Tetraderm 15g cream for external use Vertex JSC
pharmachologic effect
Wound healing, antifungal, antibacterial, glucocorticoid, anti-inflammatory.
Composition and release form Tetraderm 15g cream for external use Vertex JSC
Cream - 100 g:
- Active ingredients: gentamicin sulfate - 1 mg (in terms of gentamicin), dexpanthenol - 50 mg, mometasone furoate - 0.5 mg, econazole nitrate - 10 mg;
- Excipients: liquid paraffin (vaseline oil, mineral oil) - 120 mg; cetostearyl alcohol - 70 mg; propylene glycol - 50 mg; macrogol 6 cetostearyl ether - 20 mg; macrogol 25 cetostearyl ether - 20 mg; sodium dihydrogen phosphate dihydrate (monobasic sodium phosphate) - 2 mg; purified water - up to 1 g.
Cream for external use. 15 or 30 g in an aluminum tube. Each tube is in a cardboard pack.
Description of the dosage form
A homogeneous cream of white or almost white color.
Pharmacodynamics
Combined preparation for external use.
It has anti-inflammatory, antipruritic, antiexudative, antibacterial, antifungal (fungicidal) and regenerating effects. The activity of the drug is due to the pharmacological properties of the components included in its composition.
Gentamicin. Broad-spectrum antibiotic from the aminoglycoside group. It acts bactericidal and provides highly effective external treatment of primary and secondary bacterial skin infections. Active against gram-negative microorganisms: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae; gram-positive microorganisms: Staphylococcus aureus (coagulase-positive, coagulase-negative and some strains producing penicillinase).
Dexpanthenol is a derivative of pantothenic acid. Pantothenic acid, a water-soluble B vitamin (vitamin B5), is a component of CoA. Stimulates skin regeneration, normalizes cellular metabolism, accelerates mitosis and increases the strength of collagen fibers. An increased need for pantothenic acid is observed when the skin or tissues are damaged, and its deficiency can be compensated for by the external use of dexpanthenol. Penetrates into all layers of the skin. Has a regenerating, weak anti-inflammatory effect.
Mometasone. Synthetic corticosteroids have local anti-inflammatory, antipruritic and anti-exudative effects. GCS induce the release of proteins that inhibit phospholipase A2 and are known collectively as lipocortins, which control the biosynthesis of inflammatory mediators such as PG and LT by inhibiting the release of their common precursor, arachidonic acid.
Econazole is a synthetic imidazole derivative. Has antifungal and antibacterial effects. Inhibits the biosynthesis of ergosterol, which regulates the permeability of the cell wall of microorganisms. Easily dissolves in lipids and penetrates well into tissues. Active against dermatophytes Trichophyton, Microsporum, Epidermophyton, yeast-like fungi of the genus Candida, Corynebacterium minutissimum, as well as Malassezia furfur (Pityrosporum orbiculare), which causes pityriasis versicolor, and some gram-positive bacteria (streptococci, staphylococci).
Pharmacokinetics
Gentamicin. When applied topically, it is absorbed in small quantities. Due to low absorption, it has virtually no systemic effects.
Dexpanthenol. When applied externally, it is absorbed and converted into pantothenic acid and binds to blood plasma proteins. Pantothenic acid is not metabolized in the body and is excreted unchanged by the kidneys.
Mometasone. Absorption of mometasone when applied topically is low. 8 hours after a single application to intact skin (without an occlusive dressing), about 0.4% of the dose is found in the systemic circulation. With inflammation and damage to the skin, absorption increases. Mometasone is extensively metabolized in the liver. It is excreted mainly by the kidneys and in small quantities with bile.
Econazole When applied externally, econazole penetrates all layers of the skin and the nail plate. Therapeutic concentrations are created in the stratum corneum and other layers of the epidermis, as well as in the dermis. When applied to the skin, systemic absorption is negligible. Less than 1% of the applied dose is excreted through the intestines and kidneys.
