Triderm ointment 15g №1

Name:
Triderm. Release form Ointment. Composition 1 g of ointment contains: active ingredients: betamethasone dipropionate is equivalent to betamethasone 0.5 mg, clotrimazole 10 mg and gentamicin sulfate is equivalent to gentamicin 1 mg; excipients: liquid paraffin, white vaseline.
Description:
Soft consistency, from white to light yellow, homogeneous ointment, without foreign inclusions. Pharmacotherapeutic group Corticosteroids for use in dermatology. Corticosteroids are highly active in combination with other agents. ATC code: D07XC01. Pharmacological properties Mechanism of action Triderm combines the following mechanisms of action: the anti-inflammatory action of betamethasone dipropionate, the antibacterial action of gentamicin and the antifungal action of clotrimazole. Pharmacodynamics Betamethasone in the form of dipropionate is a potent corticosteroid (class III) with anti-inflammatory, anti-allergic and antipruritic effects. Gentamicin is an aminoglycoside antibiotic with antibacterial action. Its action is based on the suppression of protein synthesis of sensitive microorganisms. Gentamicin acts on many aerobic gram-negative and some gram-positive bacteria. In vitro, gentamicin at concentrations of 1-8 μg / ml inhibits the growth of most susceptible strains of Escherichia coli (Escherichia coli), Haemophilus influenzae (Hemophilus influenzae), Moraxella lacunata (Morax-Axenfeld sticks), Neisseria (Neisseria), indole-positive and indole-negative Proteus, Pseudomonas (Pseudomonas), including most strains of Pseudomonas aeruginosa (Pseudomonas aeruginosa), Staphylococcus aureus (Staphylococcus aureus), Staphylococcus epidermidis (Staphylococcus aureus), and Serratia (serrations). Different species and different strains of the same species can show large differences in susceptibility under in vitro conditions. In addition, in vitro susceptibility does not always correlate with in vivo susceptibility. Gentamicin is not effective against most anaerobic bacteria, fungi and viruses. Gentamicin has only minimal effect on streptococci. Resistance to gentamicin can develop in both Gram-negative and Gram-positive bacteria. Clotrimazole is a synthetic antifungal agent derived from imidazole. The spectrum of action covers a number of fungi that are pathogenic to humans and animals. Clotrimazole is effective against dermatophytes, yeasts and molds. In in vitro assays, clotrimazole has proven effective against Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, and Candida species, including Candida albicans. In accordance with the knowledge available to date, the antifungal effect of clotrimazole is due to the suppression of the synthesis of ergosterol. Ergosterol is a vital component of the fungal cell membrane. Pharmacokinetics There are no data on the pharmacokinetics of Triderm. Betamethasone Under normal conditions, when applied topically, only a part of betamethasone enters the systemic circulation. The proportion of penetration and absorption depends on the area of the body, skin condition, dosage form, age and method of application. Gentamicin When gentamicin is applied to intact skin, absorption is unlikely to be expected. With damage to the keratin layer, inflammation, application under an occlusive dressing or application over a large area, enhanced transdermal absorption should be expected. Clotrimazole Most of the applied clotrimazole remains in the stratum corneum, and absorption into the systemic circulation is negligible. 6 hours after applying 1% radioactive clotrimazole to healthy skin, as well as to skin with acute inflammation, the following concentrations could be determined: stratum corneum – 100 μg / cm3, reticular layer – 0.5-1 μg / cm3, subcutaneous tissue – 0.1 µg/cm3. Indications for use Triderm is indicated for the treatment of corticosteroid-responsive dermatoses in which bacterial and/or fungal infection either already exists or should be feared. Contraindications Skin infections (viral, bacterial including tuberculosis, as well as fungal origin), reactions to vaccines, skin ulcers and acne are contraindications for the use of topical corticosteroids. In the presence of rosacea or perioral dermatitis, applying the ointment to the face should be discarded. Hypersensitivity to one of the active or excipients of the drug, to other aminoglycoside antibiotics (cross allergy with gentamicin) or imidazole derivatives (cross allergy with clotrimazole). Triderm is not intended for use under an occlusive dressing. Triderm should not be applied to mucous membranes, the skin around the eyes