Expiration date: 11/2025
Structure and Composition:
One tablet contains griseofulvin 125 mg
in blisters of 10 pieces. in a stack of cardboard packaging 2
Description pharmaceutical form:
Tablets are white with Valium a color, bitter taste, and odorless.
Pharmachologic effect:
Antifungal antibiotic effective against fungi of the genus Trichophyton, Microsporum, Epidermophyton. It is a violation of the structure of the mitotic spindle and the synthesis of the cell wall in chitin-containing fungi suppresses the division of fungal cells in metaphase and protein synthesis due to the breakdown in communication with the messenger RNA. It accumulates in the skin, hair and nails. As separating infected keratin is a replacement of his healthy tissue.
Pharmacokinetics:
Absorption - high. Cmax - 0.5-5 mg / l, after ingestion Tmax - 4.5 hours Connection to plasma proteins -. 80%. Selectively accumulates in the stratum corneum and its appendages, and in the liver, adipose tissue, skeletal muscle. A small number distributed in body fluids and tissues. It penetrates through the placenta. It is metabolized in the liver to inactive metabolites (6-glucuronide metilgrizeofulvina and derivative). T1 / 2 - 24 hours. Excreted by the kidneys (including 1% - unchanged) and through the intestine (36% - unchanged).
Indications:
Fungal infections of the skin, hair and nails: trihofitia, crusted ringworm, mikrosporiya scalp, smooth skin, beard and mustache ringworm, athlete's smooth skin, athlete's foot, jock itch, onychomycosis.
Contraindications:
Hypersensitivity, porphyria, systemic lupus erythematosus, lupus-like syndrome, systemic blood diseases, leukopenia, acute and subacute liver disease and kidney with a violation of their functions, liver failure, cancer, cerebral circulatory disorders, post-stroke, uterine bleeding, pregnancy, during breast feeding, child age (up to 2 years - efficacy and safety have not been studied).
Application of pregnancy and breastfeeding:
Contraindicated.
Side effect:
CNS: headache, dizziness, disorientation, unusual tiredness or weakness, insomnia, peripheral neuropathy, impaired coordination of movements, limb paresthesia, confusion.
On the part of the digestive tract: nausea, vomiting, diarrhea, gastralgia, oral candidiasis, hepatitis.
From the side of hematopoiesis: granulocytopenia, agranulocytosis, leukopenia.
Allergic reactions: urticaria, skin rash, pruritus, angioedema, photosensitivity, lupus-like syndrome, erythema multiforme, Lyell's syndrome.
Drug Interactions:
It enhances the effect of ethanol. Reduces activity estrogensoderjath oral contraceptives, anticoagulants of indirect action (due to hepatic microsomal enzyme induction). Barbiturates and primidone reduce the antifungal activity.
Dosage and administration:
Inside, during or after a meal with vegetable oil. When administered to children microsporia 21-22 mg calculated for 1 kg of patient body weight per day, to adults - from 500 to 1000 mg (8 tablets per day.). The drug is taken daily to assay the first negative mushrooms, then at the same dose every other day for two weeks and then two times a week for 2 weeks.
When trihofitii (superficial and infiltrative-suppurative forms) and favus children - a rate of 18 mg / kg of body weight in the same way as when microsporia.
When onychomycosis, Trichophyton and crusted ringworm of the scalp daily dose for adults weighing up to 50 kg is 625 mg (see Table 5). The maximum daily dose - 1 g (8 Table.). The daily dose for children and teenagers - 16 mg / kg body weight.
In onihomikozah drug during the first month administered daily, the second month - a day, then two times a week in the same daily dose until complete regrowth of nails. The total duration of treatment - not less than 8 months.
Precautionary measures:
Be wary of during the drivers of vehicles and people skills relate to the high concentration of attention.
Special instructions:
Treatment is carried out under the control of the morphological composition of the blood (1 every 10-15 days).
In the process of treatment in patients with fungal infections of the scalp must be weekly shave, and head wash with warm soapy water, 2 times a week. It is recommended to rub into the scalp antifungal ointments and lubricate the pockets of 2-3% tincture of iodine.
In onihomikozah recommended to combine the use of the drug with the removal of the affected nail plates using keratolytic and local antifungal therapy.
