Content
- Overdose
- Pregnancy and lactation
- Directions for use and doses
- Release form
- Compound
- Storage conditions
- Precautionary measures
- Description
- Indications for use
- Features of application
- Conditions for dispensing from pharmacies
- Best before date
- Side effect
- Interaction with other drugs
- pharmachologic effect
- Contraindications
Precautionary measures
The drug should not be used under an occlusive dressing, as well as for lesions of the mucous membranes of the mouth, nose, and eyes. If local irritation, fungal skin infection or allergic reactions develop during treatment, the drug should be discontinued. Do not use Kremgen if you are allergic to any of its ingredients. Consult your healthcare provider if you are pregnant or planning to become pregnant, if you are taking any other medications, including over-the-counter or herbal medications, if the skin at the site where the ointment is intended to be applied is broken or the blood supply to the area is reduced, immediately after vaccination, if you have measles, chickenpox smallpox, tuberculosis, shingles, if you are taking prednisolone or other corticosteroids.
Pharmacological properties of the drug Kremgen
A combined preparation for external use containing corticosteroids and an aminoglycoside antibiotic. Synthetic GCS of the third generation fluocinonide has a pronounced and long-lasting anti-inflammatory, antiallergic, antiexudative and antipruritic effect. It inhibits the release of cytokines (IL-1, -2, γ-interferon) from lymphocytes and macrophages, inhibits the release of inflammatory mediators by eosinophils and blocks the metabolism of arachidonic acid. Stimulation of steroid receptors leads to the formation of a special class of proteins - lipocortins, which have anti-edematous activity. Fluocinonide stabilizes lysosome membranes, inhibits lysosomal phospholipase A2, which leads to a decrease in the formation of inflammatory mediators (eicosanoids, cytokines), and prevents cellular disintegration during inflammation. The second generation aminoglycoside antibiotic gentamicin binds to the ribosomes of microorganisms, causes irreversible inhibition of protein synthesis, is fixed on the cytoplasmic membranes of bacteria, disrupts their permeability, and leads to the loss of potassium ions, amino acids, and nucleotides by cells. Gentamicin exhibits bactericidal activity against Streptococcus spp., Staphуlococcus aureus (including methicillin-resistant strains), Pseudomonas aeruginosa, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae, Shigella spp., Salmonella spp., Enterobacter spp., Acinetobacter spp. Pharmacokinetics. When applied topically, the components of the drug easily penetrate all layers of the skin, including inflamed, erosive and burned areas, providing a therapeutic effect. When applied topically, fluocinonide and gentamicin have virtually no systemic effects and do not suppress the function of the adrenal cortex.
Features of application
Use in persons under 18 years of age. Kremgen is prescribed to children aged 2 years and older. In children under 10 years of age, the drug should be used with extreme caution, assessing the ratio of the risk of complications to the benefits of use. When using Kremgen for a long time (more than 10 days) in children under 10 years of age, it is necessary to monitor body weight, height, the level of free cortisol in the blood and urine, and the results of the ACTH stimulation test.
Influence on the ability to drive a car and operate machinery. Does not affect.
Special instructions for the use of the drug Kremgen
The drug can be used in children starting from 2 years of age. During pregnancy and lactation, Kremgen should be used with caution if the expected benefit to the mother outweighs the potential risk to the fetus. It is not recommended to use the drug for primary purulent lesions of the skin and soft tissues, as well as the mucous membranes of the mouth, nose, and eyes. If local irritation, fungal skin infection or allergic reactions develop during treatment, the drug should be discontinued.
Side effect
In some cases, with long-term use of the drug, like all local glucocorticosteroids, a burning sensation, itching, irritation, dry skin, folliculitis, hypertrichosis, hirsutism, the appearance of stretch marks, acne, hypopigmentation, skin atrophy, perioral dermatitis, allergic contact dermatitis, fungal skin infections. The development of local and generalized manifestations of allergic reactions is possible.
If unwanted effects or other negative effects occur, consult your doctor regarding further use of the drug.
pharmachologic effect
A combined preparation for external use containing the glucocorticosteroid fluocinonide and the aminoglycoside antibiotic gentamicin. The effect of the drug is due to the synergistic effects of the components included in its composition.
