Composition, form of production and packaging
Ointment for external application of white with a light yellow shade of color, oily, soft.
1 g
flumethasone pivalate 200 Ојg
salicylic acid 30 mg
Excipients: propylene glycol 50 mg, lanolin 50 mg, petrolatum up to 1 g.
15 g - aluminum tubes (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Combination drug with anti-inflammatory and keratolytic action for external use.
Flumethasone pivalate - synthetic GCS, has anti-inflammatory, anti-edematous, anti-allergic, antipruritic effect. Inhibits the activity of phospholipase A 2 , which leads to suppression of the synthesis of prostaglandins and leukotrienes, inhibits the release of inflammatory mediators. It inhibits the migration of leukocytes and lymphocytes to the focus of inflammation. Prevents the accumulation of neutrophils, which leads to a decrease in inflammatory exudate, production of cytokines and inhibition of migration of macrophages, thereby decreasing the processes of infiltration and granulation. Oppresses the proteolytic activity of tissue kinin, inhibits the growth of fibroblasts, prevents the development of connective tissue in the focus of inflammation. Reduces hyperemia, manifestations of hypersensitivity reactions, proliferative and exudative processes that occur in connective tissue in the focus of inflammation.
Salicylic acid - NSAIDs, promotes penetration of SCS and gives the drug an additional anti-parakeratose, moderate keratolytic and local hypothermic property, facilitates the penetration of flumetasone into the skin. In addition, it has antibacterial and fungicidal action, and also restores the protective function of the skin.Suppresses secretion of sebaceous and sweat glands.
PHARMACOKINETICS
Suction
Absorption of flumethasone pivalate is higher in children than in adults and increases when applied in the area of ​​skin folds, on the face, on the skin with damaged epidermis and skin affected by the inflammatory process, under occlusive dressings, when applied to large areas of the skin (in this case, system action).
Distribution
Due to the external route of application and keratolytic action of salicylic acid, flumethasone pivalate easily penetrates the stratum corneum, through the horny layers of the skin where it accumulates.
Metabolism
Flumethasone pivalate is not practically metabolized in the skin. After insignificant absorption into the systemic flow of flumethasone, pivalate is biotransformed in the liver.
Excretion
It is excreted in the urine and, to a lesser extent, with bile in the form of compounds with glucuronic acid, as well as in small amounts in unchanged form.
INDICATIONS
Acute and chronic allergic dermatoses, especially accompanied by excessive cornification of the skin:
- atopic dermatitis;
- diffuse neurodermatitis;
- the chronic lien of Vidal;
- various forms of subacute and chronic eczema (especially horny);
- Hyperkeratosis (eg, ichthyosis);
- chronic dyshidrosis;
- psoriasis;
- seborrhea;
- Red flat lichen;
- red warty lichen;
- as part of a combination therapy for bladder skin diseases (including blistering rashes on the skin of the palms and feet);
- pruritis with severe lichenization;
- photodermatitis;
- multiforme exudative erythema;
otitis externa;
- discoid lupus erythematosus;
- Insect bites.
DOSING MODE
Outwardly. Ointment is applied a thin layer on the skin in the affected area 2-3 times / day. After removal of acute inflammation, the drug is used 1-2 times / day. After the complete disappearance of the painful manifestations, the treatment is carried out for another 3-4 days. In chronic skin lesions, treatment should not be continued for more than 3 weeks.
Ointment can also be used in the form of an occlusive dressing, which should be changed every 24-48 hours. In the treatment of lesions on dry and defatted skin areas characterized by severe infiltration, lichenization, desquamation and hyperkeratosis, and also homosexuality, the degree of moistening can be regulated by the thickness of the applied layer, in accordance with the therapeutic requirements, characteristic for each individual case.
SIDE EFFECT
Local reactions: possible - burning, itching, dry skin; with prolonged use - skin atrophy, local hirsutism, telangiectasia, purpura, steroid acne, perioral dermatitis, pigmentation disorders.
Systemic reactions: with prolonged use, application to extensive skin areas and / or the use of occlusive dressings, side effects characteristic of GCS are possible. With external application of the drug on the skin of the eyelids in the future, sometimes, the development of cataracts or glaucoma.
CONTRAINDICATIONS
- bacterial skin diseases;
- viral skin diseases (including chicken pox, shingles);
- fungal skin diseases;
- acute wetting and subacute exudative stages of skin diseases;
- Tuberculosis of the skin;
- cutaneous manifestations of syphilis;
- neoplasm of the skin;
- precancerous skin conditions;
- vulgar and rosacea;
- trophic ulcers of the legs, associated with varicose veins;
- I trimester of pregnancy;
- infants and young children;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
Contraindicated use of the drug in the I trimester of pregnancy.
The use of the drug during pregnancy is possible as an exception, in limited areas of the skin and only if the intended benefit to the mother exceeds the potential risk to the fetus.
The use of the drug during lactation (breastfeeding) is possible in exceptional cases, for a short time, in limited areas of the skin; the use of the drug on the skin of the mammary glands is contraindicated.
APPLICATION FOR FUNCTIONS OF THE LIVER
Multiple application to large areas of skin should be avoided in patients with severe renal insufficiency (possibly the systemic action of salicylic acid).
SPECIAL INSTRUCTIONS
Lorinden A is an adequate remedy for the treatment of lesions on dry and defatted skin areas characterized by severe infiltration, lichenization, desquamation and hyperkeratosis, and also homosexuality; easy to apply, well set with dry skin, increases the fat content in it and promotes moisture retention. The degree of moistening can be controlled by the thickness of the applied layer, in accordance with the therapeutic requirements specific to each individual case.
Contraindicated apply the product to the skin of the face. It is necessary to ensure that the drug does not get on the mucous membranes and conjunctiva.
Do not exceed the course of treatment. With prolonged use of the ointment in large areas of the skin, the incidence of side effects increases.
If there is an infection at the place of application of the ointment, it is necessary to apply funds with more pronounced antibacterial or antifungal action.
With caution should be used in people with atrophic skin changes, especially in elderly patients.
Multiple application to large areas of skin should be avoided in patients with severe renal insufficiency (perhaps the systemic action of salicylic acid).
Ointment does not contaminate clothes and bed linens.
Use in Pediatrics
In children, the drug is used only in case of unconditional need, a short course, on small body surfaces.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not limit psychophysical activity, ability to drive vehicles and service moving mechanisms.
OVERDOSE
Symptoms: extremely rarely when used in very large areas of the skin, systemic manifestations of SCS and / or symptoms of salicylate poisoning are possible.
DRUG INTERACTION
During treatment with the drug it is contraindicated to carry out vaccination and immunization in connection with the immunosuppressive effect of the drug.
Do not administer in combination with other drugs for external use.
With systemic absorption of the drug, GCS reduces the effect of insulin, oral hypoglycemic agents, antihypertensive drugs, anticoagulants, reduces the concentration of praziquantel in the blood serum.
The combination of Lorinden A with the following medicines increases the risk of side effects: androgens, estrogens, oral contraceptives, anabolic steroids (hirsutism, acne), antipsychotics, bucarban, azathioprine (cataracts), holinoblockers, antihistamines, tricyclic antidepressants, nitrates (glaucoma ), diuretics (hypokalemia), cardiac glycosides (digitalis intoxication).
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in places inaccessible to children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
