Oxycort (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

D07CA01 (Hydrocortisone in combination with antibiotics)

Active Substances

Hydrocortisone

Oxytetracycline

Dosage Form

Oxycort

Aerosol for external use 300 mg+100 mg/55 ml: aerosol bottles

Dosage Form, Packaging, and Composition

Aerosol for external use in the form of a homogeneous yellow suspension, free from mechanical inclusions, with a characteristic odor.

Excipients: sorbitan trioleate (Span 85V) – 640 mg, lecithin – 4.87 mg, isopropyl myristate – up to 5.25 g, a mixture of propane, butane, and isobutane (Drivosol 35A) as a propellant – 27 g.

55 ml – aerosol bottles (1) with a valve and spray device – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Topical glucocorticosteroid + tetracycline antibiotic

Pharmacological Action

Oxycort is a drug for external use that has the combined action of two active components.

Oxytetracycline is a broad-spectrum antibiotic from the tetracycline group. It has a bacteriostatic effect on some Gram-positive bacteria: streptococci; Gram-negative bacteria: Enterobacteriaceae, Pseudomonadaceae, Pasteurellaceae (Haemophilus spp.), cocci (Neisseria spp.). It is active against microorganisms of the families Rickettsiaceae, Chlamydiaceae, Mycoplasma, Actinomyces, as well as some protozoa (Plasmodium, Entamoeba).

Hydrocortisone is a synthetic glucocorticosteroid of the adrenal cortex. It has anti-inflammatory, anti-allergic, antipruritic, and anti-edematous effects.

Pharmacokinetics

Oxytetracycline, when applied externally, is practically not absorbed into the blood and does not have a systemic effect. Hydrocortisone may slightly penetrate into the systemic circulation, is metabolized in the liver, and is excreted by the kidneys.

Violation of the integrity of the skin, inflammatory and other pathological processes of the skin, and an occlusive dressing promote the absorption of the drug.

Indications

• Allergic skin diseases complicated by secondary bacterial infection (urticaria, eczema);
• Skin diseases caused by microorganisms sensitive to oxytetracycline, as well as mixed infections (impetigo, furunculosis, folliculitis, multiple abscesses, erysipelas);
• First-degree burns and frostbite;
• Secondary infections after insect bites.

ICD codes

Dosage Regimen

Use externally only. Shake the aerosol bottle vigorously immediately before each application.

Hold the bottle in a vertical position. Spray the affected skin areas from a distance of 15-20 cm for 1-3 seconds.

Apply the spray 2 to 4 times daily. Maintain equal time intervals between applications.

Limit the treatment course duration to avoid potential adverse effects. Do not use on large body surface areas.

Avoid contact with eyes, mouth, and other mucous membranes. In case of accidental contact, rinse thoroughly with cool water.

Do not inhale the aerosol spray. Do not apply to open or deep wounds without medical supervision.

Discontinue use and consult a physician if no improvement is observed within 3-5 days, or if irritation worsens.

Do not puncture or incinerate the aerosol container, even after use. Store away from heat and open flames.

Adverse Reactions

Local reactions: burning, itching, irritation at the site of drug application, dryness and atrophy of the skin, acne-like rash, secondary infections. Long-term use of the drug on the facial skin may lead to dilation of blood vessels, as well as skin atrophy.

Development of systemic action is possible: suppression of the hypothalamic-pituitary-adrenal system. These effects may occur with long-term use of the drug and application to a large skin surface.

Contraindications

• Hypersensitivity to the components of the drug;
• Skin tuberculosis;
• Viral and fungal skin infections;
• Skin tumors and neoplasms.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and lactation is contraindicated.

Special Precautions

In case of skin irritation, the drug should be discontinued and appropriate measures initiated.

The use of oxytetracycline and other broad-spectrum antibiotics may lead to an increase in the number of resistant strains of staphylococci and Candida albicans. If an infection caused by resistant strains of bacteria or yeast fungi develops, appropriate treatment should be initiated.

The drug should not be applied to a large skin surface due to the possibility of adverse reactions characteristic of systemic steroid drugs, including suppression of the hypothalamic-pituitary-adrenal system (including symptoms of Cushing’s syndrome, glucosuria). In these cases, it is necessary to interrupt treatment and monitor the level of cortisol in the urine.

Long-term use of the drug on the skin may lead to dilation of blood vessels and skin atrophy.

It is necessary to protect the eyes from the aerosol. Do not inhale the sprayed drug. In case of contact with mucous membranes, rinse them thoroughly with cool water.

The bottle must not be opened or heated, as the contents of the bottle are under pressure and are highly flammable.

Effect on the ability to drive vehicles and mechanisms

The drug does not cause psychophysical impairments and does not affect the ability to drive vehicles.

Overdose

No symptoms of overdose have been observed with topical application of the drug.

Drug Interactions

Not established with topical application of the drug.

Storage Conditions

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

Shelf Life

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

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.