Gel Epiduo 0.1%/2.5% Galderma acne treatment (15g)

Dosage form Jar
Specifications Adapalene, Benzoyl Peroxide

Ingredient

Composition information	Content
Adapalene	0.1%
Benzoyl Peroxide	2.5%

Uses

indications

Epiduo gel vial is indicated for treatment of acne when there are clogged, acne, pustules.

Pharmacokology

Mechanism of action and pharmacological effects:

Epiduo combines two active ingredients that work through other but additional mechanisms.

Adapalen: Adapalen is a naphthoic acid derivative of chemical stability, has a retinoid activity. Researching biochemical and pharmacological parameters shows that Adapalen has the effect of acne: is a strong moderator that distinguishes cells, keratinization and anti -inflammatory effects, mechanism, adapalen combined with the nuclear receptor of specific retinoic acid. Current evidence shows that adapalen is used in place normalize cystic cystic cellularity leading to reducing the formation of small acne (microCocomedone). Adapalen inhibits the dynamic (orientation) and hyperactivity (random) chemicals of polygon leukocytes in the in vitro testing model; Adapalen also inhibits the metabolism of arachidonic acid into inflammatory mediators. In vitro studies have shown the inhibition of AP-1 element and inhibit the expression of the Toll-Like 2 receptor. This record shows that the composition of acne causes inflammation through cell intermediaries is reduced by adapalen.

benzoylperoxid: Benzoyl Peroxid is a substance that has a bactericidal effect, especially in P.acnes bacteria that appear abnormally in acne pores. In addition, Benzoyl Peroxid also peels off the skin and flakes the horny layer. Benzoyl Peroxid also works to reduce sebum, against excessive sebum production related to acne.

pharmacokinetics

Epiduo pharmacokinetics properties similar to the pharmacokinetics records of the 0.1 % gel gel used alone.

In a 30 -day clinical pharmacokinetics study conducted in patients with acne that have been tested with gel combined with a fixed dose or with a suitable formula for adapalen 0.1% under maximum conditions (apply 2g gel per day), Adapalen has not been able to quantify in most plasma samples (quantitative limit of 0.1 ng/mL). Low adapalen concentration (the highest concentration in plasma (cmax) from 0.1-0.2 ng/ml) measured in two blood samples taken from the objects treated with epiduo and in 3 blood samples taken from the objects treated with Adapalene Gel 0.1%. The area under the curve (AUC) 0-24 hours of Adapalen has been determined in the group using a fixed dose form of 1.99 ng. These results are equivalent to the results obtained in previous clinical pharmacokinetic studies on different 0.1% adapalene formulas, in which the body concentration of Adapalen is always low.

Low Benzoyl Peroxid's skin seepage; When applied on the skin, benzoyl peroxid is completely converted into benzoic acid and is removed quickly.

Before taking Gel Epiduo 0.1%/2.5% Galderma acne treatment (15g)

How to use

Gel -like pills used on the skin.

Dosage

gel epiduo should be applied all over the skin with acne once a day in the evening on clean and dry skin. Apply a thin layer of gel to use a thin layer of gel, avoid applying it to the eye and lips.

If skin irritation, patients should use moisturizer without causing acne to apply directly to the irritated skin, need to restrict the medication regularly (such as daily use), temporary suspension of medication, or stop treatment with drugs.

It is necessary to follow the treatment time prescribed by the doctor on the basis of clinical condition. Signs of early clinical improvement usually appear after 1 to 4 weeks of treatment.

Safety and effectiveness of Epiduo Gel has not been studied in children under 9 years old.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Overdose:

Epiduo Gel Form only applies to the skin once a day.

How to handle:

In case of accidentally swallowing drugs, appropriate symptomatic treatments should be taken.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Epiduo gel medicine, you may experience unwanted effects (ADR) in the treatment area:

Different levels of skin irritation may occur after applying Epiduo, usually mild or moderate, accompanied by on -site signs and symptoms (erythema, dry, flaky, burning and painful skin pain (throbbing) at the highest level of the first week of treatment then gradually decreasing.

Common, ADR> 1/100

Skin and subcutaneous tissue disorders: dry skin, irritating contact dermatitis, skin irritation in the skin, red rash, flaking skin.

Uncommon, 1/1000

Skin and tissue disorders: itching and sunburn.

Rare, ADR

No report.

Not determined frequency

visual disorders: eyelid edema.

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Epiduo gel form is contraindicated in the case:

Hypersensitivity to any ingredients of the drug.

Caution when using

Epiduo is only used on the skin. Do not apply Epiduo gel to the skin of damaged balls, or open wounds (broken, scratched), sunburned skin or eczema.

Do not let Epiduo gel stick to the eyes, mouth, nostrils or mucosa.

In case of falling into the eyes, immediately rinse with warm water.

gel epiduo contains propylene glycol can cause skin irritation.

If a reaction occurs, there is an sensitivity to any component of the formula, it is necessary to stop using EPIDUO.

Avoid excessive exposure to the sun or ultraviolet rays.

Avoid leaving the Epiduo gel on the colored material including hair and dyeing fabric because the drug can fade or discolor.

The ability to drive and operate machinery

Epiduo does not affect the ability to drive and operate machinery.

Pregnancy

Performed animal studies showing oral reproduction toxicity of exposure at high body concentrations.

Clinical experience using Adapalen and Benzoyl Peroxid at the place of women during pregnancy is limited but based on a small number of available data does not show harmful effects during pregnancy. Because the available data is limited and due to the ability to adapalen is poorly absorbed through the skin, EPIDUO should not be used during pregnancy.

Need to stop treatment in the expected pregnancy.

Breastfeeding period

There has been no study of the excretion of breast milk of the drug conducted on humans and animals after using Epiduo gel topical (adapalen/benzoyl peroxid). There is no effect on breastfed babies is expected by the level of exposure in breast -feeding women using epiduo is negligible. Epiduo can be used during breastfeeding.

It is necessary to avoid applying Epiduo gel to the chest during breastfeeding so that babies will not be exposed to the drug.

Drug interaction

There is no study of interactions that have been conducted with Epiduo.

From the previous experience with Adapalen and Benzoyl Peroxid, there is no known interaction with other drugs that can be used on the skin and at the same time with Epiduo.

However, it is not advisable to use simultaneously with retinoid or benzoyl peroxid or other drugs with similar mechanisms. Be careful if cosmetics have the effect of peeling skin, irritation or dryness used because they can cause irritation effects plus Epiduo.

The absorption of adapalen through human skin is low (see pharmacokinetic properties) and therefore is not sure to interact with systemic drugs.

Low skin permeability of benzoyl peroxid and pharmaceutical substances are completely converted into benzoic acid removed quickly. Therefore, it is not sure that the potential interaction of benzoic acid with body drugs.

Tyeum of drugs

Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.

Storage

Store under 30⁰C.

Other drugs

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