Livarol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LIVAROL

Composition:

Active substance: ketoconazole;

1 suppository contains ketoconazole 400 mg;

Excipients: butylhydroxyanisole (E 320), macrogol 1500, macrogol 400.

Pharmaceutical form. Suppositories.

Main physicochemical characteristics: white suppositories, or white with yellowish or greyish hue, torpedo-shaped. Presence of a cup-shaped depression and an air channel is permissible.

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives. Ketoconazole. ATC code G01AF11.

Pharmacological properties.

Pharmacodynamics.

The active substance is ketoconazole, a derivative of imidazolodioxolane. It exerts fungicidal and fungistatic effects against dermatophytes (Trichophyton spp., Epidermophyton floccosum, Microsporum spp.) and yeasts (Candida spp., Pityrosporum spp.). Its mechanism of action is directed at inhibiting ergosterol biosynthesis and altering the lipid composition of fungal cell membranes. The drug is also active against staphylococci and streptococci.

Pharmacokinetics.

After vaginal administration, ketoconazole is poorly absorbed, and only a small amount reaches the systemic circulation. The maximum plasma concentration of ketoconazole after administration of 400 mg of the drug ranges from 0 to 20.7 ng/mL.

Clinical characteristics.

Indications.

• Treatment of acute and chronic recurrent vaginal mycosis.
• Prevention of vaginal fungal infections in conditions of decreased body resistance and during treatment with agents that disrupt the normal vaginal microflora.

Contraindications.

Individual hypersensitivity to the components of the medicinal product, pregnancy (first trimester).

Interaction with other medicinal products and other forms of interaction.

When the medicinal product Livarol is used concomitantly with rifampicin and isoniazid, the plasma concentration of ketoconazole is reduced. When used concomitantly with cyclosporine, oral anticoagulants, and methylprednisolone, ketoconazole may increase the plasma concentration of these agents. The clinical significance of these interactions during treatment with ketoconazole in the form of vaginal suppositories is unknown.

Special precautions.

In isolated cases, local allergic reactions in the sexual partner are possible. To reduce the risk of disease recurrence, simultaneous treatment of the sexual partner is recommended. Contact with latex products (contraceptive diaphragms, condoms) should be avoided due to reduced reliability of mechanical contraception — pregnancy or sexually transmitted infections cannot be ruled out. Allergic reactions in the sexual partner are possible, including genital hyperemia; therefore, sexual intercourse should be avoided during treatment.

Livarol should be used at night, since ketoconazole exerts an osmotic and draining effect, which may lead to increased vaginal discharge. It is recommended to use hygienic sanitary pads during the night while undergoing treatment with Livarol.

If hypersensitivity reactions occur, the drug should be discontinued and medical advice should be sought.

Important information about excipients. The medicinal product contains butylhydroxyanisole (E 320), which may cause local skin reactions (e.g., contact dermatitis) or irritation of mucous membranes.

Use during pregnancy or breastfeeding.

Do not use during the first trimester of pregnancy. During the second and third trimesters of pregnancy and during breastfeeding, the medicinal product should be used only when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to influence reaction speed while driving or operating machinery.

The medicinal product generally does not affect reaction speed; however, the possibility of dizziness occurring in hypersensitive individuals should be taken into account.

Dosage and Administration.

The medicinal product is administered intravaginally. Before use, remove the suppository from its contour packaging and insert deeply into the vagina while lying on the back. Apply 1 suppository once daily for 3–5 days depending on the course of the disease. If necessary, repeat the treatment course until clinical recovery confirmed by laboratory tests. For chronic candidiasis, administer 1 suppository daily for 10 days.

During pregnancy (II–III trimester) and breastfeeding, the method of administration and dosage are as usual.

Children.

There is no experience with the use of this medicinal product in children; therefore, it should not be prescribed to this age group of patients.

Overdose.

Overdose and toxic effects have not been observed with the use of ketoconazole.

Side effects.

Immune system disorders: hypersensitivity reactions, including anaphylactic and anaphylactoid reactions, angioneurotic edema.

Skin and mucous membrane disorders: itching, rash, burning, hyperemia, irritation of the vaginal mucosa, urticaria, injection site reactions.

Gastrointestinal disorders: in isolated cases – nausea, abdominal pain.

Nervous system disorders: dizziness.

Reporting of suspected side effects.

Reporting suspected side effects after marketing authorization is highly important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report all suspected side effects and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life. 2 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

5 pessaries per blister, 1 or 2 blisters per cardboard box.

Availability category. Over-the-counter (without prescription).

Manufacturer.

LLC "FARMEKS GROUP".

Manufacturer's address and place of business.

100, Shevchenka Street, Boryspil, Kyiv region, 08301, Ukraine.