Instructions Triderm cream tube 30 g
Composition
active ingredients: betamethasone, clotrimazole, gentamycin;
1 g of cream contains: betamethasone (in the form of dipropionate) 0.5 mg, clotrimazole 10 mg and gentamicin (in the form of sulfate) 1 mg;
Excipients: mineral oil, white soft paraffin, cetostearyl alcohol, propylene glycol, polyethylene glycol cetostearyl ether, benzyl alcohol, sodium dihydrogen phosphate dihydrate, phosphoric acid, sodium hydroxide, purified water.
Dosage form
Cream.
Main physicochemical properties: soft consistency – homogeneous cream, white or almost white, free from foreign impurities.
Pharmacotherapeutic group
Corticosteroids for dermatology Corticosteroids in combination with antibiotics. Betamethasone and drugs. ATX code D07C C01.
Pharmacological properties
Pharmacodynamics.
Triderm combines three actions: the anti-inflammatory action of betamethasone dipropionate with the antibacterial activity of gentamicin sulfate and the antimycotic action of clotrimazole.
Betamethasone dipropionate is a potent (class III) corticosteroid with anti-inflammatory, antiallergic, and antipruritic effects.
Gentamicin is an aminoglycoside antibiotic with bactericidal action. It inhibits the synthesis of proteins sensitive to the antibiotic in microorganisms. Gentamicin is active against many aerobic gram-negative and few gram-positive bacteria. In vitro, gentamicin at a concentration of 1-8 μg/ml inhibits most sensitive strains of Escherichia coli, Haemophilus influenzae, Moraxella lacunata, Neisseria, indole-positive and indole-negative strains of Proteus, Pseudomonas (including most strains and Sermisycoc). strains of one In addition, in vitro sensitivity does not always correlate with in vivo sensitivity. Gentamicin is ineffective against most anaerobic bacteria, fungi and viruses. Gentamicin is only minimally effective against streptococci.
Resistance to gentamicin can develop in gram-negative and gram-positive bacteria.
Clotrimazole is a synthetic, antifungal agent of the group of imidazole derivatives. The spectrum of activity includes a number of fungi pathogenic to humans and animals. Clotrimazole provides effective action against dermatophytes, yeasts and molds. In vitro tests have demonstrated the effectiveness of clotrimazole against Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis and Candida (including Candida albicans). Based on current knowledge, the antifungal action of clotrimazole is due to inhibition of ergosterol synthesis. Ergosterol is an important component of the cell membrane of fungi.
Pharmacokinetics.
No penetration or absorption studies have been conducted for this medicinal product.
Betamethasone
Under normal conditions, only a portion of topically applied betamethasone is systemically available. The extent of penetration depends on the site of application, skin condition, dosage form used, patient age, and route of administration.
Gentamicin
Absorption can be considered when applying gentamicin to intact skin. However, increased transdermal absorption should be considered in cases of loss of the keratin layer, inflammation, and application under occlusive dressings on large skin surfaces.
Clotrimazole
After application, systemic absorption is low, with most clotrimazole remaining in the stratum corneum. The following concentrations were observed 6 hours after application of 1% radioactive clotrimazole to intact skin and with acute inflammation: stratum corneum = 100 μg/cm³, stratum reticulum = 0.5-1 μg/cm³, subcutaneous layer = 0.1 μg/
Indication
Treatment of dermatoses sensitive to corticosteroids in the presence (or suspicion) of bacterial and/or fungal infections caused by microorganisms sensitive to the components of the drug.
Contraindication
The drug is contraindicated in patients with hypersensitivity to the active substances or to any other component of the drug, other aminoglycoside antibiotics (cross-allergic reactions to gentamicin) or imidazole derivatives (cross-allergic reactions to clotrimazole). As well as in skin tuberculosis, skin manifestations of syphilis, skin reactions after vaccination, skin ulcers, acne, widespread plaque psoriasis, viral skin infections (e.g. herpes simplex, shingles), varicose veins, perioral dermatitis, acne rosacea, chickenpox, other bacterial and fungal skin infections without appropriate antibacterial and antifungal therapy.
Triderm® is not indicated for use under occlusive dressings.
Triderm should not be applied to mucous membranes, eyes, or the area around the eyes.
Do not use the cream to treat nail or scalp infections.
Interaction with other medicinal products and other types of interactions
When applying the ointment to the skin of the genitals and anus, the presence of soft paraffin or liquid paraffin (excipients in the composition of the drug) may reduce the tensile strength of latex condoms, thereby reducing their reliability during use.
Clotrimazole, when applied topically, may be an antagonist of amphotericin and other polyene antibiotics.
Application features
The cream is particularly suitable for use in the treatment of disorders in the exudative stage.
If skin irritation or hypersensitivity develops during treatment with Triderm cream, the drug should be discontinued and adequate therapy should be selected for the patient.
When applied topically, systemic absorption of active substances may be higher when the drug is applied to large areas of skin, especially with prolonged use or application to damaged skin areas. In this case, side effects observed after systemic use of active substances may occur.
With concomitant systemic administration of aminoglycoside antibiotics, the possibility of cumulative toxic effects (ototoxicity/nephrotoxicity) should be considered.
In particular, cross-allergic reactions with other aminoglycoside antibiotics should be considered.
