Instructions Lorinden A ointment tube 15 g
Composition
active ingredients: flumethasone pivalas; salicylic acid;
1 g of ointment contains flumethasone pivalate – 0.2 mg, salicylic acid – 30.0 mg;
excipients: propylene glycol, lanolin, white soft paraffin.
Dosage form
Ointment.
Main physicochemical properties: white with a light yellow tint, oily soft mass.
Pharmacotherapeutic group
Corticosteroids in combination with an antiseptic for use in dermatology.
ATX code D07B B01.
Pharmacological properties
Pharmacodynamics
The properties of Lorinden® A ointment are due to the combined action of flumethasone pivalate and salicylic acid.
Flumethasone pivalate is a synthetic glucocorticosteroid with moderate anti-inflammatory activity. When used in the form of an ointment, it has a local effect of medium intensity. It has lipophilic properties, easily penetrates the stratum corneum of the skin and has a long-lasting anti-inflammatory, antipruritic and anti-allergic effect. When applied externally, flumethasone pivalate inhibits the formation of prostaglandins and leukotrienes in the skin due to inhibition of phospholipase A2 activity and a decrease in the release of arachidonic acid from phospholipids of cell membranes. It inhibits phagocytosis and the release of interleukins and other cytokines that cause inflammatory processes. It inhibits the release of histamine and the appearance of local allergic reactions, weakens proliferative processes. Due to the local vasoconstrictor effect, it reduces exudative reactions. It reduces protein synthesis and collagen deposition.
Salicylic acid in the concentration present in the preparation has a weak keratolytic effect.
Pharmacokinetics
Flumethasone pivalate easily penetrates the stratum corneum of the skin, where it accumulates. It is not metabolized in the skin. In small quantities, it can penetrate the body when applied externally and in this case have a systemic effect. After penetration through the skin, the drug is metabolized mainly in the liver, excreted in the urine and in small quantities with bile in the form of glucuronide conjugates and in an unchanged state. Absorption of flumethasone pivalate increases when applied to delicate skin in folds or on the face, on skin with damaged epidermis or affected by an inflammatory process. The use of an occlusive dressing, which causes an increase in skin temperature and humidity, also increases the absorption of flumethasone pivalate. In addition, absorption increases with frequent use of the drug or when applied to large areas of skin. Absorption through the skin in young people is more intense than in older patients.
Topical application of salicylic acid facilitates the penetration of flumethasone pivalate through the keratinized epidermis.
Indication
Skin inflammation (without exudation) uncomplicated by bacterial infection, including allergic in nature, accompanied by persistent itching and hyperkeratosis: seborrheic dermatitis, atopic dermatitis, nodular urticaria (papular urticaria), allergic contact dermatitis, erythema multiforme, tuberculous lupus, psoriasis, lichen planus.
Contraindication
Hypersensitivity to glucocorticosteroids, salicylic acid or other components of the ointment.
Viral (e.g., herpes skin lesions) and fungal skin diseases, skin tuberculosis, skin neoplasms, acne vulgaris and rosacea, perioral and diaper dermatitis, anal itching, inflammation or ulcers of varicose veins.
Do not use on large areas of skin, especially if the integrity of the skin is compromised, such as burns.
Interaction with other medicinal products and other types of interactions
No interactions with other drugs have been identified when glucocorticosteroids are used externally.
During treatment, it is not recommended to get vaccinated against smallpox, as well as to carry out other types of immunization, especially with prolonged use on large areas of skin, given the possibility of an insufficient immune response.
Only with prolonged use on large areas of skin in response to significant absorption of salicylic acid is there an enhanced effect of methotrexate and oral hypoglycemic drugs (sulfonylurea derivatives). Lorinden® A may enhance the effect of immunosuppressive drugs and inhibit the effect of immunostimulating drugs.
Application features
Do not use continuously for more than 2 weeks. With prolonged use on large areas of skin, the frequency of side effects increases.
During external use of flumethasone pivalate, the secretion of adrenocorticotropic hormone (ACTH) by the pituitary gland may decrease due to inhibition of the pituitary-adrenal connection, the level of cortisol in the blood may decrease, and iatrogenic Cushing's syndrome may appear, which resolves after discontinuation of treatment. During treatment, periodic monitoring of adrenal function is carried out by determining the level of cortisol in the blood and urine after stimulation of the adrenal glands with ACTH. In the event of an infectious process at the site of application of the ointment, antibacterial or antifungal treatment should be used. If the infectious process does not regress, the use of the ointment should be discontinued until the infection is eliminated.
Application of the drug to the eyelids or skin around the eyes should be avoided in patients with narrow-angle or wide-angle glaucoma, as well as in patients with cataracts, given the possibility of worsening of the symptoms of the disease.