or near the eyes. Method of application and dosageAdolescents and adults 2 times a day (morning and evening) apply a thin layer on the affected areas of the skin and rub in easily, and it should cover both the entire affected area and the surrounding healthy skin surface. The duration of treatment depends on the results of both clinical examination and microbiological examination, as well as on the response to treatment. For athlete’s foot, longer treatment (2-4 weeks) may be considered. Children aged 2 to 12 Apply a small amount only to the affected areas of the skin and rub in gently. Apply no more than twice a day, taking a break between applications of the ointment, at least 6-12 hours. Apply the ointment to the face, neck, scalp, genital area, rectal area and areas with diaper rash should be under the supervision of a physician. The duration of treatment is limited to 5-7 days. See Precautions and Use in Pediatric Patients. Adverse reactions At the beginning of treatment Skin Rarely: irritation, burning, itching, dryness, hypersensitivity reactions to any of the ingredients of the drug and changes in skin color. When applied over large areas, under an occlusive dressing and / or with longer use When applied over large areas, under an occlusive dressing and / or with longer use, local skin changes are possible. When applying the ointment to large areas, there is a possibility of systemic effects (suppression of the function of the adrenal cortex). It should be borne in mind that due to reduced local resistance to infections, there is an increased risk of secondary infections. Skin Local skin changes such as atrophy (especially on the face), telangiectasias, striae, streak-like skin atrophy, skin hemorrhages, purpura, steroid acne, rosacea-like or perioral dermatitis, hypertrichosis, and changes in skin color. It is not known whether the skin color changes are reversible. Sometimes: contact hypersensitivity to gentamicin. In some patients probable photosensitivity was observed, which, however, did not reappear when repeated application of gentamicin followed by exposure to ultraviolet radiation. Endocrine system Suppression of the synthesis of endogenous corticosteroids, hypercortisolism with edema. Metabolism Diabetes mellitus (manifestation of a previously latent form). Ear, inner ear/kidney Cumulative ototoxicity/nephrotoxicity should be expected during treatment with ointment application over large areas or application on damaged skin with simultaneous systemic use of aminoglycoside antibiotics. Musculoskeletal system Osteoporosis, growth retardation (in children). Systemic adverse reactions, such as blurred vision, have also been reported with topical corticosteroids. In the event of the occurrence of the listed adverse reactions, as well as a reaction not indicated in the instructions for use, you should consult a doctor. OverdoseSymptoms: with prolonged or excessive use of local glucocorticosteroids, it is possible to suppress the pituitary-adrenal function with the development of secondary adrenal insufficiency and the appearance of symptoms of hypercortisolism, including Cushing’s syndrome. It is not expected that a single overdose of gentamicin will cause the development of any symptoms. The use of clotrimazole under an occlusive dressing for 6 hours did not lead to the development of overdose symptoms. Excessive or prolonged use of gentamicin may lead to overgrowth of antibiotic-insensitive microorganisms. Treatment: prescribe appropriate symptomatic therapy. The symptoms of acute hypercortisolism are usually reversible. If necessary, carry out a correction of the electrolyte balance. In case of chronic toxic effects, gradual withdrawal of corticosteroids is recommended. With excessive growth of resistant microorganisms, it is recommended to stop treatment with Triderm and prescribe the necessary therapy. Precautions If irritation or sensitization occurs due to the use of Triderm, treatment should be discontinued and appropriate therapy initiated. The absorption of active substances intended for topical use into the systemic circulation may be enhanced if Triderm is applied over a large area, in particular with long-term use or use on damaged skin. Under these conditions, undesirable effects may occur in the form in which they appear after the systemic use of active substances. When used in children in such cases, it is recommended to exercise extreme caution. In the case of simultaneous systemic use of aminoglycoside antibiotics, with increased percutaneous absorption, cumulative toxic effects (ototoxicity, nephrotoxicity) should