Afloderm

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AFLODERM (AFLODERM)

Composition:

Active substance: alclometasone dipropionate;

1 g of ointment contains 0.5 mg of alclometasone dipropionate;

Excipients: white soft paraffin, white wax, hexylene glycol, propylene glycol monopalmitostearate.

Pharmaceutical form. Ointment.

Main physicochemical characteristics: homogeneous ointment ranging in color from colorless to light yellow, free from foreign particles.

Pharmacotherapeutic group. Corticosteroids for dermatological use.

ATC code D07AB10.

Pharmacological Properties.

Pharmacodynamics.

Alclometasone is a synthetic, non-fluorinated, moderately acting corticosteroid for topical use. It exerts anti-inflammatory, antipruritic, immunosuppressive, vasoconstrictive, and antiproliferative effects.

The anti-inflammatory activity is associated with reduced production, release, and activity of inflammatory mediators such as kinins, histamine, lysosomal enzymes, prostaglandins, and leukotrienes, which contribute to the development of the inflammatory process.

Corticosteroids prevent vasodilation and increased vascular permeability, thereby reducing migration of inflammatory cells to sites of damaged tissue. This effect reduces serum extravasation, edema, and pain.

The immunosuppressive effect manifests as inhibition of early hypersensitivity reactions (type III and IV). The mechanism of action involves reduction of the toxic effects of antigen-antibody complexes deposited on blood vessel walls, which may lead to allergic vasculitis on one hand, and decreased activity of lymphokines, target cells, and macrophages, all contributing to the development of allergic contact dermatitis on the other hand.

Corticosteroids also prevent access of sensitized T-lymphocytes and macrophages to target cells.

The antiproliferative effect of alclometasone is manifested by reduction in the amount of hyperplastic tissue typical of psoriasis.

Pharmacokinetics

When alclometasone is applied topically to intact healthy skin, approximately 3% of the total amount of the drug is absorbed into the systemic circulation. Skin damage or use of an occlusive dressing may increase absorption of alclometasone.

Alclometasone dipropionate is metabolized primarily in the liver; metabolites are mainly excreted in urine, with a smaller portion eliminated via bile.

Clinical characteristics.

Indications.

Treatment of dermatoses sensitive to topical corticosteroid therapy (including atopic and contact dermatitis, psoriasis).

For the treatment of:

• dermatoses on skin areas with increased sensitivity (e.g., face, intertriginous areas);
• chronic dermatoses in patients with sensitive skin (children and elderly patients);
• large skin areas, especially in children—due to minimal systemic absorption;
• dermatoses requiring continuation of treatment after using more potent corticosteroids.

Contraindications.

Hypersensitivity to alclometasone or to any other components of the medicinal product, acne, rosacea, cutaneous tuberculosis, skin manifestations of syphilis, skin reactions following vaccination, viral infections (e.g., herpes simplex, herpes zoster, varicella), perioral dermatitis, rosacea, molluscum contagiosum, fungal and bacterial skin infections, varicose veins, open wounds.

Should not be used under occlusive dressings.

Interaction with other medicinal products and other forms of interaction.

Due to the presence of soft white paraffin as an excipient, application of the ointment in the anogenital area may damage the structure of latex condoms and reduce their effectiveness when used during treatment.

Special precautions for use.

Treatment should be discontinued if hypersensitivity reactions occur (skin irritation accompanied by itching, burning sensation, and redness). If bacterial infection or fungal skin infection is present, appropriate antifungal or antibacterial agents should be administered. If the desired effect is not achieved, corticosteroid therapy should be discontinued until the infection is resolved.

The drug is not intended for ophthalmic use. Afrodern should not be applied to the eyes or the area around the eyes due to the risk of developing glaucoma, cataracts, fungal eye infections, or herpes simplex exacerbation.

The drug should not be used over large skin areas for prolonged periods, especially under occlusive dressings, due to the potential for systemic absorption of alclometasone and the occurrence of systemic adverse effects.

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

Patients at risk of systemic adverse effects caused by alclometasone (children, patients with liver dysfunction, and those requiring long-term treatment) should have periodic monitoring of hypothalamic-pituitary-adrenal (HPA) axis function (urinary and plasma free cortisol tests, ACTH stimulation test). If suppression develops, the drug should be discontinued.

Local and systemic toxicity may occur, especially after prolonged use of the drug over large areas or on damaged skin, or in skin folds.

Long-term therapy with the drug should be avoided in all patients, regardless of age.

Do not use under occlusive dressings or under diapers, as they may increase systemic absorption of the active ingredients.

Certain body areas, such as the groin, axillae, and perianal region, where natural occlusion exists, are more susceptible to the development of striae during treatment with alclometasone. Therefore, use of the drug in these areas should be minimized.

Do not use in the treatment of leg varicose ulcers (trophic dermatomycoses).

Afloderm ointment contains propylene glycol monopalmitostearate, which may cause skin irritation.

