Selemicin solution vials 250mg/ml 2ml, 100pcs

Composition

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1 ml contains:

Active ingredient:

amikacin (in the form of sulfate) 250 mg;

Auxiliary substances:

sodium citrate,

sodium metabisulfite,

concentrated sulfuric acid

, d/i water.

Pharmacological action

An antibiotic of the aminoglycoside group.

A semi-synthetic broad-spectrum antibiotic that acts as a bactericidal agent.

Binding to the 30S subunit of ribosomes, it prevents the formation of a complex of transport and messenger RNA, blocks protein synthesis, and destroys the cytoplasmic membranes of bacteria. Highly active against aerobic gram-negative microorganisms:  Pseudomonas aeruginosa, Escherichia coli, Klebsiella spp., Serratia spp., Providencia spp., Enterobacter spp., Salmonella spp., Shigella spp., some gram-positive microorganisms:  Staphylococcus spp. (including those resistant to penicillin and some cephalosporins).

The drug is moderately active against Streptococcus spp.

When administered concomitantly with benzylpenicillin, it shows synergism against Enterococcus faecalis strains.

Amikacin does not lose activity under the action of enzymes that inactivate other aminoglycosides, and can remain active against strains of Pseudomonas aeruginosa resistant to tobramycin, gentamicin and netilmycin.

Amikacin is not active against anaerobic microorganisms.

Indications

Infectious and inflammatory diseases caused by gram-negative microorganisms (resistant to gentamicin, sizomycin and kanamycin) or associations of gram-positive and gram-negative microorganisms:

• respiratory tract infections (bronchitis, pneumonia, empyema, lung abscess);
• sepsis;
• bacterial endocarditis;
• infections of the Central nervous system (including meningitis);
• infection of the abdominal cavity (including peritonitis);
• urinary tract infection (pyelonephritis, cystitis, urethritis, prostatitis, gonorrhea);
• purulent infections of skin and soft tissues (including infected burns, infected sores and pressure ulcers of various origins);
• infection of the biliary tract;
• infections of bones and joints (including osteomyelitis);
• wound infection;
• postoperative infection;
• otitis media.

Use during pregnancy and lactation

The use of Selemycin during pregnancy and lactation is possible in the presence of vital indications (aminoglycosides enter breast milk in small quantities, but their absorption from the gastrointestinal tract is low, and complications associated with their use in children have not been reported).

Contraindications

• neuritis of the auditory nerve;
• severe renal failure with azotemia and uremia;
• pregnancy;
• hypersensitivity to the components of the drug (including other aminoglycosides) in the anamnesis.

With caution, the drug is used for myasthenia gravis, Parkinsonism, botulism (aminoglycosides can cause a violation of neuromuscular transmission, which leads to further weakening of skeletal muscles), dehydration, kidney failure, in newborns (especially premature babies), in the elderly, during lactation (breastfeeding).

Side effects

From the digestive system:  nausea, vomiting, liver function disorders (increased activity of hepatic transaminases, hyperbilirubinemia).

From the hematopoietic system:  anemia, leukopenia, granulocytopenia, thrombocytopenia.

From the central nervous system and peripheral nervous system:  headache, drowsiness, neurotoxic effects (muscle twitching, numbness, tingling, epileptic seizures), neuromuscular transmission disorders (respiratory arrest).

From the side of the senses:  ototoxicity (hearing loss, vestibular and labyrinth disorders, irreversible deafness), toxic effect on the vestibular apparatus (discoordination of movements, dizziness, nausea, vomiting).

From the urinary system:  nephrotoxicity – impaired renal function (oliguria, proteinuria, microhematuria).

Allergic reactions:  skin rash, pruritus, hyperemia of the skin, fever, angioedema.

Interaction

Pharmacologically incompatible with penicillins, heparin, cephalosporins, capreomycin, amphotericin B, hydrochlorothiazide, erythromycin, nitrofurantoin, vitamins B and C, potassium chloride.

