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AMIKACIN is a brand name for Amikacin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Amikacin Injection is a semi-synthetic, aminoglycoside antibiotic which is active against a broad spectrum of Gram-negative organisms, including pseudomonas and some Gram- positive organisms. Sensitive Gram-negative organisms include; Pseudomonas aeruginosa, Escherichia coli., indole-positive and indole-negative…
Verbatim from this product's MHRA label. Tap a section to expand.
Amikacin sulphate injection may be given intramuscularly or intravenously. Amikacin should not be physically premixed with other drugs, but should be administered separately according to the recommended dose and route. The patient’s pre-treatment bodyweight should be obtained for calculation of correct dosage.
The status of renal function should be estimated by measurement of the serum creatinine concentration or calculation of the endogenous creatinine clearance rate. The blood urea nitrogen (BUN) is much less reliable for this purpose. Reassessment of renal function should be made periodically during therapy.
Whenever possible, amikacin concentrations in serum should be measured to assure adequate, but not excessive levels. It is desirable to measure both peak and trough serum concentrations intermittently during therapy. Peak concentrations (30-90 minutes after injection) above 35 mcg/ml and trough concentrations (just prior to the next dose) above 10 mcg/ml should be avoided.
Dosage should be adjusted as indicated. In patients with normal renal function, once-daily dosing may be used; peak concentrations in these cases may exceed 35 mcg/ml. 25% over 30 minutes) may be used. Intramuscular and intravenous administration At the recommended dosage level, uncomplicated infections due to sensitive organisms should respond to therapy within 24 to 48 hours.
If clinical response does not occur within three to five days, consideration should be given to alternative therapy.
If required, suitable diluents for intravenous use are:
Normal saline, 5% dextrose in water. Once the product has been diluted the solution must be used as soon as possible and NOT STORED. e. 5 mg/kg q 12 h. 5 g. In endocarditis and in febrile neutropenic patients, dosing should be twice daily, as there is not enough data to support once daily dosing.
5 mg/kg q 12 h. In endocarditis and in febrile neutropenic patients dosing should be twice daily, as there is not enough data to support once daily dosing. 2). 2). The usual duration of treatment is 7 to 10 days. The total daily dose by all routes of administration should not exceed 15-20 mg/kg/day.
In difficult and complicated infections where treatment beyond 10 days is considered, the use of amikacin sulphate injection should be re-evaluated and, if continued, renal, auditory, vestibular function should be monitored, as well as serum amikacin levels.
This list is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories: very common (≥1/10), common (≥1/100, < 1/10), uncommon (≥1/1000, < 1/100), rare (≥1/10000, < 1/1000), very rare (<1/10000) and not known (cannot be estimated from the available data).
4. bAmikacin is not formulated for intavitreal use. Blindness and retinal infarction have been reported following intravitreous administrations (injection into the eye) of amikacin. All aminoglycosides have the potential to induce ototoxicity, renal toxicity, and neuromuscular blockade.
4) Renal function changes are usually reversible when the drug is discontinued. Toxic effects on the eighth cranial nerve can result in hearing loss, loss of balance, or both. Amikacin primarily affects auditory function. 4). Macular infarction sometimes leading to permanent loss of vision has been reported following intravitreous administration (injection into the eye) of amikacin.
When the recommended precautions and dosages are followed the incidence of toxic reactions, such as tinnitus, vertigo, and partial reversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting is low. Urinary signs of renal irritation (albumin, casts, and red or white cells), azotaemia and oliguria have been reported although they are rare.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Patients should be well hydrated during amikacin therapy. Caution should be applied to patients with pre-existing renal insufficiency, pre-existing hearing or vestibular damage and diminished glomerular filtration. Patients treated with parenteral aminoglycosides should be under close clinical observation because of the potential ototoxicity and nephrotoxicity associated with their use.
Safety for treatment periods which are longer than 14 days has not been established. If therapy is expected to last seven days or more in patients with renal impairment, or 10 days in other patients, a pre-treatment audiogram should be obtained and repeated during therapy.
Renal Toxicity Aminoglycosides are potentially nephrotoxic. Renal toxicity is independent of plasma obtained at the peak (Cmax). The risk of nephrotoxicity is greater in patients with impaired renal function, and in those who receive higher doses, or in those whose therapy is prolonged.
Patients should be well hydrated during treatment and renal function should be assessed by the usual methods prior to starting therapy and daily during the course of treatment. A reduction of dosage is required if evidence of renal dysfunction occurs, such as presence of urinary casts, white or red cells, albuminuria, decreased creatinine clearance, decreased urine specific gravity, increased BUN, serum creatinine, or oliguria.
If azotemia increases, or if a progressive decrease in urinary output occurs, treatment should be stopped. Elderly patients may have reduced renal function which may not be evident in routine screening tests such as BUN or serum creatinine.
