Ketodin suppositories
Producer: JV LLC Sperko Ukraina Ukraine
Code of automatic telephone exchange: G01AF11
Release form: Firm dosage forms. Suppositories vaginal.
General characteristics. Structure:
International and chemical names: Ketokonazol; tsis-1-atsetil-4-[4-[[2-(2,4 dichlorophenyl)-2-(1H-imidazole-1-илметил) - 1,3-Dioksolan-4-il] metoks] phenyl] piperazin;
main physical and chemical properties: suppositories from white till almost white color of a torpedopodobny form;
structure: 1 suppository contains 0,4 g of a ketokonazol; excipients: macrogoals, butylhydroxyanisole.
Pharmacological properties:
Pharmacodynamics. Ketokonazol is to synthetic derivatives of an imidazoldioksolan. Possesses expressed fungicidal and a fungistasis concerning dermatophytes (Trichophyton spp., Epidermophyton floccosum, Microsporum spp.), barmy mushrooms (Candida spp., Pityrosporum spp., Torulopsis spp, Cryptococcus spp., Rhodotorula spp.), dimorphous and highest mushrooms (zumitset). Are less sensitive to Aspergillus spp ketokonazol., Sporothrix schenckii, some Dermatiaceae, Mucor spp. and other fukomitseta, except for Entomophthrales. Ketokonazol is active also in relation to gram-positive cocci (Staphylococcus spp., Streptococcus spp.). The mechanism of its action consists in inhibition of biosynthesis of ergosterol and change of lipidic structure of a membrane of mushrooms, it leads to their lysis. Ketodin is active also against activators which rezistentna to antifungal antibiotics (nystatin, levorinum), and also to Clotrimazolum. Development of secondary resistance during treatment by Ketokonazol was not observed.
Pharmacokinetics. At intravaginalny use only some (<1%) Ketokonazol's number gets to a system blood stream. The maximum concentration in a blood plasma at women after intravaginalny use of 400 mg of Ketokonazol fluctuates within 0-10,7 ng/ml, it is considered trace concentration and does not lead to systemic action.
Indications to use:
Acute and chronic recurrent vulvovaginal candidiasis; prevention of developing of fungal infections of a vagina at prolonged use of antibacterial drugs, and also at primary and secondary immunodeficiency.
Route of administration and doses:
Appoint on 1 suppository a day before going to bed for 5 days in case of an acute candidosis vulvovaginitis. At recurrent vaginal candidiases treatment is begun in the first post-menstrual day, drug is used for 5-10 days a month for 3-6 months. For the prevention of a recurrence of a disease it is necessary to complete a full course of treatment even if symptoms of a disease decreased or disappeared. Ketodin is in case of need allowed to combine with system antifungal drugs.
Features of use:
Ketodin is recommended to apply for the night as are inherent to drug osmotic and drainage action that is followed by increase in allocations from a vagina.
Pregnancy and lactation. Though system absorption at intravaginalny use of a ketokonazol very low or is absent, adequate controlled clinical trials on safety of use of Ketodin for pregnant women are absent. Drug is used at pregnant women when the expected advantage for mother exceeds possible potential risk for a fruit. Breastfeeding is not a contraindication to drug use.
Use for persons up to 18 years. In the presence of indications drug is allowed for use for patients 12 years are more senior.
Influence on ability to drive the car and mechanisms. Drug does not show negative effect on ability to drive the car and mechanisms.
Side effects:
Side effects meet seldom and quickly disappear after drug withdrawal. Emergence of a burning sensation and an itch in a mucous membrane of a vagina is possible that does not demand drug withdrawal. At persons with hypersensitivity to components of drug development of allergic reactions is possible.
Interaction with other medicines:
Interaction with other medicines is not revealed.
Contraindications:
Hypersensitivity to a ketokonazol or other components of drug.
Overdose:
In case of local overdose the hyperemia, burning, an itch, irritation of a mucous membrane of a vagina can be observed. In this case syringing is recommended by water.
Storage conditions:
To store at a temperature not above +25 °C. To store in the place, unavailable to children. A period of validity - 2 years.
Issue conditions:
Without recipe
Packaging:
On 5 suppositories in a blister strip packaging and a cardboard pack.