Hydrocortisone

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HYDROCORTISONE (HYDROCORTISONE)

Composition:

Active ingredient: hydrocortisone acetate;

1 g of ointment contains hydrocortisone acetate 10 mg;

Excipients: soft white paraffin, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), lanolin, pentol, purified water, stearic acid.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment ranging from white with a yellowish tint to light yellow in color.

Pharmacotherapeutic group. Corticosteroids for dermatological use.

ATC code D07AA02.

Pharmacological properties.

Pharmacodynamics. Hydrocortisone is an active non-halogenated corticosteroid for topical use. It exerts anti-inflammatory, anti-edematous, and antipruritic effects rapidly. Its efficacy is comparable to that of halogenated steroids. Use at recommended doses does not cause suppression of the hypothalamic-pituitary-adrenal system. Although prolonged administration of large doses, especially when using occlusive dressings, may lead to increased cortisol levels in blood plasma, this does not result in reduced responsiveness of the pituitary-adrenal system; discontinuation of the drug promotes rapid normalization of cortisol production.

Pharmacokinetics.

Absorption. After application, the active substance accumulates in the epidermis, predominantly in the stratum granulosum.

Metabolism. Hydrocortisone acetate, absorbed through the skin, is metabolized to hydrocortisone and other metabolites directly in the epidermis, and subsequently in the liver.

Excretion. Metabolites and a minor portion of unchanged hydrocortisone acetate are excreted in urine and feces.

Clinical characteristics.

Indications.

Superficial non-infected dermatoses treatable with topical corticosteroids (eczema, allergic and contact dermatitis, neurodermatitis, psoriasis).

Continuation of treatment or maintenance therapy of dermatoses previously treated with more potent corticosteroids.

Contraindications.

• Skin lesions caused by bacterial infections (e.g. pyoderma, syphilitic or tuberculous lesions), viral infections (e.g. varicella, herpes simplex, herpes zoster, common warts, flat warts, condyloma, molluscum contagiosum); fungal and yeast infections; parasitic infections (e.g. scabies);
• ulcerative skin lesions and wounds;
• adverse reactions caused by corticosteroids (e.g. perioral dermatitis, striae);
• ichthyosis, juvenile plantar dermatosis, acne vulgaris, rosacea, cutaneous fragility, skin atrophy;
• hypersensitivity allergic reactions to components of the medicinal product or to corticosteroids (the latter are rare);
• skin tumors.

Interaction with other medicinal products and other forms of interaction.

There are no data on interactions with other medicinal products.

Special precautions for use.

The medicinal product should be used at the lowest doses and for the shortest duration necessary to achieve the desired therapeutic effect.

To prevent skin infections, concomitant use with antibacterial and antifungal agents is recommended.

Vaccination against smallpox or other types of immunization should not be performed during treatment with this drug due to the immunosuppressive effects of glucocorticoids.

Because of systemic absorption, treatment of large skin areas or prolonged therapy may lead to interactions similar to those observed during systemic therapy. However, no such interactions have been reported to date. If concomitant use of any other medicinal products is required, medical advice should be sought.

Use with caution in patients with diabetes mellitus.

Systemic adverse reactions following topical application of corticosteroids in adults are extremely rare but may be serious. This is particularly true for adrenal cortical suppression associated with prolonged use of the drug.

The risk of systemic effects is increased in the following cases:

• use under occlusion (plastic occlusive dressing or application in skin folds);
• application over large skin areas;
• prolonged treatment;
• use in children (children are particularly sensitive due to thin skin and relatively large body surface area);
• presence of components or excipients enhancing penetration through the stratum corneum and/or enhancing the effect of the active substance (propylene glycol).

The risk of local adverse reactions increases with the potency of the drug and duration of treatment. Use under occlusion (plastic occlusive dressing or application in skin folds) increases this risk. The facial skin, scalp, and genital areas are particularly sensitive to the development of adverse reactions. Inappropriate use, as well as presence of bacterial, parasitic, fungal, or viral infections, may mask and/or exacerbate manifestations of these diseases.

Do not apply the ointment to the eyelids due to the risk of contact with the conjunctiva and increased risk of developing open-angle glaucoma or subcapsular cataract. Avoid contact of the medicinal product with the eyes and with deep open wounds or mucous membranes. Visual disturbances may occur during treatment with systemic or topical corticosteroids. If a patient experiences symptoms such as blurred vision or other visual disturbances, an ophthalmological examination should be performed to determine the cause, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), cases of which have been reported following use of systemic or topical corticosteroid preparations.

