Instructions for Livagin-M pessaries 400 mg strip No. 10
Composition
active ingredient: ketoconazole;
1 pessary contains 400 mg of ketoconazole;
excipients: butylhydroxyanisole, macrogol 1500, macrogol 400.
Dosage form
Pessaries.
Main physical and chemical properties: pessaries are white, white with a yellowish or grayish tint, torpedo-shaped. Marbling of the surface is allowed.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives.
PBX code G01A F11.
Pharmacological properties
Pharmacodynamics
Ketoconazole is a synthetic derivative of imidazoledioxolane. It has a pronounced fungicidal and fungistatic effect on dermatophytes (Trichophyton spp., Epidermophyton floccosum, Microsporum spp.), yeast fungi (Candida spp., Pityrosporum spp., Torulopsis spp., Cryptococcus spp., Rhodotorula spp.). Ketoconazole is also active against gram-positive cocci (Staphylococcus spp., Streptococcus spp.). The mechanism of its action is to inhibit the biosynthesis of ergosterol and change the lipid composition of the fungal membrane, which leads to their lysis.
Pharmacokinetics
When administered intravaginally, only a small amount (< 1%) of ketoconazole enters the systemic circulation. The maximum plasma concentration in women after intravaginal administration of 400 mg of ketoconazole ranges from 0 to 10.7 ng/ml, which is considered trace and does not have a systemic effect.
Indication
For the treatment of acute and chronic recurrent vulvovaginal candidiasis.
For the 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 ketoconazole is used simultaneously with rifampicin and isoniazid, the concentration of ketoconazole in the plasma decreases. When used simultaneously with cyclosporine, indirect anticoagulants and methylprednisolone, ketoconazole may increase the concentration of the latter in the plasma. The practical significance of these interactions in treatment with ketoconazole in the form of pessaries is unknown.
Application features
In rare 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, therefore the possibility of pregnancy or sexually transmitted diseases cannot be ruled out. Allergic reactions in the sexual partner are possible, in particular hyperemia of the genitals, therefore, during treatment, sexual intercourse should be avoided.
Ketoconazole is recommended for use at night, as the drug has an osmotic and drainage effect, which is accompanied by increased vaginal discharge. It is recommended to use sanitary pads at night during treatment with ketoconazole.
If hypersensitivity reactions develop, the use of the drug should be discontinued and a doctor should be consulted.
You should not violate the rules for using the medicine - this can harm your health.
The medicine contains butylhydroxyanisole, which may cause skin reactions.
Ability to influence reaction speed when driving vehicles or other mechanisms
Usually has no effect, but the possibility of dizziness in people with hypersensitivity should be considered.
Use during pregnancy or breastfeeding
Systemic absorption of ketoconazole after intravaginal administration is minimal or absent, although there are no adequate controlled clinical studies on the safety of ketoconazole in pregnant women. Ketoconazole is not used in the first trimester of pregnancy. In the second and third trimesters and during breastfeeding, the drug is used only if the expected benefit to the mother outweighs the potential risk to the fetus or child.
Method of administration and doses
The pessary is released from the strip and inserted deep into the vagina in a supine position with knees bent and legs pulled to the chest or squatting. The pessary should not be cut into parts, since such a change in the storage conditions of the drug may lead to a violation of the distribution of the active substance. 1 pessary is prescribed per day before bedtime for 3-5 days. If necessary, the course of treatment is repeated until clinical and laboratory recovery. In chronic candidiasis, 1 pessary is used for 10 days.
Children
The drug is not used in children.
Overdose
In case of overdose, local reactions are possible: hyperemia, burning, itching, irritation of the vaginal mucosa. In such cases, douching with water is recommended.
Adverse reactions
Adverse reactions are usually rare and resolve quickly after discontinuation of the drug.
Skin and mucous membranes: itching, rash, burning, hyperemia, irritation of the vaginal mucosa, urticaria, possible reactions at the injection site.
Nervous system: dizziness.
Immune system disorders: hypersensitivity reactions, including anaphylactic and anaphylactoid reactions, angioedema.
If any adverse reactions occur, you should stop using the medicine and consult a doctor.
Expiration date
2 years.
The drug cannot be used after the expiration date indicated on the package.
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 strip of polyvinyl chloride film. 2 strips in a cardboard pack.
Vacation category
Without a prescription.
Producer
PJSC "Monpharm".
Location of the manufacturer and its business address
Ukraine, 19100, Cherkasy region, Monastyryshche, Zavodska st., 8.
