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Instructions for use AMIKACIN lyophilisate

Use with caution in patients with pre-existing renal impairment or pre-existing hearing or vestibular damage. Patients receiving parenteral aminoglycosides should be under close clinical monitoring due to potential ototoxicity and nephrotoxicity. Safety has not been established for treatment periods greater than 14 days. Necessary dosing precautions and adequate hydration must be observed.

In patients with impaired renal function or reduced glomerular filtration rate, renal function should be assessed by routine methods before initiation of treatment and periodically during therapy. Daily dosages should be reduced and/or the dosing interval extended according to serum creatinine concentrations to avoid the accumulation of abnormally high drug levels in the blood and to minimize the risk of ototoxicity. Regular monitoring of serum drug concentrations and renal function is especially important in elderly patients who may have decreased renal function because it may not be evident in the results of routine screening tests such as blood urea and serum creatinine.

If therapy will last seven days or more in patients with renal insufficiency, or 10 days in other patients, preliminary audiogram data should be obtained and re-evaluated during therapy. Amikacin therapy should be discontinued if subjective tinnitus or hearing loss develops or if subsequent audiograms show a significant decrease in high-frequency perception. If signs of irritation of the renal tissue (eg, albuminuria, red or white blood cells) appear, hydration should be increased and the dosage of the drug should be reduced. These disturbances usually disappear when treatment is completed. However, if azotemia increases or a progressive decrease in urine output occurs, treatment should be discontinued.

Neuro/Ototoxicity

Neurotoxicity, manifested as vestibular and/or bilateral auditory ototoxicity, may occur in patients treated with aminoglycosides. The risk of aminoglycoside-induced ototoxicity is greater in patients with impaired renal function, as well as in those receiving high doses or in those whose therapy lasts longer than 7 days. The resulting dizziness may indicate vestibular damage. Other manifestations of neurotoxicity may include numbness, tingling of the skin, muscle twitching, and seizures. As exposure increases, either due to persistently high aminoglycoside levels or high residual serum concentrations, the risk of ototoxicity increases.

Use of amikacin in patients with a history of aminoglycoside allergy or in patients who may have subclinical renal impairment or eighth nerve injury caused by prior administration of nephrotoxic and/or ototoxic agents such as streptomycin, dihydrostreptomycin, gentamicin, tobramycin, kanamycin, bikanamycin, neomycin, polymyxin B, colistin, cephaloridine, or biomycin should be considered with caution as there may be increased toxicity. In these patients, amikacin should be used only when, in the judgment of the physician, the therapeutic benefits outweigh the potential risks.

Neuromuscular toxicity

Neuromuscular blockade and respiratory paralysis have been reported after parenteral administration, installation (in orthopedic practice, abdominal irrigation, local treatment of empyema), and after oral administration of aminoglycosides. The possibility of respiratory paralysis should be considered if aminoglycosides are administered by any route, especially in patients receiving anesthetics, muscle relaxants such as tubocurarine, succinylcholine, decamethonium, or in patients receiving citrate-anticoagulated blood transfusions. If neuromuscular blockade occurs, calcium salts reverse respiratory paralysis, but mechanical ventilation may be necessary. Neuromuscular blockade and muscle paralysis have been demonstrated in laboratory animals treated with high doses of amikacin.

Aminoglycosides should be used with caution in patients with muscle disorders such as myasthenia gravis or parkinsonism, as these drugs may worsen muscle weakness due to their potential curare-like effects on neuromuscular transmission.

Renal toxicity

Aminoglycosides are potentially nephrotoxic drugs. The risk of developing nephrotoxicity is higher in patients with impaired renal function, as well as in those receiving high doses, as well as with long-term therapy. Good hydration is necessary during treatment, and renal function should be assessed by routine methods before starting therapy and during the course of treatment. If azotemia increases or a progressive decrease in urine output occurs, treatment should be discontinued.

Elderly patients may experience decreased renal function, which may not be apparent on routine screening tests such as blood urea nitrogen or serum creatinine. Determination of creatinine clearance may be more useful in such cases. Monitoring renal function during treatment with aminoglycosides is especially important in elderly patients.

In patients with known or suspected renal impairment, renal function and eighth cranial nerve function require monitoring during initiation of therapy, as well as in those whose renal function is initially normal but who develop signs of renal impairment during treatment. Amikacin concentrations should be checked whenever possible to ensure adequate dosing and avoid potentially toxic levels. Urine should be monitored for decreased specific gravity, increased protein excretion, and erythrocyturia. Blood urea, serum creatinine, or creatinine clearance should be measured periodically. Serial audiograms should be obtained whenever possible in elderly patients, especially in the high-risk group. Signs of ototoxicity (dizziness, tinnitus, tinnitus, and hearing loss) or nephrotoxicity require discontinuation of the drug or dose adjustment.

