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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 is indicated in the treatment of following infections in adults and paediatric patients including neonates (see section 5.1) − Hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) − Complicated Urogenital tract infections including pyelonephritis − Complicated Intraabdominal…
Verbatim from this product's MHRA label. Tap a section to expand.
g. 5 mg/kg all 12 hours, or 5 mg/kg every 8 hours). 5 g. For endocarditis and febrile neutropenic patients, dosing should be done twice a day, as there is insufficient data for once-daily dosing. 5 mg/kg every 12 hours. For endocarditis and febrile neutropenic patients, dosing should be done twice a day, as there is insufficient data for once-daily dosing.
2). 2). 2). 5 g/day nor be administered for a period longer than 10 days. 5 g should not be exceeded. 5 mg/kg/day in two equally divided doses (equivalent to 250 mg twice daily in adults). As the activity of amikacin is enhanced by increasing the pH, a urinary alkalizing agent may be administered concurrently.
5 mg/ml) may be used satisfactorily as an irrigating solution in abscess cavities, the pleural space, the peritoneum and the cerebral ventricles. 5 mg/ml). If instillation is desired in adults, a single dose of 500 mg is diluted in 20 ml of sterile distilled water and may be instilled through a polyethylene catheter sutured into the wound at closure.
If possible, instillation should be postponed until the patient has fully recovered from the effects of anaesthesia and muscle-relaxing drugs. Monitoring The renal function status should be evaluated by measuring the serum creatinine concentration or preferably by estimation of creatinine clearance.
Blood urea nitrogen (BUN) is far less reliable for this purpose. Assessment of renal function should be performed at the start of therapy and should be re- evaluated at regular intervals during treatment. Amikacin concentrations in serum should be measured in all patients receiving parenteral amikacin and must be measured in obesity, if high doses are being given, the elderly and in cystic fibrosis.
Both peak and trough serum concentrations should be measured intermittently during therapy to ensure adequate but not excessive serum levels. In patients receiving multiple daily dosing peak concentrations (30-90 minutes after injection) of above 35 μg/ml and trough concentrations (just before the next dose) of above 10 μg/ml should be avoided.
In patients receiving once daily (or extended interval) dosing pre-dose ('trough') concentration should be less than 5 mcg/ml. Peak concentrations (approximately 60 minutes after administration) may exceed 35 mcg/ml. If the pre-dose ('trough') concentration is high, the interval between doses must be increased.
All aminoglycosides have oto-, nephro- and neurotoxic potential. 4).
Frequency is defined using the following convention:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); Not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
MedDRA system organ class Frequency Adverse event Infections and infestations Uncommon Super infection or colonization with resistant bacteria or yeastsa. Blood and lymphatic system disorders Rare Anaemia, eosinophilia, granulocytopenia, thrombocytopenia Immune system disorders Not known Anaphylactic response (anaphylactic reaction, anaphylactic shock and anaphylactic reaction), hypersensitivity Metabolism and nutrition disorders Rare Hypomagnesemia Nervous system disorders Rare Not known Tremora , paraesthesiaa, headache, balance disorders headache, balance Paresisa Eye disorders Rare Blindness**, retinal infarcta, Ear and labyrinth disorders Common Not known Tinnitusa, hypoacusisa, Chochlear damage Deafnessa, sensory deafnessa Vascular disorders Rare Hypotonia, thrombophlebitis Cardiac disorders Rare Tachycardia and myocarditis Respiratory, thoracic and mediastinal disorders Not known Apnoea, bronchospasm Gastrointestinal disorders Uncommon Vomiting, nausea Hepatobiliary disorders Rare Elevation of liver enzymes in plasma (SGOT, SGPT, LDH, alkaline phosphatase and bilirubin) Skin and subcutaneous tissue disorders Uncommon Rare Rash Pruritus, urticaria Musculoskeletal and connective tissue disorders Rare Arthralgia, myokymiaa Renal and urinary disorders Common Not known Nephrotoxicity, oliguriaa Increase in serum creatininea, albuminuriaa, azotemiaa, red blood cells in the urine, white blood cells in the urine, cells in the urine Acute renal failure General disorders and administration site conditions Rare Not known Fever Pain in the injection site** * Changes in renal function are usually reversible at the end of therapy.
