Diprosalic®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIPROSALIC® (DIPROSALIC®)

Composition:

Active substances: betamethasone, salicylic acid;

1 g of lotion contains betamethasone dipropionate 0.64 mg, equivalent to 0.5 mg of betamethasone, and salicylic acid 20.0 mg;

Excipients: disodium edetate, hypromellose, sodium hydroxide, isopropyl alcohol, purified water.

Pharmaceutical form. Lotion.

Main physicochemical properties: colorless, slightly viscous, translucent liquid, free from foreign particles.

Pharmacotherapeutic group.

Corticosteroids for dermatological use. Potent corticosteroids in combination with other agents. ATC code D07XC01.

Pharmacological properties.

Pharmacodynamics.

Betamethasone dipropionate

Betamethasone dipropionate belongs to potent corticosteroids. When applied locally, it exerts rapid and prolonged anti-inflammatory, antipruritic, and vasoconstrictive effects.

Local treatment with corticosteroids is not etiologic therapy; upon discontinuation of treatment, recurrence of the disease is possible.

Salicylic acid

Salicylic acid, due to its keratolytic and desquamative properties, makes the lower layers of the skin more accessible to the action of betamethasone dipropionate and enhances its absorption.

Pharmacokinetics.

Systemic absorption of betamethasone dipropionate is possible, primarily after prolonged application over a large skin area.

Clinical Characteristics.

Indications.

For reduction of inflammatory symptoms of psoriasis and seborrheic scalp dermatitis.

Contraindications.

The drug is contraindicated in patients with hypersensitivity to the active substances or to any other component of the preparation.

The drug is also contraindicated in bacterial and viral infections such as syphilitic and tuberculous skin lesions; postvaccinal reactions, smallpox, chickenpox, herpes simplex, herpes zoster, perioral dermatitis, perianal pruritus, and genital pruritus; generalized plaque psoriasis; varicose veins; diaper dermatitis; molluscum contagiosum; dermatomycoses; rosacea; acne; and fungal infections.

Avoid contact of the preparation with wounds, ulcers, or mucous membranes. Diprosalic® is not intended for ophthalmic use or under occlusive dressings.

Interaction with other medicinal products and other forms of interaction.

There are no known cases of interaction with other medicinal products.

Topical application of salicylic acid should not be combined with oral administration of drugs containing acetylsalicylic acid and other nonsteroidal anti-inflammatory agents. Do not use concurrently with benzoyl peroxide or topical retinoids. Salicylic acid may increase skin permeability to other topical medicinal products, thereby increasing their systemic absorption. In addition, salicylic acid may potentiate the adverse effects of methotrexate and the hypoglycemic effect of oral antidiabetic agents—sulfonylurea derivatives. If you are taking any other medicinal products, be sure to inform your physician.

Special precautions for use

If skin irritation or signs of hypersensitivity occur, treatment should be discontinued and appropriate therapy should be prescribed for the patient.

Any adverse effects observed during systemic corticosteroid use, including suppression of adrenal cortex function, may also occur with topical application of glucocorticosteroids, especially in children.

Systemic absorption of topical corticosteroids increases with larger treated body surface areas or when occlusive dressings are used. In such cases or during prolonged treatment, appropriate precautionary measures should be taken.

High-potency corticosteroids applied over large skin areas should be used under careful and periodic monitoring, as they may suppress the hypothalamic-pituitary-adrenal (HPA) axis. If suppression develops, the medication should be discontinued, the frequency of application reduced, or the patient switched to a less potent corticosteroid.

HPA axis function usually recovers after discontinuation of the drug. In some cases, withdrawal symptoms may develop, requiring supplementation with systemic corticosteroids.

When scaling or hyperkeratosis resolves, treatment should continue with corticosteroids only.

The use of the drug under occlusive dressings is not recommended.

If excessive dryness or increased skin irritation occurs, the drug should be discontinued.

Topical corticosteroids, for various reasons, may induce psoriasis, including symptom recurrence, followed by development of tolerance, risk of pustular psoriasis, and local systemic toxicity due to impaired skin barrier function. Patients with hepatic dysfunction are more sensitive to systemic effects. Close monitoring of the patient is required.

If infection is present, appropriate antifungal or antibacterial agents should be prescribed. If the desired effect is not rapidly achieved, corticosteroid use should be discontinued until signs of infection resolve.

Appropriate precautionary measures should be followed to prevent increased absorption when applying the drug to damaged areas, atrophic skin, large body surface areas, under occlusive dressings, or in children (due to higher body surface area to body weight ratio). When applied to large body surface areas, absorption of salicylic acid should also be considered.

Topical corticosteroids may alter the clinical picture.

Relapse may occur upon interruption of treatment, as well as possible infection exacerbation and delayed wound healing.

The drug should not be applied to mucous membranes or periorbital areas due to the keratolytic effect of salicylic acid.

Application of the drug to areas with atrophic skin is contraindicated.