Fluocinonide is a synthetic, highly effective third generation glucocorticosteroid. It has a pronounced and long-lasting anti-inflammatory, antiallergic, anti-edematous and antipruritic effect. Stabilizes lysosome membranes, inhibits lysosomal phospholipase Ag, which leads to a decrease in the formation of inflammatory mediators eicosanoids, cytokines (IL-1 and 2, γ-interferon, TNF-a, etc.), 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 an anti-edematous effect.
The second generation aminoglycoside antibiotic gentamicin has a pronounced bactericidal effect. The mechanism of its antimicrobial activity consists of binding to the 308 ribosomal subunit of microorganisms, which causes irreversible inhibition of protein synthesis. Gentamicin is fixed on the cytoplasmic membranes of bacteria, disrupts their permeability, and leads to the loss of potassium ions, amino acids, and nucleotides by 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.
When applied topically, the components of the drug easily penetrate all layers of the skin, including areas with inflammatory, erosive and burn processes, providing a therapeutic effect. Upon contact with the dermis, fluocinonide is de-esterified, releasing fluocinolone, which also exhibits potent glucocorticoid effects. Due to the de-esterification effect, when applied topically, fluocinonide practically does not enter the systemic circulation. The gentamicin molecule is characterized by strongly hydrophilic properties, therefore it does not penetrate biological membranes such as the skin, intestinal wall, and does not enter the systemic bloodstream when applied topically.
KREMGEN – 15 g
INSTRUCTIONS
for medical purposes
KREMGEN
(KREMGEN)
Stock:
dyuchi speeches:
fluocinonide, gentamicin;
1 g ointment with fluocinonide 0.5 mg; gentamicin sulfate 1 mg in case of overexposure to gentamicin;
additional speeches:
propylene glycol; polyethylene glycol 4000; stearyl alcohol; glycerin; citric acid, monohydrate; Dimethicone
Medicine form.
Ointment.
Main physical and chemical authorities:
white ointment with pearlescent or pearlescent-yellow finish.
Pharmacotherapeutic group.
Dermatological conditions. Corticosteroids in combination with antibiotics. ATX code D07C C05.
Pharmacological power.
Pharmacodynamics.
A combination drug for external congestion that combines the glucocorticosteroid fluocinonide and the aminoglycoside antibiotic gentamicin. The action of the drug is due to the synergistic effects of the components that are included in the warehouse.
Fluocinonide
– synthetic, highly effective third generation glucocorticosteroid. May be expressed as a trival protizapalny, protiallergic, protinabryakova and antiverbіzhny action. Stabilizes the membranes of lysosomes, inhibits lysosomal phospholipase A2, which leads to a change in the level of mediators of inflammation of eicosanoids, cytokines (IL-1 and 2, γ-interferon, TNF-α), blocking the cascade is completed does not contain arachidonic acid in prostaglandin, it prevents cellular disintegration during the ignition process . Stimulation of steroid receptors leads to the formation of a special class of proteins - lipocortins, which may have an anti-inflammatory effect.
Second generation aminoglycoside antibiotic gentamicin
repair the bactericidal action.
The mechanism of its antimicrobial activity is related to the 30S subunit of the ribosomes of microorganisms, which causes a negative suppression of protein synthesis. Gentamicin fixes on the cytoplasmic membranes of bacteria, disrupts their penetration, causing the cells to lose potassium ions, amino acids, and nucleotides. Gentamicin is bactericidal to 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.
When applied locally, the components of the drug easily penetrate into the entire skin, including in cases of inflammation, erosion and opiate processes, exhibiting a therapeutic effect. Upon contact with the dermis, fluocinonide is deactivated, releasing fluocinolone, which also produces a pronounced glucocorticoid effect. However, the effect of fluocinonide dedeirification during local stagnation is practically not lost from the systemic blood supply. The gentamicin molecule is characterized by highly hydrophilic properties, which does not penetrate biological membranes such as the skin, intestinal wall, and does not lose systemic blood flow during local congestion.
Clinical characteristics.
Showing.
Inflammatory and allergic skin congestion, including those complicated by secondary bacterial infection: eczema of various forms and localization, dermatitis (atopic, contact, allergic, seborrheic, radiation , intertriginous, exfoliative, soporific), psoriasis, senile itching, lichen versicolor, discoid lichen sheepdog, trophic infestations (around the infestations of the gomilka, which are associated with varicose veins), care and frostbite of the skin stage I, bites of comas and arthropods.
