Indications

Gento-HC ear drops is indicated for the treatment of chronic suppurative otitis media, otitis externa and as prophylactic treatment of otitis externa following trauma. It is also indicated for post-operative local use in surgery to infected mastoid cavities. Use medicine according to the advice of a registered physician.

Pharmacology

Gentamicin is an aminoglycoside antibiotic and has a bactericidal action against many Gram-negative and some strains of Gram-positive bacteria. It binds to a specific receptor protein on the 30S subunit of bacterial ribosomes, interfering with protein synthesis and producing nonfunctional proteins. Hydrocortisone depresses formation, release, and activity of endogenous mediators of inflammation and modifies the immune response.

Dosage

Middle Ear Infection: Instill 2-4 drops in the affected ear three to four times a day and at night, or more frequently if required. Warm the suspension by holding the bottle in the hand for one to two minutes to avoid dizziness. Lie with the affected ear upward, instill drops, pump the tragus 5 times, and maintain position for two minutes. Discard unused portion after therapy. 
Ear Canal Infection: Instill 2-4 drops in the affected ear three to four times a day and at night, or more frequently if required. Warm the suspension by holding the bottle in the hand for one to two minutes. Lie with the affected ear upward, instill drops, and maintain position for two minutes. Discard unused portion after therapy. Use medicine according to the advice of a registered physician.

Administration

Wash hands: The person giving this ear drops should wash hands with soap and water. Clean ear and warm bottle: Gently clean discharge from the outer ear without inserting objects into the canal. Hold the bottle in the hand for one to two minutes to warm the suspension. 
Add drop: The recipient should lie on the side with the infected ear up. Put 2-4 drops into the infected ear without touching the tip to surfaces. Press ear or pull ear: For middle ear infection, gently press the tragus five times in a pumping motion. For ear canal infection, gently pull the outer ear lobe upward and backward. Stay on side: Remain on the side for at least two minutes. Repeat steps for the other ear if infected. Use medicine according to the advice of a registered physician.

Interaction

Gentamicin: Additive effect with neurotoxic or nephrotoxic drugs, cephalosporins, amphotericin B, ciclosporin, cisplatin, potent diuretics, and neuromuscular blocking agents. May potentiate anticoagulants, antagonize neostigmine and pyridostigmine, and increase risks with bisphosphonates, botulinum toxin, and indometacin. 
Hydrocortisone: Thiazides enhance hyperglycaemia and hypokalaemia. Increased incidence of peptic ulcer or GI bleeding with NSAIDs. Alters anticoagulant response and requires increased doses of antidiabetics and antihypertensives. Decreases serum concentration of salicylates and antimuscarinic agents. Ethanol enhances gastric mucosal irritation. Reduced efficacy with carbamazepine, phenytoin, primidone, barbiturates, and rifampicin. Mutual inhibition with ciclosporin. Enhanced effect with oestrogens or oral contraceptives.

Contraindications

This medicine is contraindicated in patients with known or suspected perforation, or risk of perforation of the tympanic membrane. It should not be used to treat viral infections of the external ear canal unless secondary bacterial infection is present. It is contraindicated in cases of known hypersensitivity to Hydrocortisone, Gentamicin, or any components of the product.

Side Effects

Ear discomfort and ear irritation may occur in rare cases. Gentamicin may cause irreversible partial or total deafness when given systemically or applied topically to open wounds or damaged skin.

Pregnancy and Lactation

Pregnancy: No adequate and well-controlled studies have been performed in pregnant women. Topical administration of corticosteroids to pregnant animals can cause foetal abnormalities. Exercise caution when used by a pregnant woman. Nursing Mothers: Administer only after careful assessment of potential risks and benefits.

Precautions and Warnings

Discontinue at the first appearance of hypersensitivity signs. Avoid long-term continuous therapy, as prolonged use may cause overgrowth of non-susceptible organisms including fungi. Perform cultures if infection does not improve after one week. Supplement with systemic antibiotics in severe infections.

Therapeutic Class

Hydrocortisone and combined preparations, Ophthalmic steroid-antibiotic combined preparations.

Storage Conditions

Store in a cool and dry place. Protect from light and freezing. Discard contents one month after opening.