Visual disturbances

Visual disturbances may occur with systemic and topical use of corticosteroids (including intranasal, inhaled, and intraocular administration). If symptoms such as blurred vision or other visual disturbances occur, the patient should undergo an ophthalmologic examination to evaluate possible causes of visual disturbances, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, reported after systemic and topical corticosteroid use.

Use during pregnancy or breastfeeding

Should not be used during the first trimester of pregnancy.

Because the safety of topical corticosteroids in pregnant women has not been established, these drugs should be prescribed only when the expected benefit to the mother clearly outweighs the potential risk to the fetus. Drugs of this group are contraindicated in high doses, for prolonged periods, or over large skin areas during pregnancy.

It is currently unknown whether topically applied corticosteroids, due to systemic absorption, can pass into breast milk; therefore, a decision should be made whether to discontinue breastfeeding when prescribing this drug.

Ability to affect reaction speed while driving or operating machinery

The drug usually does not affect reaction speed while driving or operating machinery.

Method of Administration and Dosage

Apply several drops of the lotion to the affected area and rub in gently with massaging motions into the skin or scalp. The lotion is usually applied twice daily – in the morning and in the evening. For some patients, satisfactory results may be achieved with once-daily application.

The maximum daily dose should be gradually reduced to the lowest possible dose that still allows control of symptoms.

Children

There are no clinical data on the use of this drug in children; therefore, its use in this age group is not recommended.

Since the surface area to body weight ratio is higher in children than in adults, absorption of the drug is more pronounced. Therefore, children are more susceptible to suppression of the hypothalamic-pituitary-adrenal (HPA) axis and the development of exogenous corticosteroid effects following corticosteroid use.

In children treated with topical corticosteroids, adrenal suppression, Cushing's syndrome, growth retardation, inadequate weight gain, and increased intracranial pressure have been reported.

Signs of adrenal cortex suppression include low plasma cortisol levels and lack of response to adrenocorticotropic hormone (ACTH) stimulation tests. Increased intracranial pressure may present as bulging fontanelle, headache, and bilateral optic disc swelling.

Since corticosteroids may affect growth hormone production in children, body weight and growth should be closely monitored in pediatric patients.

Overdose

Excessive or prolonged use of topical products containing salicylic acid may lead to symptoms of salicylism.

Application of large doses of the drug may enhance keratolytic effects and increase the risk of allergic reactions.

Treatment: Symptomatic therapy should be administered. Symptoms of acute hypercortisolism are usually reversible. If necessary, correct the electrolyte imbalance. In cases of chronic toxic effects, gradual withdrawal of corticosteroids is recommended.

Treatment of salicylism is symptomatic. Measures should be taken to enhance the elimination of salicylates from the body. In case of overgrowth of resistant microorganisms, treatment with the drug should be discontinued and appropriate therapy initiated. Orally administer sodium bicarbonate to alkalinize urine and enhance diuresis.

Side effects

Corticosteroids are locally absorbed through the skin. However, systemic effects of the drug may occur with prolonged use and/or application to large areas of skin, particularly in children.

Systemic effects may partially manifest as suppression of the hypothalamic-pituitary-adrenal (HPA) axis, leading to secondary adrenal insufficiency, including Cushing's syndrome. Children may absorb higher amounts of corticosteroids and are therefore more susceptible to systemic effects of the drug, even when using less than 30 g per week. Patients with severe hepatic impairment are also more sensitive to these effects.

Possible side effects associated with topical corticosteroids include: burning sensation, pruritus, irritation, dryness of the skin, stinging, skin atrophy, cracking of the skin, sensation of warmth, lamellar desquamation, focal desquamation, erythema, telangiectasia, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, and allergic contact dermatitis.

As with any medicinal product applied to the skin, allergic reactions to DiproSalik® are possible.

When the drug is applied over a large surface area or under occlusive dressings, particularly for prolonged periods, the possibility of systemic effects should be considered.

Hypersensitivity reactions may occur in individuals with known hypersensitivity to any component of the product.

DiproSalik®, lotion, is colorless and does not stain clothing.

Blurred vision has been reported with corticosteroid use (frequency unknown) (see also section "Special precautions").

Any adverse effects observed with systemic administration of glucocorticoids, including suppression of the adrenal cortex, may also occur with topical use of glucocorticosteroids.

The following adverse reactions may occur more frequently when occlusive dressings are used: maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Striae and telangiectasia, particularly on the face, may result from prolonged continuous application of the drug.

Shelf life. 1.5 years.

Storage conditions.

Store in a place inaccessible to children, at a temperature not exceeding 25 °C.

Packaging.

30 ml in bottles with dropper cap. 1 bottle per cardboard box.

Prescription status. Prescription only.

Manufacturer.

CENEXI HSC, France /
CENEXI HSC, France.

Organon Heist bv, Belgium /
Organon Heist bv, Belgium.

Manufacturer's address and location of activity.

2 rue Louis Pasteur, Herouville Saint Clair, 14200, France /
2 rue Louis Pasteur, Herouville Saint Clair, 14200, France.

Industriepark 30, 2220, Heist-op-den-Berg, Belgium /
Industriepark 30, 2220, Heist-op-den-Berg, Belgium.