Garamycin - description of the drug, instructions for use, reviews

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Manufacturers: Schering-Plough Healthcare Products (USA)

Active ingredients

  • Gentamicin

Disease class

  • Bacterial meningitis, not elsewhere classified
  • Conjunctivitis
  • Acute upper respiratory tract infection of multiple and unspecified localization
  • Syndrome of staphylococcal skin lesions in the form of burn-like blisters
  • Peritonitis
  • Infectious myositis
  • Tendon sheath abscess
  • Other infectious (teno)synovitis
  • Abscess of the bursa
  • Other infectious bursitis
  • Osteomyelitis
  • Diarrhea and gastroenteritis of suspected infectious origin
  • Meningococcal infection
  • Septicemia, unspecified
  • Gonococcal infection
  • Post-traumatic wound infection, not elsewhere classified
  • Thermal and chemical burns of unspecified localization
  • Surgical practice
  • Other tubulointerstitial kidney diseases
  • Urinary tract infection without established localization
  • Inflammatory diseases of the male genital organs, not elsewhere classified
  • Salpingitis and oophoritis
  • Gonococcal inflammatory diseases of the female pelvic organs

Clinical and pharmacological group

  • Antibacterial agents

Pharmacological action

  • Antibacterial

Pharmacological group

  • Aminoglycosides

Indications for use

For injection solution:

  • Neonatal sepsis;
  • Bacteremia;
  • Septicemia;
  • Respiratory tract infections;
  • Gastrointestinal tract infections;
  • Infections of the genitourinary tract and kidneys;
  • Infections of the central nervous system, incl. meningitis;
  • Intraperitoneal infections, incl. peritonitis;
  • Infections of the eye organs;
  • Infections of bones, soft tissues and skin, incl. infected wounds and burns;
  • Gonorrhea;
  • Perioperative infection prevention.

Cream and ointment are used to treat bacterial skin lesions.

Contraindications

Absolute:

  • Severe chronic renal failure with uremia and azotemia;
  • Acoustic neuritis;
  • History of hypersensitivity to the drug or other aminoglycosides.

Relative (due to the risk of complications, caution should be exercised):

  • Botulism;
  • Parkinsonism;
  • Myasthenia;
  • Kidney failure;
  • Dehydration;
  • Prematurity of children;
  • Newborn period;
  • Elderly age.

During pregnancy and breastfeeding, the use of the drug is possible only if there are vital indications.

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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before you start using Garamycin, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Garamycin is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!

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Directions for use and dosage

Cream and ointment

Garamycin cream and ointment are used externally: apply a thin layer to the affected skin surfaces 3-4 times a day. If necessary, the product can be used under a bandage.

Injection

Garamicin injection solution is intended for intramuscular and intravenous administration.

The drug is administered intravenously over 1.5-2 hours in a 5% dextrose solution or 0.9% sodium chloride solution, the injected volume is from 50 to 300 ml. For children, the volume of administered fluid is reduced (the concentration should not exceed 0.1% = 1 mg/ml).

For diseases of moderate severity, adults with normal renal function are prescribed 3 mg/kg per day with a frequency of administration of 2 or 3 times a day, respectively, two equal portions after 12 hours or three equal portions after 8 hours.

In severe cases of the disease with a high risk of death, the daily dose is increased to 5 mg/kg with a multiplicity of 3-4 times; after clinical improvement, the dose is reduced to 3 mg/kg/day. The course of treatment is no more than 7-10 days.

For infectious and inflammatory diseases of the urinary tract to patients with normal renal function, the drug is administered intramuscularly at a dose of 120-160 mg once a day for 7-10 days, for gonorrhea - intramuscularly at a single dose of 240-280 mg. It is recommended to administer 1/2 dose intramuscularly into each buttock.

Doses for children:

  • Newborns (up to the 7th birthday) and premature infants - 2.5-3 mg/kg every 12 hours;
  • Infants over 7 days and children under 1 year – 2.5 mg/kg every 8 hours;
  • Children over 1 year - 2-2.5 mg/kg every 8 hours.