The medicinal product should be applied with caution to the facial skin, genital area, and scalp, as these areas are most sensitive to corticosteroids.

Application to the face, skin folds, and other areas of thin skin may lead to skin atrophy and increased absorption of the drug.

It should be noted that when corticosteroids are applied to large skin areas, especially under occlusion (plastic occlusive dressing) or in skin folds, increased absorption of the drug may occur, potentially leading to adrenal cortical suppression.

Adrenal cortical suppression may develop rapidly in children. Suppression of growth hormone production may also occur. If long-term treatment is necessary, regular monitoring of the child's height and body weight, as well as plasma cortisol levels, is recommended.

The medicinal product contains methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), which may cause allergic reactions. The ointment also contains lanolin, which may cause local skin reactions (e.g., contact dermatitis).

Topically applied corticosteroids may be hazardous in patients with psoriasis for several reasons, including the "rebound syndrome" due to development of tolerance, risk of generalized pustular psoriasis, or local systemic toxicity due to impaired skin barrier function. Steroids may be used in scalp psoriasis or chronic plaque psoriasis of the hands and feet. Close monitoring of the patient is essential.

In comparative studies, no significant differences in adrenal cortical function were observed in children treated with Hydrocortisone ointment for 4 weeks.

Use during pregnancy or breastfeeding.

Pregnancy. Contraindicated.

Breastfeeding. Hydrocortisone ointment may be used in breastfeeding women only for short-term treatment and application to small skin areas. For long-term treatment or application to large areas of affected skin, breastfeeding should be discontinued.

Ability to influence reaction speed when driving vehicles or operating machinery. There are no data on the effect of Hydrocortisone ointment on the ability to drive vehicles or operate machinery. Such effects are not expected.

Method of administration and dosage.

Apply a small amount of the medicinal product to the skin 1–3 times daily. When the condition improves, usually once-daily application or 2–3 times per week is sufficient.

The duration of treatment is determined by a physician.

Hydrocortisone should be applied as a thin, uniform layer to affected skin areas. The preparation may be gently rubbed into the skin to enhance its penetration. For improved therapeutic effect, an occlusive dressing may be applied.

Children. May be used in children aged 2 years and older.

Overdose.

In case of chronic overdose or inappropriate use, adverse effects described in the section «Adverse reactions» may occur.

If symptoms of hypercorticism are observed, treatment should be discontinued.

Side effects.

When corticosteroids are used locally in diseases leading to thinning of the cornea or sclera, cases of perforation may occur. There have been reports of delayed wound healing, ptosis, mydriasis, and blurred vision (see section "Special precautions for use"). Prolonged treatment may lead to secondary skin infections, atrophic changes, and hypertrichosis. With prolonged use of the ointment, especially over large skin areas, hypercorticism may develop as a manifestation of systemic absorption of hydrocortisone. In such cases, the drug should be discontinued.

Systemic side effects following topical application of corticosteroids in adults are rare but potentially serious (see section "Special precautions for use"). This is particularly relevant for adrenal cortical suppression associated with prolonged use of the drug.

Uncommon (>1/10,000, < 1/1,000)

Skin and subcutaneous tissue disorders:

• Dermatitis, eczema, contact dermatitis;
• Allergic contact dermatitis, pustular acne;
• Skin atrophy, often irreversible, associated with epidermal thinning, telangiectasia, purpura, and striae;
• Depigmentation, hypertrichosis;
• Rosacea-like and perioral dermatitis, with or without skin atrophy;
• "Rebound effect," potentially leading to steroid dependence;
• Delayed wound healing.

Endocrine disorders: Adrenal cortical suppression.

Very rare (< 1/10,000, including isolated case reports)

Eye disorders: Increased intraocular pressure, increased risk of cataract development (with repeated exposure of the drug to the conjunctiva).

Immune system disorders: Hypersensitivity reactions.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions. Keep out of reach and sight of children. Store at a temperature not exceeding 25 °C.

Packaging. 10 g in a tube. 1 tube in a cardboard box.

Prescription status. Prescription only.

Manufacturer.

LLC "FZ "STADA"

Manufacturer's address and place of business.

37, Kyivska St., Bila Tserkva, Kyiv Oblast, 09100, Ukraine.