Polcortolon ts

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT POLCORTOLON TC (POLCORTOLON TC)

Composition:

Active substances: 1 g of suspension contains 23.12 mg of tetracycline hydrochloride and 0.58 mg of triamcinolone acetonide;

Excipients: sorbitan trioleate, lecithin, isopropyl myristate, mixture of propane, butane and isobutane.

Pharmaceutical form. Cutaneous aerosol, suspension.

Main physicochemical properties: homogeneous yellow suspension free from mechanical inclusions.

Pharmacotherapeutic group. Corticosteroids for dermatological use. Moderately potent corticosteroids in combination with antibiotics. ATC code D07CB01.

Pharmacological properties.

Pharmacodynamics.

Polcortolon TS is a combined medicinal product containing two active substances: tetracycline and triamcinolone.

Tetracycline is a broad-spectrum antibiotic with antibacterial activity.

Triamcinolone is a moderately active corticosteroid exerting anti-inflammatory, antipruritic, and vasoconstrictive effects.

Polcortolon TS acts on tetracycline-sensitive bacteria located in inflammatory foci of the skin, and also limits local inflammatory processes, reduces erythema and pruritus.

Pharmacokinetics.

Tetracycline, when applied to intact skin, exerts a local effect and practically does not penetrate into the bloodstream. When the product is applied to wounds or damaged skin, tetracycline can penetrate into the bloodstream and may cause systemic adverse effects.

Triamcinolone, when applied topically, especially over large areas of skin, may penetrate into the bloodstream. Inflammatory processes and/or other skin diseases accelerate its absorption. Use of an occlusive dressing significantly enhances percutaneous absorption of triamcinolone. After entering the bloodstream, triamcinolone undergoes hepatic metabolism and is subsequently excreted by the kidneys.

Clinical characteristics.

Indications.

Local treatment of inflammatory skin conditions complicated by infection caused by bacteria sensitive to tetracycline, in the following conditions:

• allergic skin diseases complicated by secondary bacterial infection;
• first-degree burns and frostbite;
• leg ulcers.

Contraindications.

• Hypersensitivity to tetracycline, triamcinolone, or to any excipient of the medicinal product;
• viral, fungal, or tuberculosis skin infections;
• primary bacterial infections, such as: impetigo, pyoderma, furunculosis;
• widespread plaque psoriasis;
• rosacea and common acne;
• perioral dermatitis;
• skin neoplasms and precancerous conditions;
• use in the area of the anus and genital organs.

Interaction with other medicinal products and other forms of interaction.

During treatment, other topical agents should not be used simultaneously, as this may affect the concentration of active substances at the site of application and may cause drug interactions or skin irritation.

Special precautions for use

The medicinal product is intended for topical use only. Avoid contact with mucous membranes.

Do not apply to the skin of the eyelids. Protect eyes from exposure to the product. In case of aerosol contact with eyes, rinse thoroughly with water.

Do not inhale the sprayed substance.

If there is no clinical improvement, do not use the product for longer than 7 days.

If skin irritation occurs at the site of application, discontinue use of the product. Prolonged use of the product on the skin may lead to capillary dilation and skin atrophy. The product should be used with particular caution on the facial skin. The aerosol should be used cautiously in patients with psoriasis. Do not bandage the skin to which the aerosol has been applied, and do not use under occlusive dressings. The use of occlusive dressings enhances the penetration of the product through the skin into the bloodstream, which may result in systemic adverse effects of tetracycline and/or triamcinolone, typical for corticosteroids. Hypersensitivity reactions to the antibiotic may be masked by the presence of the steroid component.

Triamcinolone may be absorbed into the bloodstream through the skin and may cause immunosuppressive effects. Therefore, during treatment with this product, patients should avoid exposure to viral infections (e.g. varicella, measles).

Patients receiving corticosteroids should not be vaccinated against varicella. Practically no other types of vaccination should be administered to patients receiving high-dose corticosteroids due to the risk of neurological complications or impaired antibody response.

The product should not be used for prolonged periods, over large skin areas, or on wounds, as there is a risk of systemic adverse effects of tetracycline and/or corticosteroid. The steroid component of the product, triamcinolone, may penetrate into the bloodstream and cause systemic effects, including suppression of the hypothalamic–pituitary–adrenal axis (e.g. Cushing's syndrome, glucosuria, hyperglycemia).

