Colposeptine® [Promestin, Chlorchinaldol]

Pharmacological properties

chlorochinaldol (5,7-dichloro-8-hydroxy-quinaldine) is a synthetic antibacterial substance of the group of quinoline derivatives, which acts bacteriostatically on gram-negative and gram-positive bacteria.

Resistance to chlorchinaldol develops slowly; there is no cross-resistance with antibiotics and other antimicrobial compounds (not groups of 8-hydroxyquinoline derivatives).

Promestrin has a local estrogenic effect on the vaginal mucosa: it promotes the proliferation of the vaginal epithelium, restores glycogen in the cells of the vaginal epithelium, which is a substrate for lactobacilli, restores the physiological pH of the vagina and thus prevents the recurrence of infections.

Pharmacokinetics With intravaginal administration, the Kolposceptin tablet interacts with the vaginal secretion, is cleaved and its components are released. Promethrin does not accumulate in tissues, less than 1% is absorbed, its T_½ is 24 hours. When administered intravaginally, promethrin does not show a resorptive effect, there are no systemic hormonal effects. Its effect on the vaginal epithelium is noted 1–2 days after the start of therapy. With intravaginal administration, chlorchinaldol is not absorbed and does not have a resorptive effect.

Indications

Vaginal atrophy due to estrogen deficiency in case of subclinical infection.

Application

1 tablet (previously moistened with water) is injected deep into the vagina for 18 days in the evening before going to bed. it is better to do this while lying on your back, slightly bending your legs at the knees. start treatment on any day of the menstrual cycle and do not interrupt for the duration of menstruation.

The duration of treatment is usually 18 days.

Children. Do not use the drug in children.

Contraindications

Hypersensitivity to any component of the drug.

Despite the absence of systemic effects, the drug should not be used, like any estrogen, with a history of estrogen-dependent tumors.

Breastfeeding (see Use during Pregnancy or Breastfeeding).

In combination with spermicides (see INTERACTIONS).

Side effects

By frequency, adverse reactions are divided into the following categories: very often (≥1 / 10); often (≥1 / 100 to 1/10); infrequently (≥ 1/1000 to 1/100); rarely (≥1 / 10,000, 1/1000); very rarely (1/10 000); unknown (impossible to estimate from the available data).

From the immune system: unknown - hypersensitivity.

From the skin and subcutaneous tissue: unknown - itching at the site of use.

From the reproductive system and mammary glands: unknown - vulvovaginal discomfort, vaginal bleeding.

special instructions

Before starting treatment, you should undergo a complete medical examination and confirm the diagnosis. mandatory is a classic gynecological examination, including a smear for backseeding.

During treatment, medical supervision is necessary.

Cases of vaginal bleeding have been reported during the use of the drug chlorchinaldol / promethrin, vaginal tablet. In case of bleeding, it is necessary to stop treatment and determine its etiology.

Chlorquinaldol is a halogenated hydroxyquinoline. Cases of cross-allergy with clioquinol, another halogenated hydroxyquinoline, have been reported.

Use during pregnancy or lactation. Pregnancy. Colposeptine is not indicated for use during pregnancy.

In clinical practice, the results of numerous epidemiological studies eliminate the risk of malformations due to the use of estrogen alone or in combination at the beginning of pregnancy, in contrast to diethylstilbestrol. As a result, in the event of pregnancy, with the use of estrogen there is no need to interrupt it.

Lactation. Systemic resorption of promethrin is weak. You should avoid taking Colposceptin during breastfeeding due to lack of data on its ingestion in breast milk.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Does not affect.

Interactions

The drug can counteract the contraceptive activity of spermicides, so their simultaneous use is not recommended. any local vaginal treatment can inactivate the contraceptive effect of topical spermicides.

Overdose

Given the route of administration and low resorption of promethrin, systemic overdose is unlikely.

Storage conditions

It does not require special storage conditions.