Indications for use Tetraderm 15g cream for external use Vertex AO
Treatment of dermatoses of inflammatory origin with concomitant bacterial and mycotic infection or a high probability of secondary infection (simple and allergic dermatitis, atopic dermatitis, including diffuse neurodermatitis), limited neurodermatitis, eczema, dermatomycosis (dermatophytosis, candidiasis, pityriasis versicolor), especially when localized in the groin area and large folds of skin.
Simple chronic lichen (limited neurodermatitis).
Contraindications
- Hypersensitivity to dexpanthenol, econazole, gentamicin, mometasone or any of the components included in the drug;
- skin post-vaccination reactions;
- lupus;
- skin manifestations of syphilis;
- chicken pox;
- herpes simplex;
- application in the area of open wounds;
- rosacea;
- perioral dermatitis;
- age under 18 years (efficacy and safety have not been established).
Application of Tetraderm 15g cream for external use Vertex AO during pregnancy and breastfeeding
There have been no controlled studies of the use of Tetraderm during pregnancy. Use during pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. During pregnancy, Tetraderm should not be used on large areas of skin or for a long period of time.
GCS are excreted in breast milk. In this regard, during lactation you should stop breastfeeding the child or use the drug Tetraderm by the mother.
Children under 18 years of age (efficacy and safety have not been established).
special instructions
Tetraderm is not intended for use in ophthalmology. Do not allow the drug to come into contact with the eyes or periorbital area.
Tetraderm cream is not recommended for use on the face and scalp. It is not recommended to use the drug under occlusive dressings, except when necessary.
Should not be used to treat varicose trophic ulcers of the leg and open wounds. Some areas of the body (inguinal folds, armpits and perianal area) are more at risk of developing stretch marks, so the duration of use of the drug in these areas of the body should be limited.
If irritation or signs of hypersensitivity are observed when using Tetraderm, treatment should be discontinued and the patient should be given another therapy.
Any side effects encountered with the use of systemic corticosteroids, including suppression of the function of the adrenal cortex, can also be observed with external use of corticosteroids. Systemic absorption of local corticosteroids may increase with long-term use, treatment of large body surfaces, or use of occlusive dressings. In such cases, it is possible to develop side effects characteristic of systemic corticosteroids.
It should be borne in mind that GCS can change the manifestations of some skin diseases, which can complicate the diagnosis. In addition, the use of GCS may cause a delay in wound healing.
With long-term therapy with GCS, sudden cessation of therapy can lead to the development of rebound syndrome, manifested in the form of dermatitis with intense redness of the skin and a burning sensation. Therefore, after a long course of treatment, Tetraderm should be discontinued gradually.
Systemic absorption of gentamicin when applied topically may be increased when applied to large areas of skin, especially during long-term treatment or in the presence of damaged skin. With long-term use of the drug Tetraderm on large surfaces of the skin with impaired integrity, there is a potential for absorption of gentamicin and, accordingly, the development of symptoms of ototoxicity and other undesirable effects characteristic of gentamicin when used systemically.
It is possible to develop cross-allergic reactions to antibiotics from the aminoglycoside group.
With prolonged external use of gentamicin, growth of insensitive microflora, including fungal ones, may be observed. In this case, as with the development of irritation, hypersensitivity reactions and superinfection, treatment must be stopped and appropriate therapy prescribed.
Impact on the ability to drive vehicles and machinery. There is no data on the negative impact of the drug Tetraderm on the ability to drive vehicles and machinery, as well as perform other activities that require concentration and speed of psychomotor reactions.
Overdose
Symptoms of gentamicin overdose: a single overdose of gentamicin is not accompanied by the appearance of any symptoms. Long-term use or use in doses exceeding the recommended ones can lead to a significant increase in insensitive microflora, incl. fungal, in the lesion.
Symptoms of dexpanthenol overdose: when applied externally, no symptoms are expected to appear.
Symptoms of mometasone overdose: with long-term use of local corticosteroids in high doses, suppression of adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercortisolism, including Itsenko-Cushing syndrome, is possible.
