Composition, form of production and packaging
Vaginal capsules are soft, oval, yellowish, shiny; the contents of the capsules are an oily suspension of white color, thick, homogeneous.
1 caps.
fenticonazole nitrate 600 mg
- "- 1000 mg
Excipients: soy lecithin, paraffin liquid, petrolatum.
The composition of the capsule shell: glycerol, gelatin, sodium propylparahydroxybenzoate, titanium dioxide, ethylparahydroxybenzoate sodium.
1 PC. - blisters (1) - packs of cardboard.
2 pcs. - blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Antifungal preparation of a wide spectrum of action for topical application in gynecology. Fenticonazole is a synthetic derivative of imidazole (its racemic mixture in the form of the nitric acid salt of fenticonazole). Has a local fungicidal and fungistatic effect. It also has antibacterial and anti-inflammatory action. The mechanism of action is to inhibit the synthesis of ergosterol, which regulates the permeability of the fungal cell membrane.
Is active against yeast fungi Candida spp. (including Candida albicans) and Gram-positive bacteria (Staphylococcus aureus, Streptococcus spp.), as well as against Trichomonas vaginalis.
Unlike other known azole compounds (in particular, econazole, miconazole and ketoconazole), fenticonazole inhibits the biosynthesis of proteases of Candida spp. at concentrations below the MIC - from 0.25 to 16 Ојg / ml. This action does not depend on the magnitude of antimycotic activity and is due to the inhibition of one of the stages of the formation of proteolytic enzymes by yeast-like fungi.
PHARMACOKINETICS
Fenticonazole practically does not undergo systemic absorption, with prolonged vaginal application its concentration in the blood is not determined. The degree of absorption in the mucous membrane is extremely low.
INDICATIONS
- vulvovaginal candidiasis;
- Vaginal trichomoniasis.
DOSING MODE
1 capsule (600 mg or 1000 mg) is injected deep into the vagina in the prone position before bedtime once. If necessary, re-use after 3 days.
In the treatment of infections caused by Trichomonas vaginalis , it is possible to reapply the capsule (600 mg or 1000 mg) after 24 hours.
With insufficient effectiveness, it is possible to repeat the course after 10 days.
SIDE EFFECT
Allergic reactions: urticaria, rash, erythema.
Local reactions: burning, itching, irritation in the place of application.
Lomexin, as a rule, is well tolerated, side effects are transitory in nature and do not require withdrawal of the drug.
CONTRAINDICATIONS
- Pregnancy;
- lactation period;
- childhood;
- Hypersensitivity to the drug.
The drug can not be administered during menstruation.
PREGNANCY AND LACTATION
Currently, data on the efficacy and safety of Lomexin during pregnancy and lactation (breastfeeding) is not enough, so the appointment of the drug in these periods is not recommended.
APPLICATION FOR CHILDREN
Contraindicated in childhood.
SPECIAL INSTRUCTIONS
With prolonged use of the drug may develop sensitization. In this case, it is necessary to discontinue treatment, and the patient should contact the attending physician.
If there is no effect within 3 weeks of therapy, treatment should be stopped and the diagnosis clarified.
The course of treatment is advisable to start after menstruation.
To avoid re-infection, it is recommended to simultaneously treat the partner with Lomexin cream, which is applied to the glans penis and foreskin.
Impact on the ability to drive vehicles and manage mechanisms
There is no evidence of a negative effect of the drug on the ability to drive and other vehicles.
OVERDOSE
Due to the low degree of absorption in the systemic blood flow, an overdose is unlikely.
DRUG INTERACTION
Drug interactions between Lomexin and other drugs have not been identified.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 30 В° C. Shelf life - 3 years.
