Amikacin instructions for use
Amikacin is an antibacterial drug. The main active ingredient of this drug (amikacin sulfate) belongs to the group of antibiotics - aminoglycosides. Amikacin is active against most bacteria that cause infectious diseases.
Release form and composition
Amikacin is produced in the form of an injection solution in ampoules of 4 ml each and a powder for preparing the solution in vials. The ampoules are packaged in a blister strip package that contains 5 or 10 ampoules of solution. In one carton pack there can be 1 or 2 blisters with the corresponding number of ampoules (5 and 10 pieces).
Powder for the preparation of the solution is available in vials. One cardboard pack can contain 1, 5 or 10 bottles.
The main active ingredient of the drug is amikacin sulfate. Its amount is 250 mg in 1 ml of solution. Also included are excipients:
- Sodium citrate for injection.
- Sulfuric acid diluted.
- Sodium disulfite.
- Water for injections.
In the vial of amikacin sulfate may be contained in several dosages - 250, 500 and 1000 mg. A different number of ampoules or vials in cartons allows for convenient use of the drug, depending on the prescribed course of treatment and dosage.
Amikacin is a pharmacological antibiotic of the third generation aminoglycoside group. It has a bacteriostatic effect (kills bacterial cells) against a wide range of different bacteria. The destruction of the bacterial cell occurs due to the binding to the subunit of the 30S ribosome and disruption of the replication process of protein molecules, which leads to the death of the bacterial cell. Amikacin is active against such groups of bacteria:
- Gram-negative bacteria (Gram stained in pink) - Salmonella spp., Enterobacter spp., Escherichia coli, Klebsiella spp., Pseudomonas aeruginosa, Shigella spp., Serratia spp., Providencia stuartii.
- Gram-positive bacteria (Gram stained purple) - Staphylococcus spp. and some strains of Streptococcus pneumoniae.
The drug does not have a bactericidal effect on anaerobic microorganisms (bacteria that can grow and multiply only in the absence of oxygen). Amikacin is effective against resistant bacteria against other antibiotics (penicillin-resistant strains of microorganisms).
After intramuscular administration, the active substance is rapidly absorbed into the blood and distributed in the body (within 10-15 minutes). Freely penetrates the blood-brain barrier, the placenta (enters the body of the fetus during pregnancy), passes into breast milk. Amikacin sulfate is excreted unchanged from the body. The half-life (the time during which half of the total concentration of the active substance is excreted from the body) is 3 hours.
Indications for use
The main indications for the use of Amikacin are severe infectious diseases caused by gram-negative bacteria (especially if they are resistant to other antibiotics). These diseases include:
- Infectious processes in the organs of the respiratory system - pneumonia (pneumonia), bacterial bronchitis , lung abscess (the formation in the lung tissue of a limited cavity filled with pus), empyema (accumulation of pus in the pleural cavity).
- Sepsis is an infectious process with the presence of pathogenic bacteria in the blood with their active growth and reproduction.
- Bacterial endocarditis is an infectious process (often purulent) of the inner lining of the heart (endocardium).
- The infection process in the brain - encephalitis, meningoencephalitis, meningitis.
- Pathological bacterial process in the abdominal organs, including peritonitis.
- Infections of the skin, subcutaneous tissue and soft tissue - abscesses, phlegmon, gangrenous processes, bedsores with necrosis, burns.
- Pathology of the liver and biliary tract - abscess of the liver, fiber, cholecystitis , empyema of the gallbladder.
- Infectious processes in the urinary and reproductive system - pyelonephritis, urethritis, cystitis with the frequent development of purulent complications.
- Wounds and postoperative infectious complications.
- Infections of bones ( osteomyelitis ) and joints (purulent arthritis).
Before using Amikacin, laboratory determination of the causative agent's sensitivity to this antibiotic is desirable.
The use of amikacin is contraindicated in such cases:
- Allergic reactions, individual intolerance to amikacin sulfate or any excipients of the drug.