Symptoms of econazole overdose: When used externally, no symptoms are expected to appear.
Treatment: symptomatic. Acute symptoms of hypercortisolism are usually reversible. If necessary, correction of electrolyte imbalance is indicated.
If there is uncontrolled growth of insensitive microorganisms or the development of a fungal infection, treatment should be stopped and appropriate therapy should be selected.
Side effects of Tetraderm 15g cream for external use Vertex AO
Classification of the frequency of side effects according to WHO recommendations: very often -&ge1/10; often - from &ge1/100 to <1/10; uncommon - from >1/1000 to <1/100; rarely - from >1/10000 to <1/1000; very rarely - <1/10000, including isolated reports; frequency unknown - based on available data, it is not possible to determine the frequency of occurrence.
From the skin: rarely - skin irritation, dry skin, burning sensation of the skin, itching, acne, skin atrophy (thinning and loss of elasticity), hypertrichosis (excessive hair growth), hypopigmentation (lightening), perioral dermatitis (rash or irritation around mouth), allergic contact dermatitis, skin maceration (softening of the upper layers of the skin), stretch marks (stretch marks), miliaria (skin irritation that develops due to increased sweating), formation of papules and/or pustules (rash); frequency unknown - skin hyperemia (redness), urticaria (blistering).
From the nervous system: frequency unknown - paresthesia (tingling and numbness).
Other: rarely - folliculitis (inflammation of the hair follicle), secondary infection.
When using external forms of GCS for a long time and/or when used on large areas of skin, or using occlusive dressings, side effects characteristic of systemic GCS may occur, including adrenal insufficiency and Cushing's syndrome.
Drug interactions
Studies of the interaction of Tetraderm with other drugs have not been conducted, but it is not recommended to use it simultaneously with other drugs for external use.
Tetraderm cream external 15 g x1
Tetraderm cream external 15 g x1 Vertex, ATX code: D07XC03 (Mometasone in combination with other drugs)
Dosage form
TETRADERM®
cream for external use note: tubes 15 g or 30 grams. No.: LP-003766 dated 08/04/16 - Valid
Release form, composition and packaging
Cream for external use, white or almost white, homogeneous.
1 g
mometasone furoate 0.5 mg
gentamicin sulfate (in terms of gentamicin) 1 mg
econazole nitrate 10 mg
dexpanthenol 50 mg
Excipients: liquid paraffin (vaseline oil, mineral oil) - 120 mg, cetostearyl alcohol - 70 mg, propylene glycol - 50 mg, macrogol 6 cetostearyl ether - 20 mg, macrogol 25 cetostearyl ether - 20 mg, sodium dihydrogen phosphate dihydrate (monobasic sodium phosphate ) - 2 mg, purified water - up to 1 g.
Clinical-pharmacological group: Drug with anti-inflammatory, antibacterial, antifungal and regenerating effects for external use Pharmacotherapeutic group: Antibiotic-aminoglycoside + tissue reparation stimulator + glucocorticosteroid for topical use + antifungal agent The scientific information provided is general and cannot be used for adoption decisions on the possibility of using a particular drug.
pharmachologic effect
Combined preparation for external use. It has anti-inflammatory, antipruritic, antiexudative, antibacterial, antifungal and regenerating effects. The activity of the drug is due to the pharmacological properties of the components included in its composition.
Gentamicin is a broad-spectrum antibiotic from the group of aminoglycosides. It acts bactericidal and provides highly effective external treatment of primary and secondary bacterial skin infections. Active against gram-negative microorganisms: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae, gram-positive microorganisms: Staphylococcus aureus (coagulase-positive, coagulase-negative and some strains producing penicillinase).
Dexpanthenol is a derivative of pantothenic acid. Pantothenic acid - a water-soluble B vitamin (vitamin B5) - is an integral part of coenzyme A. Stimulates skin regeneration, normalizes cellular metabolism, accelerates mitosis and increases the strength of collagen fibers. Penetrates into all layers of the skin. Has a regenerating, weak anti-inflammatory effect.
