Project Description
Melanin
ointment 0.05% – Unguentum Melanini 0,05%
international nonproprietary name
Not established
Ref
BP-0079
Pharmacotherapeutic group
Dermotropic, sunburnagent.
Composition of the preparation
1 g of ointment contains 0.5mg of melanin, 50 mg of biene.
Pharmacological action
Pharmacodynamics Pharmacological action is sunburn, anti-inflammatory, dermatoprotective. Active substance of the drug is melanin polyphenol pigment derived by microbiological method. Melanin us of vast gamma of bioactivity, it is photoprotective, antimutagenic, immunomodulator, antiinflammation, marked antioxidant action. Photoprotecion of melanin is determined by absorption of electromagnetic radiation in UV spectrum (UV = 320—400 nm; UV = 280—320 nm and УUV = 200—280 nm). The drug protect from unfavorable UV radiation DNA, and effectively inhibits UV-induction peroxidation of lipids, screen activity protect skin form unfavorable UV action. Biene (complex of ethylene ether of polyunsaturated fatty acids) is anti-inflammatory, dermatoprotective, stimulates repair processes. Emulsion basis provides softening and hydration effect. Melanin ointment 0.05% is of complex therapeutic and preventive photoprotective effect. It decreases the severity of skin pathologic processes after UV radiation. It eliminates erythema, itch, burning, desquamation and infiltration in injury focus, regulates skin temperature and recovers initial skin parameters. Melanin ointment 0.05% is practically not toxic, doesn’t irritate the skin in repeated applications, is ready absorbed, removed from skin and doesn’t alter skin color. Pharmacokinetics Max.blood concentrationof melanin is revealed in 1 h. After application of melanin ointment 0.05%. melanin retains long on the skin and accumulated in it providing prolonged photoprotective effect. Lexx 5% of total melanin contained in the ointment penetrates to blood stream.
Indications
Melanin ointment 0.05% is administered as therapeutic and preventive photoprotective agent in patients with discouidlupus, photodermatitis, suneczema, prurigo, urticaria, lateskinporphyria, pellagra. The drug is effective in patients with vitiligo in sunburn on dehaired skin.
Special indication
Not established
Special warning
Not established
Dosage and method of administration
Melanin ointment 0.05% is applied with a thin layer on injured focus and slightly rubbed. Applicationisadministeredfor 28—32 days 4-5 timesaday. For prevention the drug is applied with a thin layer on visually unaffected skin under sun rages.
Overdosage
No cases of overdosing revealed.
Safety measures
Not established
Side effects
Usually side effects of melanin ointment 0.05% are not evidenced. In certain cases possible short itch and burning, moderate hyperemia. If side effects are revealed cancel the drug for 1-2 days, administer antihistamines and desensitizers. After disappearance of itch, burning in injured focus continue application of melanin ointment 0.05%. Safety use of the drug in pregnancy and lactation is not determined.
Contraindications
Individual intolerance, eczema in acute conditions with oozing lesion, syphilitic skin injury, skin tuberculosis, virus disease of skin, mycotic skin diseases.
Interactions with other medicinal preparations
Melanin ointment 0.05% doesn’t provoke negative reactions in combined therapy with ascorbic acid, aloe, FBS, vitamins B1, B6, unithiol, antihistamines (corticosteroids), nicotinic acid, methionine. The drug inhibits phototoxic effect of antibiotic of tetracyclines.
The form of release
Melanin ointment 0.05% in tubes of 15g, in jars 500 g.