Ecodax, cream 1% 10 g

Dermatomycosis of the scalp caused by dermatophytes, yeasts, molds, including those complicated by superinfection with Gram-positive bacteria.

– Erythrazma.

– Lichen multiplex.

– Skin infections caused by gram-positive microorganisms.

Active ingredient

Econazole

Composition

Active ingredient:

econazole nitrate 10.0 mg

Excipients:

sodium hydroxide 0.9 mg,

sodium dihydrophosphate dihydrate 3.65 mg,
<
phosphoric acid 0,02 mg,

chlorocresol 1,0 mg,

cetomacrogol 1000 50,0 mg,
cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) 70,0 mg,

Paraffin soft white 150,0 mg,

paraffin liquid 60,0 mg,

purified water – mod. up to 1.0 g.

How to take, the dosage

Externally.

Adults and children over 18 years of age: Apply the cream with a thin even layer on the affected skin area and rub it in until it is completely absorbed twice a day (morning and evening).

Duration of application – 2 weeks, when treating highkeratinized skin areas (feet) – up to 1.5 months.

Interaction

Econazole is an inhibitor of CYP3A4/2C9.

Due to low systemic availability, clinical significant interactions are unlikely when applied to the skin. At the same time, there have been cases of interaction with oral anticoagulants. Patients taking oral anticoagulants, such as warfarin or acenocoumarol, should exercise caution and monitor the anticoagulation effect.

If you use the above or other drugs (including over-the-counter drugs) before using Ecodax® , consult your doctor.

Special Instructions

Only for external use.

In patients with eczema before the start of treatment it is necessary to carry out antieczema therapy.

If there is no effect of the current therapy within the recommended period of time it is necessary to verify the diagnosis.

In case of hypersensitivity or chemical irritation reactions or any of the side effects the drug should be discontinued and a physician should be consulted.

Avoid getting the drug in the eyes, on mucous membranes, on open wounds. If the drug accidentally gets into the eyes, rinse them with clean water or saline, and if the symptoms persist, consult a doctor.

If the drug has expired or passed its expiration date – do not throw it in the sewage system or on the street! Place the medication in a bag and put it in a trash container. These measures will help protect the environment!

Synopsis

Homogeneous homogeneous cream of white to yellowish-white color, almost odorless.

Contraindications

– Hypersensitivity to econazole and other ingredients that make up the drug;

– Children under 18 years.

Do not apply the drug to areas with damaged skin.

Side effects

According to the data of clinical trials.

Adverse reactions observed in ≥ 1% of patients who used Ecodax®.

Skin and subcutaneous tissue disorders: itching, burning sensation of the skin, general complications and reactions at the injection site: pain at the injection site.

Adverse reactions observed in ˂ 1% of patients who used Ecodax®.

Skin and subcutaneous tissue disorders: erythema, general complications and reactions at the injection site: discomfort, swelling.

According to spontaneous reports of adverse events.

The frequency of adverse reactions is given as the following gradation: Very common (≥1/10); common (≥1/100, < 1/10); infrequent (≥1/1000, < 1/100); rare (≥1/10000, < 1/1000); very rare (< 1/10000), including individual reports of unspecified frequency (frequency cannot be calculated from available data).

Immune system disorders:

Very rarely: individual intolerance to econazole and other components of the drug (hypersensitivity reactions), angioedema.

Skin and subcutaneous tissue disorders:

Very rarely: contact dermatitis, rashes, urticaria, blisters, skin peeling.

Unknown: irritation, dryness, hypopigmentation, skin atrophy.

If you have side effects mentioned in the instructions or they are aggravated, or if you notice any other side effects not mentioned in the instructions, inform the doctor.

Overdose

Accidental ingestion of Ecodax® cream may cause nausea, vomiting and diarrhea.

Treatment: gastric lavage, oral intake of activated charcoal, symptomatic therapy.

Pregnancy use

Due to the lack of clinical data, the safety of using the drug during pregnancy and breastfeeding is not established.

Before using the drug Ecodax® if you are pregnant or assume that you might be pregnant or planning to become pregnant, you should consult your doctor.

The drug usage during pregnancy is possible only under the doctor’s control if the supposed benefit for a mother exceeds the risk for a fetus. During breastfeeding, if the drug should be administered, it is necessary to decide on stopping breastfeeding.