Allergic reactions Amikacin contains sodium metabisulfite. Sodium metabisulfite may rarely cause severe hypersensitivity reactions in susceptible individuals, including anaphylactic symptoms and life-threatening bronchial spasms (bronchospasm).
Sulfite hypersensitivity is generally uncommon and more common in asthmatics than non-asthmatics. Neuromuscular toxicity Neuromuscular blockade and respiratory paresis have been reported following parenteral injection, topical lavage (such as orthopaedic and abdominal irrigation, or with local empyema treatment) or after oral administration of aminoglycosides.
5). Antidote in neuromuscular blockade: supply of calcium in ionized form (to relieve respiratory paralysis) and neostigmine. Mechanical ventilation may be necessary. In animal studies, neuromuscular blocks and myoparesis were found after administration of high doses of amikacin.
Aminoglycosides should be used with extreme caution in patients with myasthenia gravis as the curare-like effect on the neuromuscular junction may increase myasthenia with the potential for respiratory failure. Aminoglycosides should be used with caution in patients with muscular disorders such as parkinsonism, since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.
Nephrotoxicity and Ototoxicity Amikacin is potentially nephrotoxic and ototoxic; therefore, patients must be carefully monitored clinically. Particular caution should be applied to patients with pre-existing renal insufficiency, or pre-existing hearing or vestibular damage.
Safety for treatment periods which are longer than 14 days has not been established. Precautions regarding the dose should be observed and adequate hydration maintained. Neurotoxicity occurring in patients treated with aminoglycosides is manifested as vestibular and/or bilateral ototoxicity.
1 or other aminoglycoside antibiotics. − Due to the known cross sensitivities in this class of drugs, a history of hypersensitivity or serious toxic reactions to aminoglycosides may be a contraindication to all aminoglycosides. − Because of its sulfite content, Amikacin must not be used in asthmatics with sulfite hypersensitivity.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If the post-dose ('peak') concentration is high, the dose must be decreased. Auditory and vestibular function should also be monitored during treatment, in particular if longer treatment duration (>7-10 days) is considered.
Dosage in renal impairment NOTE:
In patients with impaired renal function (creatinine clearance <50 ml/min) the recommended dose has to be decreased and adjusted to the renal function. This can be achieved by increasing the dose interval and/or reducing the dose. In all patients with renal impairment, serum amikacin peak and trough concentration and renal function must be monitored regularly and the dose regimen altered as necessary (see below).
Once daily/extended interval dosing Patients with renal impairment in whom once daily dosing would be considered appropriate if their renal function were normal may receive extended interval dosing. The initial dose may be the same as in normal renal function.
The dose interval should be at least 24 hours and extended according to the degree of renal impairment and the results of serum amikacin level measurements (see Monitoring Advice). In severe renal impairment, the initial dose may have to be reduced in addition.
Once daily or extended interval dosing should be avoided in patients with a creatinine clearance less than 20 ml/minute. 73 m2. Reduced dose at fixed intervals If patients with renal impairment are given amikacin at fixed time intervals, the dose must be reduced.
In these patients, the serum amikacin concentration should be measured to ensure accurate administration and to avoid excessive serum concentrations. If a determination of serum concentration is not possible and the patient's condition is stable, serum creatinine and creatinine clearance rates are the most readily available indicators of the extent of renal dysfunction and the consequent reduction in dose.
As renal function may alter appreciably during therapy, the serum creatinine should be checked frequently and the dosage regimen modified as necessary. […]
** Amikacin is not intended for administration to the vitreous body. When amikacin was injected directly into the eye, maculopathies were observed, occasionally leading to complete loss of vision. g. alanine aminopeptidase, glutamine transferase, β-galactosidase, N- acetyl-glucosaminidase), azotemia, decrease in urine osmolarity, increase in blood urea nitrogen and serum creatinine, decrease in creatinine clearance.
