Instructions Kremgen ointment tube 15 g
Composition
active ingredients: fluocinonide, gentamicin;
1 g of ointment contains fluocinonide 0.5 mg, gentamicin sulfate 1 mg in terms of gentamicin;
excipients: propylene glycol; polyethylene glycol 4000; stearyl alcohol; glycerin; citric acid, monohydrate; dimethicone.
Dosage form
Ointment.
Main physicochemical properties: white ointment with a pearly or pearly-yellowish tint.
Pharmacotherapeutic group
Dermatological agents. Corticosteroids in combination with antibiotics.
ATX code D07C C05.
Pharmacological properties
Pharmacodynamics
A combined preparation for external use containing the glucocorticosteroid fluocinonide and the aminoglycoside antibiotic gentamicin. The action of the medicinal product is due to the synergistic effects of the components that make up its composition.
Fluocinonide is a synthetic highly effective glucocorticosteroid of the III generation. It has a pronounced and long-lasting anti-inflammatory, anti-allergic, anti-edematous and antipruritic effect. Stabilizes lysosomal membranes, inhibits lysosomal phospholipase A2, which leads to a decrease in the formation of inflammatory mediators of eicosanoids, cytokines (IL-1 and 2, γ-interferon, TNF-α), blocks the cascade of conversion of arachidonic acid into prostaglandins, prevents cellular disintegration during the inflammatory process. Stimulation of steroid receptors leads to the formation of a special class of proteins - lipocortins, which have a pronounced anti-edematous effect.
Aminoglycoside antibiotic of the second generation, gentamicin, has a pronounced bactericidal effect. The mechanism of its antimicrobial activity is to bind to the 30S subunit of the ribosomes of microorganisms, which causes irreversible inhibition of protein synthesis. Gentamicin is fixed on the cytoplasmic membranes of bacteria, disrupts their permeability, leads to the loss of potassium ions, amino acids, nucleotides by the cells. Gentamicin is bactericidal against Streptococcus spp., Staphylococcus spp. (including MRSA), Pseudomonas spp., Escherichia coli, Proteus spp., Klebsiella spp., Shigella spp., Salmonella spp., Enterobacter spp., Acinetobacter spp. and other bacteria.
Pharmacokinetics
The components of the drug, when applied topically, easily penetrate all layers of the skin, including areas with inflammatory, erosive and burn processes, exhibiting a therapeutic effect. Upon contact with the dermis, fluocinonide is deesterified, releasing fluocinolone, which also has a pronounced glucocorticoid effect. Due to the effect of deesterification, fluocinonide, when applied topically, practically does not enter the systemic circulation. The gentamicin molecule is characterized by sharply hydrophilic properties, therefore it does not penetrate biological membranes, such as the skin, intestinal wall, and does not enter the systemic circulation when applied topically.
Indication
Inflammatory and allergic skin diseases, including those complicated by secondary bacterial infection: eczema of various forms and localizations, dermatitis (atopic, contact, allergic, seborrheic, radiation, intertriginous, exfoliative, solar), psoriasis, senile pruritus, lichen planus, discoid lupus erythematosus, trophic ulcers (except leg ulcers associated with varicose veins), burns and frostbite of the skin of the first degree, insect and arthropod bites.
Contraindication
Infectious skin diseases (viral, bacterial, fungal), including skin manifestations of syphilis, skin tuberculosis, pyoderma, chickenpox, herpes, actinomycosis, blastomycosis, sporotrichosis; acne rosacea and acne vulgaris; diaper dermatitis, perioral dermatitis; anogenital itching; skin neoplasms, skin tumors; nevus, atheroma, hemangioma, xanthoma; wounds in the application areas; numerous psoriatic plaques, trophic ulcers of the lower leg associated with varicose veins, ulcerative skin lesions; erosive-ulcerative lesions of the digestive tract; hypersensitivity to the active substances or to other components of the drug. Kremgen is contraindicated in ophthalmological practice. The drug should not be used after prophylactic vaccinations.
Interaction with other medicinal products and other types of interactions
The drug may enhance the effect of immunosuppressive drugs and inhibit the effect of immunostimulating, hypotensive, diuretic, antiarrhythmic drugs, and potassium preparations.
The drug can be used with other antimicrobial agents of local and systemic action. Concomitant use with systemic corticosteroids increases the effectiveness of the drug, but also increases the likelihood of developing systemic and local side effects.
Concomitant use with nonsteroidal anti-inflammatory drugs increases the risk of systemic and local side effects.
When used simultaneously with diuretics (except potassium-sparing ones), the likelihood of developing hypokalemia increases.
Minor absorption when applied externally does not lead to interactions with other drugs.
With prolonged use, the possibility of resorption of gentamicin and increased ototoxicity of other aminoglycoside antibiotics, polymyxin B, colistin, cephaloridine, ethacrynic acid, and furosemide cannot be ruled out.
Application features
Treatment should be carried out under the supervision of a physician. It is advisable to apply the drug in short courses (no longer than 10 days) on small areas of the skin. With long-term use on large areas of the skin, the frequency of side effects associated with iatrogenic hypercorticism increases: edema, arterial hypertension, hyperglycemia and decreased glucose tolerance. Before each repeated use of the drug, the remnants of the ointment after the previous application should be washed off with warm soapy water or an antiseptic solution. It is recommended to wear loose clothing during treatment. The drug should not be used under an occlusive dressing, as well as in cases of lesions of the mucous membranes of the mouth, nose, eyes. Use with caution on areas of the body with thin skin (face, groin and inguinal areas), since an increase in the degree of absorption and the development of local side effects (telangiectasias, perioral dermatitis) is possible even after short-term use. Do not apply to the skin of the mammary glands. Application of the drug to the eyelids or skin around the eyes should be avoided in patients with cataracts, angle-closure and open-angle glaucoma due to possible exacerbation of the symptoms of the disease. Avoid contact with the eyes. If local irritation, fungal skin lesions or hypersensitivity reactions occur during treatment, the drug should be discontinued. In the event of an infection resistant to gentamicin, appropriate antibacterial or antifungal treatment should be carried out at the site of application of the ointment.