Contraindicated.
Infectious skin diseases (viral, bacterial, fungal), including skin manifestations of syphilis, skin tuberculosis, pyoderma, chickenpox, herpes, actinomycosis, blastomycosis h, sporotrichosis; erysipelas and primary acne; pelvic dermatitis, perioral dermatitis; anogenital itching; new skins, plump skins; nevus, atheroma, hemangioma, xanthoma; wounds on plots with applications; numerous psoriatic plaques, trophic lesions of the scalp, associated with varicose veins, varicose skin lesions; erosive-virazkovy urazheniya grass tract. Sensitivity to other ingredients or other components of the drug has been increased. Kremgen contraindications in ophthalmic practice. Do not use the drug after preventive treatment.
Interactions with other medicinal drugs and other types of interactions.
The drug may enhance the activity of immunosuppressive medications and suppress the activity of immunostimulant, antihypertensive, diuretic, antiarrhythmic medications, and potassium supplements.
The drug can be combined with other antimicrobial agents for local and systemic action. Intensive use of systemic corticosteroids increases the effectiveness of the drug, and also increases the likelihood of the development of systemic and local side effects.
Excessive use of non-steroidal anti-inflammatory drugs increases the risk of developing systemic and local side effects.
With one-hour stagnation with diuretic drugs (other than potassium-sparing drugs), the development of hypokalemia is likely to occur.
Do not interact with other drugs when slightly soaked in external stagnation.
During the hour of treatment with the drug, it is not recommended to work against splintering, as well as to carry out other types of immunization (especially in case of dry cured skin) through the possible availability of adequate immunological in Types of antibodies appear to produce similar antibodies.
Features of stastosuvannya.
Treatment must be carried out under the supervision of a physician. The drug should be administered in short courses (not longer than 10 days), on small areas of the skin. With prolonged drying of the skin in large areas, the incidence of side effects associated with iatrogenic hypercortisolism increases: swelling, arterial hypertension, hyperglycemia and decreased tolerance access to glucose. Before re-applying the drug to the skin, wipe off the excess of the old drug with a warm mild or antiseptic solution. During bathing time, it is recommended to wear heavy clothing. Do not put the drug under an occlusive bandage, as well as in case of inflammation of the mucous membranes, empty the mouth, nose, eyes. Be careful to place on thin-skinned body plots (facial, odorous and odorous plots), as there may be a higher level of soaking and a high risk of developing local side effects (telangiectasis ii, perioral dermatitis) after untreated stagnation. Do not put milk vines on the skin. The drug should not be applied to the eyelids or skin around the eyes of patients with cataracts, closed-cuta and sub-cuticular glaucoma through possible aggravation of symptoms of illness. There is no trace of the drug getting into the eyes. If a cystic infection, a fungal infection of the skin occurs during the treatment period, or a hypersensitivity reaction develops, the drug must be discontinued. If an infection develops that is resistant to gentamicin, a suitable antibacterial or antifungal treatment should be carried out in the place of the stagnated ointment.
With the current stagnation of the drug, it is possible: a decrease in the production of adrenocorticotropic hormone by the pituitary gland through suppression of the hypothalamic-pituitary-supraglosal system, a decrease in the level of cortisol in the blood and the development of iatrogenic syndrome I price-Cushing, which is known after administration of the drug.
If necessary, periodic monitoring of the cortisol function should be carried out to determine the level of cortisol in the blood after stimulation of ACTH.
Under special control, if the drug is used in patients with psoriasis, the local accumulation of glucocorticosteroids in patients with psoriasis can lead to an increased relapse, caused by the development of tolerance, to the risk of generalized pustulosis psoriasis and systemic toxicity caused by skin dysfunction.
Be careful to take medication if atrophy of the subcutaneous tissue is evident, especially for patients of the summer age.
During the hour of bathing, it is not recommended to use splinters against rash, or carry out other types of immunization.
Gentamicin, which is added to the drug, may cause overlapping allergic reactions with other aminoglycoside antibiotics. Systemic absorption of gentamicin in case of local congestion may be beneficial when treating large surfaces of the body, especially with long-term congestion or when there is evidence of skin damage. In such cases, there may be unwanted effects associated with systemic absorption of gentamicin. It is recommended to carefully enter during such situations, especially when cleaning children.
