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.
Compound
The drug is a white powder of amikacin sulfate (in Latin - amikacini sulfatis).
To obtain the finished dosage form, it is necessary to dilute the substance with water for injection.
The procedure for administering the drug is quite painful, therefore, as an additional solvent, another 0.5% solution of novocaine or 2% solution of lidocaine is added to the water. These drugs act as pain-relieving components and alleviate the patient’s condition during injections.
Dosage regimen
The drug is intended for injection use only and can be administered intravenously or intramuscularly.
The dosage depends on the patient's weight.
For all people over 6 years of age, the calculation is made using the formula - 5 mg per 1 kg of body weight, administered every eight hours or 7.5 mg per kg of body weight, administered every 12 hours. The maximum allowable amount of the drug is 15 mg/kg per day. The duration of the treatment course depends on the method of administration of the substance, since the bioavailability of the drug differs.
- When administered intravenously, it is higher, and 3 days to a week is enough for recovery.
- If administered intramuscularly, it may take 10 days.
The calculation of daily and single doses in children under 6 years of age is different.
In newborns who were born prematurely and are premature, the initial dose is 10 mg per 1 kg of weight, then it is reduced to 7.5 mg every 24 hours. For all other children under six years of age, the dosage is similar, but the interval between injections is reduced to 12 hours.
Use in pregnant and lactating women
"Amikacin" (in Latin - amikacinum) is strictly contraindicated for pregnant women at any stage of gestation. Under no circumstances should you use the drug while in this position. Otherwise, this can have an extremely negative impact on the formation and development of the fetus.
"Amikacin" (in Latin - amikacinum) belongs to category D among drugs that have an effect on the fetus. This means that its side effects have been proven and can cause significant damage to the health of the unborn child (impaired or absent hearing, pathologies of internal organs, and so on).
If there is an urgent need to use the medicine, then the nursing woman will have to decide on stopping lactation.
Overdose
The drug has a systemic effect, affecting all human organs. Therefore, it is extremely important to follow the rules of use and dosage regimen. This will help avoid an overdose, which can lead to serious consequences. For example:
- blockade of nerves and muscles, complete cessation of breathing;
- depressed state of the central nervous system in the form of drowsiness, lethargy, stupor, falling into a coma.
If any of the listed symptoms appear, you should immediately seek medical help from a medical organization, where the overdose will be treated with intravenous administration of calcium chloride, subcutaneous - "NeosAmikacin" was in a place that is out of reach of children.
The shelf life of the drug is 2 years from the date of production. After this time, use of the drug is strictly prohibited.
An opened bottle should not be stored under any circumstances. One bottle - one use. And nothing else. Only under such conditions the sterility of the drug is not compromised.
