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Instruction for use: Roaccutane

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Active substance Isotretinoin

ATX code D10BA01 Isotretinoin

Pharmacological group

dermotropic means

Nosological classification (ICD-10)

L21 Seborrheic dermatitis

Dermatitis seborrheic, Increased sebum separation, Seborrheic Eczema, Seborrheic dermatitis of the scalp, Seborrheic pyodermatitis, Seborrhea, Eczema seborrheic

L70 Acne

Acne nodulocystica, Acne, Comedone acne, Acne Treatment, Papulous pustular acne, Papulopustulicular acne, Papulo-pustular acne, Acne, Acne Disease, Acne, Acne vulgaris, Nodular-cystic acne, Nodular-cystic acne

Composition and form of release

Capsules 1 caps.

isotretinoin 10 mg/ 20 mg

auxiliary substances: soybean oil; beeswax yellow; soy bean oil hydrogenated; soy bean oil partially hydrogenated

capsule shell: gelatin; glycerol; Carion 83 (potato hydrolyzed starch, mannitol, sorbitol); canthaxanthin; titanium dioxide; ink for applying the inscription on the capsule (shellac, iron oxide oxide black)

in a blister of 10 pcs .; in a pack of cardboard 3 or 10 blisters.

pharmachologic effect

Pharmacological action - anti-inflammatory, anti-seborrheic.

Dosing and Administration

Inside, with meals 1 or 2 times a day.

Standard dosing regimen

The therapeutic efficacy of RoaccutaneŽ and its side effects depend on the dose and vary in different patients. This dictates the need for an individual dose selection during treatment.

Treatment with RoaccutaneŽ should be started at a dose of 0.5 mg / kg / day. In most patients, the dose varies from 0.5 to 1 mg / kg of body weight per day. Patients with very severe forms of disease or with acne in the trunk may need higher daily doses - up to 2 mg / kg. It has been proved that the frequency of remission and the prevention of relapses are optimal when using a course dose of 120-150 mg / kg (per treatment course), so the duration of therapy in specific patients varies depending on the daily dose. Complete remission of acne can often be achieved in 16-24 weeks of treatment. In patients who are very poorly tolerated the recommended dose, treatment can continue at a lower dose, but spend it longer.

In most patients, acne completely disappears after a single course of treatment. With a clear relapse, a second course of RoaccutanŽ treatment is shown at the same daily and exchange rate as the first. Since the improvement can continue up to 8 weeks after the drug is discontinued, the repeated course should be appointed no earlier than the end of this period.

Dosing in special cases. In patients with severe renal failure, treatment should begin with a lower dose (eg 10 mg / day) and then increase to 1 mg / kg / day or maximum tolerated.

Storage conditions

In a place protected from light and moisture, at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiry date printed on the package.

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