Amikacin shows synergism when interacting with carbenicillin, benzylpenicillin, cephalosporins (in patients with severe chronic renal failure, when combined with beta-lactam antibiotics, the effectiveness of aminoglycosides may decrease).

Nalidixic acid, polymyxin B, cisplatin, and vancomycin increase the risk of oto – and nephrotoxicity.

Diuretics (especially furosemide), cephalosporins, penicillins, sulfonamides and NSAIDs, competing for active secretion in the nephron tubules, block the elimination of aminoglycosides, increase their concentration in the blood serum, increasing nephrotoxicity and neurotoxicity.

Enhances the muscle-relaxing effect of curare-like drugs.

Methoxyflurane, polymyxins for parenteral use, capreomycin and other drugs that block neuromuscular transmission (halogenated hydrocarbons as drugs for inhalation anesthesia, opioid analgesics), large-volume blood transfusions with citrate preservatives-increase the risk of respiratory arrest (especially with intraperitoneal use of amikacin).

Parenteral use of Indometacin increases the risk of toxic effects of aminoglycosides (increased T1 / 2 and decreased clearance).

Amikacin reduces the effectiveness of drugs for the treatment of myasthenia gravis.

How to take, course of use and dosage

IV, iv (jet for 2 minutes or drip) 5 mg/kg every 8 hours or 7.5 mg/kg every 12 hours. Bacterial infections of the urinary tract (uncomplicated) – 250 mg every 12 hours; after a hemodialysis session, an additional dose of 3-5 mg/kg can be prescribed. The maximum dose for adults is up to 15 mg / kg / day, but not more than 1.5 g / day for 10 days.

The duration of treatment with intravenous use is 3-7 days, with intravenous use-7-10 days.

For preterm infants, the initial dose is 10 mg / kg, then 7.5 mg / kg every 18-24 hours;for newborns, 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 dosage regimen.

Patients with burns may require a dose of 5-7.5 mg / kg every 4-6 hours due to the shorter T1/2 (1-1.5 hours) in these patients.

For intravenous use, the same solutions are used as for intravenous use, having previously diluted them with 200 ml of a 5% dextrose solution or 0.9% sodium chloride solution. The concentration of amikacin in the solution for intravenous use should not exceed 5 mg / ml.

Overdose

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

Treatment:  to remove the blockade of neuromuscular transmission and its consequences-hemodialysis or peritoneal dialysis; anticholinesterase agents, calcium salts, artificial ventilation, and other symptomatic and supportive therapy.

Special instructions

Before using the drug, the sensitivity of isolated pathogens is determined using disks containing 30 micrograms of amikacin. If the growth – free zone has a diameter of 17 mm or more, the microorganism is considered sensitive, from 15 to 16 mm – moderately sensitive, and less than 14 mm-resistant.

The concentration of amikacin in plasma should not exceed 25 mcg / ml (therapeutic concentration is 15-25 mcg / ml).

During the treatment period, it is necessary to monitor the function of the kidneys, auditory nerve and vestibular apparatus at least once a week.

The likelihood of developing nephrotoxicity is higher in patients with impaired renal function, as well as when the drug is prescribed in high doses or for a long time (in this category of patients, daily monitoring of renal function may be required).

In case of unsatisfactory audiometric tests, the dose of the drug is reduced or treatment is discontinued.

Patients with infectious and inflammatory diseases of the urinary tract are recommended to take an increased amount of fluid.

In the absence of positive clinical dynamics, one should keep in mind the possibility of developing resistant microorganisms. In such cases, it is necessary to cancel treatment and start appropriate therapy.

The metabisulfite contained in ampoules of sodium can lead to the development of allergic complications in patients (up to anaphylactic reactions), especially in patients with an allergic history.

Form of production

Solution for intravenous and intramuscular use

Storage conditions

The drug should be stored in a dry place, protected from light and inaccessible to children, at a temperature not exceeding 25°C.

Shelf life

3 years

Active ingredient

Amikacin

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion

Indications

Gastrointestinal Infections, Sepsis, Pneumonia, Urinary Tract Infections, Bronchitis, Skin Infections