Candid (Tablets, Solution, Cream, Gel, Powder) Instructions for Use

ATC Code

G01AF02 (Clotrimazole)

Active Substance

Clotrimazole (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug with antifungal action for topical use in gynecology

Pharmacotherapeutic Group

Antimicrobial agents and antiseptics used in gynecology; antimicrobial agents and antiseptics, except combinations with corticosteroids; imidazole derivatives

Pharmacological Action

Antifungal agent with a broad spectrum of action for vaginal use. The action of clotrimazole is associated with the disruption of ergosterol synthesis, which is a component of the fungal cell membrane, this alters the permeability of the cytoplasmic membrane and causes subsequent cell lysis.

In low concentrations, it acts fungistatically, in high concentrations – fungicidally, and not only on proliferating cells. In 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.

Clotrimazole exhibits fungicidal and fungistatic activity against dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis), yeast-like and mold fungi (Candida spp., including Candida albicans; Torulopsis glabrata, genus Rhodotorula, Pityrosporum orbiculare).

It is active against the causative agent of pityriasis versicolor – Pityrosporum orbiculare (Malazessia furfur). Effective against gram-positive bacteria – the causative agent of erythrasmaCorynebacterium minutissimum, as well as Staphylococcus spp., Streptococcus spp., gram-negative bacteria – Bacteroides, Gardnerella vaginalis.

In high concentrations, it is active against Trichomonas vaginalis.

It does not affect lactobacilli. Primarily resistant variants of sensitive fungi are very rare; the development of secondary resistance in sensitive fungi is also noted in exceptional cases under therapeutic conditions.

Pharmacokinetics

When clotrimazole is applied intravaginally, absorption is 3-10% of the administered dose. High concentrations in vaginal secretion and low concentrations in the blood persist for 48-72 hours. It is metabolized in the liver to inactive metabolites, which are excreted from the body by the kidneys and through the intestines.

Indications

Genital infections caused by yeast-like fungi of the genus Candida (candidal vulvovaginitis); sanitation of the birth canal before childbirth.

ICD codes

Dosage Regimen

Solution

The drug is used topically. The solution is intended for dental use only.

Before use, the tip of the bottle should be pierced. 10-20 drops (0.5-1 ml) of the drug are applied to the affected areas of the oral cavity 3-4 times/day using a cotton swab. After applying the drug, you should refrain from drinking and eating.

Improvement usually occurs on the 3rd-5th day of treatment, but treatment must be continued until the clinical manifestations of the disease are completely eliminated.

If improvement does not occur after treatment or new symptoms appear, the patient should consult a doctor.

The drug should be used only according to the method of application and in the doses indicated in the instructions.

Cream, Powder

The dose, method and regimen of application are determined individually, depending on the indications, the age of the patient and the dosage form used.

For external use, the duration of treatment depends on the severity of the disease, the localization of pathological changes and the effectiveness of therapy.

The correspondence between the indications and the dosage form used should be strictly observed.

Tablets, Gel

The dose, method and regimen of application are determined individually, depending on the indications, the age of the patient and the dosage form used.

For topical application, the recommended duration of therapy is 6 days.

The correspondence between the indications and the dosage form used should be strictly observed.

Adverse Reactions

From the immune system: allergic reactions, incl. urticaria, shortness of breath, arterial hypotension, fainting.

From the digestive system frequency unknown – abdominal pain.

From the urinary system frequency unknown – frequent urination, intercurrent cystitis.

From the reproductive system frequency unknown – itching, burning, hyperemia and swelling of the vaginal mucosa, ulceration of the vaginal mucosa, rash, pelvic pain, burning sensation in the penis of the sexual partner, pain during sexual intercourse.

Other frequency unknown – headache.

Contraindications

Hypersensitivity to clotrimazole; first trimester of pregnancy, menstruation period.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy. Use in the second and third trimesters of pregnancy is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use during lactation, the issue of stopping breastfeeding should be decided.

Use in Hepatic Impairment

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

Pediatric Use

It is possible to use in children according to indications, in age-appropriate doses and dosage forms. It is necessary to strictly follow the instructions in the instructions for clotrimazole preparations regarding the use of specific dosage forms of clotrimazole in children of different ages and regarding contraindications for specific age groups in this category of patients.

Special Precautions

If allergic reactions or irritation occur at the site of application of the product, treatment should be discontinued.

To prevent reinfection, hygiene rules should be observed.

It is not recommended to apply clotrimazole to the skin in the eye area.

If clinical signs of infection persist after completion of treatment, a repeat microbiological examination should be performed to confirm the diagnosis.

To prevent infection/reinfection with genital infections, simultaneous treatment of sexual partners is necessary. During treatment, it is recommended to refrain from sexual intercourse.

When using dosage forms intended for topical intravaginal application, it is recommended to use reliable means of contraception. The risk of condom or diaphragm rupture increases when they are used simultaneously with the use of clotrimazole.

Drug Interactions

With simultaneous use with amphotericin B, nystatin, the activity of clotrimazole decreases.

Simultaneous use of clotrimazole intravaginally and tacrolimus, sirolimus orally may lead to an increase in the concentration of the latter in the blood plasma, so patients should be monitored for symptoms of overdose, if necessary, with measurement of plasma concentrations.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.