Instructions Triakutan ointment tube 15 g
Composition
active ingredients: 1 g of cream contains: betamethasone dipropionate* – 0.64 mg; gentamicin sulfate in terms of gentamicin** – 1.0 mg; clotrimazole*** – 10 mg;
excipients: methylparaben (methyl parahydroxybenzoate) (E 218) – 2.0 mg; propylene glycol; disodium edetate (Trilon B); mineral oil; white soft paraffin; cetostearyl alcohol; polyethylene glycol (macrogol) cetostearyl ether; sodium dihydrogen phosphate, monohydrate; sodium hydrogen phosphate, dodecahydrate; purified water.
* – betamethasone dipropionate, calculated as 100% substance;
** - gentamicin sulfate, expressed as gentamicin (expressed as anhydrous gentamicin);
*** - clotrimazole, calculated as 100% substance.
Dosage form
Cream.
Main physicochemical properties: white or almost white cream.
Pharmacotherapeutic group
Corticosteroids for use in dermatology. Corticosteroids in combination with antibiotics. Betamethasone and antibiotics.
ATX code D07C C01.
Pharmacological properties
Pharmacodynamics.
The drug combines the anti-inflammatory effect of betamethasone dipropionate, the antibacterial activity of gentamicin sulfate, and the antimycotic effect 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. The mechanism of action is to inhibit protein synthesis in microorganisms sensitive to the antibiotic. Gentamicin is active against many aerobic gram-negative and a few gram-positive bacteria. In vitro, gentamicin at a concentration of 1-8 μg/ml inhibits most susceptible strains of Escherichia coli, Haemophilus influenzae, Moraxella lacunata, Neisseria, indole-positive and indole-negative strains of Proteus, Pseudomonas (including most strains of Pseudomonas aeruginosa), Staphylococcus aureus, Staphylococcus epidermidis and Serratia. Different species and strains of the same species may show significant differences in in vitro susceptibility. In addition, in vitro susceptibility does not always correlate with in vivo susceptibility. 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 imidazole derivative group. The spectrum of sensitivity to clotrimazole includes a number of fungi that are pathogenic to humans and animals. Clotrimazole provides an effective effect against dermatophytes, yeasts and molds. In vitro studies have demonstrated the effectiveness of clotrimazole against Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis and Candida (including Candida albicans). It is known that the antifungal effect of clotrimazole is due to inhibition of ergosterol synthesis. Ergosterol is an important component of the cell membrane of fungi.
Pharmacokinetics.
Pharmacokinetic studies of the drug have not been conducted.
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, patient age, and route of administration.
Gentamicin. Gentamicin is not absorbed after topical application to intact skin, but after application to damaged or inflamed skin and when occlusive dressings are used on small areas of skin, gentamicin may be absorbed systemically.
Clotrimazole: Systemic absorption is low after application to the skin, with most clotrimazole remaining in the stratum corneum. The following concentrations were observed 6 hours after application of 1% radioactive clotrimazole to intact and acutely inflamed skin: stratum corneum = 100 μg/cm³, stratum reticulum = 0.5–1 μg/cm³, subcutaneous layer = 0.1 μg/cm³.
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, to other aminoglycoside antibiotics (cross-allergic reactions to gentamicin) or imidazole derivatives (cross-allergic reactions to clotrimazole). The drug is also contraindicated 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.
Triacutan® is not indicated for use under occlusive dressings. The drug 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 cream to the skin of the genitals and anus, the presence of soft paraffin (an excipient 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 the treatment of disorders in the exudative stage. The drug is not intended for use in ophthalmology.
In case of skin irritation or hypersensitivity, treatment with the cream should be discontinued and adequate therapy should be selected for the patient.
With topical application, systemic absorption of active substances may be higher when the drug is applied to large areas of skin, especially with prolonged use or when applied to damaged skin areas. In this case, the following adverse reactions may occur that are observed after systemic application of active substances.
With concomitant systemic administration of aminoglycoside antibiotics, in case of increased absorption, the possibility of cumulative toxic effects (ototoxicity/nephrotoxicity) should be taken into account.
In particular, cross-allergic reactions with other aminoglycoside antibiotics should be borne in mind.
Long-term topical use of antibiotics can sometimes lead to the growth of resistant microflora. In this case, as well as in the event of the development of superinfection, appropriate treatment should be prescribed.
The drug should be used in high doses, on large areas of the body, or with corticosteroids of strong or very strong action only under regular medical supervision, especially with regard to suppression of the hypothalamic-pituitary-adrenal (HPA) axis and possible metabolic effects. In the event of suppression of the HPA axis, the drug should be discontinued or the frequency of application should be reduced, or the patient should be transferred to a corticosteroid preparation of weaker action. HPA function is usually restored after discontinuation of the drug. In isolated cases, withdrawal symptoms may develop, requiring the addition of a systemic corticosteroid.
