Expiration date: 05/2025
Structure and Composition:
Vaginal capsules. 1 caps. contains fenticonazole nitrate 600 mg
Excipients: liquid paraffin - 0.435 g white petrolatum - 0.085 g soy lecithin - 0.008 g
Soft gelatin shell: Gelatin - Glycerol 0.209 g - 0.102 g of titanium dioxide - sodium methyl hydroxybenzoate 0.0048 g - 0.001 g Sodium propyl hydroxybenzoate - 0.0005 g
in blister 1 pc. In the paper cartons 1 blister.
Vaginal capsules 1 caps. contains fenticonazole nitrate 1000 mg
Excipients: liquid paraffin - 0.725 g white petrolatum - 0.142 g soy lecithin - 0.013 g
soft gelatin shell: Gelatin - Glycerol 0.289 g - 0,141 g of titanium dioxide - 0.0066 g of sodium etilgidroksibenzoat - 0.0016 g of sodium propyl - 0.0007 g
in blister 1 pc. In the paper cartons 1 blister.
Topical Cream 2%. 100 g contains fenticonazole nitrate 2 g
Excipients: propylene - Hydrogenated lanolin 5 g - 1 g almond oil - 10 g Cetyl alcohol - 3 g glycerol monostearate - 3 g Sodium edetate - 0.5 g of fatty acid polyglycol ether - 15 g Purified water - 60 g
in aluminum tubes to 30 g in paper cartons 1 tube.
Description pharmaceutical form:
Capsules: gelatin soft translucent ivory.
Cream: white or almost white homogeneous mass.
Characteristic:
Imidazole derivative (racemic mixture).
Pharmachologic effect:
It has fungistatic and fungicidal action. It has also anti-bacterial and anti-inflammatory action.
Pharmacokinetics:
Virtually no exposed systemic absorption, prolonged outdoor use concentration in the blood is not determined. The extent of absorption of the mucous membranes are extremely low.
Description of the pharmacological actions:
The mechanism of action is to inhibit the biosynthesis of ergosterol, a component of fungal cell membranes, causing changes in its structure and properties. Active against yeasts (including Candida albicans) and gram-positive bacteria.
Indications:
Vaginal trichomoniasis, genital candidiasis.
Contraindications:
Hypersensitivity to the drug.
Application of pregnancy and breastfeeding:
Data on the efficacy and safety of Lomexin during pregnancy and breast feeding are absent.
Side effect:
Allergic reactions: seldom - urticaria, rash, erythema.
Local reactions: burning, itching, irritation at the site of the drug. Side effects are transient and do not require discontinuation of therapy.
Drug Interactions:
Data on drug interactions are absent.
Dosage and administration:
Locally. Vaginal Capsules 600 mg. Capsules are injected deep into the vagina in the "lying" position once. However, in case of continued symptoms of vaginitis treatment can be extended to 3 days.
Vaginal Capsules 1000 mg used for 2 days.
Cream for topical application 2% of about 5 g administered one deep into the vagina once a day in the evening or when needed - 2 times a day (morning and evening). Treatment is carried out before full clinical recovery.
Overdose:
Data on overdose are not available.
Precautionary measures:
The drug should not be used during menstruation.
During treatment, do not wash the vagina. In subsequent use neutral or slightly alkaline soap.
Special instructions:
Prolonged use of the drug may develop sensitization. In this case, you must stop treatment and seek medical advice.
If the symptoms do not disappear within 3 weeks of the drug should verify the diagnosis.
A comment:
Lomexin, vaginal capsules of 600 and 1000 mg are available Catalent Italy S.p.A., Italy.
Lomexin cream for topical application of 2% is available Recordati Industria Chimica Farmaceutica S.p.A., Italy.
Marketing in Russia by CJSC "Pierre Fabre SA."
Storage conditions:
Away from open flames.
