Candide, vaginal gel 2% 30 g

Pharmacological action – antifungal topical.

Pharmacodynamics
Antimycotic effect of clotrimazole is associated with disruption of ergosterol synthesis, which is part of the cell membrane of fungi, which changes the membrane permeability and causes subsequent cell lysis. In low concentrations it is fungistatic and in high concentrations it is fungicidal, and not only on proliferating cells. In fungicidal concentrations it interacts with mitochondrial and peroxidase enzymes resulting in increase of hydrogen peroxide concentration to toxic level, which also promotes fungus cell destruction.

Effective against dermatophytes, yeast-like and mold fungi as well as Pityriasis versicolor and erythrasma pathogen. It has antimicrobial action against Gram-positive (staphylococcus, streptococcus) and Gram-negative bacteria (Bacteroides, Gardnerella vaginalis) as well as against Trichomonas vaginalis.

Pharmacokinetics
When clotrimazole is administered intravaginally, absorption is 3-10% of the administered dose. High concentrations in vaginal secretion and low concentrations in blood persist for 48-72 hours. In the liver it is quickly metabolized to inactive metabolites.

Indications

genital infections caused by yeast-like fungi of the genus Candida and/or Trichomonas vaginalis (vulvovaginal candidiasis, trichomoniasis);
genital superinfections caused by microorganisms sensitive to clotrimazole.

Pharmacological effect

Pharmacological action – local antifungal.

Pharmacodynamics
The antimycotic effect of clotrimazole is associated with a disruption in the synthesis of ergosterol, which is part of the cell membrane of fungi, which changes the permeability of the membrane and causes subsequent cell lysis. In small concentrations it has a fungistatic effect, in large concentrations it has a fungicidal effect, and not only on proliferating cells. At fungicidal concentrations, it interacts with mitochondrial and peroxidase enzymes, resulting in an increase in the concentration of hydrogen peroxide to a toxic level, which also contributes to the destruction of fungal cells.

Effective against dermatophytes, yeast-like and mold fungi, as well as the causative agent of pityriasis versicolor (Pityriasis versicolor) and the causative agent of erythrasma. Has an antimicrobial effect against gram-positive (staphylococci, streptococci) and gram-negative bacteria (Bacteroides, Gardnerella vaginalis), as well as against Trichomonas vaginalis.

Pharmacokinetics
With intravaginal administration of clotrimazole, absorption is 3–10% of the administered dose. High concentrations in vaginal secretions and low concentrations in the blood persist for 48–72 hours. In the liver, it is quickly metabolized to inactive metabolites.

Special instructions

To prevent urogenital reinfection, simultaneous treatment of sexual partners is necessary.

For trichomoniasis, for more successful treatment, other drugs that have a systemic effect (for example, metronidazole – orally) should be used together with Candida.

During pregnancy, treatment with vaginal gel should be carried out without an applicator.

In patients with liver failure, the functional state of the liver should be periodically monitored.

If signs of hypersensitivity or irritation appear, stop treatment.

Avoid contact of the drug with the mucous membrane of the eyes.

Do not use the drug during menstruation.

If there is no effect within 4 weeks, the diagnosis should be confirmed.

Active ingredient

Clotrimazole

Composition

1 g of gel contains:

Active ingredient:

Clotrimazole 20 mg;

Excipients:

Cetyl alcohol;

Propylene glycol, glycerol;

Benzyl alcohol;

Cetomacrogol emulsion wax;

Carbopol 940 (carbomer 940);

Sodium hydroxide;

Chlorocresol;

Purified water

Pregnancy

Clinical and experimental studies have not established that the use of the drug during pregnancy or breastfeeding has a negative effect on the health of the woman or fetus (child). However, the question of the advisability of prescribing the drug should be decided individually after consulting a doctor.

Contraindications

hypersensitivity to clotrimazole or excipients;
menstrual period;
pregnancy (first trimester).

With caution:
breastfeeding period.

Side Effects

Itching, burning, hyperemia and swelling of the vaginal mucosa, headache, gastralgia, frequent urination, intercurrent cystitis, burning sensation in the penis of the sexual partner, pain during sexual intercourse.

Interaction

When administered vaginally, clotrimazole reduces the activity of amphotericin B and other polyene antibiotics.

When used simultaneously with natamycin and nystatin, the activity of clotrimazole may be reduced.

Overdose

The use of the drug in high doses does not cause any reactions or life-threatening conditions.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C (do not freeze)
Keep out of the reach of children.

Shelf life

3 years
Do not use after the expiration date indicated on the package.

Manufacturer

Glenmark Pharmaceuticals Ltd, India