Instructions for use LATICORT cream
Apply externally.
Apply a small amount of ointment to the affected areas of the skin, no more than 1-2 times a day. Treatment should not be continued without interruption for more than 2 weeks. The drug should not be used on the facial skin for longer than 1 week.
You should not use more than one tube of cream per week.
If lichenification or keratinization of the affected areas of the skin develops excessively, it is possible to use an ointment under an occlusive dressing (using wax paper), which must be changed every 24 hours.
For children over 2 years old
Use the drug with caution, only when necessary, once a day and on a small area of skin. Do not use on children's faces.
Features of application
Treatment with the drug should not be carried out without interruption for more than 2 weeks.
Under the influence of external use of hydrocortisone butyrate, due to inhibition of the pituitary-adrenal system, a decrease in the production of adrenocorticotropic hormone (ACTH) by the pituitary gland may be observed, as well as a decrease in the level of cortisol in the blood and the development of iatrogenic Itsenko-Cushing syndrome, which regresses after cessation of treatment. Periodic monitoring of the functioning of the adrenal cortex is indicated by determining the level of cortisol in the blood and urine after stimulation of the adrenal glands with the hormone ACTH.
If symptoms of infection are detected in the area of application, appropriate antibacterial or antifungal treatment should be administered. If the symptoms of the infection do not improve, you should stop using Laticort until the infection is treated.
The use of the drug on the eyelids or on the skin around the eyelids should be avoided in patients with narrow or wide angle anterior chamber glaucoma and in people with cataracts due to the possibility of exacerbating the symptoms of the disease. Avoid contact of the drug with the eyes and mucous membranes.
Apply the cream to the skin of the face, groin and armpits only in very necessary cases, due to increased absorption and the high risk of side effects of the drug (telangiectasia, perioral dermatitis), even after short-term use.
Do not use under an occlusive dressing (except in cases of severe hyperkeratosis and on the recommendation of a doctor), since such a dressing enhances the absorption of the corticosteroid into the body; moreover, atrophy or stretching of the skin, and superinfection may occur. Carefully
using this drug for existing atrophy of skin tissue, especially in elderly patients.
Use the drug especially carefully for patients suffering from psoriasis, since external use of glucocorticosteroids for psoriasis can be dangerous and cause a relapse of the disease due to the development of addiction, the risk of generalized pustular psoriasis and systemic toxicity caused by skin dysfunction.
Use extreme caution and avoid long-term treatment in children over two years of age.
Children, who have a higher body surface area to body weight ratio than adults, are at increased risk of adverse systemic corticosteroid effects, including hypothalamic, pituitary, adrenal dysfunction and Cushing's syndrome. Treatment with corticosteroids may adversely affect the growth and development of children.
Contains cetostearyl alcohol, which may cause local skin reactions (eg contact dermatitis).
Contains methylhydroxybenzoate, which may cause allergic reactions (possibly delayed).
Laticort ointment for external use 0.1% 15g
Compound
Active substance: hydrocortisone butyrate - 1 mg. Excipients: white petroleum jelly - up to 1 g.
Pharmacokinetics
Suction
After application, hydrocortisone butyrate accumulates in the epidermis, mainly in the granular layer; systemic absorption is negligible. A small amount of hydrocortisone butyrate is absorbed into the systemic circulation unchanged. The absorption of hydrocortisone butyrate is enhanced when used on thin skin in the folds or on the face, as well as on areas with damaged epidermis or on skin affected by an inflammatory process. Absorption of hydrocortisone butyrate is also enhanced by the use of an occlusive dressing, frequent application of the drug, or application to a large area of skin.
In children, the absorption of hydrocortisone butyrate through the skin is more pronounced than in adults.
Metabolism
Most hydrocortisone butyrate is metabolized to hydrocortisone and other metabolites directly in the epidermis and subsequently in the liver.
Removal
Metabolites and a small part of unchanged hydrocortisone butyrate are excreted mainly by the kidneys and through the intestines with bile.
Indications for use
Subacute and chronic superficial, non-infected skin diseases sensitive to local corticosteroids:
- dermatitis, incl. atopic, contact, seborrheic;
- eczema;
- psoriasis.
