Комфодерм М2
Комфодерм М2 Uses, Dosage, Side Effects, Food Interaction and all others data.
Carbamide peroxide, also known as urea-hydrogen peroxide, is a water-soluble, white crystalline solid compound consisting of hydrogen peroxide and urea. As it is a source of hydrogen peroxide, it can be found in disinfecting and dental bleaching products. Some adverse effects of carbamide peroxide as a dental bleaching agent include dentin sensitivity and/or gingival irritation led by unstable and reactive H+ free radicals and low pH from prolonged use. It may also alter enamel surface morphology via enamel mineral loss and surface roughening . The FDA considers carbamide peroxide to be safe in oral mucosal injury drug products as an oral wound healing agent, although there is insufficient data to establish general recognition of the effectiveness of this ingredient as an oral wound healing agent . It is available in OTC otic drugs as non-water, non-oil-based solutions used to soften, loosen and remove excessive ear wax, or cerumen.
Carbamide peroxide releases hydrogen peroxide and free radicals upon contact with water or outer surfaces of ear and tooth. Hydrogen peroxide exerts cerumenolytic, enamel-bleaching and antiseptic actions. In vitro, the chemical stability of ceramics against bleaching agents was observed after treatment with 15% carbamide peroxide for 56 h, 16% carbamide peroxide for 126 h, 10% or 15% carbamide peroxide and 38% hydrogen peroxide for 30 minutes or 45 minutes, respectively . According to in vitro studies, high (37%) or low (10 or 16%) concentrated carbamide peroxide agents were similarly effective as oral bleaching agents . Treatment with carbamide peroxide may lead to demineralization which involves decreased mineral content of enamel calcium, phosphate, and fluoride, and alteration of the chemical, structural, and mechanical properties . Carbamide peroxide may affect the organic components of the enamel and lead to increased susceptibility to erosion, fracture stability or decreased abrasion resistance of the treated area .
Trade Name | Комфодерм М2 |
Generic | Carbamide Peroxide + Methylprednisolone Aceponate |
Type | |
Therapeutic Class | |
Manufacturer | |
Available Country | Russia |
Last Updated: | September 19, 2023 at 7:00 am |
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Uses
Carbamide peroxide is a medication used to loosen ear wax, whiten teeth, and clean oral wounds.
Indicated as a dental bleaching agent.
Indicated as an oral wound healing agent in oral mucosal injuries.
Indicated as an aid in the removal of hardened ear wax.
Methylprednisolone aceponate is a corticosteroid indicated in the treatment of corticosteroid-responsive dermatoses.
Комфодерм М2 is also used to associated treatment for these conditions: Excess ear waxAllergic Contact Eczema, Atopic Dermatitis (AD), Dermatitis, Eczematous, Eczema, Contact, Eczema, Dyshidrotic, Neurodermatitis
How Комфодерм М2 works
Carbamide peroxide release hydrogen peroxide upon contact with teeth, which is a strong oxidizing and bleaching agent. It also release free radicals such as H+ or H3O+ . Hydrogen peroxide also acts as an antiseptic, especially in sites with relative anaerobiosis. Following otic administration, carbamide peroxide complex releases hydrogen peroxide that breaks up the hardened wax. The hydrogen peroxide component, which further breaks down into water, is also a cerumenolytic that hydrates the desquamated sheets of corneocytes, which are the major constituent of cerumen plugs . The glycerol and urea facilitates softening of the cerumen, either with or without syringing . Both hydrogen peroxide and urea mildly induce keratolysis with disintegration of the ear wax to help reduce the keratin-load in the ear debris and allow other active components to reach the skin under the debris .
Toxicity
Oral LD50 in rat is >2000 mg/kg .
Volume of Distribution
No established pharmacokinetic data.
Elimination Route
Upon treatment into the external auditory canal or the dental cavity, exposure to carbamide peroxide is limited to the intimate contact with the treated area without any systemic absorption.
Half Life
No established pharmacokinetic data.
Clearance
No established pharmacokinetic data.
Elimination Route
No established pharmacokinetic data.
Innovators Monograph
You find simplified version here Комфодерм М2