Candistin Ear Drop

Indications of Candistin 10 ml

This ear drop is indicated for the treatment of superficial bacterial and fungal infections of the external auditory canal and the middle ear, caused by organisms susceptible to the action of Ofloxacin and Clotrimazole.

Pharmacology

It’s an antibacterial, antifungal, anti-inflammatory, and topical local anesthetic drug all rolled into one. This ear drop was created with the goal of preserving the natural environment of the external ear canal.

Ofloxacin is a fluoroquinolone antibiotic with a broad spectrum of antimicrobial activity against otic infections and no ototoxicity. Hence For any application in the middle ear space, Ofloxacin is favored over Aminoglycosides. Ofloxacin works as an antibacterial agent by inhibiting bacteria’s DNA gyrase. Ofloxacin has been demonstrated to be effective against the bacteria that cause otic infections: Staphylococcus aureus and Streptococcus pneumoniae are Gram-positive bacteria. Escherichia coli, Haemophilus influenzae, Moraxella catarrhalis, Proteus mirabilis, and Pseudomonas aeruginosa are Gram-negative bacteria.

Clotrimazole is a synthetic imidazole derivative that is a broad-spectrum antifungal medication that has fungicidal activity against Candida, Microsporum, and Trichophyton, which cause superficial mycotic infections of the outer or middle ear. Clotrimazole inhibits the formation of Ergosterol by Cytochrome P-450, which reduces the integrity of fungal cell walls and hence inhibits fungal growth. Clotrimazole can also be used to treat germs like Streptococci and Staphylococci. Clotrimazole’s antibacterial properties make it ideal for treating mixed bacterial-fungal infections.

When compared to other topical corticosteroids, Beclomethasone Dipropionate is a powerful steroid. Anti-inflammatory, antipruritic, and vasoconstrictive characteristics are shared by beclomethasone and other topical corticosteroids. It activates phospholipase A2 and blocks the release of arachidonic acid in a sequential manner, reducing the production, release, and activity of prostaglandins, leukotrienes, and other inflammatory mediators.

Lidocaine Hydrochloride is a topical local anesthetic used to relieve ear pain and stinging.

Dosage & Administration of Candistin 10 ml

Adults & Children: Instill 2-5 drops three to four times daily into the affected ear for 7-14 days.

Otitis Externa with intact tympanic membrane: From age 06 months & older.

Chronic Suppurative Otitis Media with perforated tympanic membrane: 12 years & older.

Instruction to use: To apply, tilt the head to one side so that the ear is facing up. Then gently pull the ear lobe up & backward in case of adults and children older than 3 years. In the case of pediatric patients gently pull the ear lobe down & backward.

Contraindications

Patients who are allergic to Ofloxacin or other quinolones, or any of the drugs’ components, should avoid using this ear drop. It should not be used if you have an ear infection caused by a virus.

Side Effects of Candistin 10 ml

This ear drop does not have many systemic negative effects. Itching, burning, irritation, dryness, earache, headache, vertigo, dizziness, redness, folliculitis, hypertrichosis, acne-form eruptions, and hypopigmentation are all possible side effects when using this product.

Pregnancy & Lactation

There is no evidence of safety during pregnancy or lactation. When the active ingredients are given topically, it is unknown if they transfer into breast milk. As a result, the potential benefit of this product during pregnancy or lactation must be balanced against the potential risk to the fetus or nursing infant.

Precautions & Warnings

If a favorable response does not occur in one week, discontinue the use of this preparation and obtain cultures to guide further treatment.

As with other anti-infective preparations, prolonged use may result in the overgrowth of nonsusceptible organisms.

If local irritation or sensitization occurs, discontinue this preparation and institute appropriate therapy.

If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

Not for Ophthalmic use. Not for injection.

Storage Conditions

Keep away from light and moisture, and store below 25?C.