Pharmacodynamics and pharmacokinetics
Pharmacodynamics
The drug Momederm belongs to the group of synthetic corticosteroids. It has a pronounced anti-inflammatory, antiexudative, vasoconstrictor and antipruritic effect. It is assumed that the mechanism of action of GCS when applied topically is based on the release of proteins that inhibit phospholipase . Under their influence, the biosynthesis of potent inflammatory mediators ( leukotrienes and prostaglandins ) and the process of their release from arachidonic acid are inhibited, which leads to a decrease in inflammation and exudative reactions.
Pharmacokinetics
Momederm solution and ointment, when applied topically, have a weak absorption rate and low bioavailability. Absorption from the skin surface increases dramatically when using occlusive dressings and when applied to skin with an inflammatory process or damaged epidermis. Absorption increases when Momederm is applied to large areas of skin and with frequent use. Metabolism of mometasone furoate occurs in the liver. Excreted mainly by the kidneys. The half-life is about 6 hours.
Momederm instructions for use
Composition Active ingredient: 1 g of cream contains mometasone furoate 1 mg Excipients: hexylene glycol, propylene glycol monopalmitostearate, stearyl alcohol, ceteareth-20, aluminum octenyl succinate starch, titanium dioxide (E171), white wax, white soft paraffin, concentrated phosphoric acid, purified water . Dosage form Cream.
Basic physical and chemical properties: White or almost white, homogeneous mass with a specific odor.
Pharmacological group Corticosteroids for local use in dermatology.
ATX code D07A C13.
Pharmacological properties Pharmacological Mometasone furoate is a synthetic GCS for local use with anti-inflammatory, antipruritic and antiexudative effects.
Pharmacokinetics Pharmacokinetic studies have shown that systemic absorption following topical application of mometasone furoate 0.1% is minimal; approximately 0.4% of the dose is excreted from the body within 72 hours after application. It was almost impossible to determine the nature of the metabolites due to the small amounts present in blood plasma and excreta.
Indications: Inflammatory phenomena and itching in dermatoses amenable to corticosteroid therapy, including psoriasis (except widespread plaque psoriasis) and atopic dermatitis, in adults and children over 2 years of age.
Contraindications The drug is contraindicated in patients with hypersensitivity to mometasone furoate or to any of the components of the drug or to other corticosteroids. Momederm® is contraindicated for rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital itching, pigtail rashes, bacterial (for example, impetigo, pyodermitis), viral (for example, herpes simplex, herpes zoster and chickenpox, simple warts, genital warts , molluscum contagiosum), parasitic and fungal (eg candida or dermatophyte) infections, tuberculosis, syphilis or post-vaccination reactions. Momederm® should not be used on wounds or ulcerated skin.
Special precautions Special precautions are required when used in patients with psoriasis, where topical treatment with corticosteroids can be dangerous, especially due to the possibility of relapse of the disease due to the development of intolerance, as well as due to the risk of developing pustular psoriasis and general toxicity caused by disruption of the integrity skin. GCS can influence the development of other diseases and may complicate the determination of an accurate diagnosis. Contains stearyl alcohol, which may cause local skin reactions (eg contact dermatitis).
Interaction with other drugs and other types of interactions Not established.
Features of use In case of irritation or sensitization, it is necessary to stop using the drug and begin appropriate treatment. If a concomitant skin infection develops, an appropriate antifungal or antibacterial drug should be used. If positive dynamics cannot be achieved within a short time, the use of Momederm® cream should be discontinued until the infection is completely eliminated. Systemic absorption with local use of various corticosteroids can lead to reversible inhibition of the function of the hypothalamic-pituitary-adrenal axis with possible glucocorticosteroid insufficiency after cessation of treatment. Some patients may experience manifestations of Cushing's syndrome, hyperglycemia and glycosuria. Patients receiving a topical steroid over large areas of skin or using occlusive dressings should be periodically monitored for hypothalamic-pituitary-adrenal axis suppression. This can be done by performing an ACTH stimulation test, measuring morning plasma cortisol and media other than urine. Any side effects encountered with the use of systemic corticosteroids, including suppression of adrenal cortex function, can also be observed with local use of corticosteroids, especially in infants and children. Occlusions should not be used on children or on the face. Avoid contact of the cream with mucous membranes. If long-term treatment is suddenly stopped, symptoms may return in the form of dermatitis with intense redness, irritation and burning. This can be prevented by slow withdrawal of the drug by, for example, treatment intermittently, up to complete cessation of use of the cream. GCS can change the signs of some lesions and complicate the determination of the appropriate diagnosis, and will also delay recovery. Momederm® cream is not intended for ophthalmic use, including application to the eyelids. Do not allow the drug to come into contact with the eyes. The drug contains propylene glycol, which can cause skin irritation, as well as stearyl alcohol, which can cause local skin reactions (for example, contact dermatitis).
