Lorinden® s

I N S T R U C T I O N for medical use of the medicinal product LORINDEN® C (LORINDEN® C)

Composition:

Active substances: flumethasoni pivalas, clioquinol:

1 g of ointment contains flumethasone pivalate – 0.2 mg, clioquinol – 30 mg;

Excipients: white wax, soft white paraffin.

Pharmaceutical form. Ointment.

Main physicochemical characteristics: greasy mass of white color with yellow or grey tint.

Pharmacotherapeutic group. Corticosteroids in combination with antiseptics for dermatological use. ATC code D07BB01.

Pharmacological properties.

Pharmacodynamics.

The properties of Lorinden® C ointment are due to the combined action of flumetasone pivalate and clioquinol.

Flumetasone pivalate is a synthetic glucocorticosteroid with moderate anti-inflammatory activity. When applied as an ointment, it exerts a local effect of medium intensity. It has lipophilic properties, easily penetrates into the stratum corneum of the skin and provides prolonged anti-inflammatory, antipruritic, and antiallergic effects. Upon topical application, flumetasone pivalate inhibits the formation of prostaglandins and leukotrienes in the skin by suppressing phospholipase A2 activity and reducing the release of arachidonic acid from cellular membrane phospholipids. It suppresses phagocytosis and the release of interleukins and other cytokines that cause inflammatory processes. It inhibits histamine release and the development of local allergic reactions, and reduces proliferative processes. Due to its local vasoconstrictive effect, it decreases exudative reactions. It reduces protein synthesis and collagen deposition.

Clioquinol exerts antibacterial activity against Gram-positive and Gram-negative bacteria, as well as weak antifungal activity.

Pharmacokinetics.

Flumetasone pivalate readily penetrates into the stratum corneum of the skin, where it accumulates. It is not metabolized in the skin. In small amounts, it may penetrate into the systemic circulation following topical application and, in such cases, may exert systemic effects. After penetration through the skin, the drug is primarily metabolized in the liver and excreted in the urine and, to a minor extent, in bile, mainly as glucuronide conjugates and in unchanged form. Absorption of flumetasone pivalate is increased when applied to thin skin areas such as skin folds or the face, or to skin with damaged epidermis or affected by inflammatory processes. The use of occlusive dressings, which increase skin temperature and moisture, also enhances the absorption of flumetasone pivalate. Furthermore, absorption increases with frequent application or application over large skin areas. Transdermal absorption is more intense in younger individuals compared to elderly patients.

Clioquinol exerts a local effect and is practically not absorbed into the bloodstream.

Clinical characteristics.

Indications.

For local treatment of non-exudative skin lesions complicated by bacterial infection and accompanied by pruritus and hyperkeratosis: seborrheic dermatitis, atopic dermatitis, allergic contact dermatitis, erythema multiforme, lupus erythematosus, psoriasis, lichen planus.

Contraindications.

Hypersensitivity to flumetasone pivalate, other corticosteroids, clioquinol, or to any other components of the ointment.

Viral (e.g., varicella, herpes simplex), fungal or bacterial (such as tuberculosis) skin infections, skin tumors, acne vulgaris and rosacea, perioral and diaper dermatitis, perianal pruritus, vulvar pruritus, inflammatory conditions or ulcers of varicose veins.

Do not apply over large areas of skin, especially when skin integrity is impaired, such as in burns.

Interaction with other medicinal products and other forms of interaction.

No interactions with other medicinal products have been reported with topical application of glucocorticosteroids.

Vaccination against smallpox and other forms of immunization are not recommended during treatment, particularly with prolonged use over large skin areas, due to the possibility of inadequate immune response.

Lorinden® C ointment may enhance the effect of immunosuppressive medicinal products and suppress the effect of immunostimulatory medicinal products.

Special precautions for use.

Do not use continuously for more than 2 weeks. With prolonged use over large areas of skin, the frequency of adverse effects increases. The medication should be discontinued immediately if it causes itching, dryness, or allergic skin reactions.

With topical application of flumetasone pivalate, there may be a reduction in pituitary adrenocorticotropic hormone (ACTH) secretion due to suppression of the hypothalamic-pituitary-adrenal axis, a decrease in blood cortisol levels, and the development of iatrogenic Cushing's syndrome, which resolves after discontinuation of treatment. If infection at the site of application worsens, additional use of antibacterial or antifungal medications is required. If signs of infection do not resolve, the use of the drug should be discontinued.

Avoid applying the medication to the eyelids or skin around the eyes in patients with narrow- or wide-angle glaucoma or cataracts, due to the potential for worsening of disease symptoms.

Visual disturbances may occur during systemic and topical use of corticosteroids.