A creatinine clearance determination may be more useful. Monitoring of renal function in elderly patients during treatment with aminoglycosides is particularly important. Renal and eighth-cranial nerve function should be closely monitored especially in patients with known or suspected renal impairment at the onset of therapy, and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy.
Amikacin sulphate injection is contraindicated in patients with known allergy to amikacin or any component of the formulation. A history of hypersensitivity or serious toxic reactions to aminoglycosides may contraindicate the use of any aminoglycoside because of the known cross sensitivities of patients to drugs in this class.
Aminoglycosides may impair neuromuscular transmission, and should not be given to patients with myasthenia gravis. 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If definite clinical response does not occur within 3 to 5 days, therapy should be stopped and the antibiotic susceptibility pattern of the invading organism should be rechecked. Failure of the infection to respond may be due to resistance of the organism or to the presence of septic foci requiring surgical drainage.
Intravenous administration The solution is administered to adults over a 30 to 60 minute period. Specific recommendation for intravenous administration In paediatric patients the amount of diluents used will depend on the amount of amikacin tolerated by the patient.
The solution should normally be infused over a 30 to 60 minute period. Infants should receive a 1 to 2 hour infusion. Elderly Amikacin is excreted by the renal route, renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.
5 g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15 g should not be exceeded. d. in adults). As the activity of amikacin is enhanced by increasing the pH, a urinary alkalinising agent may be administered concurrently.
Impaired renal function In patients with renal impairment reflected by creatinine clearance less than 50 mL/min, administration of the recommended total daily dose of amikacin in single daily doses is not desirable since these patients will have protracted exposure to high trough concentrations.
See below for dosage adjustments in patients with impaired renal function. For patients with impaired renal function receiving usual twice or three times daily dosing, whenever possible, serum amikacin concentrations should be monitored by appropriate assay procedures.
Doses should be adjusted in patients with impaired renal function either by administering normal doses at prolonged intervals or by administering reduced doses at fixed intervals. Both methods are based on the patient’s creatinine clearance or serum creatinine values since these have been found to correlate with aminoglycoside half-lives in patients with diminished renal function.
These dosage schedules must be used in conjunction with careful clinical and laboratory observations of the patient and should be modified as necessary, including modification when dialysis is being performed. Normal Dose at Prolonged Intervals Between […]
Serum concentrations of amikacin should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels. Urine should be examined for decreased specific gravity, increased excretion of proteins, and the presence of cells or casts.
Blood urea nitrogen, serum creatinine, or creatinine clearance should be measured periodically. Serial audiograms should be obtained where feasible in patients old enough to be tested, particularly high risk patients. Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss) or nephrotoxicity requires discontinuation of the drug or dosage adjustment.
Concurrent and/or sequential, oral, or topical use of other neurotoxic or nephrotoxic products, particularly bacitracin, cisplatin, amphotericin B, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycosides, should be avoided.
Other factors that may increase risk of toxicity are advanced age and dehydration. Patients suffering from pre-existing renal insufficiency should be assessed by the usual methods prior to therapy and periodically during therapy. Daily doses should be reduced and/or the interval between doses lengthened in accordance with serum creatinine concentrations to avoid accumulation of abnormally high blood levels and to minimise the risk of ototoxicity.
e. blood urea and serum creatinine. Neurotoxicity Neurotoxicity, manifested as vestibular and/or bilateral ototoxicity, can occur in patients treated with aminoglycosides. The risk of aminoglycoside-induced ototoxicity is greater in patients with impaired renal function, and in those who receive high doses, or in those whose therapy is prolonged over 5-7 days of treatment, even in healthy patients.
High frequency deafness usually occurs first and can be detected only by audiometric testing. Vertigo may occur and may be evidence of vestibular injury. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.
Ototoxicity The risk of ototoxicity due to aminoglycosides increases with the degree of exposure to either persistently high peak or high trough serum concentrations. Patients developing cochlear or vestibular damage may not have symptoms during therapy to warn them of developing eighth nerve toxicity, and total or partial irreversible bilateral deafness or disabling vertigo may occur after the drug has been discontinued.
Aminoglycoside-induced ototoxicity is usually irreversible. There is an increased risk of ototoxicity in patients with mitochondrial DNA mutations (particularly the nucleotide 1555 A to G substitution in the 12S rRNA gene), even if aminoglycoside serum levels are within the recommended range during treatment.
Alternative treatment options should be considered in such patients. In patients with a family history of relevant mutations or aminoglycoside induced deafness, alternative treatments or genetic testing prior to administration, should be considered.
Neuromuscular Toxicity Neuromuscular blockade and respiratory paralysis have been reported following parenteral injection, topical instillation (as in orthopaedic and abdominal irrigation or in local treatment of empyema), and following oral use of aminoglycosides.
The possibility of respiratory paralysis should be considered if aminoglycosides are administered by any route, especially in patients receiving anaesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, atracurium, rocuronium, vecuronium or in patients receiving massive transfusions of citrate-anticoagulated blood.
If neuromuscular blockade occurs, calcium salts may reverse […]