Lomexin cream for vaginal and external use 2% tubes 78g No. 1

Composition and release form

1 pc in blister; 1 blister in a cardboard pack.

1 pc in blister; 1 blister in a cardboard pack.

in aluminum tubes of 30 g; in a cardboard pack 1 tube.

Lomexin cream for vaginal and external use 2% tubes 78g No. 1

Name

Lomexin cream d/vag. and adv. approx. 2% in aluminum tubes 78g. complete with dosage in package No. 1

Description

White homogeneous cream.

Main active ingredient

Fenticonazole nitrate.

Release form

Cream.

Dosage

2% in aluminum tubes 78g.

Pharmacodynamics

Lomexin is a broad-spectrum antifungal drug. — In vitro: has a fungistatic and fungicidal effect against dermatophytes (all types of fungi of the genus Trichophyton, Microsporum, Epidermophytori), Candida albicans and other pathogens of fungal diseases of the skin and mucous membranes. Inhibitory activity against acid protease secreted by Candida albicans has also been demonstrated in vitro. - In vivo: guinea pigs with cutaneous mycosis caused by dermatophytes and Candida fungi recovered within 7 days. Lomexin also has antibacterial activity against gram-positive bacteria. Proposed mechanism of action: blocks oxidative enzymes due to the accumulation of peroxides, causes necrosis of fungal cells; has a direct effect on membranes.

Pharmacokinetics

In pharmacokinetic studies in both animals and humans, extremely negligible absorption of the drug by the mucous membranes was demonstrated. When treating dermatological skin lesions, less than 0.5% of the dose of the drug applied under an occlusive dressing penetrates. Following vaginal administration of fenticonazole in humans, negligible absorption was observed: pharmacokinetic studies conducted in two groups of patients treated with fenticonazole nitrate 1000 mg vaginally showed that absorption in patients with vulvovaginal candidiasis averaged 1.81 ± 0.57% ;while in patients with healthy vaginal mucosa or cervical cancer, the average absorption is 0.58-1.12%.

Indications for use

Externally • Dermatomycosis caused by dermatophytes (Trichophyton, Microsporum, Epidermophyton), in various localizations: fungal infection of the skin of the extremities, fungal infection of the skin of the feet (“athlete’s foot”), fungal infection of the skin of the hands, fungal infection of the skin of the face, dermatophytic onychomycosis. • Skin candidiasis (diaper rash, angular stomatitis, facial candidiasis, diaper-induced candidiasis, inguinal and scrotal candidiasis); balanitis, balanoposthitis; onychomycosis and paronychia. • Pityriasis versicolor (caused by Pityrosporum orbiculare and P. ovale). • Otomycosis (caused by Candida or yeast); only in the absence of damage to the eardrum. • Erythrasma. • Mycosis with the presence of bacterial superinfection (caused by Gram-positive bacteria). Intravaginal • Vulvovaginal candidiasis

Directions for use and doses

Externally, Lomexin is prescribed for the treatment of hairless skin, skin folds and mucous membranes. The drug is applied 1-2 times a day in an even thin layer to previously cleaned and dried affected areas, covering approximately 1 cm of the surface of healthy skin and gently rubbed in. Mainly used in the treatment of dry mycosis: pityriasis versicolor, erthyrasma, onychomycosis (the cream is applied under an occlusive dressing). The drug is also suitable for the treatment of male genital mycoses. The duration of treatment depends on the etiology of the pathogen and the location of the infection. Symptoms of the disease usually disappear after 2-4 weeks. The recommended duration of treatment is 4 weeks. Lomexin is non-greasy, non-staining and can be easily removed with water. The drug is also suitable for the treatment of mycoses of the skin of the male external genitalia. Intravaginally There are no data on the safety and effectiveness of use in children under 16 years of age. For children over 16 years of age, the recommended dose is the same as for adults. One full applicator (about 5 g) is inserted into the vagina using a reusable applicator in a lying position, 1 time per day, before bedtime and, if necessary, in the morning for three days. In case of vulvitis, the cream can be applied in a thin layer to the surface of the vulva. To avoid reinfection, it is recommended to simultaneously treat the partner with a cream that is applied to the glans penis and foreskin. Using the dispenser: 1. Attach the dispenser to the tube instead of the cap. 2. Gently squeeze out the contents of the tube until the dispenser is completely filled. If resistance appears, pull the dispenser plunger up slightly. The dispenser must be completely filled with cream, unless otherwise prescribed by the attending physician. 3. Remove the dispenser filled with cream from the tube (the piston is fully extended). Close the tube with a lid. 4. Insert the dispenser deeply into the vagina (as far as possible), while lying on your back with your knees bent. By pressing on the plunger, squeeze out all the cream from the dispenser. After each use, wash the applicator with warm water (not higher than 50 °C) and soap and dry.

Use during pregnancy and lactation

Pregnancy There is limited data on the use of fenticonazole in pregnant women. Animal studies have shown no teratogenic effects, and embryotoxic and fetotoxic effects have only been observed with very high oral doses. However, even if transdermal penetration is negligible, possible risks cannot be ruled out. Low systemic exposure is expected for vaginal treatment. The applicator should not be used during pregnancy. Both dermatological and vaginal treatment with fenticonazole during pregnancy should be under medical supervision. Breastfeeding Animal studies using the oral route have shown that fenticonazole and/or its metabolites can be excreted in milk. Even in the absence of data indicating that vaginal use of fenticonazole in humans causes excretion of the drug and/or its metabolites into milk, a risk to the child cannot be excluded. During breastfeeding, fenticonazole should be used under medical supervision. Reproductive function. Human studies of the effect of fenticonazole on reproductive function have not been conducted, but animal studies have not shown any effect of the drug on reproductive function.

