Hydrocortisone

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HYDROCORTISONE

Composition:

Active substance: hydrocortisone acetate;

1 g of ointment contains hydrocortisone acetate 10.0 mg;

Excipients: white soft paraffin, paraffin oil, propylparaben (E 216), ethanol 96%.

Pharmaceutical form. Ointment.

Main physicochemical properties: homogeneous white ointment with a faint odor.

Pharmacotherapeutic group. Corticosteroids for dermatological use.

ATC code D07AA02.

Pharmacological properties.

Pharmacodynamics.

Hydrocortisone is an active non-halogenated corticosteroid for topical use. It rapidly exerts anti-inflammatory, anti-edematous, and antipruritic effects. 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 application of large doses, particularly under occlusive dressings, may lead to increased plasma cortisol levels, this is not associated with reduced responsiveness of the pituitary-adrenal system, and discontinuation of the drug results in rapid normalization of cortisol production.

Pharmacokinetics.

Absorption. After application, the active substance accumulates in the epidermis, primarily 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 small 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;
• corticosteroid-induced adverse reactions (e.g. perioral dermatitis, striae);
• ichthyosis, juvenile plantar dermatosis, acne vulgaris, rosacea, skin fragility, skin atrophy;
• hypersensitivity allergic reactions to the drug components or corticosteroids (the latter are rare);
• skin neoplasms.

Interaction with other medicinal products and other types of interactions.

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 infectious skin lesions, 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 glucocorticosteroids.

Because of possible 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.

The risk of developing local adverse reactions increases with the potency of the drug and duration of treatment. Use under occlusion (plastic occlusion or application in skin folds) increases this risk. Facial skin, scalp, and genital areas are particularly sensitive to corticosteroids. Inappropriate use, as well as the 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 transfer onto the conjunctiva and increased risk of developing open-angle glaucoma or subcapsular cataract.

Application of the drug to the face, flexural areas, and other areas of thin skin may lead to skin atrophy, increased absorption of the drug, and development of local adverse reactions.

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

Adrenal cortex 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, body weight, and plasma cortisol levels is recommended.

Topically applied corticosteroids may be hazardous in patients with psoriasis for several reasons, including "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. Careful monitoring of the patient is essential.

The medicinal product Hydrocortisone ointment contains propylparaben (E 216), which may cause allergic reactions (possibly delayed).

Visual disturbances.

Avoid contact of the medicinal product with eyes, deep open wounds, and mucous membranes. Visual disorders may occur during treatment with systemic or topical corticosteroid drugs. If a patient experiences symptoms such as blurred vision or other visual disturbances, an ophthalmologist should be consulted to determine the cause, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSC), cases of which have been reported following the use of systemic or topical corticosteroid drugs.

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 affect reaction speed when driving or operating machinery.

There are no data on the effect of Hydrocortisone ointment on the ability to drive or operate machinery. Such an effect is not expected.

Method of Administration and Dosage

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

The duration of treatment is determined by a physician.

Hydrocortisone should be applied as a thin, even layer to the affected skin areas. The drug may be gently rubbed into the skin to accelerate penetration. For enhanced therapeutic effect, an occlusive dressing may be used; however, the risk of adverse reactions should be considered (see section "Special Warnings and Precautions for Use").

Children

Use in children aged 2 years and older.

Overdose

Chronic overdose or inappropriate use may lead to adverse effects described in the section "Adverse Reactions".

If symptoms of hypercorticism occur, treatment should be discontinued.

Adverse reactions.

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"). With prolonged treatment, secondary skin infections, atrophic changes, and hypertrichosis may develop. Prolonged use of the ointment, especially over large skin areas, may lead to hypercorticism as a manifestation of systemic absorption of hydrocortisone. In such cases, the medication should be discontinued.

Systemic adverse reactions following topical application of corticosteroids in adults are rare but may be serious (see section "Special precautions for use"). This is particularly relevant to adrenocortical suppression associated with prolonged use of the drug.

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

Disorders of the skin and subcutaneous tissue:

• dermatitis, eczema, contact dermatitis;
• allergic contact dermatitis, pustular acne;
• skin atrophy, often irreversible, accompanied by epidermal thinning, telangiectasia, purpura, and striae;
• depigmentation, hypertrichosis;
• rosacea-like and perioral dermatitis, with or without skin atrophy;
• "rebound effect", which may lead to steroid dependence;
• delayed wound healing.

Endocrine disorders: adrenocortical suppression.

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

Eye disorders: increased intraocular pressure, increased risk of cataract development (with repeated exposure of the conjunctiva to the drug), blurred vision (frequency unknown, see also section "Special precautions for use").

Immune system disorders: hypersensitivity reactions.

Shelf life. 3 years.

Shelf life after first opening of the tube – 6 months.

Storage conditions.

Store at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

10 g or 15 g in a tube; 1 tube per cardboard box.

Prescription category.

Prescription only.

Manufacturer.

LLC "Arpimed".

Manufacturer's location and address of business activity.

Building 19, 2nd microdistrict, city of Abovyan, Kotayk region, Republic of Armenia.