If systemic signs of corticosteroid adverse effects occur, treatment with the product must be discontinued immediately, and monitoring of urinary cortisol concentration should be performed.

During treatment, avoid exposure to sunlight or artificial UV light (including solarium use). Photodermatitis may occur due to the presence of tetracycline.

Prolonged use of the product may lead to the development of tetracycline-resistant bacterial strains or fungal infections, as well as tetracycline allergy.

If infections caused by tetracycline-resistant bacteria or fungi develop, appropriate antibacterial or antifungal treatment should be initiated.

Extremely flammable aerosol.

Pressurized container: may burst if heated.

Keep away from heat sources, hot surfaces, sparks, open flames, and other sources of ignition. No smoking.

Do not spray near open flames or other sources of ignition.

Pressurized container: do not pierce or burn, even after use.

Protect from sunlight. Do not expose to temperatures exceeding 50 °C / 122 °F.

Use during pregnancy or breastfeeding

The medicinal product should not be used during pregnancy or breastfeeding.

Effect on the ability to drive or operate machinery

There are no data available on the influence of the product on the ability to drive or operate machinery.

Method of Administration and Dosage

Adults and children aged 14 years and older

Spray the affected skin areas with the aerosol stream, holding the can vertically with the spray nozzle facing upward, from a distance of approximately 15–20 cm for 1–3 seconds. Repeat the procedure 2–4 times daily at regular intervals.

Extremely flammable aerosol. Do not use near open flame or other sources of ignition.

Caution! Protect eyes from exposure to the sprayed substance; do not inhale.

Shake the can vigorously several times before each use.

After each application, thoroughly wash hands with soap and water.

The duration of treatment is determined individually by a physician.

Children

The drug must not be used in children under 14 years of age due to lack of experience with its use.

Extreme caution must be exercised when using the drug in children aged 14 years and older, due to the potential for systemic effects of tetracycline or the steroid component triamcinolone.

In children, the ratio of body surface area to body weight is greater than in adults; therefore, the risk of systemic corticosteroid effects—including hypothalamic-pituitary-adrenal (HPA) axis suppression (e.g., Cushing's syndrome)—is higher than in adults. In addition, prolonged use of corticosteroids may impair growth and development in children.

Overdose

If the drug is applied over large areas of skin, in high doses, under occlusive dressing, or to damaged skin, it may penetrate into the bloodstream and cause systemic effects of corticosteroids or tetracycline (see section "Special Warnings and Precautions for Use").

Symptoms of overdose may include an intensification of adverse reactions associated with local application of the drug, as well as adverse effects typical of systemic steroid therapy, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis (e.g., Cushing's syndrome, glucosuria, hyperglycemia).

In cases of chronic corticosteroid intoxication, gradual discontinuation of the aerosol is recommended.

Treatment is symptomatic.

Adverse reactions.

Triamcinolone is a steroid component of the medicinal product that may cause local adverse symptoms such as burning, itching, irritation at the site of application, excessive drying, excessive hair growth, skin atrophy, contact dermatitis, perioral dermatitis, maceration of the skin, acneiform eruptions, skin striae, miliaria, rash, hypertrichosis, depigmentation and pigmentation of the skin, secondary skin infections, and folliculitis. These manifestations are very rare and occur mainly in patients using occlusive dressings.

With prolonged use and/or application to large areas of skin, triamcinolone may penetrate into the bloodstream and cause systemic adverse reactions typical of corticosteroids, including suppression of pituitary and adrenal gland function. In children, growth and developmental disturbances may also occur.

Prolonged use of the product on the facial skin may lead to skin atrophy and dilation of blood vessels.

Tetracycline contained in the product may cause local skin irritation, allergic reactions, photodermatosis, and/or promote the growth of fungi or resistant bacterial strains.

Hypersensitivity reactions, exfoliative dermatitis, rosacea, plaque formation, and erythema may also occur. When applied in the area of the eyelids, ocular complications are possible.

Reporting of suspected adverse reactions

After marketing authorization of the medicinal product, it is very important to collect reports of suspected adverse reactions. This enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions through the national pharmacovigilance system.

Shelf life.

2 years.

Storage conditions.

Keep out of reach of children and store at a temperature not exceeding 25 °C.

Packaging.

17.3 g of suspension in an aerosol can, 1 can per cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Tarchomin Pharmaceutical Plant "Polfa" S.A.

Manufacturer's address and place of business.

2 A. Fleminga Street, 03-176 Warsaw, Poland.