Use during pregnancy or breastfeeding During pregnancy and breastfeeding, the drug should be used only as prescribed by a doctor. However, even in this case, it is necessary to avoid using the cream on large areas of the skin or for a long period. There is no sufficient evidence of the safety of the drug for women during pregnancy. As with other topical corticosteroids, Momederm® should be prescribed to pregnant women only if the potential benefit to the mother outweighs the potential risk to the fetus. It is unknown whether topical application of corticosteroids can cause significant systemic absorption, resulting in amounts of the drug that may be found in breast milk. Momederm® should be used during breastfeeding only after a careful benefit-risk analysis. If treatment is prescribed in large doses or used for a long period, breastfeeding should be stopped.
The ability to influence reaction speed when driving vehicles or operating other mechanisms has not been established.
Directions for use and dosage Apply Momederm® Cream in a thin layer to the affected areas of the skin once a day. The duration of treatment is determined by the severity, course of the disease and is determined individually. The use of topical corticosteroids in children and on the face should be limited to the minimum amount compared to effective therapeutic regimens, and the duration of treatment should not exceed 5 days. Children. For children over 2 years of age, the drug is used only as prescribed by a doctor. Since in children the ratio of surface area to body weight is greater than in adults, children are at greater risk of suppressing the function of the hypothalamic-pituitary-adrenal axis and manifestations of Cushing's syndrome when using any topical corticosteroids, which increases when applied to an area of more than 20% of the surface bodies. It is recommended to use the smallest amount of corticosteroids necessary to obtain a therapeutic effect. The course of treatment should not exceed 5 days. Long-term treatment with GCS may delay the growth and development of the child. The safety of using Momederm® in children for more than 6 weeks has not been studied. There are only limited data on the treatment of children under 2 years of age. Mometasone should not be used to treat diaper dermatitis. The cream should be used as an occlusive dressing, unless directed by a doctor, and should also be applied to areas under diapers or underpants that do not allow moisture to pass through.
Overdose Excessive long-term use of topical corticosteroids can suppress the function of the hypothalamic-pituitary-adrenal axis and may manifest in secondary adrenal insufficiency, which is usually reversible. If this system is suppressed, the interval between applications should be increased or GCS with less activity should be used or the drug should be discontinued. The steroid content of each container is so small that in the unlikely event of accidental ingestion, there will be little or no toxic effect.
Adverse Reactions The following are the adverse reactions reported in connection with the use of Momedermu®, by organ system and frequency: very common (≥1/10); often (≥1/100, ≤1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, ≤1/1000); very rare (<1/10000); unknown (cannot be estimated from available data). Infections and infestations: very rarely - folliculitis; unknown - infections, boils. From the nervous system: very rarely - burning sensation; invisible-paresthesia From the skin and subcutaneous tissue: very rarely - itching, invisible-contact dermatitis, skin hypopigmentation, hypertrichosis, atrophic stripes of the skin, acne dermatitis, skin atrophy. General disorders and reactions at the application site: incredible pain at the application site. Propylene glycol and stearyl alcohol included in the drug may cause skin irritation and local skin reactions. Local adverse reactions that have been rarely reported with topical dermatological corticosteroids include: dryness and irritation of the skin, dermatitis, perioral dermatitis, skin maceration, striae, exacerbation of the disease, erythema, miliaria and telangiectasias, papular, pustular rashes and tingling sensation.
Shelf life: 2 years. After opening -4 weeks.
Storage conditions Store out of the reach of children at a temperature not exceeding 25°C. Do not freeze.
Packaging 15 g or 30 g of cream in a tube.
Vacation category: Prescription.
