Polcortolon TC (Aerosol) Instructions for Use

Marketing Authorization Holder

Tarchomin Pharmaceutical Works Polfa, S.A. (Poland)

Contact Information

TARCHOMIN PHARMACEUTICAL WORKS POLFA S.A. (Poland)

ATC Code

D07CB01 (Triamcinolone in combination with antibiotics)

Active Substances

Triamcinolone acetonide (BAN)

Tetracycline (Rec.INN)

Dosage Form

Polcortolon TC

Aerosol for external use 10 mg+400 mg/30 ml: aerosol bottles

Dosage Form, Packaging, and Composition

Aerosol for external use in the form of a homogeneous yellow suspension without mechanical inclusions with a characteristic odor.

Excipients: sorbitan trioleate (Span 85V) – 180 mg, lecithin – 3 mg, isopropyl myristate – up to 3.3 g, a mixture of propane, butane and isobutane (Drivosol 35A) as a propellant – 14 g.

30 ml – aluminum aerosol bottles with a continuous action valve and a spray device (1) – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Topical glucocorticosteroid + tetracycline antibiotic

Pharmacological Action

Triamcinolone acetonide is a synthetic glucocorticoid, a fluorine derivative of prednisolone, which has anti-inflammatory, antipruritic, anti-exudative and anti-allergic effects.

Tetracycline hydrochloride is a broad-spectrum antibiotic. It has a bacteriostatic effect by suppressing protein synthesis in microorganisms.

Pharmacokinetics

Tetracycline, when applied externally, has a local effect and practically does not penetrate into the systemic circulation.

Triamcinolone, when applied externally, may slightly penetrate into the systemic circulation. The inflammatory process and skin diseases accelerate the absorption of the drug. Triamcinolone is metabolized in the liver and excreted by the kidneys.

Indications

• Allergic skin diseases complicated by secondary bacterial infection (urticaria, atopic dermatitis, eczema);
• Skin diseases caused by microorganisms sensitive to tetracycline, as well as mixed infections (impetigo, furunculosis, folliculitis, hidradenitis, erysipelas, etc.).

ICD codes

Dosage Regimen

Externally. Shake the bottle before use. The affected areas are sprayed with an aerosol stream for 3 seconds, holding the bottle in an upright position at a distance of about 15-20 cm from the skin surface.

For adults, the procedure is performed 2-4 times/day at equal intervals. The duration of treatment is determined individually and averages 5-10 days. In persistent cases of the disease, the course of treatment can be extended up to 25 days. Use for more than 4 weeks is not recommended.

For children over 3 years of age, the drug is prescribed for a short period of time, only once a day and sprayed on small areas of the skin surface.

Adverse Reactions

When used for a short time and when applied to small areas of the skin surface, the drug does not cause significant side effects.

Possible: itching, skin irritation, purpura.

Rarely (with prolonged use and when using occlusive dressings): development of secondary infectious lesions, acne, post-steroid vascular purpura, inhibition of epidermal growth, dry skin, increased hair growth, pigmentation, skin atrophy, telangiectasia; photosensitivity.

With prolonged use of glucocorticosteroids on large areas of the skin, the frequency of side effects in the form of peripheral edema, arterial hypertension, hyperglycemia, and immunosuppressive effect increases.

Contraindications

• Viral, fungal skin infections;
• Skin tuberculosis;
• Vaccination period;
• Tumors and precancerous conditions of the skin;
• Syphilis (skin manifestations);
• Chickenpox;
• Violation of the integrity of the skin at the sites of application of the drug;
• Children under 3 years of age;
• Hypersensitivity to the components of the drug.

With caution: glaucoma.

Use in Pregnancy and Lactation

Should not be used in the first trimester of pregnancy. The use of Polcortolon TC in later stages of pregnancy is possible only if the intended benefit outweighs the possible risk of complications.

It is not known to what extent Triamcinolone acetonide for external use is excreted in breast milk. After oral administration of corticosteroids, no significant amount of hormones that could affect the child was found in breast milk. When prescribing Polcortolon TC to nursing mothers, special caution should be exercised, assessing the intended benefit for the mother and the risk of side effects in the child. In exceptional cases, the drug is recommended to be used for a short time on limited areas of the skin and not to be applied to the skin of the mammary glands.

Pediatric Use

Contraindicated in children under 3 years of age. The use of the drug in children over 3 years of age should be limited, because long-term use and high doses of corticosteroids can affect the growth and development of the child.

Special Precautions

Long-term use of the drug should be avoided.

Use Polcortolon TC on the skin of the face with special caution, since the absorption of the drug increases and the possibility of side effects (telangiectasia, skin atrophy, perioral dermatitis) increases even after short-term use.

Use with caution in persons with existing atrophic skin changes, especially in elderly patients.

If skin irritation or other side effects occur, it is necessary to interrupt treatment and consult a doctor.

Long-term use of tetracycline, which is part of the Polcortolon TC drug, may contribute to an increase in the number of resistant strains of staphylococci, as well as Candida albicans. In this case, appropriate treatment should be prescribed.

Vaccination and immunization should not be carried out during treatment with glucocorticosteroids.

Tetracycline, which is part of the drug, can cause photosensitivity, so areas of the skin with applied aerosol should be protected from direct sunlight.

Eyes should be protected when spraying the aerosol; do not inhale the sprayed drug. Care must be taken to ensure that the drug does not get into the eyes, as this may cause glaucoma. If the drug accidentally gets into the eyes, they should be thoroughly rinsed with warm water.

Use in pediatrics

Polcortolon TC is not used in children under 3 years of age. The use of the drug in children should be limited, because long-term use and high doses of corticosteroids can affect the growth and development of the child.

Effect on the ability to drive vehicles and mechanisms

The drug does not limit psychophysical activity, the ability to drive a vehicle and operate moving mechanisms.

Overdose

Overdose of Polcortolon TC with external use is very rare. However, symptoms of overdose may occur with improper or prolonged use of the drug on large areas of the skin, manifested in side effects characteristic of the systemic use of glucocorticosteroid drugs with suppression of the pituitary-adrenal function.

Drug Interactions

Not established.

Storage Conditions

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

Shelf Life

Shelf life – 2 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed by 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.