Hydrocortisone, oxytetracycline

Instruction manual

For medical use of the drug

Structure:

Active ingredients: hydrocortisone, oxytetracycline;

1 g of ointment contains: hydrocortisone acetate - 10 mg, oxytetracycline hydrochloride - 30 mg;

excipients: methyl parahydroxybenzoate (E 218), mineral oil, soft yellow paraffin.

Dosage form.

Ointment.

Basic physico-chemical properties: yellow ointment.

Pharmacotherapeutic group.

Low active corticosteroids in combination with antibiotics. hydrocortisone and antibiotics. Code ATX D07C A01.

Pharmacological properties.

Pharmacodynamics

The drug Hyoxysone is characterized by a combined effect.

Oxytetracycline is an antibiotic of the tetracycline group, the mechanism of action of which is to inhibit the synthesis of protein microorganisms. The drug has a bacteriostatic effect on both gram-positive and gram-negative bacteria.

Hydrocortisone acetate belongs to the group of corticosteroids with moderate local anti-inflammatory, antipruritic and vasoconstrictive effects.

Pharmacokinetics

When applied topically, oxytetracycline penetrates into the systemic circulation in a small amount.

Hydrocortisone acetate, when applied topically, especially to small areas of the skin, is absorbed through the skin, metabolized to hydrocortisone and other metabolites directly in the epidermis, and only a small portion is then absorbed in the liver.

Metabolites and a small portion of unchanged hydrocortisone acetate are excreted in the urine or bile.

Clinical characteristics.

Indications.

Treatment of dermatoses complicated by infection (dry forms and areas that are flaky); primary allergic dermatoses, various forms of eczema, prurigo, contact and seborrheic dermatitis, obsolete psoriasis.

Contraindications

Skin lesions caused by bacterial infections (eg, pyoderma, syphilitic), viral infections (eg, herpes zoster, common wart, flat wart, genital warts, molluscum contagiosum); infections caused by fungi and yeast; parasitic infections (e.g. scabies); ulcerative skin lesions; ichthyosis, juvenile plantar dermatosis, acne vulgaris, rosacea, fragility of the vessels of the skin, atrophy of the skin; neoplasms of the skin.

Allergy to corticosteroids, oxytetracycline hydrochloride, or drug components. It is not recommended for conventional and rosacea, perioral dermatitis (dermatitis perioralis), after preventive vaccinations. Do not use on wounds, with precancerous conditions of the skin and skin cancer. Contraindicated in bacterial infections (including tuberculosis), viral infections (including herpes, chickenpox).

Special security measures.

Treatment should be discontinued when symptoms of skin irritation appear.

If after 7 days of using the drug no improvement is observed, treatment should be discontinued due to the fact that hydrocortisone can mask the symptoms of an infection that develops.

Do not use without a break for more than 2 weeks. Long-term use can lead to the development of bacterial resistance to oxytetracycline hydrochloride and mitotic superinfection.

Avoid contact with eyes, mucous membranes and wounds.

Do not use around the eyes due to the risk of glaucoma or cataracts.

The skin of the face and scalp, as well as the genitals, is especially sensitive to the occurrence of adverse reactions. With inappropriate use, as well as in the presence of bacterial, parasitic, fungal or viral infections, the manifestations of these diseases can be masked and / or amplified. On the skin of the face, as well as in the inguinal region, apply only in case of emergency, since it is possible to increase absorption and a high risk of side effects (telangiectasia, perioral dermatitis) even after short-term use. Care should be taken to use the drug in the presence of atrophy of the subcutaneous tissue, mainly in the elderly.

Due to the fact that corticosteroids can penetrate the skin, the use of the drug for a long time and on large areas of the skin should be avoided.The drug should not be used under an occlusive dressing due to possible epidermal atrophy, skin stretching and superinfection. Corticosteroids are characterized by systemic side effects, hypothalamic-pituitary-adrenal dysfunction, including hyperglycemia in Cushings syndrome, glucosuria. Due to the content of corticosteroids, the drug should be used with caution in patients with psoriasis.

Interaction with other drugs and other types of interactions.

When applied topically for the recommended doses, no interaction was detected.

It is not recommended to use two or more drugs for local application at the same time due to possible changes in the concentration of active substances at the place of application of the preparations or reddening of the skin.

During the treatment with ointment, it is not recommended to vaccinate against smallpox or other types of immunization.

Features of the application.

Use during pregnancy or lactation.

The drug is contraindicated during pregnancy and lactation.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

The drug does not limit mental and motor ability, as well as the ability to drive vehicles and work with other mechanisms.

Dosage and administration.

The drug is intended for topical use. ointment is applied in a thin layer on dry affected skin and areas that are peeling, 2-3 times a day. do not use ointment under an occlusive dressing. treatment is usually carried out within 1-2 weeks. can not be applied to the skin for more than 1 week. within a week, it is recommended to use no more than 10 g of ointment.

Children.

Do not use the drug in children.

Overdose.

With prolonged use on large areas of the skin, in large doses, when applied under an occlusive dressing, overdose symptoms may appear, which are manifested by an increase in systemic side effects characteristic of corticosteroids (hyperglycemia, glucosuria, cushing syndrome) or oxytetracycline. in case of an overdose, the use of the drug should be gradually discontinued.

Adverse Reactions

On the part of the skin and subcutaneous tissue:

• local skin irritation, rash, burning sensation, itching, sweating, dry skin;
• hypertrichosis, discoloration or depigmentation of the skin;
• contact dermatitis, eczema, delayed wound healing, redness, striae formation, steroid-induced purpura, skin discoloration, skin maceration, acne-like lesions;
• perioral dermatitis, which is accompanied or not accompanied by atrophy of the skin, inhibition of epidermal growth, atrophy of the subcutaneous tissue;
• inflammation of the hair follicles, the development of secondary bacterial or fungal infections;
• “Rebound effect”, which can lead to steroid dependence;
• telangiectasia.

From the endocrine system: adrenocortical suppression, hyperglycemia, glucosuria.

Systemic disorders are observed due to the absorption of hydrocortisone acetate into the systemic circulation and cause:

• Cushings syndrome, intracranial hypertension;
• angioedema;
• increased resistance of bacterial strains;
• blastomycosis.

From the side of the organs of vision: increased intraocular pressure and the risk of cataracts (with the systematic exposure of the drug to the conjunctiva).

From the side of the immune system: allergic reactions, hypersensitivity reactions, including angioedema, photosensitivity.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Packaging.

15 g of ointment in a tube number 1 in a pack of cardboard.

Vacation category.

On prescription.

Manufacturer.

Pao "chemical farm" red star ".

The location of the manufacturer and the address of the place of business.

61010, Ukraine, Kharkov, st. Gordienkovo, 1.