Rederm^® (Ointment) Instructions for Use

Marketing Authorization Holder

Vertex, JSC (Russia)

Contact Information

VERTEX JSC (Russia)

ATC Code

D07XC01 (Betamethasone in combination with other drugs)

Active Substances

Salicylic acid (USP)

Betamethasone (Rec.INN)

Dosage Form

Rederm®

Ointment for external use 0.05%+3%: tubes 5 g, 15 g or 30 g

Dosage Form, Packaging, and Composition

Ointment for external use white or almost white, semi-transparent, homogeneous.

Excipients: liquid paraffin (mineral oil), white soft paraffin (white petrolatum).

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

Clinical-Pharmacological Group

A drug with anti-inflammatory and keratolytic action for external use

Pharmacotherapeutic Group

Topical glucocorticosteroid + keratolytic agent

Pharmacological Action

A combined drug containing the active substances – betamethasone dipropionate and salicylic acid.

Betamethasone dipropionate is a synthetic fluorinated glucocorticosteroid that has anti-inflammatory, antipruritic, and vasoconstrictive effects.

Salicylic acid, having a keratolytic effect, promotes the penetration of betamethasone into the skin. It has a bacteriostatic and some fungicidal effect.

The combined action of the active components leads to a rapid reduction in the severity of symptoms such as itching, irritation, erythema, and pain.

Pharmacokinetics

Data on the pharmacokinetics of the drug Rederm^® are not provided.

Indications

Reduction of inflammatory manifestations of dry and hyperkeratotic dermatoses sensitive to glucocorticosteroid therapy, including:

• Psoriasis;
• Chronic atopic dermatitis;
• Neurodermatitis;
• Lichen planus;
• Eczema (including nummular eczema, hand eczema, eczematous dermatitis);
• Dyshidrosis;
• Seborrheic dermatitis of the scalp;
• Ichthyosis and other ichthyosis-like conditions.

ICD codes

Dosage Regimen

The drug is used externally. Apply a thin layer to the affected areas of the skin 2 times a day (in the morning and at night). In some patients, a maintenance effect can be achieved with less frequent applications.

The course of treatment should not exceed 3 weeks. The duration of treatment, features of the treatment regimen, and repeated courses of treatment must be agreed with the doctor.

For children aged 2 to 12 years, apply a thin layer 1 or 2 times a day for no more than 5 days.

The drug should be used only according to the method of application and in the doses indicated in the instructions for use. Before using the drug, if necessary, the patient should consult a doctor.

Adverse Reactions

Skin and subcutaneous tissue disorders common – burning, itching, irritation, dry skin, folliculitis, hypertrichosis, acne-like eruptions, acne, hypopigmentation, telangiectasia, perioral dermatitis, allergic contact dermatitis, skin maceration, skin atrophy, miliaria, secondary infections.

Eye disorders blurred vision.

Endocrine system disorders with prolonged use and application to large areas of the skin, mainly in children, the occurrence of systemic side effects of glucocorticoids is possible – hypokalemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Cushing’s syndrome.

If side effects listed in the instructions occur, or they worsen, or any other side effects not listed in the instructions appear, the patient must inform the doctor.

Contraindications

• Hypersensitivity to betamethasone, salicylic acid, other components of the drug;
• Rosacea, acne, perioral dermatitis;
• Bacterial, viral, or fungal skin infections;
• Trophic ulcers due to chronic venous insufficiency, wounds;
• Skin tumors;
• Post-vaccination skin reactions;
• Perianal and genital itching;
• Children under 2 years of age;
• Pregnancy (long-term treatment in large doses);
• Breastfeeding period.

With caution

Children under 12 years of age, hepatic insufficiency, long-term treatment, application to extensive skin areas, use of occlusive dressings.

Use in Pregnancy and Lactation

Pregnancy

The safety of glucocorticoids applied to the skin has not been established. During pregnancy, the use of the drug is possible if the potential benefit to the mother outweighs the possible risk to the fetus or child. Topical glucocorticoids should not be used during pregnancy in large doses or for a long time. Before using the drug Rederm^®, if the patient is pregnant, or suspects she might be pregnant, or is planning a pregnancy, she should consult a doctor.

Breastfeeding period

Since it has not yet been clarified whether the level of systemic absorption of topical glucocorticoids is sufficient to produce detectable concentrations in breast milk, either breastfeeding or the use of the drug should be discontinued, taking into account how necessary its use is for the mother. Before using the drug Rederm^®, it is necessary to consult a doctor.

Use in Hepatic Impairment

The drug should be used with caution in hepatic insufficiency.

Pediatric Use

The use of the drug is contraindicated in children under 2 years of age.

In children over 2 years of age, the drug should be used with caution.

Special Precautions

If skin irritation or signs of allergic reactions appear during the use of the drug Rederm^®, treatment should be discontinued.

In case of associated fungal or bacterial infection, appropriate therapy should be prescribed.

Avoid getting the drug in the eyes and on mucous membranes, as well as application in the anogenital area, on areas of extensive skin lesions, especially with impaired skin integrity.

The use of the drug in children under 12 years of age should only be under medical supervision. Children are more susceptible than adults to the risk of suppression of the hypothalamic-pituitary-adrenal system when using topical glucocorticosteroids due to the larger ratio of body surface area to body weight and, consequently, increased absorption of the drug. There have been reports of decreased function of the hypothalamic-pituitary-adrenal system, Cushing’s syndrome, growth retardation, insufficient weight gain, and increased intracranial pressure in children receiving topical glucocorticosteroids. Suppression of the hypothalamic-pituitary-adrenal system in children is determined by low plasma cortisol levels and lack of response to ACTH stimulation. Increased intracranial pressure is manifested by bulging fontanelle, headaches, and bilateral papilledema.

When using the drug in children or for the treatment of skin lesions on the face, the duration of treatment should not exceed 5 days.

The use of the drug under occlusive dressings is not recommended. With prolonged treatment, application to large skin surfaces, or the use of occlusive dressings, systemic absorption of the glucocorticosteroid and salicylic acid is possible. When discontinuing long-term treatment with the drug, it is recommended to do so gradually.

Rederm^® is not intended for use in ophthalmology. When glucocorticosteroids are applied externally, visual impairment may occur. If the patient experiences symptoms such as blurred vision or other visual disturbances, the patient should be referred to an ophthalmologist to evaluate possible causes of visual impairment, which may include cataract, glaucoma, and rare conditions such as central serous chorioretinopathy (CSCR), which have been reported after systemic and topical glucocorticosteroid use.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms prolonged use of topical glucocorticosteroids in large doses can cause suppression of the pituitary-adrenal system, which can lead to the development of secondary adrenal insufficiency and the appearance of symptoms of hypercortisolism, including Cushing’s syndrome. Long-term use in large doses of drugs containing salicylic acid can lead to salicylic acid poisoning.

Treatment symptomatic. Acute symptoms of hypercortisolism are usually reversible. If necessary, correction of electrolyte balance is recommended. In case of chronic toxic effects, gradual withdrawal of glucocorticoids is recommended. In case of salicylic acid poisoning, measures should be taken to rapidly eliminate salicylic acid from the body, for example, oral administration of sodium bicarbonate to alkalinize the urine and force diuresis.

Drug Interactions

Interaction of the drug with other medicinal products has not been studied.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 2 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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.