be expected. The possibility of cross-allergy to other aminoglycoside antibiotics should be considered. With prolonged treatment with drugs containing antibiotics, insensitive microorganisms may appear. In this case, or if superinfection occurs, appropriate therapy should be initiated. High-dose, extensive application or use under an occlusive dressing of a potent or very potent corticosteroid should be carried out only under regular medical supervision, especially in view of the suppression of endogenous corticosteroid production and possible metabolic effects. Avoid use on open wounds and broken skin. The period of continuous use, if possible, should not exceed 2-3 weeks. Very strong, strong and moderate corticosteroids should be used on the face and in the genital area with extreme caution and for no longer than 1 week. Near the eyes, in principle, only low-acting corticosteroids are used (because of the risk of developing glaucoma). Corticosteroids may mask the symptoms of an allergic skin reaction to the drug’s ingredients. The patient should be instructed to use the drug only to treat their current skin condition and not to give the drug to others. With the use of systemic and local corticosteroids (including intranasal, inhalation and intraocular administration), visual disturbances may occur. If symptoms such as blurred vision or other visual disturbances occur, the patient should be evaluated by an ophthalmologist to evaluate possible causes of visual impairment, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy, which have been reported after corticosteroid use systemic and local action. Use in Pediatric Patients This medicinal product is not recommended for use in children under 2 years of age. Pediatric patients may be more sensitive than adult patients to the suppression of the hypothalamic-pituitary-adrenal axis and exogenous corticosteroid activity induced by topical corticosteroids, because absorption is more intense due to the greater ratio of skin surface area to body weight. Hypothalamic-pituitary-adrenal axis suppression, Cushing’s syndrome, linear growth retardation, weight gain retardation, and increased intracranial pressure have been reported with topical corticosteroids in children. Symptoms of adrenal suppression in children include, among others, low plasma cortisol levels and no response after adrenocorticotropic hormone (ACTH) stimulation. Symptoms of increased intracranial pressure include fontanel bulging, headaches, and bilateral papilledema, among others. Use during pregnancy or lactation Pregnancy In animal studies, topical corticosteroids have been shown to be teratogenic. There are no data on the use in pregnant women. Aminoglycosides cross the placental barrier and may harm the fetus if taken by pregnant women. There have been reports of complete irreversible bilateral congenital deafness in children whose mothers took aminoglycosides during pregnancy, including gentamicin. There are no sufficient data on the topical use of gentamicin in pregnant women. There are no sufficient data on the use of clotrimazole in pregnant women. The results of animal studies have not found any risks to the fetus. Triderm should only be used when absolutely necessary. Triderm should not be applied over a large area, in large quantities or for a long time. Breastfeeding There are no data on the excretion of gentamicin, clotrimazole and topical corticosteroids into breast milk, but corticosteroids that enter the systemic circulation also pass into breast milk. When applying Triderm to the mammary glands, breastfeeding is contraindicated. The ability to influence the reaction rate when driving vehicles or working with other mechanisms As a rule, the drug does not affect the reaction rate when driving vehicles or working with other mechanisms. Interaction with other drugs and other forms of interaction Due to the content of white soft paraffin and liquid paraffin, the tear strength and, therefore, the safety of using latex condoms may decrease, this should be taken into account when using the ointment in the genital or anal area. When applied topically, clotrimazole may antagonize amphotericin and other polyene antibiotics. Shelf life 3 years. It is not recommended to use the drug after the expiration date indicated on the package. Storage conditionsKeep out of the reach of children at a temperature not exceeding 25°C. Packing 15 g in aluminum tubes. One tube along with instructions for use in a cardboard box. Vacation categoryBy prescription. 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