Manufacturer : Elfa A.T. Pharmaceutical Plant / Pharmaceutical Work Jelfa SA
Location 58-500 m. Jelenia Góra, st. Vincentego Pola, 21, Poland.
Side effects
Side effects appear in rare cases and mainly in the form of local reactions: burning, maceration of the skin, itching, prickly , folliculitis , paresthesia , hypertrichosis , acne , skin atrophy , hypopigmentation , allergic contact dermatitis , secondary infection. The risk of side effects increases when using occlusive dressings.
When using the solution and ointment for a long time or applied to large areas, especially with the use of occlusive dressings, side symptoms that are characteristic of systemic corticosteroids may appear, including Cushing's syndrome and adrenal insufficiency.
Momederm cream 15g No. 1
Name
Momederm cream for topical approx. 1 mg/g in tubes 15 g in pack No. 1
Description
White or almost white homogeneous mass with a characteristic odor of hexylene glycol.
Main active ingredient
Mometasone
Release form
Cream
Dosage
15 g
Pharmacological properties
Momederm® is a drug from a group of medicines called topical corticosteroids. It is classified as a potent corticosteroid. These medications are applied to the surface of the skin to reduce redness and itching caused by certain skin conditions.
Indications for use
Topical treatment of symptoms of inflammation and itching in skin diseases amenable to corticosteroid therapy, including psoriasis (except widespread psoriasis) and atopic dermatitis.
Directions for use and doses
For adults, Momederm cream is applied in a thin layer to the affected areas of the skin once a day. Do not use under an occlusive dressing. Continuous use of the drug should not exceed 2 weeks. Children In children, corticosteroids should be used in the lowest dose possible, taking into account the achieved therapeutic effect, and the duration of treatment should not exceed 5 days. Since there is insufficient data on the use of the drug in children under 2 years of age, the drug is not used in children in this age group.
Use during pregnancy and lactation
The safety of using topical glucocorticosteroids in pregnant and lactating women has not been proven. During pregnancy, a drug can be prescribed only if the benefit to the mother outweighs the potential risk to the fetus. However, the medicine should not be used on large areas of the body or for a long time. It should be borne in mind that the use of the drug may affect the development of the fetus, because when applied topically, mometasone furoate can cross the placental barrier. Animal studies have shown that topical corticosteroids may have a teratogenic effect. Corticosteroids may pass into breast milk. The decision to stop breastfeeding or discontinue the drug should be made taking into account the need for the drug for the mother.
Precautionary measures
If irritation or sensitivity occurs while using Momederm®, treatment should be discontinued and appropriate therapy should be initiated. Momederm®, like other topical medications containing corticosteroids, should not be applied to large surfaces of the skin, used under sealed bandages, used continuously for a long time, applied to the skin of the face and flexor surfaces of joints, skin folds. Mometasone is contraindicated in children under 2 years of age; children over 2 years of age should be prescribed mometasone with extreme caution. Children may be more likely to experience topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and the development of Cushing's syndrome than adult patients due to their greater skin surface area to body weight ratio. If it is necessary to use a diaper for a child, the drug should not be applied to the skin under the diaper, since an undesirable effect such as a sealed bandage may occur. In children, in particular, the lowest effective dose of a corticosteroid-containing drug that will relieve symptoms should be used. Long-term treatment with corticosteroids in children may affect their growth and development. There are no data regarding the safety of use of the drug in children for more than 6 weeks. There are insufficient data regarding treatment in children under 2 years of age. Abrupt cessation of treatment should be avoided. After abrupt cessation of treatment, a rebound phenomenon may develop, manifested by intense redness, a burning sensation and tingling (pain). This can be prevented by gradually reducing the dose of the drug and increasing the intervals between application of the drug. If infection occurs, treatment with an appropriate antifungal or antibacterial drug should be initiated. Dosage forms of Momederm® for topical use cannot be used in ophthalmology (on the eyes or periorbital areas). Avoid contact of the drug with eyes, open wounds and mucous membranes. If the drug gets into your eyes or mucous membranes, it is recommended to rinse them with sufficient water. As with the use of systemic glucocorticosteroids, after external use of the drug, cataracts and glaucoma or such a rare disease as central serous chorioretinopathy (CSC) may develop. Consult your doctor if blurred vision or other visual disturbances occur. Special precautions should be taken in patients with psoriasis, where topical treatment with corticosteroids may be hazardous, particularly due to the possibility of disease recurrence due to development of resistance, as well as the risk of generalized pustular psoriasis and general toxicity caused by disruption of the integrity of the skin. Corticosteroids may alter the appearance of some diseases, which may make it difficult to make a correct diagnosis. Contains stearyl alcohol, which may cause local skin reactions (for example, contact dermatitis). Should not be applied to atrophied skin. It is necessary to use the drug in the smallest amount for the shortest possible period necessary to achieve a therapeutic effect. Do not use on facial skin for more than 5 days. Monopalmitostearate, a component of propylene glycol, may irritate the skin.
