контрактне виробництво
свічки контактне виробництво
виробництво торгова марка
Livagin-M®
Release form
Pessaries.
For children
Not used
For pregnant women
Not recommended
For nursing mothers
Not recommended
For drivers
With caution
Storage temperature
to 25 °C
INSTRUCTION
storage
active substance: ketoconazole; 1 pessary contains 400 mg of ketoconazole; excipients: butylhydroxyanisole, macrogol 1500, macrogol 400.
Medicinal form
Pessaries. The 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. ATX 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 consists in inhibiting the biosynthesis of ergosterol and changing the lipid composition of the mushroom membrane, which leads to their lysis. Pharmacokinetics. When administered intravaginally, only a small (< 1%) amount of ketoconazole enters the systemic bloodstream. The maximum concentration in blood plasma in women after intravaginal use 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 fungal infections of the vagina with reduced resistance of the body and against the background of treatment with drugs that disrupt the normal microflora of the vagina.
Contraindication
Individual hypersensitivity to the components of the drug, pregnancy (I trimester).
Interaction with other medicinal products and other forms of interaction
With the simultaneous use of ketoconazole with rifampicin and isoniazid, the concentration of ketoconazole in plasma decreases. With simultaneous use with cyclosporine, indirect anticoagulants and methylprednisolone, ketoconazole can increase the concentration of the latter in plasma. The practical significance of these interactions during treatment with ketoconazole in the form of pessaries is unknown.
Features of use
In isolated 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 preparations (contraceptive diaphragms, condoms) should be avoided due to a decrease in the reliability of mechanical contraception, so the possibility of pregnancy or sexually transmitted diseases is not excluded. Allergic reactions in the sexual partner, in particular hyperemia of the genitals, are possible, so during the treatment you should refrain from sexual life. Ketoconazole is recommended to be used at night, as the drug has an osmotic and draining effect, which is accompanied by an increase in 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 stopped and a doctor should be consulted. You should not violate the rules of use of the medicinal product - it can harm your health. The medicine contains butylhydroxyanisole, which can cause skin reactions. Use during pregnancy or breastfeeding. Systemic absorption with intravaginal use of ketoconazole is extremely small or absent, although there are no adequate controlled clinical studies on the safety of ketoconazole use in pregnant women. Ketoconazole is not used in the first trimester of pregnancy. In the II-III trimesters and during breastfeeding, the drug is used only when the expected benefit for the mother exceeds the potential risk for the fetus or child. The ability to influence the speed of reaction when driving vehicles or other mechanisms. Usually does not affect, but the possibility of developing dizziness in people with hypersensitivity should be taken into account.
Methods of application
The pessary is released from the strip and inserted deep into the vagina in a supine position with knees bent and legs pulled up to the chest or squatting. Pessaries should not be cut into parts, as such a change in the storage conditions of the drug can lead to a violation of the distribution of the active substance. Prescribe 1 pessary per day before going to bed for 3-5 days. If necessary, the course of treatment is repeated until clinical and laboratory recovery. In case of chronic candidiasis, 1 pessary is used for 10 days. Children. The drug is not used for children.
Overdose
In case of overdose, local reactions are possible: hyperemia, burning, itching, irritation of the mucous membrane of the vagina. In such cases, douching with water is recommended.
Side effects
Adverse reactions usually occur rarely and disappear quickly after the withdrawal of the drug. From the side of the skin and mucous membranes: itching, rash, burning, hyperemia, irritation of the mucous membrane in the vagina, urticaria, possible reactions at the injection site. From the digestive tract: nausea, abdominal pain. From the side of the nervous system: dizziness. From the immune system: hypersensitivity reactions, including anaphylactic and anaphylactoid reactions, angioedema. In case of any adverse reactions, 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 higher than 25 ºС. Keep out of the reach of children.
Packaging
5 pessaries in a strip of polyvinyl chloride film. 1 or 2 strips in a cardboard pack.
Leave category
Without a prescription.
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.