CANDID

INSTRUCTIONS for medical use of the medicinal product CANDID (CANDID)

Composition:

Active substance: clotrimazole;

1 g of powder contains 10 mg of clotrimazole;

Excipients: talc, corn starch, colloidal anhydrous silicon dioxide, cosmetic fragrance.

Pharmaceutical form. Topical powder.

Main physicochemical properties: homogeneous white or light yellow powder with a pleasant odour.

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. Hydrogen peroxide concentration increases to toxic levels, resulting in further cell damage.

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

Pharmacokinetics

When applied to the skin, clotrimazole penetrates into the stratum corneum and accumulates there. Only a minimal 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 of the excipients. 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 effect of clotrimazole is enhanced by high concentrations of propyl parahydroxybenzoate.

High doses of dexamethasone inhibit the antifungal activity of clotrimazole.

Special precautions for use.

Do not swallow.

The product is intended for dermatological use only.

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

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

Cross-sensitivity 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.

Application 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.

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 affect reaction speed when driving or operating machinery.

No effect.

Method of Administration and Dosage

Before applying the powder, wash the affected area with soap having a neutral pH and dry thoroughly. Apply the powder to the prepared affected area.

For adults, apply Candid powder to affected areas 2–3 times daily until symptoms of the disease have disappeared. The expected duration of treatment is as follows:

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

After subjective symptoms have resolved, continue using the medication for an additional 2 weeks, depending on the condition, to ensure therapeutic effectiveness.

Children.

There is no experience with the use of Candid powder 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 (including application 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 necessary if a life-threatening dose was ingested within the previous hour or if visible signs of overdose are present (e.g., dizziness, nausea, or vomiting). Gastric lavage should only be performed if adequate airway protection is ensured.

Adverse reactions.

Immune system disorders.

Allergic reactions, including discomfort, anaphylactic/anaphylactoid reactions (anaphylactic shock, angioedema, hypotension, syncope, dyspnea, urticaria), fainting.

Skin and subcutaneous tissue disorders.

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.

4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

30 g of the medicinal product in a bottle; 1 bottle per cardboard pack.

Supply category.

Over-the-counter.

Manufacturer.

Glenmark Pharmaceuticals Ltd. / Glenmark Pharmaceuticals Ltd.

Manufacturer's address and location of business operations.

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.