Lactodepanthol (Suppositories) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Contact Information

NIZHPharm group of companies (Russia)

ATC Code

G01AD01 (Lactic acid)

Active Substance

Lactic acid (Ph.Eur. European Pharmacopoeia)

Dosage Form

Lactodepanthol

Vaginal suppositories 100 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

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

Excipients: mixture of macrogols: macrogol 1500 – (92-98)%, macrogol 400 – (8-2)%.

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

Clinical-Pharmacological Group

Drug regulating the balance of vaginal microflora

Pharmacotherapeutic Group

Antimicrobial agents and antiseptics used in gynecology; antimicrobial agents and antiseptics, except combinations with corticosteroids; organic acids

Pharmacological Action

Lactic acid is a natural product of the vital activity of lactic acid bacteria of the vagina, providing a pH of the vaginal secretion in the range of 3.5-4.5.

Suppositories with lactic acid help restore and maintain normal pH and vaginal flora, suppressing the growth of acid-sensitive pathogenic and opportunistic flora.

Lactic acid creates an acid reserve to correct the shift in pH to the alkaline side observed in vaginal infections. It helps to increase the natural protection of the vagina from genital infections.

Preclinical safety data

In an acute experiment, it was not possible to achieve toxic or lethal effects with intravaginal application in doses up to 10000 mg/kg (by finished dosage form) or in doses up to 333 mg/kg (by active substance) in female rats. The drug in all studied doses does not lead to the development of pathological shifts in the functions of the studied organs and systems, does not cause dystrophic, destructive, focal sclerotic changes in the parenchymal cells and stroma of the studied organs and does not have a local irritant effect when administered intravaginally.

Administration of suppositories with lactic acid (100 mg) to rats for 14 days did not have a general toxic effect on the animals or a local irritant effect on the vaginal mucosa. Daily intravaginal application of the drug for 30 days in doses of 9.1 and 91.0 mg/kg (by active substance) to female rats and in doses of 1.4 and 14.0 mg/kg to female rabbits does not lead to the development of pathological shifts in the general condition and behavior of the animals. The administration of the drug is not accompanied by a local irritant effect or tissue necrosis at the site of application (vaginal mucosa).

Lactic acid is a normal physiological component of vaginal fluid. Data on mutagenic and carcinogenic effects, on the effect of lactic acid on reproductive function are absent.

Pharmacokinetics

Pharmacokinetic data are not available.

Indications

Adults

• To normalize disturbed vaginal microflora and pH, incl. in bacterial vaginosis (as part of combination therapy).

ICD codes

Dosage Regimen

Adults

One vaginal suppository is inserted into the vagina (lying on the back with legs slightly bent) once/day. The course of treatment is 10 days.

Children

The safety and efficacy of Lactodepanthol in children aged 0 to 18 years have not been established to date. Data are not available.

Method of administration

Intravaginally. Before use, the suppository is removed from the contour packaging.

Adverse Reactions

Possible allergic reactions, itching; in isolated cases – burning in the vagina, which disappear after discontinuation of the drug.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting systems of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to lactic acid or to any of the excipients included in the drug;
• Candidal vulvovaginitis.

Use in Pregnancy and Lactation

Special studies of Lactodepanthol during pregnancy and breastfeeding have not been conducted. In studies conducted in animals, there were no signs of toxic effects of lactic acid on the fetus. In clinical studies of lactic acid in various dosage forms for intravaginal administration, no safety problems were identified.

Given the fact that Lactic acid is an intermediate product of mammalian metabolism and is normally present in the human body, incl. in amniotic fluid, breast milk, the use of Lactodepanthol during pregnancy and breastfeeding is possible after assessing the potential benefit for the mother and the risk for the fetus and the breastfed infant.

Consult your doctor before use.

Pediatric Use

Contraindicated for use in children under 18 years of age.

Special Precautions

If burning and itching occur, it is recommended to undergo an examination to exclude a fungal infection of the vagina.

Effect on the ability to drive vehicles and mechanisms

Does not affect.

Overdose

No cases of drug overdose have been reported.

Drug Interactions

No data available.

Storage Conditions

The drug should be stored at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 5 years.

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.