assessment of the available adverse event information. A causal relationship with miconazole nitrate/miconazole cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observe in clinical practice.
Clinical Trial Data: Adverse reactions reported among 834 patients who received miconazole nitrate 2% cream and/or placebo cream base in 21 double-blind clinical trials are presented in Table 1 as follows. Included in the table are all adverse events considered to be related to study drug. A dash indicates that the adverse reaction was not reported by patients in the specified treatment group. (See Table 1.)

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Postmarketing Data: In addition to the adverse reactions reported during clinical studies and listed previously, the following adverse reactions have been reported during postmarketing experience (Table 2). The frequencies are provided according to the following convention: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1000 and <1/100; Rare ≥1/10000 and <1/1000; Very rare <1/10000, including isolated reports.
In Table 2, adverse reactions are presented by frequency category based on spontaneous reporting rates. (See Table 2.)

Click on icon to see table/diagram/image

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

Incompatibilities: None known.
Instructions for Use and Handling: To open the tube, unscrew the cap. Then pierce the seal of the tube with the pin on the top of the cap.

Do not store above 25°C.
Shelf Life: 2 years.

Topical Antifungals & Antiparasites

D01AC02 - miconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.

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