Avoid applying the medicine to open wounds or damaged skin.
Continuous treatment for more than 2–3 weeks is not recommended.
Very potent, potent, and moderate-potency corticosteroids should be used with caution on the face and genitals, and the duration of treatment should not exceed 1 week.
In general, only low-dose corticosteroids should be used around the eyes (due to the risk of 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 personal treatment of the existing skin condition and not to share it with others.
Visual disturbances may occur with systemic and topical corticosteroids (including intranasal, inhaled, and intraocular administration). 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 disturbances, which may include cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy, which have been reported following the use of systemic and topical corticosteroids.
Children.
Pediatric patients may be more susceptible to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) suppression and Cushing's syndrome than adult patients because of a larger skin surface area to body mass ratio.
In children receiving topical corticosteroids, suppression of the function of the GHNS, Cushing's syndrome, growth retardation, insufficient weight gain, and increased intracranial pressure were observed.
Manifestations of adrenal suppression: low plasma cortisol levels and no response to the adrenal stimulation test with adrenocorticotropic hormone (ACTH) drugs. Increased intracranial pressure is manifested by fontanelle protrusion, headache, and bilateral optic disc edema.
Propylene glycol, which is part of the medicine, may cause skin irritation.
Methylparaben, which is contained in the cream, may cause allergic reactions (possibly delayed).
Cetostearyl alcohol, which is part of the medicinal product, may cause local skin reactions (e.g. contact dermatitis).
Use during pregnancy or breastfeeding
Pregnancy
Experimental studies have shown teratogenic effects of topical corticosteroids. There are no data on their use in pregnant women.
Animal studies have not demonstrated a risk of exposure to the drug on the fetus.
Triacutan® should be used during pregnancy only if clearly needed. Triacutan® 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 are excreted in human milk. However, systemic corticosteroids are found in human milk, so breastfeeding should be discontinued during treatment.
Triacutan® should not be applied to the mammary glands during breastfeeding.
The drug should not be used in the first trimester of pregnancy. The drug can be prescribed only in case of absolute necessity at a later stage, if the expected benefit to the mother outweighs the potential risk to the fetus.
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 should apply a thin layer of the drug to the entire affected surface and adjacent intact skin 2 times a day, morning and evening. The duration of treatment depends on the patient's clinical response to treatment, as well as clinical and microbiological indicators.
In the case of athlete's foot, a longer course of treatment (2–4 weeks) may be necessary.
Children
It is not recommended for use in children, as there is no experience with the drug in patients of this age category.
Overdose
With prolonged or excessive use of local glucocorticosteroids, 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 should not be excluded 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 microorganisms insensitive to the antibiotic.
Treatment. Administer appropriate symptomatic therapy. Symptoms of acute hypercorticism are usually reversible. If necessary, electrolyte balance should be corrected. In case of chronic toxicity, withdrawal of corticosteroids should be gradual.
In case of overgrowth of resistant microorganisms, it is recommended to discontinue treatment with the drug and prescribe the necessary antifungal or antibacterial therapy.
Adverse reactions
Starting treatment
From the skin side
Rare: skin irritation, burning sensation, itching, dry skin, hypersensitivity reactions to one of the components of the medicinal product and skin discoloration.
When applied to large areas of skin and/or for a long time, local skin changes may occur. When applied to large areas of skin, systemic reactions may occur (adrenal suppression, fainting, hypotension, shortness of breath, discomfort/pain, malaise).
It is important to remember the increased risk of developing secondary infections due to reduced local resistance to infection.
From the skin side
Localized skin changes such as skin atrophy (especially facial), telangiectasia, exudation, blistering, edema, urticaria, skin maceration, sweating, pigmentation disorders (hypopigmentation), hypochromia, striae, focal skin peeling, skin tingling, skin flaking, skin induration, skin cracking, feeling of warmth, follicular rash, erythema, stretch marks, subcutaneous hemorrhages, purpura, steroid acneiform eruptions, rosacea-like/perioral dermatitis, hypertrichosis and skin discoloration. It is not known whether these skin discolorations are reversible.
Uncommon: contact sensitization to gentamicin.
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. Any side effects observed with systemic use of glucocorticoids, including suppression of the adrenal cortex, may also occur with their local use.
Metabolic
The appearance of latent diabetes mellitus.
From the organs of vision
Blurred vision.
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 Triacutan® cream is applied to large areas of the body or to areas of affected skin.
From the musculoskeletal system
Osteoporosis, growth retardation (in children).
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of reach of children.
Packaging
15 g in a tube; 1 tube in a pack.
Vacation category
According to the recipe.
Producer
Location of the manufacturer and its business address
Ukraine, 01032, Kyiv, Saksaganskoho St., 139.