Contact of the drug with eyes and mucous membranes should be avoided.
Use on the skin of the face, groin, and in the inguinal area only if absolutely necessary, as increased absorption and a high risk of side effects (telangiectasia, perioral dermatitis) are possible, even after short-term use.
The use of the ointment under an occlusive dressing should be limited to exceptional situations due to the possibility of atrophy and defects of the epidermis, and superinfection.
The drug should be used with caution in the presence of subcutaneous tissue atrophy, especially in the elderly.
When treating chronic conditions, such as psoriasis or chronic eczema, the medication should not be abruptly discontinued.
It should be used with caution in patients with psoriasis, as topical use of glucocorticosteroids in this case may lead to relapses of the disease due to the development of tolerance, the risk of spreading pustular psoriasis, and systemic toxicity due to skin dysfunction.
The product contains propylene glycol and lanolin, which may cause skin irritation and local skin reactions (e.g. contact dermatitis).
Use during pregnancy or breastfeeding
In animal studies, it has been confirmed that glucocorticosteroids have a teratogenic effect even when administered internally at low doses. Teratogenic effects have also been confirmed with cutaneous application of potent glucocorticosteroids. There have been no controlled studies of the possible teratogenic effect of topical application of flumethasone pivalate in pregnant women.
Lorinden® A ointment can be used by pregnant women only for a short time, on small areas of skin and only if, in the opinion of the doctor, the benefit outweighs the possible risk of use. The drug should not be used in the first trimester of pregnancy.
The extent of penetration of flumethasone pivalate into breast milk when applied externally is unknown. When oral glucocorticosteroids are used, significant amounts of these hormones that could affect the newborn's body have not been detected in breast milk. However, it is recommended to use Lorinden® A ointment with caution and under the supervision of a doctor to women who are breastfeeding. In some cases, the drug can be used for a short time on small areas of the skin. Do not apply Lorinden® A ointment to the skin of the mammary glands.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not limit mental and motor abilities, as well as the ability to drive vehicles or other mechanisms.
Method of administration and doses
The drug is intended for topical use. The ointment should be applied in a thin layer to the affected skin 1-2 times a day. It is allowed to use the drug under an occlusive dressing. Treatment should not be carried out continuously for more than 2 weeks. It is not allowed to use on the skin of the face for more than 1 week. It is recommended to use no more than 1 tube per week.
In case of increased lichenization or excessive hyperkeratosis, it is permissible to use an occlusive dressing, which should be changed every 24 hours.
Children
The drug should not be used in children under 12 years of age. Children over 12 years of age may use the ointment in individual cases on small areas of skin. The drug should not be applied to the skin of the face.
Overdose
With prolonged use on large areas of the skin, symptoms of overdose may appear, manifested by increased side effects (swelling, burning sensation, irritation, itching, hypertension, hyperglycemia, increased sensitivity to infections, dysfunction of the hypothalamic-pituitary-adrenal system, growth and development inhibition in children, and in severe cases, the development of Cushing's syndrome. The drug should be gradually discontinued in a timely manner or weak glucocorticosteroids should be used. Symptoms of salicylate poisoning may rarely appear: headache, dizziness, ringing in the ears, extremely rarely - impaired acid-base balance, decreased visual acuity. Symptomatic therapy.
Adverse reactions
Skin and subcutaneous tissue disorders: rash, skin peeling, acne, post-steroid purpura, epidermal growth inhibition, subcutaneous tissue atrophy, dry skin, burning sensation, irritation, itching sensation, excessive body hair growth or alopecia, skin discoloration or hyperpigmentation, skin atrophy and disruption of skin integrity, telangiectasia, contact and perioral dermatitis, inflammation of hair follicles, secondary infections. In isolated cases, urticaria, maculopapular rash or exacerbation of existing changes may occur.
On the part of the organs of vision: when applied externally to the skin of the eyelids, cataracts or glaucoma may sometimes develop.
Cardiovascular system: arterial hypertension.
On the part of the endocrine system: glycosuria, hyperglycemia, dysfunction of the hypothalamic-pituitary-adrenal system, Cushing's syndrome, growth and development inhibition in children.
Others: application of the ointment under an occlusive dressing, given the increased absorption, may cause systemic effects, manifested in the form of edema, arterial hypertension, and increased susceptibility to infections.
Hypersensitivity reactions are possible in individuals with individual intolerance to any component of the drug.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ºС.
Packaging
15 g in a tube; 1 tube in a box.
Vacation category
According to the recipe.
Producer
Farmzavod Yelfa A.T.
Location of the manufacturer and its business address
58- 500 m. Jelenia Góra, 21 W. Pola St., Poland.
