GENTAMICIN EYE DROPS COMPOSITION: Gentamicin Sulphate B.P. 0.3%wIv Gentamicin base (3000 units/ml) Benzalkonium Chloride Solution B.P. 0.02% vIv Sterile Buffered base q.s. Gentamicin is a bactericidal antibiotic of the aminoglycoside group. lt has a broad spectrum of action including numerous gram-positive and gram-negative bacteria. Gentamicin is particularly effective against pseudomonas aeruginosa. In addition, it affects staphylococci resistant to penicillin. INDICATIONS: Treatment of infections of the external structures of the eye and its adnexa caused by susceptible bacteria. Such infections include conjunctivitis, keratitis, kerato-conjunctivitis, corneal ulcers, blepharitis and blepharon conjunctivitis, acute meibomianitis, episcleritis and dacryocystitis. Also indicated for the treatment of otitis externa. CAUTION: Not for use with contact lenses. Avoid prolonged use. Prolonged use may lead to skin sensitisation and the emergence of resistant organisms. Cross-sensitivity with other aminoglycoside antibiotics may occur. WARNINGS AND PRECAUTIONS: In severe infections, topical use of gentamicin should be supplemented with appropriate systemic antibiotic treatment. Gentamicin may cause ototoxicity (vestibular damage; irreversible partial or total deafness) when given systemically or when applied topically to open wounds or damaged skin. Topical application of gentamicin into the middle ear also carries a theoretical risk of ototoxicity in susceptible patients. PHARMACODYNAMICS: Gentamicin is a bactericidal antibiotic that works by irreversibly binding the 30S subunit of the bacterial ribosome, interrupting protein synthesis. This mechanism of action is similar to other Aminoglycosides. PHARMACOKINETICS PROFILE: 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. CONTRAINDICATIONS: Hypersensitivity to any antibiotic of the aminoglycoside group. DRUG INTERACTION: Potent diuretics such as ethacrynic acid and frusemide are believed to enhance any risk of ototoxicity whilst amphotericin B, cisplatin and cyclosporin and cephalosporins are potential enhancers of nephrotoxicity. Concurrent use with other potentially nephrotoxic or ototoxic drugs should be avoided unless considered essential by the physician. Neuromuscular blockade and respiratory paralysis have been reported in patients from the administration of aminoglycosides to patients who have received curare-type muscle relaxants during anaesthesia. PREGNANCY/LACTATION: Gentamicin has been shown to depress body weights, kidney weights, and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. OVERDOSAGE AND TREATMENT OF OVERDOSAGE: Taking too much gentamicin, may cause the following: dizziness, hearing loss, numbness, skin tingling, muscle twitching or seizures. If you think you, or someone you care for, might have accidentally taken more than the recommended dose of gentamicin or intentional overdose is suspected, contact your local hospital. SIDE EFFECTS: Short-lasting and transient irritations of the skin such as skin rash, itching, stitching pain may occur, however, usually they do not necessitate interruption of treatment. In allergic sensibilization (Potently red conjunctiva, swollen eye lids) the drug should be discontinued immediately. A cross allergy to Gentamicin and other antibiotics of the aminoglycoside group may occur. Long-term topical application of Gentamicin may facilitate the growth of insensitive microorganisms, e.g., fungi. DOSAGE AND ADMINISTRATION: Gentamicin is instilled to the affected eye in a dose of 2-3 drops every 3-4 hours. In very severe infections 2 drops are instilled every hour. Gentamicin is instilled 2-3 drops in the external ear canal every 3-4 hours. Drops are applied during the day. After gradual improvement, the number of applications may be reduced. WARNING: Store below 30ºC. Discard the solution after 8 days from the day of opening of the bottle.
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