If symptoms such as blurred vision or other visual disturbances occur, patients should consult an ophthalmologist to evaluate possible causes, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported with systemic and topical corticosteroid use.

Avoid contact of the drug with the eyes and mucous membranes.

Use on the facial skin, groin, and axillary areas only when absolutely necessary, as increased absorption and adverse effects (such as telangiectasia, perioral dermatitis) may occur even after short-term use.

Use of the ointment under occlusive dressing should be limited to exceptional circumstances due to the risk of epidermal atrophy, skin defects, and superinfection.

Exercise caution when using the medication in patients with subcutaneous tissue atrophy, particularly in elderly individuals.

During treatment of chronic conditions such as psoriasis or chronic eczema, the drug should not be abruptly discontinued. Use with caution in patients with psoriasis, as topical application of glucocorticosteroids may lead to disease relapses due to development of tolerance, generalized pustular psoriasis, or systemic toxicity resulting from skin barrier dysfunction.

Use during pregnancy and breastfeeding.

Animal studies have confirmed that glucocorticosteroids have teratogenic effects even at low doses when administered systemically. Teratogenic effects have also been demonstrated with topical application of glucocorticosteroids. Controlled studies on the potential teratogenic effects of topical flumetasone pivalate in pregnant women have not been conducted.

Lorinden® C ointment may be used in pregnant women only for short periods, on small skin areas, and only if, in the physician’s opinion, the benefit outweighs the potential risk. Use of the drug during the first trimester of pregnancy is contraindicated.

The extent of flumetasone pivalate excretion in breast milk following topical application is unknown. With oral administration of glucocorticosteroids, significant amounts affecting the newborn have not been detected in breast milk. Nevertheless, Lorinden® C ointment should be used with caution during breastfeeding. In selected cases, short-term use on small skin areas may be considered. Do not apply Lorinden® C ointment to the skin of the breasts.

Ability to influence reaction rate when driving or operating machinery.

The medication does not impair mental or motor functions or the ability to drive or operate machinery.

Method of Administration and Dosage.

The medication is intended for topical use. Apply the ointment as a thin layer to the affected skin area 1–2 times daily. Treatment should not exceed 2 weeks continuously. Do not use on facial skin for longer than 1 week. It is recommended not to use more than one tube per week.

In cases of marked lichenification or excessive hyperkeratosis, an occlusive dressing may be used, which should be changed every 24 hours.

Children.

Do not use the medication in children under 12 years of age. Use with caution in children aged 12 years and older. The ointment may be used in individual cases on small areas of skin. Do not apply the medication to the facial skin.

Children may absorb a proportionally larger amount of topical corticosteroid and are therefore more susceptible to systemic side effects due to their underdeveloped skin barrier and larger skin surface area relative to body mass compared to adults.

Overdose.

With prolonged use over large skin areas, symptoms of overdose may occur, manifested by an increase in adverse effects, including edema, burning sensation, irritation, itching, arterial hypertension, hyperglycemia, increased susceptibility to infections, and, in severe cases, development of Cushing's syndrome. The medication should be discontinued gradually and in a timely manner, or a weak-acting glucocorticosteroid should be used instead. Symptomatic therapy is recommended.

Adverse Reactions

Skin and subcutaneous tissue disorders: acne, post-steroidal purpura, epidermal growth suppression, subcutaneous tissue atrophy, dry skin, burning sensation, irritation, itching, excessive hair growth or alopecia, skin discoloration or hyperpigmentation, skin atrophy and impaired skin integrity, telangiectasia, perioral dermatitis, folliculitis, secondary infections. In isolated cases: urticaria, maculopapular rash, or exacerbation of existing symptoms may occur.

Eye disorders: when applied externally to the skin of the eyelids, cataract or glaucoma may occasionally develop.

Blurred vision is possible.

Other: systemic absorption of the active substance may lead to systemic adverse effects associated with flumetasone pivalate. These typically occur with prolonged use, application over large skin areas, use under occlusive dressing, or in children.

Systemic adverse effects of flumetasone pivalate typical of corticosteroids may occur, including hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, growth and developmental retardation in children, hyperglycemia, glucosuria, edema, arterial hypertension, increased susceptibility to infections, and reduced immunity. Neurotoxic effects may occur with local application of clioquinol, particularly with prolonged use or use under occlusive dressing.

Hypersensitivity reactions may occur in individuals with known hypersensitivity to any component of the medicinal product.

Shelf life.

3 years.

Storage conditions. Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 15 g in a tube; 1 tube per box.

Prescription status. Prescription only.

Manufacturer. Jelfa Pharmaceutical Plant A.T.

Manufacturer's address and place of business.

58-500 Jelenia Góra, ul. Wincentego Pola 21, Poland.