Repeated use of antibiotics and inodes can lead to the growth of resistant microflora, including fungi. For this type of disease, therapy should be prescribed and considered to be a type of treatment.
Suspension during pregnancy or breastfeeding.
The drug is contraindicated during pregnancy. During the period of treatment with the preparation, the breasts should be pinched.
This is due to the fluidity of the reaction during treatment with vehicles or other mechanisms.
The drug does not affect the speed of psychomotor reactions.
Method of congestion and dosage.
Apply the drug with a thin ball to the skin area 2-3 times per dose. The severity of the treatment course is determined by the doctor individually and depends on the nature of the illness.
Children.
The drug is prescribed to children over 2 years of age. Apply the drug with care, under the supervision of a physician, only once per dose, on a small area of the skin. Do not apply ointment to the child's skin. The use of this drug is only possible if the bark is exposed to a potential risk of developing adverse reactions. When taking the drug, children need to be aware of the possibility of a sign of suppression of the hypothalamic-pituitary-supraglosal system, which occurs more often in children, less in adult patients, is associated with greater absorption of the drug in children through a greater ratio of the skin area to the mass body. In children who took corticosteroids for local congestion, there was a suppressed function of the supraneural glands, Cushing's syndrome, growth inhibition, lack of body weight, and increased intracranial tension. Demonstrate the suppression of the function of the measles of the supra-neural glands: a low level of cortisol in the blood plasma and a lack of response to a test with stimulation of the supra-neural glands due to the stagnation of ACTH preparations. Displacement of the intracranial pressure is manifested by a swollen ventricle, headache, and double disc swelling of the visual nerve.
Overdose.
In case of severe or severe stagnation of local glucocorticosteroids, including fluocinonide, especially in children, there is no risk of developing systemic effects (secondary deficiency of the epithelium and the appearance of symptoms of hypercortisolism). Symptoms of hypercortisolism are caused by werewolves. Trivalent administration of gentamicin may lead to the growth of resistant fungal or bacterial microflora. Likuvannya is more symptomatic. With severe drying of the skin, symptoms of overdose may appear, which manifest themselves in addition to side effects.
Adverse reactions.
From the side of the skin and under the skin:
liver irritation, irritation, erythema, itching, dry skin, foliculitis, hypertrichosis, striae, acne-like rash, oral dermatitis, allergic contact dermatitis, urticaria, plaque-papular irritation, maceration of the skin at the site of application, loss of integrity of the skin, hyperkeratosis, furunculosis , fungal infections of the skin. In case of severe stagnation, possible skin atrophy, mural hirsutism, telangiectasia, purpura, disturbed pigmentation, hypertrichosis, alopecia, especially in women, possible development of secondary infections of the skin iri.
On the side of the grass tract:
when applied to large areas of the skin, especially with severely dried out, possible gastritis and steroidal infection of the scalp.
On the side of the endocrine system:
hyperglycemia. When applied to large areas of the skin, systemic manifestations may occur: insufficiency of supraneural glands, Cushing's syndrome, steroid-induced diabetes.
On the side of the immune system:
decreased support for the body. In case of severe congestion, it is possible: development of secondary immunodeficiency (exacerbation of chronic infectious diseases, generalization of the infectious process, development of opportunistic infections), increased reparative processes sіv, developments of local and generalized manifestations of allergic reactions.
On the side of the cardiovascular system:
arterial hypertension, possible development of swellings.
Term of attribution.
3 rocks. Do not freeze the drug after completing the terms of reference indicated on the package.
Save your mind.
Store at a temperature not exceeding 25 ° C. Store out of the reach of children.
Package.
15 g or 30 g in aluminum tubes with varnish coatings with membranes and screw-on lids, in a cardboard box.
Release category.
For the recipe.
Virobnik.
Joint Ukrainian-Spanish enterprise “Sperko Ukraine”.
The location of the distributor and the address of the place of promotion of activity.
21027, Ukraine, metro station Vinnytsia, st. 600-richya, 25.
Tel.: + 38(0432)52-30-36. Email
www.sperco.com.ua
Instructions Kremgen
