Amikacin, 250 mg/ml 2 ml 10 pcs

1 ml amikacin (in the form of sulfate) 250 mg.

Auxiliary substances: sodium disulfite (sodium metabisulfite), sodium citrate d / i (sodium citrate pentasquihydrate), sulfuric acid diluted, water d / i.

Indications

Infectious and inflammatory diseases caused by Gram-negative microorganisms (resistant to gentamicin, sisomycin and kanamycin) or associations of Gram-positive and Gram-negative microorganisms:
respiratory tract infections (bronchitis, pneumonia, pleural empyema, pulmonary abscess),
sepsis, septic endocarditis, CNS infections (including meningitis),
abdominal infections (includingPeritonitis),
complicated urogenital tract infections (pyelonephritis, cystitis, urethritis),
purulent skin and soft tissue infections (including infected burns).Infections of the skin and soft tissues (including infected burns, infected ulcers and bedsores of various genesis),
biliary tract, bone and joint infections (including osteomyelitis),
wound infection, postoperative infections.

Active ingredient

Composition

1 ml amikacin (in the form of sulfate) 250 mg.

Auxiliary substances:

Sodium disulfite (sodium metabisulfite),

sodium citrate d/i (sodium citrate pentasquihydrate),

sulfuric acid diluted,

water d/i.

How to take, the dosage

I/m, v/v (by jet, within 2 minutes or by drip), adults and children over 6 years old – 5 mg/kg every 8 hours or 7.5 mg/kg every 12 hours; bacterial urinary tract infections (uncomplicated) – 250 mg every 12 hours; an additional dose of 3-5 mg/kg may be prescribed after a hemodialysis session. Maximal dose for adults is up to 15 mg/kg/day, but not more than 1.5 g/day for 10 days.
Duration of treatment by intravenous injection is 3-7 days, by intravenous injection – 7-10 days.

In premature infants the initial dose is 10 mg/kg, then 7.5 mg/kg every 18-24 hours;

In newborns and children under 6 years old the initial dose is 10 mg/kg, then 7.5 mg/kg every 12 hours for 7-10 days.

Patients with renal insufficiency need to adjust the dosing regimen.

Patients with burns may require a dose of 5-7.5 mg/kg every 4-6 h due to a shorter T1/2 (1-1.5 h) in these patients.
For intravenous administration a solution prepared ex tempore from lyophilized powder with addition of 2-3 ml of water for injection to the contents of the bottle (0.25 or 0.5 g powder) is used. For intravenous administration the same solutions are used as for intravenous injection, pre-diluted with 200 ml of 5% dextrose solution or 0.9% NaCl solution. The concentration of amikacin in the solution for intravenous injection should not exceed 5 mg/ml.

Interaction

Pharmaceutically incompatible with penicillins, heparin, cephalosporins, capreomycin, amphotericin B, hydrochlorothiazide, erythromycin, nitrofurantoin, vitamins B and C, KCl.

It shows synergism in interaction with carbenicillin, benzylpenicillin, cephalosporins (in patients with severe CKD beta-lactam antibiotics may decrease the effect of aminoglycosides).

Nalidixic acid, polymyxin B, cisplatin and vancomycin increase the risk of ototoxicity and nephrotoxicity.
Diuretics (especially furosemide), cephalosporins, penicillins, sulfonamides and NSAIDs, competing for active secretion in nephron tubules, block elimination of aminoglycosides and increase their serum concentrations, increasing nephro- and neurotoxicity.

It increases the myorelaxant effect of curare-like drugs.

Methoxyflurane, polymyxins for parenteral administration, capreomycin, etc. Drugs that block neuromuscular transmission (halogenated hydrocarbons as drugs for inhalation anesthesia, narcotic analgesics), transfusion of large amounts of blood with citrate preservatives increase the risk of respiratory arrest (especially with intraperitoneal administration of amikacin).

Parenteral administration of indomethacin increases the risk of aminoglycoside toxicity (increased T1/2 and decreased clearance).

Decreases the effect of antimiasthenic drugs.

Special Instructions

The sensitivity of isolated pathogens is determined before use using discs containing 30 µg amikacin. When the diameter of the growth-free zone is 17 mm or more the microorganism is considered sensitive, from 15 to 16 mm – moderately sensitive, less than 14 mm – resistant.

The concentration of amikacin in plasma should not exceed 25 µg/ml (therapeutic concentration is 15-25 µg/ml).
During the treatment at least once a week the renal function, the auditory nerve and the vestibular system should be controlled.

The possibility of nephrotoxicity is higher in patients with impaired renal function as well as when prescribed in high doses or for a long time (daily monitoring of renal function may be required in this category of patients).
In case of unsatisfactory audiometric tests the drug dose is reduced or the treatment is stopped.

In the presence of “vital” indications the drug may be used in pregnant and lactating women (aminoglycosides penetrate into breast milk in small amounts, but they are poorly absorbed from the gastrointestinal tract and complications associated with them in breast children have not been reported).

Patients with infectious and inflammatory diseases of the urinary tract are advised to take increased amounts of fluids.

In the absence of positive clinical dynamics it should be remembered about the possibility of development of resistant microorganisms. In these cases, treatment should be stopped and appropriate therapy started.

The sodium bisulfite in the ampoule can cause allergic complications (up to and including anaphylactic reactions) in patients, especially in those with a history of allergy.

Contraindications

Hypersensitivity (including history of other aminoglycosides), neuritis of the auditory nerve, severe CPN with azotemia and uremia, pregnancy.

With caution.

Myasthenia gravis, parkinsonism, botulism (aminoglycosides may cause disruption of neuromuscular transmission, leading to further weakening of skeletal muscles), dehydration, renal failure, newborn period, premature babies, old age, lactation period.

Side effects

Digestive system: nausea, vomiting, liver dysfunction (increased activity of liver transaminases, hyperbilirubinemia).
Blood organs: anemia, leukopenia, granulocytopenia, thrombocytopenia.
Nervous system disorders: headache, somnolence, neurotoxic effect (muscle twitching, numbness, tingling sensation, epileptic seizures), violation of neuromuscular transmission (respiratory arrest).
Sensory organs: ototoxicity (decreased hearing, vestibular and labyrinth disorders, irreversible deafness), toxic effects on the vestibular system (discoordination of movements, dizziness, nausea, vomiting).
Urinary system: nephrotoxicity – renal dysfunction (oliguria, proteinuria, microhematuria).
Allergic reactions: skin rash, itching and hyperemia, fever, angioedema.

Overdose

Symptoms: toxic reactions (hearing loss, ataxia, dizziness, urinary disorders, thirst, decreased appetite, nausea, vomiting, ringing or tinnitus, respiratory disorders).

Treatment: to relieve neuromuscular transmission blockade and its consequences – hemodialysis or peritoneal dialysis; cholinesterase inhibitors, Ca2+ salts, EVI, other symptomatic and supportive therapy.