Candiva Ear Drops

Clotrimazole (Candiva Ear Drops) contains Clotrimazole, an imidazole antifungal drug, for topical use in superficial fungal infections.
Each mL contains: Clotrimazole 10 mg (1% w/v), Propylene Glycol USP base q.s.

Pharmacology: Pharmacodynamics: Mechanism of Action: Clotrimazole, an imidazole derivative, exerts antifungal effects by inhibition of fungal sterol synthesis. Clotrimazole appears to inhibit the enzymatic conversion of 2, 4-methylenedihydrolanosterol to demethylsterol, the precursor to ergosterol, which is an essential building block of the cytoplasmic membrane of the fungi.
Antimicrobial Spectrum: Fungi: Clotrimazole is a broad-spectrum antifungal agent that inhibits the growth of most fungi pathogenic to man, including the following: Candida spp; Dermatophytes (Trichophyton, Microsporum, Epidermophyton), Malassezia furfur.
Gram positive bacteria: Clotrimazole is known to possess in vitro activity against certain Gram positive bacteria.
Pharmacokinetics: Quantified pharmacokinetic studies for Clotrimazole (Candiva Ear Drops) have not been extensively conducted. Following are the relevant pharmacokinetic details of other topical Clotrimazole formulations: Systemic absorption following use of topical Clotrimazole preparations is very low. Estimated bioavailability is less than 0.5%. No Clotrimazole could be detected in the serum and the biochemical monitoring remained unchanged in animal studies with cutaneous Clotrimazole application. Clotrimazole concentrations achieved in the epidermal layers exceed the minimal inhibitory concentrations (MICs) for almost all pathogenic fungi. The highest levels are achieved in the stratum corneum (50 to 100 mcg/mL) and the lowest in the stratum basale papillare (1.53 to 3 mcg/mL). Absorbed Clotrimazole appears to be largely excreted in the feces, primarily via biliary excretion.

Clotrimazole (Candiva Ear Drops) are indicated for the topical treatment of otomycosis caused by susceptible fungi as aforementioned.

Thoroughly clean the ear canal of cerumen or debris. If possible, the fungal lesion should be scraped off from the site before instilling the ear drops to ensure better efficacy of the drug. Instill 4 or 5 drops in the infected ear 3-4 times daily. The patient should lie with the affected ear upward; instill the solution and let the patient remain in this position for few minutes to ensure penetration of the medication into the ear canal. Children should be supervised during the use of Clotrimazole (Candiva Ear Drops). Directions of instillation in children are specific to their age due to the difference in the ear canal characteristics: For children younger than 3 years, gently pull the outer ear down and toward the back of the head and then instill the ear drops.
For children older than 3 years, gently pull the outer ear up (like for adults) and toward the back of the head and then instill the ear drops.

Overdose with topical Clotrimazole preparations is unlikely. Studies have shown that topically applied Clotrimazole is well-tolerated and there is no evidence of systemic absorption.

Hypersensitivity reactions to Clotrimazole or other ingredients of the product.
Viral and non-susceptible bacterial infections of external auditory canal, including varicella and herpes simplex infections.
Perforation of the eardrum.

For OTIC use only.
Avoid contact with the eyes.
Clotrimazole (Candiva Ear Drops) should be discontinued if there are signs of sensitivity to any of its ingredients.
Clotrimazole (Candiva Ear Drops) should not be used for prolonged treatment.
In case of accidental ingestion, seek professional assistance (refer to Overdosage).
Use in Children: Cautious use in children (especially under 2 years of age), strictly under the advice and supervision of a doctor.
Safety and effectiveness in children have been established for Clotrimazole when used as indicated and in the recommended dosage. Children should be supervised during the use of Clotrimazole (Candiva Ear Drops). Lesser doses and lesser duration of therapy must be preferred in children. (Also refer to Dosage & Administration).

Pregnancy: Pregnancy Category B: Topically applied Clotrimazole is well-tolerated and there is no evidence of systemic absorption, embryotoxicity or teratogenicity in various animal studies.
Lactation: Excretion of Clotrimazole in breast milk is unknown. Clotrimazole (Candiva Ear Drops) should be used in lactating women, only if clearly needed.

Topical preparations of Clotrimazole are generally well tolerated. Adverse events that may occur with use of topical Clotrimazole preparations include: erythema, stinging, burning, pruritus, urticaria, and edema. Contact dermatitis may occur rarely.

Store at temperatures not exceeding 30°C.

Ear Anti-Infectives & Antiseptics

A01AB18 - clotrimazole ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth.

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