For elderly people and patients with impaired renal excretory function, as well as for severe burn disease, the dose of Garamycin is determined depending on the concentration of gentamicin in the blood plasma. The interval between administrations of average doses is determined by the formula: interval (in hours) = creatinine concentration (mg/100 ml) x 8.

For severe infectious processes, it is recommended to administer smaller doses with greater frequency. In this case, a single dose should be selected so that the maximum concentration of gentamicin does not exceed 0.012 mg/ml.

For obesity, ascites and edema, the dose is determined by “dry” and “ideal” body weight.

In case of impaired renal function and hemodialysis after the session, it is recommended to administer the drug in the following dose: adults - 1-1.7 mg/kg, children - 2-2.5 mg/kg, depending on the severity of the infection.

Release form and composition

The drug is available in the form of cream, ointment, and solution for injection.

The main active ingredient of Garamycin is gentamicin sulfate, its content in each dosage form is:

  • One ampoule with injection solution – 40 mg, 80 mg;
  • One gram of cream or ointment – ​​1 mg.

The drug is supplied to the pharmacy chain in the following dosage forms:

  • Solution in glass ampoules of 1 ml, 2 ml, in cardboard packs of 10 pieces;
  • Cream or ointment in aluminum tubes of 15 g.

Side effects

  • Digestive system: nausea, vomiting, hyperbilirubinemia, increased activity of liver transaminases;
  • Hematopoietic organs: granulocytopenia, leukopenia, thrombocytopenia, anemia;
  • Nervous system: sensation of numbness, paresthesia, muscle twitching, drowsiness, headache, epileptic seizures; in children - psychosis;
  • Urinary system: renal dysfunction (microhematuria, proteinuria, oliguria); in some cases – renal tubular necrosis;
  • Sense organs: labyrinthine and vestibular disorders, hearing loss, tinnitus, irreversible deafness;
  • Allergic reactions: fever, skin rash, itching, eosinophilia, angioedema;
  • Other: fever, superinfection;
  • Laboratory indicators: in children – hypokalemia, hypocalcemia, hypomagnesemia.

special instructions

During treatment, serum gentamicin concentrations and creatinine clearance should be monitored, especially in the elderly.

The risk of developing nephrotoxicity is higher in patients with impaired renal function, as well as when using the drug in high doses or for a long period. For this reason, renal function should be regularly monitored: 1-2 times a week, and daily in patients receiving large doses or being treated for more than 10 days.

To prevent the development of hearing impairment, it is necessary to periodically (1-2 times a week) examine vestibular function to determine hearing loss at high frequencies. In case of unsatisfactory audiometric tests, the dose should be reduced or the drug discontinued.

Patients with infectious and inflammatory diseases are advised to consume increased amounts of fluid during treatment.

The possibility of developing microbial resistance should be taken into account. In this case, it is necessary to discontinue Garamycin and prescribe appropriate treatment based on the antibiogram data.

The possibility of neuromuscular blockade and respiratory paralysis should be kept in mind.

pharmachologic effect

The therapeutic effect of Celestoderm ointment with Garamycin and other external agents with similar active substances is due to the properties of its constituent components:

  • Gentamicin is a broad-spectrum antibiotic that is effective when applied topically against most of the most common pathogens - streptococcus (beta-hemolytic, alpha-hemolytic), Staphylococcus aureus (coagulase-positive, coagulase-negative and some penicillinase-producing strains), as well as gram-negative bacteria : Aerobaster aerogenes, Pseudomonas aeruginosa, Proteus vulgaris, Escherichia coli and Klebsiella pneumonia;
  • The glucocorticosteroid betamethasone valerate, which is part of the ointment with Garamycin, has an antiallergic and anti-inflammatory effect, inhibiting the release of inflammatory mediators and cytokines, reducing the metabolism of arachidonic acid, inducing the formation of lipocortins with anti-edematous activity and reducing vascular permeability.