Prolonged topical use of antibiotics may sometimes lead to the growth of resistant microflora. In this case, as well as in the event of the development of superinfection, the drug should be discontinued and appropriate treatment should be prescribed.
Corticosteroids with high potency on large areas of skin should be used with careful and periodic monitoring because they may cause suppression of the hypothalamic-pituitary-adrenal (HPA) axis. If suppression develops, the drug should be discontinued, the frequency of application reduced, or the patient transferred to a less potent corticosteroid. HPA function usually recovers when the drug is discontinued. In isolated cases, withdrawal symptoms may develop, requiring the addition of a systemic corticosteroid.
Avoid applying the drug to open wounds or damaged skin.
Continuous treatment for more than 2-3 weeks is not recommended.
Strong, potent, and moderate-potency corticosteroids should be used with caution on the face and genitals, and the course of treatment should not exceed 1 week.
In general, only low-dose corticosteroids should be used in the area around the eyes (glaucoma).
Corticosteroids may mask the symptoms of an allergic reaction to one of the components of the drug.
The patient should be instructed to use the drug only for individual treatment and not to share it with others.
Use during pregnancy or breastfeeding
Pregnancy.
Experimental studies have shown teratogenic effects of topical corticosteroids. There are no data on its use in pregnant women.
Aminoglycosides cross the placental barrier and may cause fetal harm when administered to pregnant women. There have been reports of complete irreversible bilateral congenital deafness in infants whose mothers received aminoglycosides (including gentamicin) during pregnancy. There are insufficient data on the use of topical gentamicin in pregnant women. There are insufficient data on the use of clotrimazole in pregnant women.
Animal studies have not shown a risk of exposure to the drug on the fetus.
Triderm should only be used when absolutely necessary.
Triderm should not be used in large doses, on large areas of skin, or for long periods of time.
Lactation.
It is not known whether topical gentamicin, clotrimazole, and corticosteroids pass into breast milk. However, systemic corticosteroids appear in breast milk.
Triderm should not be applied to the mammary glands of women who are breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The effect on the ability to drive vehicles or operate other automated systems has not been studied.
Method of administration and doses
Adults: Apply a thin layer of Triderm to the entire affected area and adjacent intact skin twice a day, morning and evening. The duration of treatment depends on the patient's clinical response to treatment, as well as clinical and microbiological parameters.
In the case of athlete's foot, a longer course of treatment (2-4 weeks) may be required.
Children.
It is not recommended for use in children, as there is no experience with the drug in patients of this age group.
Overdose
With prolonged or excessive use of topical corticosteroids, suppression of the pituitary-adrenal system is possible with the development of secondary adrenal insufficiency and the appearance of symptoms of hypercorticism, including Cushing's disease.
It cannot be ruled out that a single overdose of gentamicin leads to the appearance of overdose symptoms.
Excessive and prolonged topical use of gentamicin may lead to overgrowth of antibiotic-insensitive microorganisms.
Treatment. Appropriate symptomatic therapy is prescribed. Symptoms of acute hypercorticism are usually reversible. If necessary, correct the electrolyte balance. In case of chronic toxicity, the withdrawal of corticosteroids should be gradual.
In case of overgrowth of resistant microorganisms, it is recommended to discontinue treatment with Triderm and prescribe the necessary antifungal or antibacterial therapy.
Adverse reactions
Starting treatment
From the skin side
When applied to large areas of skin, under occlusive dressings and/or for a long time, local skin changes may occur. When applied to large areas of skin, systemic reactions (adrenal suppression, fainting, hypotension, shortness of breath, discomfort/pain, malaise) may occur.
It is important to remember the increased risk of developing secondary infections due to reduced local resistance to infection.
Localized skin changes may occur, such as skin atrophy (particularly of the face), telangiectasia, exudation, blistering, edema, urticaria, skin maceration, sweating, pigmentation disorders (hypopigmentation), hypochromia, striae, focal skin peeling, skin tingling, skin laxity, skin induration, skin cracking, sensation of warmth, follicular rash, erythema, stretch marks, subcutaneous hemorrhages, purpura, steroid-induced acne, rosacea/perioral dermatitis, hypertrichosis, and skin discoloration. It is not known whether these skin discolorations are reversible.
Uncommon: contact sensitization to gentamicin.
Possible photosensitization has been observed in some patients; however, this effect is not reproduced by repeated administration of gentamicin followed by exposure to ultraviolet radiation.
On the part of the endocrine system: inhibition of the synthesis of endogenous corticosteroids, excessive adrenal activity with edema.
On the metabolic side, the appearance of latent diabetes mellitus.
From the side of the hearing organs, inner ear/from the side of the kidneys: With concomitant systemic use of aminoglycoside antibiotics, cumulative ototoxicity/nephrotoxicity may occur when applying Triderm cream to large areas of skin or to affected skin.
Musculoskeletal disorders: osteoporosis, growth retardation (in children).
Cetostearyl alcohol, which is part of the medicinal product, may cause local limited skin reactions (e.g. contact dermatitis).
Expiration date
2 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25 °C.
Packaging
15 or 30 g in aluminum tubes. 1 tube in a cardboard box.
Vacation category
According to the recipe.
Producer
Schering-Plough Labo NV, Belgium.
Location of the manufacturer and its business address
Industriepark 30, Heist-op-den-Berg, Antwerp, B-2220, Belgium.