- Diseases of the inner ear, which are accompanied by inflammation of the auditory nerve - amikacin sulfate in this case can lead to toxic nerve damage with deterioration or loss of hearing.
- Severe pathology of the liver or kidneys, accompanied by their functional insufficiency.
- Pregnancy at any time.
Determining the presence of contraindications is carried out before the use of Amikacin.
Dosing and Administration
Amikacin is a parenteral form of the drug. It is administered intramuscularly or intravenously. The powder is dissolved before injection in 2-3 ml of water for injection. The injection is performed in compliance with the rules of asepsis of an antiseptic to prevent infection of the injection site. The dosage of the drug is determined by the type of infection, its localization in the body and the severity of the course. The standard dosage for adults and children ages one month is 5 mg / kg body weight, which is administered 3 times a day. It is also possible the introduction of 7.5 mg / kg body weight 2 times a day (daily dose of 15 mg). The course of treatment is on average 10 days. Heading dose of the drug should not exceed 15 g.
Amikacin sulfate or auxiliary components of the drug after it enters the body can lead to the development of a number of side effects:
- Allergic reactions - severity may be different, from rash and itching of the skin to anaphylactic shock (the development of multiple organ failure with a decrease in systemic arterial pressure). Also, a variant of an allergic reaction may be nettle rash (rash and slight swelling of the skin, resembling a nettle burn); angioedema (pronounced localized swelling of the skin and subcutaneous tissue mainly in the face or genitals).
- Side effects of the digestive system - increased levels of liver enzymes in the blood (ALT, AST), indicating the destruction of hepatocytes (liver cells), an increase in the concentration of bilirubin in the blood, nausea and vomiting.
- Negative reactions of the hematopoietic system - leukopenia (decrease in the number of leukocytes), anemia (decrease in the level of hemoglobin and the number of erythrocytes), thrombocytopenia (decrease in the number of platelets).
- Changes in the urinary system - albuminuria (the appearance of protein in the urine), microhematuria (the appearance of a small amount of blood in the urine), the development of renal failure.
The development of one of their side effects requires discontinuation of the drug and further symptomatic therapy.
Exceeding the permissible dose with the introduction of Amikacin can lead to the development of such pathological reactions of the body:
- Ataxia - a violation of coordination, manifested in a change in gait (staggering gait).
- Tinnitus, a sharp decrease in hearing acuity up to its complete loss.
- Severe dizziness.
- Urinary Disorder.
- Thirst, nausea and vomiting.
- Disturbance of breath, shortness of breath.
Treatment of overdose is carried out in conditions of the intensive care unit. For the speedy removal of Amikacin from the body, hemodialysis (hardware blood purification) and symptomatic therapy are performed.
The use of the drug is possible only by prescription and under the supervision of a physician with the obligatory consideration of specific instructions:
- Newborns and children under the age of 1 month, the drug is administered only under strict medical reasons at a dose of 10 mg / kg body weight, which is divided into 10 days.
- In the absence of a therapeutic effect after 48-72 hours from the start of therapy, it is necessary to decide whether to replace an antibiotic or the tactics of treating an infectious pathology.
- With other drugs Amikacin is used with great care with constant monitoring of the functional activity of the liver, kidneys and central nervous system.
- Amikacin is used with extreme caution in people with myasthenia (muscle weakness) and parkinsonism.
Amikacin in pharmacies available only by prescription.
Terms and conditions of storage
Amikacin has a shelf life of 3 years. Keep it in a dark, dry, cool place out of the reach of children. Air temperature - no more than + 25 ° C.
Drugs in which the active ingredient is amikacin sulfate are Ambiotic, Lorikacin, Fleksit.
Amikacin powder for preparing injection solution 500 mg, 1 pc. - from 15 rubles.
Amikacin solution for intravenous and intramuscular administration of 250 mg / ml, 20 pcs. - from 300 rubles.