For the treatment of mycotic infections of the skin and nails and superinfections due to Gram-positive
bacteria.

Topical Administration
 Apply a thin film of the cream to the infected area twice daily and rub with a finger until it
disappears.
 For prophylactic therapy , apply once daily
 The duration of treatment is 2-6 weeks according to the severity of the case.

Mycloess®Cream: must not come in contact with the mucus membranes of the eyes -General hygienic
measures should be observed to control sources of infections.

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic
availability after topical application, clinically relevant interactions are rare. However, in patients on oral
anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

Pregnancy
In animals miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses. Only
small amounts of miconazole nitrate are absorbed following topical administration. However, as with other
imidazoles, miconazole nitrate should be used with caution during pregnancy.
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 relevant.

Adverse drug reactions reported among 834 patients who received miconazole nitrate 2% cream (n=426)
and/or placebo cream base (n=408) in 21 double-blind clinical trials are presented in Table 1 below.
Moreover, adverse drug reactions
from spontaneous reports during the worldwide post-marketing experience with Daktarin that meet
threshold criteria are included below. 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 and <1/1,000
Very rare <1/10,000, including isolated reports
Adverse reactions obtained from clinical studies and post-marketing surveillance are presented by
frequency category based on incidence in clinical trials or epidemiology studies, when known.
Immune System Disorders (not known) anaphylactic reaction, Hypersensitivity, Angioneurotic edema. Skin
and Subcutaneous Tissue Disorders (uncommon) Skin burning sensation, Skin inflammation, Skin
hypopigmentation. (not known) Urticaria.
Contact dermatitis, Rash, Erythema, Pruritus. General Disorders and Administration Site Conditions
(uncommon) Application site irritation, Application site burning, Application site pruritus, Application site
reaction NOS, Application site warmth.
 

If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying
may be used if considered necessary.

 Mycoless
®
is abroad spectrum antifungal with activity against the common dermatophytes, yeast and
other fungi , and it has a bactericidal activity against certain gram-positive bacilli and cocci .
 Mycoless
®
inhibits the biosynthesis of ergosterol of the cytoplasmic membrane resulting in fungal
cell necrosis
 Miconazole Nitrate does not produce detectable blood levels after topical application.

Absorption: There is little absorption through skin or mucous membranes when miconazole nitrate is
applied topically.
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.

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.

 Cetyl Alcohol.
 Liquid Paraffin.
 Glyceryl monostearate.
 Cremophor A6.
 Cermophor A25.
 Propylene glycol.
 Methyl paraben.
 Propyl paraben.
 Glycerol.
 Purified water.

Not applicable.

Store at temperature below 30ºC.

Carton box containing Aluminum tube containing of 20 gm along with a leaflet.

No special requirements.