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Lomexin® (Capsules, Cream) Instructions for Use

ATC Codes

D01AC12 (Fenticonazole)

G01AF12 (Fenticonazole)

Active Substance

Fenticonazole (Rec.INN registered by WHO)

Clinical-Pharmacological Group

External and topical antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Fenticonazole is an antifungal agent, an imidazole derivative. It inhibits the synthesis of ergosterol, disrupting the permeability of the fungal cell wall.

It is active against Candida spp. (including Candida albicans) and gram-positive bacteria ( Staphylococcus aureus, Streptococcus spp.), as well as against Trichomonas vaginalis.

Unlike other known azole compounds, Fenticonazole inhibits the biosynthesis of proteases in Candida spp. at concentrations below the minimum inhibitory concentration – from 0.25 to 16 µg/ml. This action is independent of the magnitude of the antimycotic activity and is due to the inhibition of one of the stages of proteolytic enzyme formation by yeast-like fungi.

Pharmacokinetics

It is practically not subject to systemic absorption. The degree of absorption through mucous membranes is extremely insignificant.

Indications

  • For the treatment of vulvovaginal candidiasis, a fungal infection caused by yeast of the genus Candida.
  • For the treatment of vaginal trichomoniasis, a parasitic infection caused by Trichomonas vaginalis.

Apply the product strictly for the conditions listed above as directed by a healthcare professional.

ICD codes

ICD-10 code Indication
A59 Trichomoniasis
B37.3 Candidiasis of vulva and vagina
N77.1 Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere
ICD-11 code Indication
1A92 Trichomoniasis
1F23.10 Candidiasis of vulva and vagina
1F65 Enterobiasis
1H0Z Unspecified infection
1A94.0 Genital or urogenital tract infection caused by Herpes simplex virus
GA41 Ulcerative or erosive diseases of vulva

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the product intravaginally at a frequency of one to two times per day.

Continue the treatment course for a duration of three to six days, as determined by the severity of the infection and the specific dosage form prescribed.

The exact dose is dependent on the formulation used; follow the specific instructions provided for the capsules or cream.

Adverse Reactions

Localized reactions at the application site, such as a burning sensation, itching, and local irritation, may occur during treatment.

Allergic reactions, including urticaria, skin rash, and erythema, have been reported rarely. Discontinue use and seek medical attention if signs of a hypersensitivity reaction appear.

Contraindications

  • Do not use in patients with a known hypersensitivity to Fenticonazole, other imidazole derivatives, or any of the excipients in the formulation.
  • Use is contraindicated during the first trimester of pregnancy due to potential risks to fetal development.

Always verify patient history for these conditions prior to initiating therapy to prevent adverse outcomes.

Drug Interactions

Due to the negligible systemic absorption following intravaginal application, clinically significant pharmacokinetic drug interactions are not expected.

No specific drug interaction studies have been conducted; however, the potential for interactions with systemically administered medications is considered low.

Overdose

Overdose is unlikely due to the local application and minimal systemic absorption of the active substance.

In the event of accidental ingestion, symptomatic and supportive measures are recommended. No specific antidote exists.

Use in Pregnancy and Lactation

Use in the first trimester of pregnancy is contraindicated.

Currently, data on the efficacy and safety of using Fenticonazole in the second and third trimesters of pregnancy and during lactation are not available.

Special Precautions

With prolonged use, sensitization may develop.

Do not use during menstruation. It is advisable to start the course of treatment after menstruation.

To avoid reinfection, simultaneous treatment of sexual partners is recommended.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Recordati Ireland Ltd. (Ireland)

Manufactured By

Catalent Italy, S.P.A. (Italy)

Dosage Forms

Lomexin® Bottle Rx Icon Vaginal capsules 600 mg: 1 or 2 pcs.
Bottle Rx Icon Vaginal capsules 1000 mg: 1 or 2 pcs.

Dosage Form, Packaging, and Composition

Vaginal capsules soft, oval, shiny, yellowish in color; the capsule contents are a thick, homogeneous, oily suspension of white color.

1 caps.
Fenticonazole nitrate 600 mg

Excipients: soy lecithin, liquid paraffin, petrolatum.

Shell composition: glycerol, gelatin, sodium propylparahydroxybenzoate, titanium dioxide, sodium ethylparahydroxybenzoate.

1 pc. – blisters (1) – cardboard packs.
2 pcs. – blisters (1) – cardboard packs.

Vaginal capsules soft, oval, shiny, yellowish in color; the capsule contents are a thick, homogeneous, oily suspension of white color.

1 caps.
Fenticonazole nitrate 1000 mg

Excipients: soy lecithin, liquid paraffin, petrolatum.

Shell composition: glycerol, gelatin, sodium propylparahydroxybenzoate, titanium dioxide, sodium ethylparahydroxybenzoate.

1 pc. – blisters (1) – cardboard packs.
2 pcs. – blisters (1) – cardboard packs.

Marketing Authorization Holder

Recordati Ireland Ltd. (Ireland)

Manufactured By

Recordati Industria Chimica E Farmaceutica S.p.A. (Italy)

Or

Recordati Ilac Sanayi Ve Ticaret A.S. (Turkey)

Dosage Form

Bottle OTC Icon Lomexin® Cream for vaginal and external use 2%: tubes 30 g, 78 g with dispenser

Dosage Form, Packaging, and Composition

Cream for vaginal and external use white, homogeneous.

100 g
Fenticonazole nitrate 2.00 g

Excipients: water – 60.50 g, glyceryl monostearate – 3.00 g, disodium edetate – 0.50 g, fatty acids and macrogol ether – 15.00 g, hydrogenated lanolin – 1.00 g, almond oil – 10.00 g, propylene glycol – 5.00 g, cetyl alcohol – 3.00 g.

30 g – aluminum tubes (1) – cardboard packs.
78 g – aluminum tubes (1) with a dispenser – plastic cases (1) – cardboard packs.

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