Instructions Hydrocortisone ointment 1% tube 10 g
Composition
active ingredient: hydrocortisone acetate;
1 g of ointment contains hydrocortisone acetate 10 mg;
excipients: white soft paraffin, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), lanolin, pentol, purified water, stearic acid.
Dosage form
Ointment.
Main physicochemical properties: ointment from white with a yellowish tint to light yellow.
Pharmacotherapeutic group
Corticosteroids for use in dermatology.
ATX code D07A A02.
Pharmacological properties
Pharmacodynamics. Hydrocortisone is an active non-halogenated corticosteroid for topical use. It quickly has anti-inflammatory, anti-edematous, antipruritic effects. Its effectiveness is the same as that of halogenated steroids. Use in recommended doses does not cause suppression of the hypothalamic-pituitary-adrenal system. Although the use of large doses of the drug for a long time, especially when using occlusive dressings, may lead to an increase in the content of cortisol in the blood plasma, this is not accompanied by a decrease in the reactivity of the pituitary-adrenal system, and withdrawal of the drug contributes to the rapid normalization of cortisol production.
Pharmacokinetics.
Absorption. After application, the active substance accumulates in the epidermis, mainly in the granular layer.
Metabolism: Hydrocortisone acetate absorbed through the skin is metabolized to hydrocortisone and other metabolites directly in the epidermis and then in the liver.
Excretion: Metabolites and a small portion of unchanged hydrocortisone acetate are excreted in the urine and feces.
Indication
Superficial non-infected dermatoses treated with topical corticosteroids (eczema, allergic and contact dermatitis, neurodermatitis, psoriasis).
Continuation of treatment or maintenance therapy for dermatoses that have been treated with stronger corticosteroids in the past.
Contraindication
Skin lesions caused by bacterial infections (e.g. pyoderma, syphilitic or tuberculous lesions), viral infections (e.g. chickenpox, herpes simplex, herpes zoster, common warts, flat warts, condyloma, molluscum contagiosum); infections caused by fungi and yeasts; 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, fragility of skin vessels, skin atrophy; allergic reactions of hypersensitivity to the components of the drug or corticosteroids (the latter occur rarely); skin neoplasms.
Interaction with other medicinal products and other types of interactions
There are no data on interactions with other drugs.
Application features
The drug should be used in the lowest doses and for the shortest period necessary to achieve the desired therapeutic effect.
To prevent skin infections, it is recommended to prescribe it in combination with antibacterial and antifungal agents.
During treatment with the drug, vaccination against smallpox or other types of immunization are not recommended due to the immunosuppressive effect of glucocorticosteroids.
Due to absorption, treatment of large areas of skin or treatment over a long period of time may cause interactions similar to those observed with systemic therapy. However, none of these interactions have been reported to date. If concomitant use of any other medicinal products is necessary, a doctor should be consulted.
Use with caution in diabetes.
Systemic adverse reactions to topical corticosteroids in adults are extremely rare but can be serious, especially adrenocortical suppression with prolonged use.
The risk of systemic effects increases in the following cases:
application with a bandage (cellophane bandage or application in skin folds); application on large areas of skin; long-term treatment; application to children (children are extremely sensitive due to their thin skin and relatively large surface area); in the presence of components or excipients that enhance penetration through the stratum corneum and/or enhance the effect of the active substance (propylene glycol).
Do not apply the ointment to the eyelids due to the possibility of contact with the conjunctiva and an increased risk of developing ordinary glaucoma or subcapsular cataracts. Avoid contact with the eyes, deep open wounds, and mucous membranes. Visual disturbances may occur with systemic or topical corticosteroids. If the patient experiences symptoms such as blurred vision or other visual disturbances, he or she should consult an ophthalmologist to determine the cause, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSR), which have been reported following systemic or topical corticosteroid use.
The drug should be applied with caution to the skin of the face, genitals and scalp, the skin of which is 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 borne in mind that when corticosteroids are used on large areas of skin, especially with the use of a (cellophane) bandage or in the area of folds, there is a possibility of increased absorption of the drug, which may lead to suppression of adrenocortical function.
Adrenal suppression can develop rapidly in children. Growth hormone production may also be suppressed. If long-term treatment is necessary, it is advisable to regularly monitor the child's height and weight, as well as determine plasma cortisol levels.
The medicine contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions. The ointment also contains lanolin, which may cause local skin reactions (e.g. contact dermatitis).
Topical corticosteroids can be dangerous for patients with psoriasis for a number of reasons, including rebound syndrome due to tolerance, the risk of generalized pustular psoriasis, or local systemic toxicity due to compromised skin barrier function. Steroids may be used for scalp psoriasis or for chronic scaly psoriasis of the hands and feet. Close monitoring is important.
When conducting comparative studies, no significant differences in adrenocortical function were noted in children who were treated with Hydrocortisone ointment for 4 weeks.
Use during pregnancy or breastfeeding
Pregnancy. Contraindicated.
Breastfeeding. Hydrocortisone ointment should only be used by breastfeeding women for short-term treatment and on small areas of skin. Breastfeeding should be discontinued for long-term treatment or application to large areas of affected skin.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the effect of Hydrocortisone ointment on the ability to drive or use machines. No effects are expected.
Method of administration and doses
Apply a small amount of the drug to the skin 1–3 times a day. When the condition improves, it is usually sufficient to use the drug once a day or 2–3 times a week.
The duration of use is determined by the doctor.
Hydrocortisone should be applied in a thin, even layer to the affected skin. The product can be gently rubbed into the skin to accelerate its penetration. An occlusive dressing can be applied to ensure a better therapeutic effect.
Children: Use in children over 2 years of age.
Overdose
In case of chronic overdose or inappropriate use, side effects described in the "Adverse Reactions" section may occur.
If symptoms of hypercorticism occur, treatment should be discontinued.
Side effects
In the case of topical use of corticosteroids in diseases that lead to thinning of the cornea or sclera, cases of perforation may be observed. There is information about delayed wound healing, ptosis, mydriasis, blurred vision (see the section "Special instructions for use"). In the case of long-term treatment, the development of secondary infectious skin lesions, atrophic changes, hypertrichosis is also possible. With prolonged use of the ointment, especially on large affected areas of the skin, the development of hypercorticism is possible as a manifestation of the resorptive effect of hydrocortisone. In such cases, the drug should be discontinued.
Systemic adverse reactions to topical corticosteroids in adults are rare but can be serious (see section 4.4). This is particularly true of adrenocortical suppression with prolonged use.
Rare (>1/10,000, <1/1,000)
Skin and subcutaneous tissue disorders:
dermatitis, eczema, contact dermatitis; contact allergy, pustular acne; skin atrophy, often irreversible, accompanied by thinning of the epidermis, telangiectasias, purpura and striae; depigmentation, hypertrichosis; rosacea-like and perioral dermatitis, accompanied or not accompanied by skin atrophy; "ricochet effect", which can lead to steroid dependence; delayed wound healing.
Very rare (< 1/10,000, including isolated reports).
On the part of the organs of vision: increased intraocular pressure, increased risk of cataracts (with systematic contact of the drug with the conjunctiva).
Immune system disorders: hypersensitivity reactions.
Expiration date
22 months.
Do not use after the expiry date stated on the packaging.
Storage conditions
Keep out of the reach of children. Store at a temperature not exceeding 25 ºС.
Packaging
10 g in a tube. 1 tube in a cardboard pack.
Vacation category
According to the recipe.
Producer
LLC "FZ "BIOPHARMA".
Location of the manufacturer and its business address
Ukraine, 09100, Kyiv region, Bila Tserkva, Kyivska st., 37.