Contraindications
- hypersensitivity to hydrocortisone (or any corticosteroids) and excipients of the drug;
- bacterial, fungal and viral (including chicken pox, herpes simplex) skin infections;
- acne, rosacea;
- perioral dermatitis;
- post-vaccination period;
- violation of the integrity of the skin (wounds, ulcers);
- skin tumors;
- tuberculous or syphilitic skin lesions;
- children under 2 years of age;
- I trimester of pregnancy.
Carefully:
- application to large areas of skin, damaged skin, use in large doses, as well as long-term therapy with the drug (especially in children over 2 years of age);
- application to facial skin and intertriginous skin (skin folds, armpits, groin area, folds of arms and legs);
- use of occlusive dressings;
- application to the skin around the eyes or eyelids (risk of developing glaucoma, cataracts), incl. in patients with glaucoma or cataracts;
- breastfeeding period;
- atrophic changes in the subcutaneous tissue, especially in the elderly.
Directions for use and doses
The drug is used externally.
The ointment is applied in a thin layer to the affected areas of the skin with massaging movements to improve penetration. In cases of resistant disease, for example, when dense psoriatic plaques are localized on the elbows and knees, the drug must be used under an occlusive dressing, which must be changed every 24 hours.
In adults, the drug should be used no more than 2 times a day. The course of treatment with the drug is no more than 2 weeks; on facial skin - no more than 5 days. During the week, the dose of the drug should not exceed 30-60 g of ointment.
Laticort® is contraindicated in children under 2 years of age.
In children, due to a higher ratio of body surface area to body weight than in adults, dysfunctions of the hypothalamic-pituitary-adrenal system are more easily developed and undesirable reactions characteristic of GCS occur, incl. growth and development delay.
In children over 2 years of age, Laticort® should be used with great caution, only 1 time/day on small areas of skin under the supervision of a physician, in short courses (no more than 7 days); should not be used on the face.
If there is no improvement after treatment with Laticort® or new symptoms appear, the patient should consult a doctor.
The drug should be used only according to the method of application and in the doses indicated in the instructions. If necessary, the patient should consult a doctor before using the drug.
Storage conditions
The drug should be stored out of the reach of children, at a temperature not exceeding 25°C.
Best before date
3 years. Do not use after the expiration date.
special instructions
Avoid contact of Laticort ointment with the eyes and mucous membranes.
If, with external use of Laticort® ointment, signs of hypersensitivity or skin irritation are observed, as well as increased side effects or effects not specified in the instructions, the patient should stop treatment and consult a doctor.
With long-term use and/or application to large surfaces of the skin, when using occlusive dressings and during therapy in children, systemic absorption of GCS is possible; it is possible to suppress the function of the hypothalamic-pituitary-adrenal system and develop symptoms of hypercortisolism.
During drug therapy, periodic monitoring of the function of the adrenal cortex is necessary by determining the level of cortisol in the blood and urine after stimulation of the adrenal glands with adrenocorticotropic hormone (ACTH).
In case of development of a secondary bacterial or fungal infection, it is necessary to prescribe external use of an antibacterial or antifungal drug. If symptoms of infection persist, use of Laticort should be discontinued until the infection has resolved.
Laticort® should be applied with caution to the skin around the eyes or eyelids due to the risk of developing glaucoma or cataracts, incl. in patients with a history of these diseases, because an exacerbation of the course of these diseases may occur.
If a patient experiences symptoms such as blurred vision or other visual disturbances, consider referring the patient to an ophthalmologist to investigate possible causes of the disturbance, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy.
Laticort® should be used with extreme caution on the skin of the face and intertriginous skin (skin folds, armpits, groin, folds of the arms and legs) due to increased absorption of GCS through thin skin and the possibility of side effects (telangiectasia, skin atrophy, perioral dermatitis) even after short-term use.
On the skin of the face more often than on other surfaces of the body, after long-term treatment with topical corticosteroids, atrophic changes may appear; the course of treatment in this case should not exceed 5 days.
Laticort® is used with caution under an occlusive dressing due to increased absorption of GCS into the blood; the development of atrophy of the epidermis, stretch marks and the addition of infection is possible.
The drug should be used with caution in case of atrophic changes in the subcutaneous tissue, especially in the elderly.
