Selemycin - Instructions For Use, Antibiotic Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Selemycin

Selemycin: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. Use in the elderly
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Selemycin

ATX code: J01GB06

Active ingredient: amikacin (Amikacin)

Manufacturer: Medochemie Ltd. (Medochemie Ltd.) (Cyprus)

Description and photo update: 2019-25-12

Prices in pharmacies: from 8987 rubles.

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Selemycin - an antibacterial drug of the aminoglycoside group, has a wide spectrum of bactericidal action.

Release form and composition

The drug is available in the form of a solution for infusion and intramuscular (i / m) administration: clear liquid, yellowish or colorless (2 ml in vials, 5 vials in blisters, 20 packs in a cardboard box and instructions for using Selemycin).

1 ml of solution contains:

• active substance: amikacin sulfate (in terms of amikacin base) - 250 mg;
• auxiliary components: sodium citrate, concentrated sulfuric acid, sodium metabisulfite, water for injection.

Pharmacological properties

Pharmacodynamics

Selemycin is a semisynthetic antibacterial drug with a broad spectrum of action, acts bactericidal. The pharmacological effect of the drug is due to the property of its active substance, amikacin, to bind to the 30S ribosome subunit and prevent the formation of a complex of transport and messenger RNA (ribonucleic acid), which leads to blocking protein synthesis and destruction of bacterial cytoplasmic membranes.

Amikacin is an aminoglycoside that is highly active against the following aerobic gram-negative microorganisms: Klebsiella speciales (spp.), Providencia spp., Serratia spp., Enterobacter spp., Shigella spp., Salmonella spp., Pseudomonas aerug colinosa. Escherichia. In addition, some gram-positive microorganisms Staphylococcus spp. Are sensitive to amikacin. (including species resistant to penicillin and some cephalosporins). With regard to Streptococcus spp. Selemycin is moderately active.

When combined with benzylpenicillin, amikacin has a synergistic effect against strains of Enterococcus faecalis.

Amikacin remains active under the action of enzymes that inactivate other aminoglycosides. Strains of Pseudomonas aeruginosa resistant to gentamicin, tobramycin and netilmicin are susceptible to it.

Anaerobic microorganisms are not sensitive to amikacin.

Pharmacokinetics

After i / m administration of Selemycin, amikacin is absorbed quickly and in full. Its maximum concentration (C _max) when administered intramuscularly at a dose of 7.5 mg per 1 kg of body weight (mg / kg) of the patient is reached after 1.5 hours and is 0.021 mg / ml. With _max after intravenous (i / v) drip dose of 7.5 mg / kg for 0.5 h - 0.038 mg / ml.

Plasma protein binding - from 4 to 11% of the administered dose.

With parenteral administration, amikacin is well distributed in the extracellular fluid (lymphatic, ascitic, pericardial, synovial and peritoneal fluids, the contents of abscesses, pleural effusion). The substance is found in high concentrations in urine. In breast milk, bile, bronchial secretions, sputum, aqueous humor of the eye and cerebrospinal fluid (CSF), its content is insignificant. It penetrates well into all tissues of the body and accumulates intracellularly. A high level of amikacin concentration is noted in organs with good blood supply, such as the liver, spleen, myocardium, lungs, kidneys, and it can also accumulate in the cortex. Its content is lower in muscle, adipose tissue and bones.

When administered to adult patients in medium therapeutic doses, amikacin does not overcome the blood-brain barrier, the permeability increases slightly in cases of inflammation of the meninges. Penetrates through the placenta, is found in the amniotic fluid and fetal blood.

Concentrations of the drug in CSF are higher in neonates than in adults.

The volume of distribution (V _d): adults - 0.26 l / kg, children - 0.2-0.4 l / kg. V _d in newborns less than 1 week old: with a body weight of less than 1500 g - up to 0.68 l / kg, with a body weight of more than 1500 g - up to 0.58 l / kg. V _d in patients with cystic fibrosis - 0.3-0.39 l / kg.

After intravenous or intramuscular administration, the average therapeutic concentration of the drug is maintained for 10-12 hours.

The active substance in the body is not biotransformed.

Half-life (T _1/2): adults - 2–4 hours, children - 2.5–4 hours, newborns - 5–8 hours. The final T _1/2 (release from intracellular depots) is more than 100 hours.

