Generic Name

Composition

Therapeutic Category

Division

Clotrimazole + Lidocaine

Clotrimazole 1% w/v+ Lidocaine 2% w/v Ear Drops

Anti-infective

COSMO

    BRAND COMPOSITION DESCRIPTION
    CLOTIME L

    Clotrimazole IP                                1% w/v

    Lidocaine Hydrochloride BP        2% w/v

    Clear colourless solution filled in a 13.2 ml overflow capacity gamma sterilized lupolene vials plugged with gamma sterilized inner seal and capped with gamma sterilized caps.

     

    PATIENT INFORMATION

    Administration:

    • Use the ear drops as directed in the label.
    • Do not apply it to the eyes and never administer it by mouth.
    • If you suffer from an opening of the ear drum, tell your physician, as increased side effects may occur in patients with this condition.
    • Use the solution within one month after opening the container.
    • Do not use if the solution contains particles/suspended matter.

    Storage: Store below 25°C in a cool, dry place; Protect from light and moisture; Keep out of reach of children.

    Missed dose: Take the missed dose as soon as you remember; Skip the missed dose if it is almost time for your next scheduled dose; Do not take extra medicine to make up the missed dose.

     

    PHARMACOLOGY

    Clotrimazole

    Clotrimazole is a synthetic imidazole derivative. Clotrimazole is a broad-spectrum antifungal agent that has fungicidal activity against fungi responsible for superficial mycotic infections affecting the outer or middle ear including Candida, Microsporum, Trichophyton.

    Clotrimazole acts against fungi by inhibiting 14α demethylase enzyme thus prevent the conversion of lanosterol to ergosterol. Inhibition of ergosterol synthesis therefore, leads to structural and functional impairment of the fungal cytoplasmic membrane.

     Lidocaine

    Lidocaine (Lignocaine) is commonly applied topically for its strong local anesthetic properties. It has been proven to reduce pain in the auditory canal in patients affected by acute ear infections. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na+) channels in the neuronal cell membrane that are responsible for signal propagation.

     INDICATIONS

    Otomycosis, Fungal otitis externa.

     DOSE

    Instill 4 to 5 drops into the affected ear, 3 to 4 times daily.

     CONTRAINDICATIONS

    Hypersensitivity

     ADVERSE DRUG REACTIONS

    Common side effects such as itching or burning sensations in the ears may occur. Consult your physician immediately if any of these side effects persist or worsen, or if you notice any unusual symptoms after applying these ear drops.

    PRESENTATION

    Each vial contains 10ml of solution.