Instructions Hydrocortisone ointment 1% tube 10 g
Composition
active ingredient: hydrocortisone acetate;
1 g of ointment contains hydrocortisone acetate 10.0 mg;
excipients: white soft paraffin, vaseline oil, propylparaben (E 216), ethanol 96%.
Dosage form
Ointment.
Main physicochemical properties: homogeneous white ointment with a faint odor.
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 leads to a 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, skin vascular fragility, skin atrophy;
- allergic hypersensitivity reactions to the components of the drug or corticosteroids (the latter occur rarely);
- skin neoplasm.
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.
The risk of local adverse reactions increases with increasing drug potency and duration of treatment. Application with a bandage (cellophane bandage or application to skin folds) increases this risk. The skin of the face and scalp, as well as the genitals, is particularly sensitive to corticosteroids. In case of inappropriate use, as well as in the presence of bacterial, parasitic, fungal or viral infections, the manifestations of these diseases may be masked and/or exacerbated.
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.
Application of the drug to the face, flexors, and other areas of thin skin may lead to skin atrophy, increased absorption of the drug, and the development of local adverse reactions.
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.
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 chronic scaly psoriasis of the hands and feet. Close monitoring is important.
The medicinal product Hydrocortisone, ointment, contains propylparaben (E 216), which may cause allergic reactions (possibly delayed).
Visual impairment.
Avoid contact with eyes, deep open wounds, and mucous membranes. Visual disturbances may occur with systemic or topical corticosteroids. If a patient experiences symptoms such as blurred vision or other visual disturbances, they should consult an ophthalmologist to determine the cause, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSR), which has been reported with systemic or topical corticosteroids.
Use during pregnancy or breastfeeding
Pregnancy. Contraindicated.
Breastfeeding. The drug Hydrocortisone, ointment, can be used by women who are breastfeeding only for short-term treatment and application to small areas of skin. 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 other mechanisms
There is no data on the effect of the drug 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 areas of the skin. The drug can be gently rubbed into the skin to accelerate its penetration. To ensure a better therapeutic effect, an occlusive dressing can be applied, but the risk of adverse reactions should be taken into account (see section "Special instructions").
Children
Use for 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.
Adverse reactions
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"). 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 skin lesions, 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, with or without skin atrophy;
- "ricochet effect", which can lead to steroid dependence;
- delayed wound healing.
Endocrine disorders: adrenocortical suppression.
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), blurred vision (frequency unknown, see also the section "Special instructions for use").
Immune system disorders: hypersensitivity reactions.
Expiration date
3 years.
The shelf life after first opening the tube is 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 in a cardboard pack.
Vacation category
According to the recipe.
Producer
LLC “Arpimed”.
Location of the manufacturer and its business address
Republic of Armenia, Kotayk region, Abovyan city, 2nd microdistrict, building 19.