Visual disturbances

Visual disturbances may occur with both 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 ophthalmological examination to evaluate possible causes of visual impairment, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported after systemic and topical corticosteroid use.

Use during pregnancy or breastfeeding.

Pregnancy.

Since the safety of topical corticosteroids in pregnant women has not been established, the drug should not be used during the first trimester of pregnancy. These drugs may be prescribed only in later stages of pregnancy if the expected benefit to the mother clearly outweighs the potential risk to the fetus. Drugs of this class are contraindicated in high doses and for prolonged periods during pregnancy.

Breastfeeding period.

It is currently unknown whether corticosteroids, after topical application and subsequent systemic absorption, can pass into breast milk. Therefore, when deciding whether to discontinue breastfeeding or discontinue use of the drug, the necessity of drug administration should be taken into account.

Ability to affect reaction speed while driving or operating machinery.

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

Dosage and Administration

Apply Afloderm cream externally only, 2–3 times daily, by applying a thin layer to the affected area and gently rubbing it in. Treatment should be discontinued once symptoms have resolved. The frequency and duration of treatment are determined individually by a physician, depending on the severity of the disease.

Do not use the drug for prolonged periods over large skin areas or under occlusive dressings, as this may enhance the absorption of alclometasone, except in the treatment of severe and persistent (resistant) dermatitis.

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

Children.

Do not use the drug in children under 12 years of age.

Use in children only after consultation with and under close medical supervision. Increased drug absorption in children should be considered due to the higher ratio of skin surface area to body weight, which may lead to enhanced systemic toxicity and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.

Children are more likely than adults to develop signs of HPA axis suppression and external corticosteroid effects from topical corticosteroids. In children receiving topical corticosteroid therapy, suppression of the hypothalamic-pituitary-adrenal system, Cushing's syndrome, linear growth retardation, inadequate weight gain, and increased intracranial pressure may occur. Signs of adrenal suppression in children include low plasma cortisol levels and lack of response to adrenocorticotropic hormone (ACTH) stimulation. Increased intracranial pressure manifests as bulging fontanelle, headache, and bilateral optic disc edema.

The duration of treatment in children should be minimized.

Overdose.

With prolonged or excessive use of topical glucocorticosteroids, especially when applied over large areas, on damaged skin, or under occlusive dressings—particularly in children—systemic absorption may occur, leading to systemic adverse effects such as hyperglycemia, glucosuria, suppression of pituitary-adrenal function resulting in secondary adrenal insufficiency, and symptoms of hypercorticism, including Cushing's disease.

Signs of hypothalamic-pituitary-adrenal (HPA) axis suppression in children include linear growth retardation, inadequate weight gain, low plasma and urinary cortisol levels, and lack of response to ACTH stimulation. Increased intracranial pressure may present as bulging fontanelle, headache, and bilateral optic disc edema.

Treatment. In case of overdose, discontinue the drug. Initiate appropriate symptomatic therapy using standard supportive measures to maintain normal body function. Symptoms of acute hypercorticism are usually reversible. If necessary, correct electrolyte imbalances. In cases of chronic toxic effects, gradual withdrawal of corticosteroids is recommended. Withdrawal symptoms (e.g., fever, myalgia, arthralgia, weakness) are very rare but may require systemic corticosteroid replacement therapy.

Side effects

Side effects may be local or systemic. Local side effects occur more frequently under occlusive dressings.

Any adverse effects associated with systemic use of glucocorticoids, including adrenal cortex suppression, may also occur with topical application.

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

Adverse reactions observed during use of the medicinal product are classified by organ systems and frequency of occurrence: very common: ≥ 1/10; common: ≥ 1/100 – < 1/10; uncommon: ≥ 1/1000 – < 1/100; rare: ≥ 1/10,000 – < 1/1000; very rare: < 1/10,000; unknown (frequency cannot be estimated due to limited available data).

Skin and subcutaneous tissue disorders.

Common: itching, burning sensation, erythema, skin irritation or exacerbation of existing skin conditions, dryness of the skin, papular rash.

Very rare: acneiform eruptions, skin maceration, pruritus, skin induration, sensation of warmth, lamellar desquamation, focal desquamation, depigmentation or hyperpigmentation of the skin, miliaria, folliculitis, steroid-induced acne, skin atrophy, striae, ecchymoses (especially on the face), hypertrichosis, allergic contact dermatitis, perioral dermatitis, secondary infection.

Ophthalmological disorders.

Unknown: blurred vision (see also section "Special precautions").

Shelf life. 3 years.

Storage conditions.

Store at temperatures not exceeding 30 °C.

Keep out of reach and sight of children.

Packaging.

20 g or 40 g in a tube, 1 tube per cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Belupo, lijekovi i kozmetika, d.d.

Manufacturer's address and place of business.

Danica 5, 48000 Koprivnica, Croatia.