Concomitant and/or sequential 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 the risk of toxicity are advanced age and dehydration.

Other

Aminoglycosides are rapidly and almost completely absorbed when they are applied topically in conjunction with surgical procedures. Irreversible deafness, renal failure, and death due to neuromuscular blockade have been reported during irrigation of large and small surgical fields.

Like other antibiotics, the use of amikacin may result in overgrowth of nonsusceptible microorganisms. In this case, appropriate therapy should be prescribed.

Cases of irreversible vision loss have been reported after injection of amikacin into the vitreous humor of the eye.

Children

Aminoglycosides should be used with caution in preterm infants and neonates due to the immaturity of renal tissue in these patients as a result of the prolonged half-life of these drugs.

Intraperitoneal use of amikacin is not recommended for young children.

Impact on the ability to drive vehicles and operate machinery

Use with caution for vehicle drivers and people whose activities require increased concentration and good coordination of movements.

Use of the drug Amikacin

IM or IV. Adults and children are prescribed at a dose of 15 mg/kg body weight per day, dividing the daily dose into 2 administrations. In severe cases and for infections caused by Pseudomonas , the daily dose is divided into 3 administrations. The maximum daily dose is 1.5 g. The maximum course dose should not exceed 15 g. The duration of treatment is usually 3–7 days with intravenous administration and 7–10 days with intramuscular administration. Newborns, including premature infants, are prescribed an initial dose of 10 mg/kg, and then 7.5 mg/kg every 12 hours. When treating patients with impaired renal function, the daily dose should be reduced and/or the intervals between doses should be increased. The dose is reduced depending on the creatinine content in the blood plasma and the patient’s body weight. The interval between antibiotic administrations is calculated by multiplying the plasma creatinine level by 9; for example, if the creatinine level is 2 mg, the drug is prescribed every 18 hours. Administration of amikacin by intravenous infusion to adults and children should be carried out using a volume of fluid sufficient for drip infusion over 30–90 minutes (at a rate of 60 drops per 1 min), and for newborns - 1-2 hours. The concentration of p-ra amikacin when administered intravenously should not exceed 5 mg/ml. IV injection of amikacin should be given very slowly (over 2–7 minutes).

Pharmacological properties of the drug Amikacin

An aminoglycoside antibiotic with a broad spectrum of activity against gram-positive and gram-negative bacteria. Has a bactericidal effect. It is obtained semi-synthetically from kanamycin A. After intramuscular administration, it is quickly absorbed and distributed in the body. It is excreted unchanged in the urine mainly due to glomerular filtration. About 20% of the antibiotic binds to blood plasma proteins. A number of gram-negative microorganisms are sensitive to amikacin, including Pseudomonas spp., E. coli, Proteus spp . (indole-positive and indole-negative strains), Klebsiella spp., Enterobacter spp., Serratia spp., Salmonella spp., Shigella spp., Mima Herellea, Citrobacter freundii, Providencia spp., as well as gram-positive microorganisms ( Staphylococcus spp. and some strains of Streptococcus pneumoniae ). The antibiotic does not affect most anaerobes. Many strains of gram-negative microorganisms resistant to gentamicin may be sensitive to amikacin. Staphylococci resistant to penicillin, methicillin, and some cephalosporins are sensitive to amikacin.

Drug interactions Amikacin

The simultaneous administration of amikacin with anesthetics and muscle relaxants can cause blockade of neuromuscular transmission and paralysis of the respiratory muscles. Do not simultaneously use other ototoxic and/or nephrotoxic drugs, in particular antibiotics such as streptomycin, polymyxin B, neomycin, gentamicin. The simultaneous use of amikacin and fast-acting diuretics, for example derivatives of ethacrynic acid, furosemide, mannitol (especially if the diuretic is administered intravenously), can lead to the development of irreversible deafness. Amikacin should not be mixed with other antibacterial agents in the same volume.

Side effects of the drug Amikacin

Possible albuminuria, hematuria, cylindruria, hyperazotemia and oliguria; manifestations of ototoxicity (partially reversible or irreversible deafness, tinnitus, vestibular disorders), increased activity of liver transaminases and bilirubin concentration in the blood serum, allergic reactions (skin rash, itching, fever, less often - Quincke's edema), changes in the composition of peripheral blood (anemia , leukopenia, granulocytopenia, thrombocytopenia), nausea, vomiting, headache, drowsiness, very rarely - disturbance of neuromuscular transmission.