Interaction with other drugs
Not installed.
Contraindications
Momederm should not be used in patients with hypersensitivity to mometasone furoate, other corticosteroids or any of the auxiliary components included in its composition. Momederm, like other topical medications containing corticosteroids, is contraindicated for acne vulgaris, rasacea, perioral dermatitis, bacterial (for example, impetigo, pyoderma), viral (for example, chickenpox, herpes simplex, shingles, warts vulgaris, genital condylomas, molluscum contagiosum) and fungal (for example, caused by yeast-like fungi and dermatophytes) skin infections and parasitic infestations. Momederm should not be used for reactions after vaccination, tuberculosis, syphilis, anal itching and itching in the external genital area, diaper dermatitis, and in children under 2 years of age.
Compound
1 gram of the drug contains: Active ingredient: Mometasone furoate 1.0 mg Excipients: hexylene glycol; propylene glycol monopalmitostearate; stearyl alcohol and cetyl stearyl ether-20; aluminum starch octenyl succinate; titanium dioxide – E171; white beeswax; white soft paraffin; phosphoric acid 10%; purified water.
Overdose
To date, no cases of overdose have been reported. Long-term topical treatment with corticosteroids can lead to suppression of the hypothalamic-pituitary-adrenal axis and, as a consequence, to adrenal insufficiency. In case of overdose, treatment should be symptomatic and supportive and should be continued for as long as possible. Chronic symptoms of corticosteroid overdose are usually irreversible. If necessary, electrolyte imbalances should be compensated. In case of chronic overdose, it is recommended to gradually withdraw corticosteroids.
Side effect
Like all medicines, Momederm® can cause side effects, although not everyone gets them. After using Momederm®, the following adverse reactions may occur: skin disorders: burning, tingling, itching, acne, thinning of the skin and subcutaneous fat, formation of stretch marks, depigmentation or change in skin color, excessive hair growth, inflammation of the hair follicle, rash, inflammation of the skin around the mouth, allergic contact dermatitis, skin maceration, prickly heat, secondary infections. Blurred vision – incidence unknown. After applying the drug to a large surface of the skin or using it for a long time, especially when using occlusive dressings, the drug enters the systemic circulation. All adverse reactions that are possible with the use of systemic corticosteroids, including suppression of adrenal function, can also occur after topical use of corticosteroids. This is especially true for children (see section “Peculiarities of application”). General weakness, edema, menstrual and cycle irregularities, increased blood pressure, and delayed growth and development in children may occur. Please tell your doctor or pharmacist if you experience any side effects or other side effects not listed in this leaflet.
Storage conditions
After the first opening of the pipe, use within 4 weeks. Store at a temperature not exceeding 25 °C, do not freeze. Keep out of the reach of children.
Analogs
Level 4 ATC code matches: Gistan-N
Sinalar
Avecourt
Mesoderm
Betazon
Silkaren
Elokom
Flucinar
Sinaflan
Celestoderm
Cutivate
Advantan
Betamethasone
Beloderm
Mometasone Furoate
Uniderm
Momat
The following have similar pharmacological effects: Advantan , Cutivate , Uniderm , Betamethasone , Mometasone , Flutsar , Elozon , Elokom , Mometox , Prednitop , Sterocort and others.
Price, where to buy
The price of Momederm ointment 15 g varies between 370-395 rubles; in a tube of 30 g 576-590 rubles per package. You can buy Momederm in most pharmacies in Moscow and Russian cities.
- Online pharmacies in UkraineUkraine
Pharmacy24
- Momederm 1 mg/g 15 g No. 1 cream
101 UAH. order - Momederm 15 g ointment Farmzavod Elfa A.T., Poland
101 UAH order