Mometasone is a synthetic glucocorticoid that has local anti-inflammatory, antipruritic and antiexudative effects. GCS induce the release of lipocortins, which inhibit phospholipase A2 and control the biosynthesis of inflammatory mediators such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.
Econazole is a synthetic imidazole derivative. Has antifungal and antibacterial effects. Inhibits the biosynthesis of ergosterol, which regulates the permeability of the cell wall of microorganisms. Easily dissolves in lipids and penetrates well into tissues. Active against dermatophytes Trichophyton, Microsporum, Epidermophyton, yeast-like fungi of the genus Candida, Corynebacterium minutissimum, as well as Malassezia furfur (Pityrosporum orbiculare), which causes pityriasis versicolor, and some gram-positive bacteria (Streptococcus spp., Staphylococcus spp.).
Pharmacokinetics
Gentamicin
When used externally, it is absorbed in small quantities. Due to low absorption, it has virtually no systemic effects.
Dexpanthenol
When applied externally, it is absorbed and converted into pantothenic acid and binds to blood plasma proteins. Pantothenic acid is not metabolized in the body and is excreted unchanged by the kidneys.
Mometasone
Absorption of mometasone when applied topically is low. 8 hours after a single application to intact skin (without an occlusive dressing), about 0.4% of the dose is found in the systemic circulation. With inflammation and damage to the skin, absorption increases. Mometasone is extensively metabolized in the liver. It is excreted mainly by the kidneys and in small amounts with bile.
Econazole
When applied externally, econazole penetrates all layers of the skin and the nail plate. Therapeutic concentrations are created in the stratum corneum and other layers of the epidermis, as well as in the dermis. When applied to the skin, systemic absorption is negligible. Less than 1% of the applied dose is excreted through the intestines and kidneys.
Indications
Treatment of dermatoses of inflammatory origin with concomitant bacterial and mycotic infection or with a high probability of secondary infection (simple and allergic dermatitis, atopic dermatitis (including diffuse neurodermatitis), eczema, dermatomycosis (dermatophytosis, candidiasis, pityriasis versicolor), especially when localized in the groin area and large folds of skin, simple chronic lichen (limited neurodermatitis).
ICD-10 codes
Dosage regimen
The drug is used externally. The cream is applied to the affected areas of the skin in a thin layer, gently rubbing, 2 times a day.
The duration of treatment is individual, depends on the size, location of the lesion and the severity of the disease and is usually 1-2 weeks. For tinea pedis, the average duration of treatment is 2-4 weeks. It is not recommended to use the drug for more than 4 weeks.
Side effect
Classification of the frequency of side effects according to WHO recommendations: very often (≥1/10), often (from ≥1/100 to <.1/10), infrequently (from ≥1/1000 to <.1/100), rarely ( from ≥1/10,000 to <.1/1000), very rare (<.1/10,000, including isolated reports), frequency unknown (it is not possible to determine the frequency of occurrence based on available data).
From the skin: rarely - skin irritation, dry skin, burning sensation of the skin, itching, acne, skin atrophy, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, stretch marks, miliaria, formation of papules and/or pustules, folliculitis, frequency unknown - skin hyperemia.
From the nervous system: frequency unknown - paresthesia (tingling and numbness).
Other: rarely - secondary infection, frequency unknown - urticaria.
When using external forms of GCS for a long time and/or when used on large areas of skin, or using occlusive dressings, side effects characteristic of systemic GCS may occur, including adrenal insufficiency and Cushing's syndrome.
Contraindications for use
Skin post-vaccination reactions, skin tuberculosis, skin manifestations of syphilis, chickenpox, herpes simplex, use in open wounds, rosacea, perioral dermatitis, age under 18 years (efficacy and safety have not been established), hypersensitivity to dexpanthenol, econazole, gentamicin, mometasone or any of the components included in the drug.
With caution: pregnancy, use on large areas of skin, long-term use, violation of the integrity of the skin, when using occlusive dressings.
Use during pregnancy and breastfeeding
Use during pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. During pregnancy, the drug should not be used on large areas of skin or for a long period of time.
