Contraindications
Hypersensitivity to gentamicin or other aminoglycosides. Myasthenia gravis. Known or suspected perforated tympanic membrane (otic).
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Special Precautions
Patient with family history of ototoxicity, pre-existing vertigo, tinnitus, or hearing loss; neuromuscular disorders (e.g. parkinsonism); hypocalcaemia, hypokalaemia, hypomagnesaemia; significant obesity. Dehydrated patients. Patients with certain MT-RNR1 gene variants. Not intended for long-term treatment (otic/ophthalmic/topical). Avoid concomitant or sequential use of other neurotoxic and/or nephrotoxic drugs, and concomitant use with potent diuretics. Renal impairment. Neonates, children, and elderly. Pregnancy and lactation. Patient Counselling Ophthalmic: This drug may cause transient blurring of vision, if affected, do not drive or operate machinery. Remove contact lenses prior to instillation of eye drops and wait for at least 15 minutes before reinserting the lenses. Monitoring Parameters Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Obtain urine output, urinalysis, BUN, serum creatinine, or CrCl periodically. Closely monitor peak and trough serum gentamicin concentrations periodically (especially for systemic treatment); eighth cranial nerve function (particularly in patients with known or suspected renal impairment); hearing function prior to initiation, during and after treatment. Assess for signs and symptoms of serious skin reactions, ototoxicity, neurotoxicity and nephrotoxicity.
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Adverse Reactions
Significant: Nephrotoxicity (reversible), neurotoxicity manifested by ototoxicity (both vestibular and auditory effects); neuromuscular blockade, respiratory paralysis; bacterial or fungal superinfection (prolonged use), including Clostridioides difficile-associated diarrhoea and pseudomembranous colitis; severe cutaneous adverse reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis), hypersensitivity reactions; delayed corneal healing (ophthalmic); local sensitisation, including burning or stinging sensation and irritation (otic/ophthalmic/topical).
Blood and lymphatic system disorders: Anaemia, agranulocytosis, granulocytopenia, leucopenia, thrombocytopenia, eosinophilia.
Eye disorders: Blurred vision, eye pruritus, bacterial and fungal corneal ulcers, non-specific conjunctivitis, conjunctival epithelial defects, conjunctival hyperaemia.
General disorders and administration site conditions: Inj site pain, fever.
Gastrointestinal disorders: Vomiting, nausea, stomatitis, increased salivation.
Investigations: Increased serum transaminases, weight loss.
Metabolism and nutrition disorders: Hypomagnesaemia (prolonged use); decreased appetite.
Musculoskeletal and connective tissue disorders: Arthralgia, muscle weakness.
Nervous system disorders: Headache, myasthenia gravis-like syndrome, convulsions, lethargy, peripheral neuropathy or encephalopathy.
Psychiatric disorders: Depression, confusion, hallucinations.
Renal and urinary disorders: Oliguria, Fanconi-like syndrome, acute renal failure.
Skin and subcutaneous tissue disorders: Rash, pruritus, purpura, urticaria, alopecia; dermatitis (otic/ophthalmic); erythema (topical).
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ROUTE(S) : Ophth: C
ROUTE(S) : IM / IV / Parenteral: D
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Drug Interactions
Increased risk of ototoxicity with potent diuretics (e.g. etacrynic acid, furosemide). Enhanced neurotoxic and/or nephrotoxic effects with other aminoglycosides (e.g. amikacin, neomycin), vancomycin, viomycin, colistin, amphotericin B, polymyxin B, cisplatin, ciclosporin, and cephalosporins (particularly cefaloridine). May increase the risk of neuromuscular blockade and respiratory paralysis with neuromuscular blocking agents (e.g. suxamethonium, decamethonium, tubocurarine). Increased risk of hypocalcaemia with bisphosphonates. May decrease thrombin levels and increase the risk of bleeding with oral anticoagulants. May antagonise the effects of neostigmine or pyridostigmine. Concomitant use with indometacin may increase the plasma gentamicin concentrations in neonates.
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ATC Classification
S01AA11 - gentamicin ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
S02AA14 - gentamicin ; Belongs to the class of antiinfectives used in the treatment of ear infections. S03AA06 - gentamicin ; Belongs to the class of antiinfectives used in ophthalmologic and otologic preparations. D06AX07 - gentamicin ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases. J01GB03 - gentamicin ; Belongs to the class of other aminoglycosides. Used in the systemic treatment of infections. |