Livarol suppositories 400 mg No. 10

Instructions for Livarol suppositories 400 mg No. 10

Composition

active ingredient: ketoconazole;

1 pessary contains 400 mg of ketoconazole;

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

Dosage form

Pessaries.

Main physical and chemical properties: pessaries are white, white with a yellowish or grayish tint, torpedo-shaped. The presence of a funnel-shaped depression and an air core is allowed.

Pharmacotherapeutic group

Antimicrobial and antiseptic agents used in gynecology.

ATX code G01A F11.

Pharmacological properties

Pharmacodynamics

The active substance is ketoconazole, an imidazoledioxolane derivative. It has fungicidal and fungistatic effects on dermatophytes (Trichophyton spp., Epidermophyton floccosum, Microsporum spp.) and yeasts (Candida spp., Pityrosporum spp.). The mechanism of action is aimed at inhibiting ergosterol biosynthesis and changing the lipid composition of the fungal membrane.

The drug is active against staphylococci and streptococci.

Pharmacokinetics

When used vaginally, the drug is poorly absorbed, a small amount of the drug enters the systemic circulation. The maximum concentration of ketoconazole in blood plasma after using 400 mg of the drug ranges from 0 to 20.7 ng/ml.

Indication

Treatment of acute and chronic recurrent vaginal mycosis. Prevention of vaginal fungal infections with reduced body resistance and against the background of treatment with drugs that disrupt the normal vaginal microflora.

Contraindication

Individual hypersensitivity to the components of the drug, pregnancy (I trimester).

Interaction with other medicinal products and other types of interactions

When Livarol is used simultaneously with rifampicin and isoniazid, the concentration of ketoconazole in plasma decreases. When used simultaneously with cyclosporine, indirect anticoagulants and methylprednisolone, ketoconazole may increase the concentration of the above-mentioned drugs in plasma. The practical significance of these interactions in treatment with ketoconazole in the form of vaginal pessaries is unknown.

Application features

In rare cases, local allergic reactions in the sexual partner are possible. To reduce the risk of recurrence of the disease, simultaneous treatment of the sexual partner is recommended. Contact with latex products (contraceptive diaphragms, condoms) should be avoided.

During treatment, you should abstain from sexual activity.

Livarol is recommended to be used at night, as the drug has an osmotic and drainage effect, which is accompanied by an increase in vaginal discharge. It is recommended to use sanitary pads at night during treatment with Livarol.

If hypersensitivity reactions develop, the drug should be discontinued and a doctor should be consulted.

Ability to influence reaction speed when driving vehicles or other mechanisms

No effect.

Use during pregnancy or breastfeeding

Do not use in the first trimester of pregnancy. In the second and third trimesters of pregnancy and during breastfeeding, the drug is used only when the expected benefit to the mother outweighs the potential risk to the fetus or child.

Method of administration and doses

The drug is used intravaginally. Before use, the pessary is removed from the contour packaging and inserted deep into the vagina in the supine position. 1 pessary is used per day for 3-5 days, depending on the course of the disease. If necessary, the course of treatment is repeated until clinical recovery, confirmed by laboratory tests. In chronic candidiasis, 1 pessary is used for 10 days.

During pregnancy (II-III trimester) and breastfeeding, the method of administration and doses are normal.

Children

There is no experience with the use of the drug in children, so it should not be prescribed to this age group of patients.

Overdose

Overdose and toxic effects when using the drug have not been identified.

Adverse reactions

Hyperemia and irritation of the vaginal mucosa, vaginal itching at the site of pessary insertion, allergic reactions (skin rashes, urticaria) are possible.

In rare cases, nausea and dizziness may occur.

Expiration date

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 ºС.

Keep out of reach of children.

Packaging

5 pessaries in a blister, 2 blisters in a cardboard box.

Vacation category

Without a prescription.

Producer

LLC "PHARMEX GROUP".

Location of the manufacturer and its business address

Ukraine, 08301, Kyiv region, Boryspil city, Shevchenko street, building 100.