When using the drug externally, the following are possible: a decrease in the production of adrenocorticotropic hormone by the pituitary gland due to suppression of the hypothalamic-pituitary-adrenal system, a decrease in the level of cortisol in the blood, and the development of iatrogenic Itsenko-Cushing syndrome, which disappears after discontinuation of the drug.
If long-term use is necessary, periodic monitoring of adrenal cortex function should be performed by determining cortisol levels in the blood and urine after stimulation with adrenocorticotropic hormone.
The drug should be used under special supervision in patients with psoriasis, since topical application of glucocorticosteroids to areas affected by psoriasis may lead to the spread of relapse caused by the development of tolerance, to generalized pustular psoriasis, and systemic toxicity caused by skin dysfunction.
The drug should be used with caution in the presence of subcutaneous tissue atrophy, especially in elderly patients.
During treatment, it is not recommended to get vaccinated against smallpox, as well as to undergo other types of immunization.
Gentamicin, which is part of the drug, may cause cross-allergic reactions with other aminoglycoside antibiotics. Systemic absorption of gentamicin when applied topically may be higher when treating large body surfaces, especially with long-term use or in the presence of skin lesions. In such cases, undesirable effects associated with systemic absorption of gentamicin may occur. Appropriate precautions are recommended in such cases, especially when treating infants and children.
Prolonged topical use of antibiotics may sometimes lead to the growth of resistant microflora, including fungi. In this case, therapy should be discontinued and appropriate treatment should be prescribed.
With prolonged use (more than 14 days) on large areas of skin, especially in patients with chronic renal failure, it is necessary to take into account the possibility of resorptive effects of gentamicin: ototoxicity (dizziness, nausea, tinnitus), nephrotoxicity (increased blood urea and creatinine levels, decreased diuresis), increased serum bilirubin and transaminase levels.
This medicine contains propylene glycol, which may cause skin irritation.
This medicinal product contains stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy. Breastfeeding should be discontinued during treatment with the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the speed of psychomotor reactions.
Method of administration and doses
The drug should be applied in a thin layer to the affected areas of the skin 2–3 times a day. The duration of the treatment course is determined by the doctor individually and depends on the nature of the disease.
The drug is prescribed to children over 2 years of age. The drug should be used with caution, under the supervision of a physician, only once a day, on a small area of skin. Do not apply the ointment to the child's face. The use of this drug is possible only if the expected benefit outweighs the potential risk of adverse reactions. When using the drug in children, it is necessary to take into account the possibility of signs of suppression of the hypothalamic-pituitary-adrenal system, which occur more often in children than in adult patients, which is associated with greater absorption of the drug in children due to a greater ratio of skin area to body weight. In children receiving corticosteroids for topical use, suppression of adrenal function, Itsenko-Cushing syndrome, growth retardation, insufficient weight gain, increased intracranial pressure were noted. Manifestations of suppression of adrenal cortex function: low plasma cortisol levels and lack of response to the adrenal stimulation test with ACTH drugs. Increased intracranial pressure is manifested by fontanelle protrusion, headache, and bilateral optic disc edema.
Overdose
With prolonged or excessive use of topical glucocorticosteroids, including fluocinonide, especially in children, the risk of developing systemic effects (secondary adrenal insufficiency and the appearance of symptoms of hypercorticism) cannot be excluded. Symptoms of hypercorticism are usually reversible. Prolonged topical use of gentamicin may lead to the growth of resistant fungal or bacterial microflora. In this case, it is recommended to discontinue use of the drug and conduct symptomatic treatment. With prolonged use on large areas of skin, symptoms of overdose may appear, manifested by increased side effects.
Adverse reactions
Skin and subcutaneous tissue: burning sensation, irritation, erythema, itching, dry skin, folliculitis, hypertrichosis, striae, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, urticaria, maculopapular eruptions, skin maceration at the application site, skin integrity disorders, hyperkeratosis, furunculosis, fungal skin infections. With prolonged use, skin atrophy, local hirsutism, telangiectasias, purpura, pigmentation disorders, hypertrichosis, alopecia, especially in women, may develop secondary skin infections.
On the part of the digestive tract: when applied to large areas of skin, especially with prolonged use, gastritis and steroid gastric ulcer are possible.
On the part of the endocrine system: hyperglycemia. When applied to large areas of the skin, systemic manifestations are possible: adrenal insufficiency, Itsenko-Cushing's syndrome, steroid diabetes mellitus.
On the part of the immune system: decreased body resistance. With prolonged use, the following are possible: development of secondary immunodeficiency (exacerbation of chronic infectious diseases, generalization of the infectious process, development of opportunistic infections), slowing down of reparative processes, development of local and generalized manifestations of allergic reactions.
From the cardiovascular system: arterial hypertension, possible development of edema.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
15 g or 30 g in a tube; 1 tube in a pack.
Vacation category
According to the recipe.
Producer
Joint Ukrainian-Spanish enterprise "Sperco Ukraine".
Location of the manufacturer and its business address
21027, Ukraine, Vinnytsia, 600-anniversary St., 25.
Phone: + 38(0432)52-30-36. E-mail: trade@sperco.com.ua
www.sperco.ua
