Universal reference book for medicines
Product name: LATICORT® (LATICORT)

Active substance: hydrocortisone butyrate

Type: GCS for external use

Manufacturer: PHARMACEUTICAL WORKS JELFA (Poland)
Composition, form of production and packaging
?
Solution for external use 0.1% colorless, transparent, with the smell of isopropyl alcohol, without sediment and mechanical inclusions.
1 ml

hydrocortisone butyrate 1 mg

Excipients: glycerol - 30 mg, povidone - 2.5 mg, citric acid - 1.72 mg, sodium citrate - 0.78 mg, isopropanol - 0.50 mg, purified water - up to 1 ml.

20 ml - polyethylene bottles (1) - packs of cardboard.

?
Cream for external use 0.1% in the form of a homogeneous mass of white.
1 g

hydrocortisone butyrate 1 mg

Excipients: white petrolatum - 150 mg, paraffin liquid - 60 mg, cetostearyl alcohol - 72 mg, cetomacrogol - 18 mg, citric acid - 4.2 mg, sodium citrate - 2.8 mg, methylparahydroxybenzoate - 2 mg, purified water - up to 1 g.

15 g - aluminum tubes (1) - cardboard packs.

?
Ointment for external use 0.1% in the form of an almost colorless, transparent fatty mass.
1 g

hydrocortisone butyrate 1 mg

Excipients: white petrolatum - up to 1 g.

15 g - aluminum tubes (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Synthetic nonhalogenated GCS for external use.
It has a rapid anti-inflammatory, anti-edematous, antipruritic and anti-allergic action. Due to local vasoconstrictive action reduces exudative reactions.
The use of the drug in recommended doses does not cause suppression of the hypothalamic-pituitary-adrenal system.

PHARMACOKINETICS

Suction

After application, the active substance accumulates in the epidermis, mainly in the granular layer.

Metabolism

Hydrocortisone butyrate, 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 part of unchanged hydrocortisone butyrate is excreted by the kidneys and with bile.

INDICATIONS

Uninfected, sensitive to local SCS skin diseases that occur with excessive keratinization:

- seborrheic dermatitis;

- atopic dermatitis;

- erythroderma;

- contact eczema;

- psoriasis;

- Red flat lichen.

Insect bites.

DOSING MODE

Apply externally.

In adults, a small amount of the drug is applied to the affected skin 1-3 times / day.
The course of treatment is 1-3 weeks. The dose of the drug used during the week should not exceed 30-60 g. To improve the penetration the drug is applied by massaging movements. In cases of refractory disease, for example, in the localization of dense psoriatic plaques on the elbows, knees, the drug should be used under occlusive dressings.
In children, the drug is used from 6 months of age.

In childhood, suppression of the function of the adrenal cortex can develop more quickly.
In addition, there may be a decrease in the excretion of growth hormone.When using the drug for a long time, it is necessary to observe the body weight, growth, plasma cortisol level. In control studies in children who received 30-60 grams of Laticort® ointments on a weekly basis, there were no abnormalities of adrenal cortex function.
When using the drug on the face or under occlusive dressings (diapers, diapers), a greater degree of absorption is possible, so it is recommended to apply a minimal dose of the drug.
Treatment should be short-term and under the supervision of a doctor.
SIDE EFFECT

Side effects are rare and are reversible.

Local reactions: rarely - skin irritation.

With long-term use and / or application to large surfaces, with occlusive dressings, acne-like changes, hypopigmentation, sweating, folliculitis, striae, skin atrophy, hypertrichosis and secondary skin infections are rare in rare cases.

In rare cases, the development of allergic contact dermatitis.

CONTRAINDICATIONS

- bacterial, viral and fungal skin infections;

- acne vulgaris, rosacea;

- perioral dermatitis;

- violation of the integrity of the skin (wounds, ulcers);

- skin tumors;

- tuberculosis or syphilitic skin lesions;

- Post-vaccination period;

- Children's age up to 6 months, with itching in the anus - up to 12 years;

- Hypersensitivity to the components of the drug.

With caution
should prescribe the drug for diabetes, tuberculosis (systemic damage).
PREGNANCY AND LACTATION

The use of Laticort ® in pregnant women is allowed in cases when, according to the attending physician, the potential benefit for a pregnant woman prevails over the possible risk to the fetus.
In these cases, the application should be short and limited to small areas of the skin. It is not recommended to use in the first trimester of pregnancy.
In the period of breastfeeding should be used for a short time on a small surface of the skin and not applied to the skin of the breast.

APPLICATION FOR CHILDREN

In children, the drug is used from 6 months of age.

In childhood, suppression of the function of the adrenal cortex can develop more quickly.
In addition, there may be a decrease in the excretion of growth hormone.When using the drug for a long time, it is necessary to observe the body weight, growth, plasma cortisol level. In control studies in children who received 30-60 grams of Lacicort ® every week in any form, no adrenal cortex function was detected.
When using the drug on the face or under occlusive dressings (diapers, diapers), a greater degree of absorption is possible, so it is recommended to apply a minimal dose of the drug.
Treatment should be short-term and under the supervision of a doctor.
APPLICATION IN ELDERLY PATIENTS

With caution use the drug in cases of already existing atrophic skin conditions, especially in the elderly.

SPECIAL INSTRUCTIONS

Avoid contact with the drug Laticort ® in the eye.

If a secondary bacterial or fungal infection develops, an external antibacterial or antifungal agent should be prescribed.

With extreme caution, the drug should be applied to the skin of the face due to the possibility of side effects (telangiectasia, atrophy, perioral dermatitis).

If after 7 days of application there is no improvement or if there is a worsening of the condition, and also if the symptoms recur after a few days after cancellation, the drug should be discontinued and consulted by a doctor.

Although the use of the drug in high doses for a long time, especially with the use of occlusive dressings, can lead to an increase in the content of cortisol in the blood plasma, this is never accompanied by a decrease in the reactivity of the pituitary-adrenal system, and the withdrawal of the drug leads to a rapid normalization of cortisol production.

With caution use the drug in cases of already existing atrophic skin conditions, especially in the elderly.

The risk of side effects when using the drug Laticort ® is lower than when using halogenated GCS.

Laticort ® ointment is recommended for use in subacute inflammatory conditions and lichenification.

Impact on the ability to drive vehicles and manage mechanisms

The use of the drug does not limit the psychophysical abilities of the patient, the ability to drive vehicles and maintain machinery in motion.

OVERDOSE

There is no evidence of an overdose of Laticort ® .
With prolonged use of the drug in large doses, symptoms of hypercorticism may appear.
Treatment: spend symptomatic therapy against the background of a gradual withdrawal of the drug.

DRUG INTERACTION

Data on the drug interaction of the drug Laticort ® with other means is not available.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children, at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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