CANDID

INSTRUCTION FOR MEDICINAL USE OF THE MEDICINAL PRODUCT CANDID (CANDID)

Composition:

Active substance: clotrimazole;

100 ml of solution contain 1 g of clotrimazole;

Excipient: propylene glycol.

Pharmaceutical form. Topical solution.

Main physicochemical characteristics: colorless clear viscous liquid.

Pharmacotherapeutic group.

Antifungal agents for topical use. Imidazole and triazole derivatives.

ATC code D01A C01.

Pharmacological Properties.

Pharmacodynamics.

Clotrimazole is an imidazole derivative and a broad-spectrum antifungal agent. Its mechanism of action involves inhibition of ergosterol synthesis, which is essential for the formation of the fungal cell membrane, leading to disruption of membrane permeability and subsequent cell destruction. In addition, clotrimazole inhibits peroxidase activity, which further facilitates accumulation of hydrogen peroxide within the fungal cell. The concentration of hydrogen peroxide increases to a toxic level, resulting in further cell destruction.

Clotrimazole has a broad spectrum of activity: it is effective against dermatophytes and yeasts; it also exhibits antibacterial activity against causative agents of erythrasma, staphylococci (Staphylococcus spp.) and streptococci (Streptococcus spp.).

Pharmacokinetics.

When applied to the skin, it penetrates into the stratum corneum and accumulates there. Only a small amount of the drug is absorbed through the skin following topical application. It is almost not absorbed into the systemic circulation.

Clinical characteristics.

Indications.

Fungal skin and mucous membrane infections caused by pathogens sensitive to clotrimazole.

Pityriasis versicolor, erythrasma.

Contraindications.

Hypersensitivity to clotrimazole or to any other components of the drug. Hypersensitivity to other imidazoles.

Interaction with other medicinal products and other forms of interaction.

Clotrimazole inhibits the action of other topical antifungal agents, particularly amphotericin, nystatin, and natamycin.

The antimicrobial activity of clotrimazole is enhanced by high concentrations of propyl hydroxybenzoate.

Dexamethasone in high doses inhibits the antifungal activity of clotrimazole.

Special precautions for use

The product is intended for use in dermatological practice only.

The use of the product in ophthalmology is contraindicated. Avoid contact of the product with eyes. Do not apply near the eye area. Do not swallow.

Do not scratch itchy affected areas of skin, as this may lead to spreading of the infection.

In some cases, bacterial resistance to clotrimazole may occur. If no therapeutic effect is observed, alternative treatment methods should be considered.

Cases of cross-hypersensitivity reactions have been reported; therefore, if an allergic reaction to any imidazole-derivative antifungal agent occurs, cross-reactivity to other agents of this group should be considered. If an allergic reaction develops, treatment with clotrimazole should be discontinued.

Sexual contact should be avoided during treatment, as the infection may be transmitted to the partner.

Use of the solution in the genital area (external genital organs and perineum in women, or glans penis and foreskin in men) may reduce the effectiveness and safety of latex products such as condoms and diaphragms. This effect is temporary and may occur only during treatment.

The medicinal product contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding

Clinical studies on the effect of clotrimazole on female fertility have not been conducted; however, animal studies have shown no effect of clotrimazole on fertility.

The number of studies on the use of clotrimazole during pregnancy is limited. Animal studies have not revealed any direct or indirect adverse effects in terms of reproductive toxicity. As a precautionary measure, it is advisable to avoid using clotrimazole during the first trimester of pregnancy.

Breastfeeding should be discontinued during treatment with clotrimazole.

Ability to influence reaction rate when driving or operating machinery

No effect.

Method of Administration and Dosage

For adults, apply Candid, topical solution, to affected areas 2–3 times daily until symptoms of the disease disappear. The expected duration of treatment for symptom resolution is as follows:

• Dermatomycoses – 3–4 weeks;
• Erythrasma – 2–4 weeks;
• Tinea versicolor – 1–3 weeks.

After subjective symptoms have disappeared, treatment should be continued for an additional 2 weeks depending on the condition, to ensure therapeutic effectiveness.

Children.

There is no experience with the use of the drug in children; therefore, it should not be used in this patient population.

Overdose.

There is no risk of acute intoxication, as overdose is unlikely following a single vaginal dose or topical application to the skin (even over large skin areas under conditions favoring increased absorption), or after accidental oral ingestion. There is no specific antidote.

In case of accidental oral ingestion, gastric lavage may rarely be required if a life-threatening dose was ingested within the previous hour or if visible symptoms of overdose are present (e.g., dizziness, nausea, or vomiting). Gastric lavage should be performed only if adequate airway protection is ensured.

Side effects.

Immune system

Allergic reactions, including anaphylactic/anaphylactoid reactions (anaphylactic shock, angioneurotic edema, arterial hypotension, fainting, dyspnea, urticaria), syncope.

Skin and subcutaneous tissue

Redness, blistering, peeling, burning/heat sensation, tingling, local swelling, itching, rash, general irritation, pain/discomfort, peeling/exfoliation, dryness sensation; allergic, contact dermatitis.

The appearance of these symptoms requires discontinuation of treatment with the medicinal product.

Shelf life.

2 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

20 ml in a bottle with a tamper-evident cap. 1 bottle per cardboard box.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

Glenmark Pharmaceuticals Ltd./Glenmark Pharmaceuticals Ltd.

Manufacturer's address and location of business activity.

Plot No E-37/39, M.I.D.C., Industrial Estate, Satpur, Nasik – 422 007, India/Plot No E-37/39, M.I.D.C., Industrial Estate, Satpur, Nasik – 422 007, India.