Hydrocortisone + Natamycin + Neomycin (Ointment) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

D07CA01 (Hydrocortisone in combination with antibiotics)

Active Substances

Hydrocortisone (Rec.INN registered by WHO)

Natamycin (Rec.INN registered by WHO)

Neomycin (Rec.INN registered by WHO)

Dosage Form

Hydrocortisone + Natamycin + Neomycin

Ointment for external use 10 mg+10 mg+3500 IU/1 g: tube 15 g, 20 g, 25 g, 30 g, 35 g, 40 or 50 g

Dosage Form, Packaging, and Composition

Ointment for external use from white to yellow in color.

Excipients: liquid paraffin – 927.67 mg, polyethylene – 48.83 mg.

15 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
35 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
15 g – plastic tubes (1) – cardboard packs.
20 g – plastic tubes (1) – cardboard packs.
25 g – plastic tubes (1) – cardboard packs.
30 g – plastic tubes (1) – cardboard packs.
35 g – plastic tubes (1) – cardboard packs.
40 g – plastic tubes (1) – cardboard packs.
50 g – plastic tubes (1) – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Topical glucocorticosteroid + aminoglycoside antibiotic + antifungal agent

Pharmacological Action

A combined medicinal product that has antibacterial, antifungal, and local anti-inflammatory action due to the components in its composition.

Natamycin belongs to the polyene antibiotics of the macrolide group and has a fungicidal effect. It is active against yeast and yeast-like fungi (especially Candida spp.). Dermatophytes are less sensitive to natamycin.

Neomycin is a broad-spectrum antibiotic from the aminoglycoside group, active against gram-positive bacteria Staphylococcus spp., Enterococcus spp.; gram-negative bacteria Klebsiella spp., Proteus spp., Escherichia coli and others.

Hydrocortisone has anti-inflammatory and vasoconstrictive action. It eliminates inflammatory phenomena and itching accompanying various types of dermatoses.

Pharmacokinetics

Natamycin and Neomycin are practically not absorbed through intact skin and mucous membranes. Absorption of neomycin through damaged skin is possible when applied to extensive wound and burn surfaces.

From 1% to 3% of hydrocortisone is absorbed through intact skin; with dermatitis, the amount of absorbed hydrocortisone doubles, and with infectious skin lesions, it can increase fivefold.

In children, the absorption of hydrocortisone through intact skin is higher than in adults. The degree of absorption of the drug into the systemic bloodstream decreases with age.

Indications

Dermatoses amenable to glucocorticosteroid therapy, complicated by secondary bacterial and/or fungal infection (especially caused by Candida spp.).

ICD codes

Dosage Regimen

Apply a thin layer of ointment to the affected skin areas two to three times daily.

Limit the duration of application to the minimum period necessary to achieve therapeutic effect.

Do not use for more than one to two weeks without medical supervision.

Avoid application to large body surface areas, especially in children and infants.

Do not use under occlusive dressings unless specifically directed by a physician.

Wash hands before and after applying the ointment, unless treating the hands themselves.

Ensure the skin is clean and dry prior to each application.

Gently rub in the ointment until absorbed.

Discontinue use and consult a physician if no improvement is observed within 3-4 days.

Immediately cease treatment if signs of skin atrophy, irritation, or hypersensitivity occur.

Exercise extreme caution when applying the ointment to the face, eyelids, or areas with thin skin.

Do not apply to open wounds, ulcerated skin, or mucous membranes.

Adverse Reactions

Side effects with external use develop rarely and are reversible.

Allergic reactions rarely – itching, burning, redness, or dryness of the skin.

Dermatological reactions: extremely rarely – atrophy and thinning of the skin, telangiectasias, striae, purpura, rosacea-like and perioral dermatitis, delayed wound healing, depigmentation, hypertrichosis, withdrawal syndrome after discontinuation of treatment; contact dermatitis to Neomycin.

Systemic reactions with external use of glucocorticosteroids for a long time on large areas of the skin, or when using occlusive dressings, especially in children, the development of side effects due to the systemic action of glucocorticosteroids is possible – symptoms of suppression of adrenal cortex function.

Contraindications

Tuberculosis of the skin; skin manifestations of syphilis; viral skin infections; skin post-vaccination reactions; open wounds; ulcerative skin lesions; acne; rosacea; ichthyosis; anogenital pruritus; skin tumors; hypersensitivity to the components of the drug.

With caution

In systemic tuberculosis, in patients with a history of damage to the IX pair of cranial nerves against the background of the use of aminoglycosides. In the presence of perforation of the eardrum and direct exposure of neomycin to the middle ear, there is a risk of ototoxic action; children under 1 year of age.

Use in Pregnancy and Lactation

If use is necessary in case of planned, suspected, or existing pregnancy, as well as during breastfeeding, a doctor’s consultation is required.

Pediatric Use

Contraindicated in children under 1 year of age.

Special Precautions

When applied to the eyelid area and periorbital area, there is a risk of increased intraocular pressure and development of cataracts.

In case of prolonged treatment, in the presence of wounds and ulcers, there is a theoretical risk of ototoxic and nephrotoxic action of neomycin.

If superinfection appears or fungal microflora develops excessively, the use of the drug should be discontinued and appropriate measures taken.

Use in pediatrics

In children, it should be used under medical supervision. When applied to large surfaces or under occlusive dressings, the possibility of suppression of the function of the hypothalamic-pituitary-adrenal system should be considered.

Drug Interactions

Cross-hypersensitivity between neomycin and drugs of similar chemical structure, for example, kanamycin, paromomycin, gentamicin, and cross-resistance between neomycin and other antibiotics of the aminoglycoside group is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.