Indications

Gentamicin & Hydrocortisone ear drops is indicated for the treatment of chronic suppurative otitis media, otitis externa and as prophylactic treatment of otitis externa following trauma. Gentamicin & Hydrocortisone ear drops is also indicated for post-operative local use in surgery to infected mastoid cavities.

Gentamicin & Hydrocortisone cream is indicated for redness, itching, and swelling of the skin

Pharmacology

Gentamicin is an aminoglycoside that binds to 30s and 50s ribosomal subunits of susceptible bacteria disrupting protein synthesis, thus rendering the bacterial cell membrane defective.

Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.

Dosage

Ear Drops-

For 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. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for two minutes. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed. For 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. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for two minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.


Cream-

For redness, itching, and swelling of the skin: Apply to the affected area of the skin two or three times per day.

Administration

Ear Drops need to shake well immediately before use.

Interaction

Gentamicin: Additive effect with other neurotoxic and/or nephrotoxic drugs including cephalosporins, methicillin, amphotericin B, ciclosporin, cisplatin, potent diuretics (e.g. ethacrynic acid, furosemide) and neuromuscular blocking agents (e.g. succinylcholine, tubocurarine). May potentiate the effect of anticoagulants (e.g. warfarin, phenindione). May antagonise the effect of neostigmine and pyridostigmine. Increased risk of hypocalcaemia with bisphosphonates. Increased risk of neuromuscular blockade with botulinum toxin. Indometacin may increase the plasma concentration of gentamicin in neonates.

Hydrocortisone: Thiazides may enhance hyperglycaemia and hypokalaemia caused by corticosteroids. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents. Ethanol may enhance gastric mucosal irritation. Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Mutual inhibition of metabolism between ciclosporin and corticosteroids increase plasma cone of both drugs. Enhanced effect in women taking oestrogens or oral contraceptives.

Contraindications

History of hypersensitivity to aminoglycoside; pregnancy; hepatic impairment.

Side Effects

Allergic contact dermatitis, Transient irritation, burning, stinging, Increased redness, lacrimation

Pregnancy & Lactation

Pregnancy Category- C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Precautions & Warnings

Concurrent use of neuromuscular blocking agents; myasthenia gravis, parkinsonism; conditions predisposing to ototoxicity and nephrotoxicity; lactation. Monitor plasma concentrations of gentamicin in patients receiving high doses or prolonged courses, in infants, elderly, patients with renal impairment, cystic fibrosis or significant obesity. Monitor auditory and renal functions.

Therapeutic Class

Hydrocortisone & Combined preparations, Ophthalmic steroid - antibiotic combined preparations