Drug interactions

  • Curare-like drugs: their muscle relaxant effect is enhanced;
  • Antimyasthenic drugs: their effectiveness decreases;
  • Loop diuretics, cisplatin, other oto- and nephrotoxic drugs: nephro- and ototoxicity of gentamicin increases;
  • Penicillin antibiotics (for example, carbenicillin, ampicillin): the antimicrobial effect of gentamicin increases;
  • Indomethacin parenterally: the risk of developing toxic effects of Garamycin increases;
  • Methoxyflurane, parenteral polymyxins and other drugs that block neuromuscular transmission (narcotic analgesics, halogenated hydrocarbons as an agent for inhalation anesthesia, large amounts of blood transfusion with citrate preservatives): increases the risk of nephrotoxicity and respiratory arrest due to increased neuromuscular blockades

In solution form, Garamycin is pharmaceutically incompatible with any other drugs, so they cannot be mixed in the same syringe.

Cream for external use Garamycin

Instructions for medical use of the drug

Description of pharmacological action

Inhibits protein synthesis in microbial cells by blocking the 30S ribosomal subunit. In high concentrations, it disrupts the barrier functions of the cytoplasmic membranes of microbes and causes their death.

Indications for use

Septicemia, bacteremia, neonatal sepsis, kidney and genitourinary tract infections, intraperitoneal infections (including peritonitis), infections of the gastrointestinal tract, respiratory tract, eyesight, central nervous system (including meningitis), skin, bones and soft tissues (including infected burns and wounds), perioperative prevention of infection, gonorrhea. Cream, ointment - bacterial skin lesions.

Release form

Cream 1 mg/g; tube 15 g.

Pharmacodynamics

Broad-spectrum bactericidal antibiotic from the aminoglycoside group. It binds to the 30S subunit of ribosomes and disrupts protein synthesis, preventing the formation of a transport and messenger RNA complex, resulting in erroneous reading of the genetic code and the formation of non-functional proteins. It has a bactericidal effect - in high concentrations it reduces the barrier functions of cell membranes and causes the death of microorganisms. Gram-negative microorganisms - Proteus spp. - are highly sensitive to gentamicin (MIC less than 4 mg/l). (including indole-positive and indole-negative strains), Escherichia coli, Klebsiella spp., Salmonella spp., Shigella spp., Campylobacter spp.; gram-positive microorganisms - Staphylococcus spp. (including penicillin-resistant); sensitive at MIC 4-8 mg/l - Serratia spp., Klebsiella spp., Pseudomonas spp. (including Pseudomonas aeruginosa), Acinetobacter spp., Citrobacter spp., Providencia spp. Resistant (MIC more than 8 mg/l) - Neisseria meningitidis, Treponema pallidum, Streptococcus spp. (including Streptococcus pneumoniae and group D strains), Bacteroides spp., Clostridium spp., Providencia rettgeri. In combination with penicillins (including benzylpenicillin, ampicillin, carbenicillin, oxacillin), acting on the synthesis of the cell wall of microorganisms, it is active against Enterococcus faecalis, Enterococcus faecium, Enterococcus durans, Enterococcus avium, almost all strains of Streptococcus faecalis and their varieties (including Streptococcus faecalis liguifaciens, Streptococcus faecalis zymogenes), Streptococcus faecium, Streptococcus durans. Resistance of microorganisms to gentamicin develops slowly, however, strains resistant to neomycin and kanamycin may also exhibit resistance to gentamicin (incomplete cross-resistance). Does not affect fungi, viruses, protozoa.

Use during pregnancy

During pregnancy, it is possible only for health reasons (adequate and strictly controlled studies have not been conducted in humans. There are reports that other aminoglycosides led to deafness in the fetus). During treatment, it is necessary to stop breastfeeding (passes into breast milk).

Contraindications for use

Hypersensitivity (including a history of other aminoglycosides), acoustic neuritis, severe chronic renal failure with azotemia and uremia, pregnancy. With caution. Myasthenia gravis, parkinsonism, botulism (aminoglycosides can cause disruption of neuromuscular transmission, which leads to further weakening of skeletal muscles), dehydration, renal failure, neonatal period, prematurity, old age, lactation.