With long-term use of GCS, sudden cessation of therapy can lead to the development of rebound syndrome, manifested in the form of dermatitis with intense redness and a burning sensation. Therefore, after long-term therapy, Laticort® should be discontinued gradually, for example, by switching to an intermittent treatment regimen before stopping it completely.
Use in pediatrics
Laticort ointment should be used with caution, especially as long-term therapy, in children over 2 years of age, since in this group of patients, due to a higher ratio of body surface area to body weight than in adults, hypothalamic-pituitary dysfunction may develop more quickly -adrenal system and undesirable effects characteristic of GCS may occur, incl. growth and development delay.
The use of the drug in children should be carried out under the supervision of a physician. Children should receive the minimum dose of the drug sufficient to achieve an effect. In children, the course of treatment should not exceed 7 days. Occlusive dressings should not be used.
Description
Glucocorticosteroid for external use.
Dosage form
Ointment for external use in the form of an almost colorless, translucent fatty mass.
Use in children
Contraindicated for use in children under 2 years of age.
Pharmacodynamics
Hydrocortisone is a synthetic non-halogenated glucocorticoid drug for external use.
Inhibits the release of cytokines (interleukins and interferon) from lymphocytes and macrophages, inhibits the release of inflammatory mediators by eosinophils, disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins. Reduces inflammatory cell infiltrates, reduces the migration of leukocytes, incl. lymphocytes to the area of inflammation.
It has anti-inflammatory, decongestant or vasoconstrictor and antipruritic effects.
Due to the local vasoconstrictive effect, it reduces exudative reactions.
The use of ointment in recommended doses does not cause suppression of the hypothalamic-pituitary-adrenal system.
Side effects
The incidence of adverse reactions is classified according to WHO recommendations as follows: very often (≥1/10), often (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rarely ( ≥1/10,000 and <1/1000), very rare (<1/10,000), frequency unknown (cannot be estimated from available data).
Side effects are rare and reversible.
From the skin and subcutaneous tissue: frequency unknown - acne-like symptoms, post-steroid purpura, atrophy of the epidermis and subcutaneous tissue, dry skin, hypertrichosis or alopecia, depigmentation or hyperpigmentation of the skin, stretch marks, telangiectasia, perioral dermatitis, inflammation of the hair follicles, secondary infections, skin irritation . Sometimes urticaria or a maculopapular rash may occur, which may worsen existing skin diseases.
On the part of the visual organ: frequency unknown - decreased visual acuity. When using the drug on the skin of the eyelids, glaucoma or cataracts can sometimes develop, and in rare cases, central serous chorioretinopathy (CSC).
Systemic disorders: frequency unknown - with long-term use and/or application to large surfaces of the skin, when using occlusive dressings and during therapy in children, symptoms of hypercortisolism may develop (hyperglycemia, glycosuria, reversible inhibition of adrenal function, manifestations of Itsenko-Cushing syndrome, growth retardation and development in children, arterial hypertension, decreased immunity), as a manifestation of the resorptive effect of flumethasone.
If any of the side effects indicated in the instructions are aggravated or any other side effects not listed in the instructions are noted, the patient should immediately inform the doctor.
Use during pregnancy and breastfeeding
Pregnancy
The use of Laticort® is contraindicated in the first trimester of pregnancy.
It is possible to use the drug Laticort® for the treatment of pregnant women as prescribed by the attending physician if the expected benefit to the mother outweighs the potential risk to the fetus. In these cases, therapy should be short-term and limited to small areas of skin.
Breast-feeding
There is no data on the amount of hydrocortisone that passes into breast milk when used externally. The drug should be used with caution during breastfeeding, in short courses and on small areas of the skin.
In cases where GCS is intended to be used in large doses and/or for a long time, breastfeeding should be stopped.
Interaction
Interaction of the drug Laticort® when used externally with other drugs has not been identified.
Overdose
With prolonged use of the drug or the use of an occlusive dressing, as well as in the case of use on large areas of affected skin with increased resorption capacity, an overdose is possible, accompanied by signs of hypercortisolism.
Treatment: symptomatic therapy, drug withdrawal (with long-term therapy - gradual withdrawal or prescription of drugs with less activity).
Impact on the ability to drive vehicles and operate machinery
Laticort® does not affect the ability to drive vehicles and machines.