It is excreted through the kidneys mainly unchanged by glomerular filtration (65–94%). The renal clearance of amikacin is 79-100 ml / min.

In case of impaired renal function, T _1/2 increases in adults, depending on the degree of impairment and can last up to 100 hours. T _1/2 in cystic fibrosis is 1-2 hours. Due to increased clearance in burns and hyperthermia, T _1/2 may decrease compared to with average performance.

In hemodialysis for 4–6 hours, 50% of the administered dose is eliminated, in 48–72 hours of peritoneal dialysis - 25%.

Indications for use

The use of the antibiotic Selemycin is indicated for the treatment of infectious and inflammatory diseases caused by gram-negative microorganisms resistant to gentamicin, sisomycin and kanamycin or associations of gram-negative and gram-positive microorganisms, including pathologies such as:

• respiratory tract infections (bronchitis, pleural empyema, pneumonia, lung abscess);
• sepsis;
• septic endocarditis;
• meningitis and other central nervous system (CNS) infections;
• abdominal infections (including peritonitis);
• urinary tract infections (cystitis, urethritis, pyelonephritis, prostatitis, gonorrhea);
• purulent infections of the skin and soft tissues (including infected burns, ulcers or bedsores of various origins);
• biliary tract infections;
• osteomyelitis and other infections of bones and joints;
• otitis;
• postoperative infections;
• infected wounds.

Contraindications

Absolute:

• severe chronic renal failure with azotemia and uremia;
• neuritis of the auditory nerve;
• period of pregnancy;
• an indication of a history of hypersensitivity to aminoglycosides;
• individual intolerance to the components of the drug.

Selemycin should be used with caution to treat premature or newborn infants, as well as patients with renal failure, myasthenia gravis, parkinsonism, dehydration, botulism, in old age, during lactation.

Selemycin, instructions for use: method and dosage

Selemycin solution is used by intravenous drip or jet (within 2 minutes) and intramuscular injection.

In a solution for intravenous administration, the concentration of amikacin should not exceed 5 mg / ml. When preparing for intravenous drip, the required dose of the drug should be dissolved in 200 ml of 0.9% sodium chloride solution or 5% dextrose solution.

The daily dose of the drug, depending on the frequency of procedures, is administered at regular intervals.

Recommended dosage of Selemycin:

• usual dose: 5 mg / kg of the patient's body weight 3 times a day or 7.5 mg / kg 2 times a day;
• dose for bacterial uncomplicated urinary tract infections: 250 mg 2 times a day;
• dose used in the treatment of burns: 5–7.5 mg / kg of body weight 4–6 times a day.

The maximum daily dose for adults is not more than 15 mg / kg of body weight.

The duration of the course of treatment with the / in the introduction is 3-7 days, in / m - 7-10 days.

After a hemodialysis session, additional administration of Selemycin is indicated at a dose of 3-5 mg / kg.

The starting dose for newborns (including premature infants) is 10 mg / kg body weight. Further treatment is continued at a dose of 7.5 mg / kg 2 times a day, for premature infants - 7.5 mg / kg once a day. The duration of the course is 7-10 days.

With renal failure, patients require a correction of the dosage regimen of Selemycin.

Side effects

• on the part of the hematopoietic organs: leukopenia, thrombocytopenia, anemia, granulocytopenia;
• from the digestive system: nausea, vomiting, functional liver disorders (hyperbilirubinemia, increased activity of hepatic transaminases);
• from the senses: ototoxicity (hearing impairment, irreversible deafness, vestibular and labyrinthine disorders), toxic effects on the vestibular apparatus (nausea, vomiting, dizziness, impaired coordination of movements);
• from the nervous system: headache, drowsiness, the appearance of symptoms of neurotoxicity (feeling of numbness and / or tingling, muscle twitching, epileptic seizures), disorders of neuromuscular transmission up to respiratory arrest;
• from the urinary system: nephrotoxicity (microhematuria, oliguria, proteinuria);
• from the immune system: allergic reactions (including pruritus, rash, Quincke's edema, hyperemia, fever).

Overdose

Symptoms: toxic reactions - nausea, vomiting, thirst, loss of appetite, dizziness, a feeling of stuffiness or ringing in the ears, hearing loss, ataxia, urinary disorder, respiratory failure.

