Instructions for Candiklin for urinary tract infections 300 mg No. 1
Composition
active ingredient: sertaconazole;
1 pessary contains sertaconazole nitrate 300 mg;
excipients: colloidal anhydrous silicon dioxide, solid fat.
Dosage form
Pessaries.
Main physicochemical properties: oval pessaries of white or almost white color.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives. ATX code G01 AF.
Pharmacological properties
Pharmacodynamics
Sertaconazole is an antifungal drug, an imidazole derivative, with high fungicidal activity and intended for topical use in gynecology. The mechanism of action is to inhibit the synthesis of ergosterol and increase the permeability of the cell membrane, which leads to the destruction of pathogens. It is effective against pathogenic yeast fungi (Candida albicans, Candida spp. and Malassezia furfur), dermatophytes (Trichophyton, Epidermophyton and Microsporium spp.) and pathogens that cause infectious diseases of the skin and mucous membranes, including gram-positive strains (Staphylococcus, Streptococcus).
Pharmacokinetics
There is no systemic absorption. With vaginal application, the concentration of the active substance in the blood plasma did not reach the detection limit. After vaginal application of radiolabeled sertaconazole, no radioactivity was detected in the plasma.
Indication
Topical treatment of vaginal candidiasis.
Contraindication
Known hypersensitivity to antifungal agents, imidazole derivatives, or to any of the excipients of the medicinal product.
Simultaneous use of the drug with latex condoms or a pessary (diaphragm).
Interaction with other medicinal products and other types of interactions
When pessaries are used simultaneously with local contraceptives, their spermicidal effect may be reduced.
Concomitant use with latex condoms or pessaries is contraindicated due to the risk of damage to them.
Application features
If the diagnosis of candidiasis is confirmed, factors (hygienic or lifestyle) that contribute to the development and manifestations of the fungal infection should be identified and eliminated.
During treatment, to avoid relapses, it is not recommended to use soap with an acidic pH and douching. You should use mainly cotton underwear.
It is also advisable to apply an antifungal cream containing sertaconazole to the vulva and perineum area.
It is recommended to abstain from sexual intercourse when using the medicine.
It is recommended to consider simultaneous treatment of the sexual partner.
Treatment can be carried out during menstruation.
It is also recommended to treat other pathogenic microorganisms that may be associated with candidiasis.
Treatment should be discontinued if a local allergic reaction occurs.
In the absence of characteristic clinical signs of vaginal candidiasis, a positive microbiological test result alone is not an indication for treatment.
Use during pregnancy or breastfeeding
There are no data on the presence of embryotoxicity and teratogenic effects of sertaconazole. Given the method of administration (single dose treatment) and the lack of systemic absorption of the drug, the use of sertaconazole in pregnant women is possible provided that the expected benefit to the woman outweighs the potential risk to the fetus.
There is no data on the penetration of sertaconazole into breast milk. The drug should not be used during breastfeeding, except in cases where, in the opinion of the doctor, the expected benefit to the mother outweighs the potential risk to the child.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Adults should insert 1 pessary deep into the vagina, preferably in the supine position, in the evening before bedtime once a day. If the clinical signs of the disease do not disappear, the drug can be repeated after 7 days.
Children.
Sertaconazole is not used in children.
Overdose
After vaginal use, overdose was practically not observed.
Side effects
Immune system disorders: Transient local irritation (burning sensation and itching) may occasionally occur. This may be due to the action of cell fragments during the death of pathogens, so this reaction may be a sign of successful therapy.
Allergic reactions often occur.
Reporting a suspected adverse reaction
Reporting suspected adverse reactions after a medicinal product has been authorised is important. This allows for continuous monitoring of the benefit/risk ratio of the medicinal product.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
1 pessary in a strip of polyvinyl chloride film. 1 strip in a pack.
Vacation category
According to the recipe.
Producer
Location of the manufacturer and address of its place of business.
Ukraine, 19161, Cherkasy region, Uman district, Avramivka village, Zavodska st., 8