GCS are excreted in breast milk. In this regard, breastfeeding or use of the drug by a nursing mother should be stopped.
Use in children The use of the drug is contraindicated in people under 18 years of age (efficacy and safety have not been established).
special instructions
The drug is not intended for use in ophthalmology. Avoid contact of the drug with the eyes and periorbital area.
The drug is not recommended for use on the face and scalp.
The use of the drug with occlusive dressings is not recommended, except when necessary.
The drug should not be used to treat varicose trophic ulcers of the leg and open wounds.
Some areas of the body (inguinal folds, armpits and perianal area) are more at risk of developing stretch marks, so the duration of use of the drug in these areas of the body should be limited.
If irritation or signs of hypersensitivity are observed when using the drug, treatment should be stopped and another therapy should be selected.
It should be borne in mind that GCS can change the manifestations of some skin diseases, which can complicate the diagnosis. In addition, the use of GCS may cause a delay in wound healing.
With long-term therapy with GCS, sudden cessation of treatment can lead to the development of rebound syndrome, manifested in the form of dermatitis with intense redness of the skin and a burning sensation. Therefore, after a long course of treatment, the drug should be discontinued gradually.
Systemic absorption of gentamicin when applied topically may be increased when applied to large areas of skin, especially during long-term treatment or in the presence of skin lesions. With prolonged use of the drug on large surfaces of the skin with a violation of its integrity, there is a potential for absorption of gentamicin and, accordingly, the development of symptoms of ototoxicity and other undesirable effects characteristic of gentamicin when used systemically.
It is possible to develop cross-allergic reactions to aminoglycoside antibiotics.
With prolonged external use of gentamicin, growth of insensitive microflora, including fungal ones, may be observed. In this case, as with the development of irritation, hypersensitivity reactions and superinfection, treatment must be stopped and appropriate therapy prescribed.
Drug interactions
The drug is not recommended for use simultaneously with other drugs for external use.
Tetraderm®
Tetraderm® is not intended for use in ophthalmology. Do not allow the drug to come into contact with the eyes or periorbital area.
Tetraderm® cream is not recommended for use on the face and scalp. It is not recommended to use the drug under occlusive dressings, except when necessary.
Should not be used to treat varicose trophic ulcers of the leg and open wounds. Some areas of the body (inguinal folds, armpits and perianal area) are more at risk of developing stretch marks, so the duration of use of the drug in these areas of the body should be limited.
If irritation or signs of hypersensitivity are observed when using Tetraderm®, treatment should be discontinued and the patient should be given another therapy.
Any side effects encountered with the use of systemic corticosteroids, including suppression of the function of the adrenal cortex, can also be observed with external use of corticosteroids. Systemic absorption of local corticosteroids may increase with long-term use, treatment of large body surfaces, or use of occlusive dressings. In such cases, it is possible to develop side effects characteristic of systemic corticosteroids.
It should be borne in mind that GCS can change the manifestations of some skin diseases, which can complicate the diagnosis. In addition, the use of GCS may cause a delay in wound healing.
With long-term therapy with GCS, sudden cessation of therapy can lead to the development of rebound syndrome, manifested in the form of dermatitis with intense redness of the skin and a burning sensation. Therefore, after a long course of treatment, Tetraderm® should be discontinued gradually.
Systemic absorption of gentamicin when applied topically may be increased when applied to large areas of skin, especially during long-term treatment or in the presence of skin lesions. With long-term use of the drug Tetraderm® on large surfaces of the skin with impaired integrity, there is a potential for absorption of gentamicin and, accordingly, the development of symptoms of ototoxicity and other undesirable effects characteristic of gentamicin when used systemically.
It is possible to develop cross-allergic reactions to antibiotics from the aminoglycoside group.
With prolonged external use of gentamicin, growth of insensitive microflora, including fungal ones, may be observed. In this case, as with the development of irritation, hypersensitivity reactions and superinfection, treatment must be stopped and appropriate therapy prescribed.
