Livarole^® (Suppositories) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Contact Information

NIZHPharm group of companies (Russia)

ATC Code

G01AF11 (Ketoconazole)

Active Substance

Ketoconazole (Rec.INN registered by WHO)

Dosage Form

Livarole®

Vaginal suppositories 400 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories white or white with a yellowish, or grayish, or creamy tint, torpedo-shaped; marbling and the presence of an air core and a funnel-shaped depression on the cut are allowed.

Excipients: butylhydroxyanisole, macrogol mixture (macrogol 1500, macrogol 400).

5 pcs. – contour cell packs (1) – cardboard boxes.
5 pcs. – contour cell packs (2) – cardboard boxes.

Clinical-Pharmacological Group

Topical antifungal drug

Pharmacotherapeutic Group

Antimicrobial agents and antiseptics used in gynecology; antimicrobial agents and antiseptics, except combinations with corticosteroids; imidazole derivatives

Pharmacological Action

Synthetic antifungal drug from the group of imidazoledioxolane derivatives for topical application. It has a fungicidal and fungistatic effect, the mechanism of which consists in the inhibition of ergosterol biosynthesis and a change in the lipid composition of the fungal membrane.

Active against dermatophytes (Trichophyton spp., Epidermophyton floccosum, Microsporum spp.) and yeast and yeast-like fungi (Candida spp., Pityrosporum spp., dimorphic fungi and eumycetes).

Also active against Staphylococcus spp. and Streptococcus spp.

Pharmacokinetics

Systemic absorption with intravaginal use of the drug Livarole^® is insignificant.

Indications

• Treatment of acute and chronic recurrent vaginal candidiasis;
• Prevention of fungal infections of the vagina with reduced body resistance and during treatment with antibacterial agents and other drugs that disrupt the normal vaginal microflora.

ICD codes

Dosage Regimen

The drug is used intravaginally.

Prescribe 1 supp./day for 3-5 days depending on the course of the disease.

For chronic candidiasis, 1 supp./day is prescribed for 10 days.

The patient should be warned that she should not interrupt the course of treatment on her own, even if the disturbing symptoms have disappeared, because incomplete treatment can lead to the transition of the disease into a chronic form.

If the symptoms of the disease persist or worsen during treatment, the patient should stop treatment and consult a doctor.

Method of application

Remove the suppository from the contour packaging (the contour cell packaging of each suppository is equipped with special “wings” that allow easy and quick removal of the suppository without damaging it).

The suppository is inserted deep into the vagina in the supine position.

Adverse Reactions

Local reactions: hyperemia and irritation of the vaginal mucosa, vaginal itching.

Allergic reactions: skin rash, urticaria.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, the patient should inform the doctor.

Contraindications

• Pregnancy;
• Breastfeeding period;
• Age under 18 years;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Clinical data on the use of ketoconazole in women during pregnancy and breastfeeding are limited.

The use of the drug during pregnancy is contraindicated.

If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

No data.

Use in Renal Impairment

No data.

Pediatric Use

Contraindicated for use under the age of 18 years.

Geriatric Use

No data.

Special Precautions

To reduce the risk of disease recurrence, simultaneous treatment of the sexual partner is recommended.

In rare cases, allergic reactions (penile hyperemia) in the sexual partner are possible.

If clinical signs of infection persist after completion of treatment, a repeated microbiological examination should be performed to confirm the diagnosis.

The use of suppositories may reduce the reliability of mechanical contraception (latex-containing condoms and vaginal diaphragms). During treatment, it is recommended to choose reliable methods of contraception.

Effect on the ability to drive vehicles and mechanisms

The use of the drug does not affect the ability to drive vehicles and mechanisms.

Overdose

Due to low absorption of the drug with intravaginal use in recommended (therapeutic) doses, overdose is unlikely.

In case of accidental ingestion of the drug, symptoms of poisoning are possible.

Treatment: there is no specific antidote. If necessary, activated charcoal should be taken and symptomatic treatment should be carried out.

Drug Interactions

Due to low absorption with intravaginal use, interaction with other drugs is unlikely.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F) in the consumer packaging (cardboard box).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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.