Treatment: the appointment of symptomatic and supportive therapy. The use of hemodialysis or peritoneal dialysis is shown to remove the blockade of neuromuscular transmission and its consequences, if necessary, artificial ventilation of the lungs, anticholinesterase preparations and calcium salts.

special instructions

Before using Selemycin, it is necessary to establish the degree of sensitivity of the isolated microorganisms. To determine the sensitivity, discs containing 0.03 mg of amikacin are used. The causative agent of infection is considered sensitive if the diameter of the free from growth zone is 17 mm or more, moderately sensitive - from 15 to 16 mm, resistant to the drug - less than 14 mm.

The content of amikacin in plasma should not exceed the therapeutic concentration, which is from 0.015 to 0.025 mg / ml.

Treatment with the drug must be accompanied by regular (once every 7 days) monitoring of renal function, vestibular apparatus and auditory nerve. The use of Selemycin is associated with an increased risk of nephrotoxicity, therefore, if it is necessary to prescribe high doses or a long course of therapy, as well as in the treatment of patients with impaired renal function, daily monitoring of renal function is required.

Unsatisfactory audiometric tests are the basis for dose reduction or withdrawal of Selemycin.

When treating infectious and inflammatory diseases of the urinary tract, patients are advised to consume a large amount of liquid.

The development of resistant microorganisms is possible, therefore, in the absence of positive clinical dynamics, it is necessary to discontinue the use of Selemycin and begin alternative therapy.

When administering the solution, especially to patients with an allergic history, the existing risk of developing allergic complications up to anaphylactic reactions should be taken into account.

Application during pregnancy and lactation

It is contraindicated to use the antibiotic Selemycin during pregnancy.

With caution, only in the presence of vital indications is the appointment of aminoglycosides allowed during breastfeeding.

Pediatric use

Selemycin should be used with caution to treat neonates, including premature infants.

With impaired renal function

The use of Selemycin for the treatment of patients with severe chronic renal failure with azotemia and uremia is contraindicated.

Caution should be exercised and the dosage regimen should be adjusted for patients with renal insufficiency.

Use in the elderly

Selemycin should be used with caution to treat elderly patients.

Drug interactions

Consideration should be given to the pharmaceutical incompatibility of the amikacin solution with heparin, cephalosporins, penicillins, erythromycin, capreomycin, amphotericin B, hydrochlorothiazide, nitrofurantoin, potassium chloride, vitamins B and C.

When used simultaneously with benzylpenicillin, carbenicillin, cephalosporins, Selemycin exhibits synergism. In severe chronic renal failure, aminoglycoside efficacy may decrease due to interaction with beta-lactam antibiotics.

When combined therapy with nalidixic acid, polymyxin B, cisplatin or vancomycin increases the risk of developing nephro- and ototoxicity.

With concomitant therapy with cephalosporins, penicillins, NSAIDs (non-steroidal anti-inflammatory drugs), sulfonamides, diuretics, especially furosemide, the concentration of aminoglycosides in the blood serum increases, causing an increase in nephro- and neurotoxicity.

Against the background of the use of Selemycin, curariform agents enhance the muscle relaxant effect.

During the period of treatment with amikacin, care should be taken if it is necessary to carry out transfusion of large volumes of blood with citrate preservatives, the use of methoxyflurane, polymyxins for parenteral administration, capreomycin or other drugs that block neuromuscular transmission (opioid analgesics, inhalation anesthesia with halogenated hydrocarbons), due to increased risk of respiratory arrest.

The likelihood of developing the toxic effects of aminoglycosides increases with simultaneous use with indomethacin for parenteral administration.

The combination of Selemycin with anti-myasthenic drugs helps to reduce their effect.

Analogs

The analogues of Selemycin are Amikacin, Amikacin-Vial, Amikacin-Ferein, Amikacin sulfate, Amikabol, etc.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C in a dark place.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Selemycin

Reviews of Selemycin from patients or doctors are currently absent.

Selemycin price in pharmacies

The price of Selemycin for a package containing 100 ampoules with a solution can range from 9324 rubles.

Selemycin: prices in online pharmacies

Drug name Price Pharmacy

Selemycin solution for infusion and i / m 250mg / ml 2ml n100 8987 RUB Buy

Selemycin 250 mg / ml solution for infusion and intramuscular injection 2 ml 100 pcs. 8987 RUB Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!