Precautionary measures

If hypersensitivity reactions develop, you must stop using the drug and consult a doctor to prescribe appropriate treatment. The use of topical drugs, especially long-term, may cause sensitization. In this case, you should stop using it and consult your doctor. Lomexin contains propylene glycol, which may cause skin irritation. The drug also contains lanolin and cetyl alcohol, which can cause local skin reactions (for example, contact dermatitis). External use When applied to affected areas of the skin, a slight burning sensation may occur, which quickly passes. Contact of the drug with the eyes should be avoided. In case of accidental contact with eyes, rinse them with plenty of water. Vaginal use The patient should consult a doctor if: - if the symptoms are not eliminated within one week - if the symptoms recur (more than 2 infections within the last 6 months) - if there have been cases of sexually transmitted diseases in the past, or contact with an infected partner - if the patient is under 16 or over 60 years of age - if there is a known hypersensitivity to imidazoles or other antifungal drugs - the presence of abnormal or irregular vaginal bleeding - blood-stained vaginal discharge - the appearance of vulval or vaginal inflammation, ulcers or blisters - sensation of pain below abdominal pain or dysuria - any side effects such as erythema, itching or rash associated with treatment. Fenticonazole should be used during pregnancy and lactation under medical supervision. During the period of use of the drug, it is recommended to use reliable methods of contraception. During intravaginal use, a slight burning sensation may occur, which quickly passes. It is advisable to start the course of treatment after menstruation. To avoid reinfection, it is recommended to simultaneously treat the partner with Lomexin cream, which is applied to the glans penis and foreskin. The cream should not be used in combination with barrier contraceptives.

Interaction with other drugs

No interaction studies have been conducted. Fatty fillers and oils contained in the cream may damage latex contraceptives.

Contraindications

Hypersensitivity to the active substance or to any of the auxiliary components of the drug.

Compound

per 1 g of cream: Active substance: Fenticonazole nitrate 20.0 mg Excipients: Water, glyceryl monostearate, disodium edetate, fatty acids and macrogol ester, hydrogenated lanolin, almond oil, propylene glycol (E1520), cetyl alcohol.

Overdose

There have been no cases of drug overdose reported. Fenticonazole is topical and is not intended for oral use. If accidentally taken orally, abdominal pain and vomiting may occur.

Side effect

Lomexin has low absorption and therefore, if used properly, any systemic adverse reactions are unlikely. Long-term use of topical medications may cause irritation. When applied vaginally with an applicator, a slight burning sensation may occur. Side effects are listed according to the MedDRA classification in accordance with the damage to organs and organ systems and the frequency of development: very often (? 1/10), often (from? 1/100 to

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of the reach of children.

Lomexin vaginal capsules 600 mg No. 2

A country

Italy
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Active substance

Fenticonazole

Compound

1 capsule contains: fenticonazole nitrate 600 mg.
Excipients: soy lecithin, liquid paraffin, petrolatum. Vaginal capsules are soft, oval, yellowish in color, shiny. The contents of the capsules are an oily, white, thick, homogeneous suspension.

pharmachologic effect

A broad-spectrum antifungal drug for topical use in gynecology. Fenticonazole is a synthetic derivative of imidazole (its racemic mixture in the form of fenticonazole nitrate salt). It has a local fungicidal and fungistatic effect. It also has antibacterial and anti-inflammatory effects. The mechanism of action is to inhibit the synthesis of ergosterol, which regulates the permeability of the cell membrane of fungi. 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 (particularly econazole, miconazole and ketoconazole), fenticonazole inhibits the biosynthesis of proteases by Candida spp. at concentrations below the MIC - from 0.25 to 16 μg/ml. This effect does not depend on the magnitude of the antimycotic activity and is due to the inhibition of one of the stages of the formation of proteolytic enzymes by yeast-like fungi.

Indications for use

- vulvovaginal candidiasis; - vaginal trichomoniasis.

Mode of application

1 capsule (600 mg or 1000 mg) is inserted deep into the vagina in a lying position before bed once. If necessary, re-use after 3 days. When treating infections caused by Trichomonas vaginalis, it is possible to re-use the capsule (600 mg or 1000 mg) after 24 hours. If the effectiveness is insufficient, a second course may be taken after 10 days.

Side effect

Allergic reactions: urticaria, rash, erythema. Local reactions: burning, itching, irritation at the site of application. Lomexin is generally well tolerated; side effects are transient and do not require discontinuation of the drug.

Contraindications

- pregnancy; - lactation period; - childhood; - hypersensitivity to the drug. The drug should not be prescribed during menstruation.

Overdose

Due to the low degree of absorption into the systemic circulation, an overdose is unlikely.

special instructions

With prolonged use of the drug, sensitization may develop. In this case, it is necessary to stop treatment and the patient should contact her doctor. If there is no effect within 3 weeks of therapy, treatment should be stopped and the diagnosis clarified. It is advisable to start the course of treatment after menstruation. To avoid reinfection, it is recommended to simultaneously treat the partner with Lomexin cream, which is applied to the glans penis and foreskin. Effect on the ability to drive vehicles and operate machinery There is no data on the negative impact of the use of the drug on the ability to drive a car or other vehicles.

Storage conditions

Room temperature

Dispensing conditions in pharmacies

On prescription