AMIKACIDE Amikacin 50mg / mL Solution for IM/IV Injection 3mL 5's

Adult, childn & older infant 15 mg/kg/day given as a single dose or divided into 2-3 equal doses administered at equally divided intervals. Uncomplicated UTI Single dose of 500 mg daily or 250 mg bid. Newborn Loading dose: 10 mg/kg, followed by 7.5 mg/kg every 12 hr; 0-7 days, <2 kg 7.5 mg/kg every 18-24 hr for 7-10 days. Peritoneal dialysis 7.5 mg/kg. Renal impairment CrCl >80 mL/min 15 mg/kg every 24 hr, 60-80 mL/min 12 mg/kg every 24 hr, 40-60 mL/min 7.5 mg/kg every 24 hr, 30-40 mL/min 4 mg/kg every 24 hr, 20-30 mL/min 7.5 mg/kg every 48 hr, 10-20 mL/min 4 mg/kg every 48 hr, <10 mL/min 3 mg/kg every 72 hr.

Known hypersensitivity to amikacin and other components of this product.
History of hypersensitivity or toxic reactions to aminoglycosides.

This product contains metabisulfite which may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
Safety for treatment periods longer than 14 days has not been established.
Patients treated with parenteral aminoglycosides should be under close clinical observation. Amikacin sulfate injection is potentially nephrotoxic, ototoxic and neurotoxic. Avoid concurrent use of other ototoxic or nephrotoxic agents because of the potential additive effects.
Patients with preexisting tinnitus, vertigo, subclinical high-frequency hearing loss, or renal impairment and patients who are receiving high doses and/or prolonged therapy with aminoglycosides or who have received prior ototoxic drugs are especially susceptible to ototoxicity and should be carefully observed for signs of eighth cranial nerve damage during aminoglycoside therapy.
Assess kidney function by the usual methods prior to starting therapy and daily during the course of treatment. If signs of renal irritation appear, increase hydration. A reduction in dosage may be recommended if other evidence or renal dysfunction occurs such as decreased creatinine clearance, decreased urine specific gravity, and increased BUN, creatinine or oliguria. Stop the treatment if azotemia increases or if a progressive decrease in urinary output occurs.
Amikacin should be used with caution in patients with neuromuscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular function.
Use of amikacin may result in overgrowth of nonsusceptible organisms. If this occurs, appropriate therapy should be instituted.
General: Prescribing amikacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patients and increases the risk of the development of drug-resistant bacteria.
Use in Children: Use amikacin with caution and in reduced dose in premature and full-term neonates because of the renal immaturity of these patients and resulting prolongation of serum half-life of the drug.
Use in Elderly: Special care is required when using amikacin in the elderly in whom renal function may be impaired, as old age appears to be an independent risk factor for ototoxicity and nephrotoxicity. Measure blood levels frequently and give the drug for no longer than is essential.

All aminoglycosides have the potential to induce auditory, vestibular, and renal toxicity and neuromuscular blockade. They occur more frequently in patients with present or past history of renal impairment, of treatment with other ototoxic or nephrotoxic drugs, and in patients treated for longer periods and/or with higher doses than recommended.
Neurotoxicity-ototoxicity: Toxic effects on the eighth cranial nerve can result in hearing loss, loss of balance or both. Amikacin primarily affects auditory function. Cochlear damage includes high frequency deafness and usually occurs before clinical hearing loss can be detected.
Neurotoxicity-Neuromuscular Blockage: Acute muscular paralysis and apnea can occur after treatment with aminoglycosides.
Nephrotoxicity: Elevated serum creatinine, albuminuria, presence of casts, red and white blood cells in the urine, azotemia, and oliguria have been reported. Renal function changes are usually reversible when the drug is discontinued.
Others: Rarely, skin rash, drug fever, headache, paresthesia, tremor, nausea and vomiting, eosinophilia, arthralgia, anemia, hypotension, and hypomagnesemia.

Neurotoxic, Ototoxic or Nephrotoxic Drugs: Avoid concurrent and/or sequential use with other drugs with similar toxic potential (e.g., other aminoglycosides, acyclovir, amphotericin B, bacitracin, capreomycin, cephalosporins, colistin, cisplatin, methoxyflurane, polymyxin B, vancomycin), if possible. In addition, do not give amikacin concurrently with ethacrynic acid, furosemide, urea, or mannitol because of the possibility of an increased risk of ototoxicity due to additive effects of altered serum and tissue concentrations of the antibiotics. Keep in mind the possibility that dimenhydrinate and other anti-emetics may mask symptoms of vestibular ototoxicity.
General Anesthetics and Neuromuscular Blocking Agents: Concurrent use of an aminoglycoside with general anesthetics of neuromuscular blocking agents (e.g., succinylcholine, tubocurarine) may potentiate neuromuscular blockade and cause respiratory paralysis. Use with caution in patients receiving such agents and observe signs of respiratory depression.
Neomycin: Oral neomycin may potentiate the effects of oral anticoagulants. Monitor prothrombin times in patients receiving concomitant oral aminoglycoside and oral anticoagulant therapy and adjust the dose of the anticoagulant as required.
Anti-infective Agents: In vitro studies indicate that the antibacterial activity of aminoglycosides and beta-lactam antibiotics or vancomycin may be additive or synergistic against some organisms including enterococci and P. aeruginosa. In vitro studies also indicate that aminoglycosides and extended-spectrum penicillins also exert a synergistic bactericidal effect against Enterobacteriaceae.

Aminoglycosides