Side effects

From the digestive system: nausea, vomiting, increased activity of “liver” transaminases, hyperbilirubinemia. From the hematopoietic organs: anemia, leukopenia, granulocytopenia, thrombocytopenia. From the nervous system: muscle twitching, paresthesia, numbness, epileptic seizures, headache, drowsiness, in children - psychosis. From the urinary system: nephrotoxicity - impaired renal function (oliguria, proteinuria, microhematuria), in rare cases - renal tubular necrosis. From the senses: ototoxicity - tinnitus, hearing loss, vestibular and labyrinthine disorders, irreversible deafness. Allergic reactions: skin rash, itching, fever, angioedema, eosinophilia. Laboratory indicators: in children - hypocalcemia, hypokalemia, hypomagnesemia. Other: fever, development of superinfection.

Directions for use and doses

External use - apply a thin layer to the affected skin surface 3-4 times a day, apply a bandage if necessary.

Overdose

Symptoms: decreased neuromuscular conduction (respiratory arrest). Treatment: adults are administered intravenously anticholinesterase drugs (prozerin), as well as Ca2+ preparations (CaCl2 10% 5-10 ml, calcium gluconate 10% 5-10 ml). Before administering proserin, atropine is first administered intravenously at a dose of 0.5-0.7 mg, the pulse is expected to increase, and after 1.5-2 minutes 1.5 mg (3 ml of 0.05% solution) of proserin is administered intravenously. If the effect of this dose turned out to be insufficient, the same dose of proserine is re-administered (if bradycardia appears, an additional injection of atropine is given). Children are administered Ca2+ preparations. In severe cases of respiratory depression, mechanical ventilation is necessary. Can be eliminated using hemodialysis (more effective) and peritoneal dialysis.

Interactions with other drugs

Pharmaceutically incompatible (cannot be mixed in one syringe) with other drugs (including other aminoglycosides, amphotericin B, heparin, ampicillin, benzylpenicillin, cloxacillin, carbenicillin, capreomycin). Increases the muscle relaxant effect of curare-like drugs. Reduces the effect of antimyasthenic drugs. Methoxyflurane, polymyxins for parenteral administration and other 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 nephrotoxicity and respiratory arrest (as a result of increased neuromuscular blockade). “Loop” diuretics increase oto- and nephrotoxicity (decreased tubular secretion of gentamicin). Toxicity increases when combined with cisplatin and other oto- and nephrotoxic drugs. Penicillin antibiotics (ampicillin, carbenicillin) enhance the antimicrobial effect by expanding the spectrum of activity. Parenteral administration of indomethacin increases the risk of developing toxic effects of aminoglycosides (increased T1/2 and decreased clearance).

Precautions for use

Treatment must be carried out with constant monitoring of renal function; It is advisable to monitor the level of gentamicin in the blood. The possibility of neuromuscular blockade and respiratory paralysis should be kept in mind.

Special instructions for use

If there are vital indications, it can be used in pregnant and lactating women. Aminoglycosides pass into breast milk in small quantities. However, they are poorly absorbed from the gastrointestinal tract, and no complications associated with them have been reported in infants. The sodium bisulfite contained in ampoules can cause the development of allergic complications in patients, especially in patients with an allergic history. Patients with infectious and inflammatory diseases of the urinary tract are recommended to take increased amounts of fluid. During treatment with aminoglycosides, the concentration of the drug in the blood serum should be determined (to prevent the administration of low ineffective doses or, conversely, an overdose of the drug), as well as control of QC, especially in the elderly. The likelihood of developing nephrotoxicity is higher in patients with impaired renal function, as well as when prescribed in high doses or for a long time, therefore regularly (1 or 2 times a week, and in patients receiving high doses or being treated for more than 10 days - daily) renal function should be monitored. To avoid the development of hearing impairment, it is recommended to regularly (1 or 2 times a week) test vestibular function to determine hearing loss at high frequencies (if audiometric tests are unsatisfactory, the dose of the drug is reduced or treatment is stopped). During treatment, microbial resistance may develop. In such cases, it is necessary to discontinue the drug and prescribe treatment based on the antibiogram data.

Storage conditions

List B.: At a temperature of 2–30 °C.

Best before date

60 months

ATX classification:

J Antimicrobials for systemic use

J01 Antimicrobials for systemic use

J01G Aminoglycosides

J01GB Other aminoglycosides

J01GB03 Gentamicin

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