Instructions for Lomexin vaginal soft capsules 600 mg blister No. 1
Composition
active ingredient: fenticonazole nitrate;
1 capsule contains 200 mg or 600 mg of fenticonazole nitrate;
excipients (for soft capsules of 200 mg): medium chain triglycerides, colloidal anhydrous silicon dioxide; capsule shell: gelatin, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate (E 217);
excipients (for soft capsules of 600 mg): light mineral oil, white soft paraffin, soy lecithin; capsule shell: gelatin, glycerin, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate (E 217).
Dosage form
Soft vaginal capsules.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives. ATC code G01A F12.
Indication
Genital candidiasis (thrush): vulvovaginitis, colpitis, mixed infections of the mucous membranes of the genital tract.
Contraindication
Hypersensitivity to the components of the drug.
Method of administration and doses
It is applied intravaginally.
Vaginal soft capsules 200 mg
One capsule is inserted deep into the vagina in the supine position in the evening before bedtime. The course of treatment is 3 days or as recommended by the doctor.
Vaginal soft capsules 600 mg
One capsule is inserted deep into the vagina in the lying position in the evening before going to bed. If symptoms persist, another capsule can be applied after three days.
To avoid re-infection, it is recommended to simultaneously treat the partner with Lomexin® cream by applying the cream to the glans penis and foreskin.
Adverse reactions
Lomexin® is usually well tolerated when applied topically.
Minor temporary reactions of redness or a burning sensation have rarely occurred, which usually disappear quickly.
Treatment should be discontinued in the event of a hypersensitivity reaction or the development of resistance in microorganisms.
When used in recommended doses, the drug is practically not absorbed, so systemic effects are excluded.
Overdose
There have been no reports of overdose.
Use during pregnancy or breastfeeding
The drug should not be used during pregnancy and breastfeeding, as there are no research data on the use of the drug in these groups of patients.
Children.
The drug is not used in children.
Special safety precautions
When using the medicine, you should follow the recommendations set out in this instruction manual.
A temporary, slight burning sensation may occur when applying the drug to affected areas or when inserted into the vagina.
Prolonged use of the drug may cause sensitization. In this case, you should stop using the drug and consult a doctor.
The ability to influence the reaction speed when driving or working with other mechanisms
The drug does not affect the ability to drive vehicles and work with other mechanisms.
Interaction with other medicinal products and other types of interactions
Fatty substances contained in soft vaginal capsules can damage latex contraceptives.
Pharmacological properties
Pharmacodynamics. Lomexin® is a broad-spectrum antifungal agent.
The drug exhibits high fungistatic and fungicidal activity against dermatophytes (all species of Trichophyton, Microsporum, Epidermophyton), Candida albicans, and other fungal infections of the skin and mucous membranes. The drug inhibits the acid proteinase of Candida albicans.
The drug has an antibacterial effect against gram-positive microorganisms.
It is assumed that the mechanism of action of fenticonazole nitrate is inhibition of enzyme oxidation by accumulated peroxide and necrosis of fungal cells, which is manifested by a direct effect on membranes.
Lomexin® also exhibits activity against Trichomonas vaginalis in vivo and in vitro.
Pharmacokinetics.
Pharmacokinetic studies have shown negligible absorption through the skin in animals and humans.
A small amount of fenticonazole nitrate was absorbed through the vaginal mucosa in women.
In preclinical studies, Lomexin® did not show mutagenic potential, did not contribute to increased sensitivity, phototoxicity, and photoallergy.
Animal studies have not shown any effect of fenticonazole nitrate on the functions of male or female gonads and on the early stages of reproduction.
Pharmaceutical characteristics.
Main physicochemical properties:
Soft vaginal capsules 200 mg: soft gelatin capsules, teardrop-shaped, ivory-colored;
Soft vaginal capsules 600 mg: soft gelatin capsules, oval in shape, ivory in color.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
Soft vaginal capsules 200 mg: 3 or 6 capsules in a PVC/PVDC/aluminum blister. One blister in a cardboard box.
Soft vaginal capsules 600 mg: 1 or 2 capsules in a PVC/PVDC/aluminum blister. One blister in a cardboard box.
Vacation category
According to the recipe.
Producer
Catalent Italia S.p.A., Italy/
Catalent Italy SpA, Italy.
Location.
Via Nettunense Km. 20, 100 – 04011, Aprilia (LT), Italy/
Via Nettunense Km. 20, 100 – 04011, Aprilia (LT), Italy.
Registration certificate holder.
Recordate Island Ltd, Rahins East, Ringeskiddie, Co. Cork, Ireland/
Recordati Ireland Ltd, Raheens East, Ringaskiddy, Co.Cork, Ireland.
