Micoson^® (Cream) Instructions for Use

Marketing Authorization Holder

Agio Pharmaceuticals, Ltd. (India)

ATC Code

D01AC02 (Miconazole)

Active Substance

Miconazole (Rec.INN registered by WHO)

Dosage Form

Micoson®

Cream for external use 2%: tube 15 g

Dosage Form, Packaging, and Composition

Cream for external use white or almost white, homogeneous, with a specific odor, free from foreign particles.

Excipients: propylene glycol, white soft paraffin, ceto-stearyl alcohol, cetomacrogol 1000, light liquid paraffin, disodium edetate, anhydrous disodium hydrogen phosphate, chlorocresol, purified water.

15 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Miconazole has an antifungal effect.

It inhibits the synthesis of ergosterol, changes the lipid composition and permeability of the cell wall.

It is active against dermatophytes, yeasts and other fungi.

It exhibits antimicrobial activity against gram-positive microorganisms.

Pharmacokinetics

Only a small number of metabolites are detected in the blood during local applications.

It is rapidly degraded in the liver, 14-22% of the dose is excreted through the kidneys as inactive derivatives.

Indications

• Dermatomycoses caused by fungi sensitive to the drug (including with secondary infection by gram-positive microorganisms).

ICD codes

Dosage Regimen

Externally.

The cream is applied to the washed and thoroughly dried skin, rubbing lightly into the affected areas 2 times/day (morning and evening).

If necessary, an occlusive dressing is used.

Treatment is continued until the symptoms completely disappear and for several subsequent days to prevent relapses.

During therapy, mycological control is carried out, the results of which determine the duration of treatment (usually its duration is 2-6 weeks).

Adverse Reactions

In case of hypersensitivity to the components of the drug, local allergic reactions are noted – skin redness, burning and tingling sensations at the site of application of the drug; in rare cases – urticaria, edema, rash, erythema.

Contraindications

• Hypersensitivity to the components of the drug.

With caution diabetes mellitus, microcirculation disorders.

Use in Pregnancy and Lactation

When applied topically, Miconazole is not absorbed.

The drug can be used during pregnancy and the period of breastfeeding.

Special Precautions

If the patient experiences skin irritation, or develops hypersensitivity (allergic reactions appear) during the use of this drug, treatment should be discontinued and an appropriate course of therapy prescribed.

It is not recommended to use the cream for more than 4 weeks.

For external use only.

Avoid contact of the drug with the eyes.

Overdose

The use of the drug in increased doses does not cause any reactions and conditions dangerous to life.

In case of unintended use of the drug (orally), the following symptoms are possible: anorexia, nausea, vomiting, gastralgia, impaired liver function; rarely – drowsiness, hallucinations, pollakiuria, skin allergic reactions.

There is no specific antidote.

It is necessary to prescribe activated charcoal orally.

If necessary, treatment is symptomatic.

Drug Interactions

It enhances the effect of indirect anticoagulants, oral hypoglycemic drugs, phenytoin.

Storage Conditions

In a place protected from light at a temperature not exceeding 25°C (77°F).

Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

Over-the-counter.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.