In case of minor irritations (albumin, erythrocytes, leukocytes or cylinders in urine) the fluid intake should be increased. After discontinuation of the drug, renal impairment is usually reversible. As with all aminoglycosides, there have been reports of nephrotoxicity and acute renal failure following approval of amikacin.
5- 5 % of the treated patients. 4). When treating with amikacin, special attention should be paid to cochlear damage. These are manifested as tinnitus, pressure in the ears and initially merely as audiometrically detectable decrease of acoustic perceptions in the high frequency range (> 4000 Hertz) above the speech range.
However, hearing loss can develop to complete, irreversible deafness despite discontinuation of the aminoglycoside. Vestibular disorders manifest in initial symptoms such as dizziness, nausea, and vomiting. In the clinical examination usually a nystagmus is detected.
At the first sign of hearing or balance disorders, amikacin therapy should be discontinued.
Disorder of the nervous system Neuromuscular blockades:
Specific risks are very rare when taking aminoglycosides. The occurrence of neuromuscular blockade, which can lead to respiratory arrest, can occur especially with intrapleural or intraperitoneal administration. The neuromuscular blocking properties of the aminoglycosides are enhanced by inhalation narcotics or muscle relaxants or curare-like drugs.
Particularly at risk are patients with myasthenia gravis. Respiratory paresis requires artificial respiration. In addition, the application of potassium salts may be considered as a countermeasure. Immune system disorders Due to the content of sulfite it can lead to hypersensitivity reactions that may manifest as vomiting, diarrhoea, wheezing, acute asthma attack, disturbance of consciousness or shock in individual cases, especially in bronchial asthma.
These reactions can vary widely individually and can lead to life- threatening conditions 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.
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Ototoxicity 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. High frequency deafness usually occurs first and can be detected only by audiometric testing.
Vertigo or dizziness may occur and may be evidence of vestibular injury. Other manifestations of neurotoxicity include numbness, tingling of the skin, muscle twitching and muscle spasms. At the first sign of hearing and/or balance disorders, therapy with amikacin should be discontinued.
The risk of ototoxicity due to aminoglycosides increases with the level of exposure either through consistently high peak serum concentrations or high serum trough concentrations. Patients who develop auditory or vestibular damage may not have any symptoms during therapy that may alert them to eighth nerve damage, and total or partial irreversible bilateral deafness or disabling vertigo may occur after the drug has been discontinued.
Aminoglycoside-induced ototoxicity is usually irreversible. Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears and hearing loss) or nephrotoxicity requires discontinuation of the drug or dosage adjustment. The use of amikacin in patients with a history of allergy to aminoglycosides or in patients who may have subclinical renal or eighth nerve damage induced by prior administration of nephrotoxic and/or ototoxic agents such as streptomycin, dihydrostreptomycin, gentamicin, tobramycin, kanamycin, bekanamycin, neomycin, polymyxin B, colistin, cephaloridine, or viomycin should be considered with caution, as toxicity may be additive.
In these patients amikacin should be used only if, in the opinion of the physician, therapeutic advantages outweigh the potential risks. Nephrotoxicity Aminoglycosides are potentially nephrotoxic. Renal toxicity appears independent of plasma obtained at the peak (Cmax).
The risk of nephrotoxicity is increased in patients with impaired renal function and in patients receiving high doses or prolonged drug therapy. 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. Aminoglycosides may be inactivated by betalactams. ) taken for laboratory testing and then interfere with aminoglycoside level assays.
The samples should therefore be adequately treated after collection (immediate determination, storage in the freezer or addition of beta-lactamase). Concurrent and/or sequential systemic, 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. Other Aminoglycosides are quickly and almost totally absorbed when they are applied topically, except to the urinary bladder, in association with surgical procedures.
Irreversible deafness, renal failure and death due to neuromuscular blockade have been reported following irrigation of both small and large surgical fields with an aminoglycoside preparation. Prolonged antibiotic use may occasionally lead to overgrowth of resistant pathogens.
The patient should be constantly monitored in this regard. Should a superinfection occur […]