Lactogynal vaginal capsules, 14pcs

Composition

Composition for 1 capsule

Active ingredient:

Freeze-dried culture of lactobacilli L. casei rhamnosus Doderleini with at least 1 x 108 CFU of viable bacteria.

Excipients: magnesium stearate 3.41 mg, lactose monohydrate-5.59 mg, components of the drying protective medium (potato starch, lactose monohydrate, sodium glutamate, sodium thiosulfate).

Shell: gelatin.

Note:

Composition of the protective drying medium:

potato starch (~41.0% by weight of lyophilizate), lactose monohydrate (~20.6% by weight of lyophilizate), sodium glutamate (~4.5% by weight of lyophilizate), sodium thiosulfate (~26.8% by weight of lyophilizate).

Characteristics

Lactobacillus casei is a species of gram-positive rod-shaped anaerobic non-spore-forming bacteria.

Lactobacillus casei is a normal obligate flora of the human oral cavity, intestines, vulva and vagina.

Pharmacological action

Eubiotic

ATX code: G01AX14

Pharmacological properties

of Lactobacillus casei, along with other types of lactobacilli (L. acidophilus, L. fermentum, L. cellobiosum, etc. ), are present in the normal flora of the vulva and vagina of a woman. Colonization of the vagina with live L. casei rhamnosus Doderleini rods creates a similar physiological environment in the vagina. The L. casei rhamnosus Doderleini strain in Lactojinal ® has antagonistic activity against a wide range of pathogenic and opportunistic bacteria (including Staphylococcus spp., Proteus spp., enteropathogenic Escherichia coli), improves local metabolic processes and promotes the restoration of natural local immunity.

With the introduction of a capsule of the drug Lactojinal® in the vagina, the gelatin shell of the capsule dissolves with the release of a freeze-dried culture of live lactobacilli. In vitro, L. casei rhamnosus Doderleini has been shown to reduce pH within a few hours. This property of L. casei rhamnosus Doderleini, when the drug is introduced into the vagina, helps restore its natural microflora.

Lactobacillus deficiency is one of the most important factors in the development of candida vulvovaginitis. Lactobacilli are physiological antagonists of yeast-like fungi of the genus Candida due to the secretion of antifungal substances and competition for receptors on vaginal epithelial cells (inhibit the attachment of Candida to vaginal epithelial cells, inhibit their growth and reproduction).

The results of a clinical study showed the effectiveness of Lactojinal® in restoring normal vaginal microflora and preventing recurrent candida vulvovaginitis when used after completion of antifungal therapy.

An in vitro study showed resistance of the Lactobacillus casei subsp. rhamnosus LCR35 strain when co-cultured with a number of antibacterial drugs, including metronidazole and clindamycin. In addition, in vitro and in vivo studies revealed the phenomenon of potentiation of the action of antibiotics by metabolites of the probiotic strain Lactobacillus casei subsp. rhamnosus LCR35, which may contribute to improving the effectiveness of treatment of bacterial vaginosis with simultaneous use of an antibiotic and Lactojinal®. The results of a clinical study showed the effectiveness of Lactojinal® in the treatment of bacterial vaginosis when used simultaneously with the antibacterial drug clindamycin, vaginal cream 2%.

Indications

Restoration of normal vaginal microflora in bacterial vaginosis from the first day of antibacterial therapy or immediately after its completion; in preparation for elective gynecological operations; in prenatal preparation of pregnant women at risk for bacterial vaginosis.

Prevention of recurrent vulvovaginal candidiasis (including exacerbations of recurrent vulvovaginal candidiasis) after local and / or systemic antifungal therapy.

Use during pregnancy and lactation

Lactojinal® can be used during pregnancy and lactation.

Contraindications

Side effects

Allergic reactions (including itching, burning, redness in the genital area; increased mucosal discharge from the vagina).

If you experience any of the side effects listed in the instructions, or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

It is not recommended to use the drug together with spermicidal agents.

It can be used simultaneously with antibacterial, antiviral and immunomodulatory drugs.

No clinically significant cases of interaction were reported.

If you are using the above medications or other medications (including over-the-counter medications), please consult your doctor before using the drug.

How to take, course of use and dosage

Method of application – intravaginally.

Insert the capsule deep into the vagina, wetting it in a small amount of water to speed up the dissolution of the drug.

Restoration of normal vaginal microflora in the treatment of bacterial vaginosis:

• one capsule in the morning and evening for 7 days or one capsule daily for 14 days after completion of antibacterial therapy; or
• one capsule daily for 14 days from the first day of antibacterial therapy.

When preparing for elective gynecological operations, prenatal preparation of pregnant women at risk for bacterial vaginosis: one capsule in the morning and evening for 7 days or one capsule daily for 14 days – as part of complex therapy.

The dosage regimen should be adjusted depending on the severity of the clinical effect.

Prevention of recurrent vulvovaginal candidiasis (including exacerbations of recurrent vulvovaginal candidiasis) after local and / or systemic antifungal therapy: 1 capsule per night. The duration of therapy with the drug is determined by the doctor. The course of treatment should not exceed 21 days. The issue of conducting repeated courses is decided individually.

If there is no improvement after treatment, or if the symptoms worsen or new symptoms appear, you should consult your doctor. Use the drug only according to the indications, the method of use and in the doses indicated in the instructions for use.

Overdose

No overdose cases have been reported.

Description

Transparent gelatin capsules of size “0”, filled with light yellow powder with a brownish tinge of color.

Special instructions

After use, the capsule dissolves, leaving no stains on the laundry or smell.

The drug is intended for use in women over 18 years of age.

Influence on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles or engage in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Capsules are vaginal. 14 capsules each in a colorless transparent glass bottle, capped with a chlorobutyl elastomer stopper; the neck of the bottle with the stopper is wrapped in a protective transparent PVC shrink film. The bottle together with the instructions for use is placed in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf

life is 2 years. Do not use after the expiration date.

Active ingredient

Freeze-dried culture of lactobacilli Lactobacillus casei rhamnosus Doderleini

Dosage form

vaginal capsules

Description

For adults

Indications

Vaginal candidiasis, From thrush, After a course of antibiotic therapy