Nebcin (Solution) Instructions for Use

Marketing Authorization Holder

Eli Lilly (France)

ATC Code

J01GB01 (Tobramycin)

Active Substance

Tobramycin (Rec.INN registered by WHO)

Dosage Form

Nebcin

Injection solution 80 mg/2 ml: fl. 5 pcs.

Dosage Form, Packaging, and Composition

2 ml – vials (5) – blister packs.

Clinical-Pharmacological Group

Antibiotic of the aminoglycoside group

Pharmacotherapeutic Group

Antibiotic-aminoglycoside

Pharmacological Action

A broad-spectrum antibiotic from the aminoglycoside group. It acts bacteriostatically (blocks the 30S ribosomal subunit and disrupts protein synthesis).

It is highly active against gram-negative microorganisms (Pseudomonas aeruginosa, Acinetobacter spp., Escherichia coli, Klebsiella spp., Serratia spp., Providencia spp., Enterobacter spp., Proteus spp., Salmonella spp., Shigella spp.), as well as some gram-positive microorganisms: Staphylococcus spp. (including strains resistant to penicillins, cephalosporins), some strains of Streptococcus spp.

Aminoglycosides in combination with penicillins or some cephalosporins are effective for the treatment of infections caused by Pseudomonas aeruginosa or Enterococcus faecalis.

Pharmacokinetics

After intramuscular administration, it is rapidly distributed throughout organs and tissues. It crosses the placental barrier. C_max in blood serum is detected 40-90 minutes after administration; with intramuscular administration at a dose of 1 mg/kg, C_max in plasma is 3-7 mg/l. Therapeutic concentration persists for 8 hours. T_1/2 with normal renal function is 2 hours. 80-84% of the administered dose is excreted by the kidneys unchanged, 10-20% – through the intestines.

Indications

Infectious diseases caused by susceptible microorganisms: biliary tract infections; bone and joint infections (including osteomyelitis); CNS infections (including meningitis); abdominal infections (including peritonitis); respiratory tract infections (including pneumonia, pleural empyema, lung abscess); skin and soft tissue infections (including infected burns); urinary tract infections (including pyelonephritis, pyelitis, cystitis); sepsis; postoperative infections.

ICD codes

Dosage Regimen

Intramuscularly and intravenous drip.

A single dose for adults and children over 1 year is 1 mg/kg of body weight, the daily dose is 3 mg/kg of body weight; the maximum daily dose is 5 mg/kg of body weight.

Children from 1 week to 1 year: 6-7.5 mg/kg/day, divided into 3-4 equal doses.

Premature or newborn infants up to 1 week of life: up to 4 mg/kg/day, divided into 2 equal doses every 12 hours.

The usual duration of treatment is 7-10 days. For severe and complicated infections, a longer course of therapy is possible (under control of renal function, hearing and vestibular apparatus status, since the manifestation of neurotoxicity is most likely when the course of treatment exceeds 10 days).

Adverse Reactions

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

From the hematopoietic organs: anemia, leukopenia, granulocytopenia, thrombocytopenia, leukocytosis.

From the nervous system: headache, neurotoxic effect (muscle twitching, paresthesia, epileptic seizures); rarely – neuromuscular blockade (difficulty breathing, drowsiness, weakness).

From the sensory organs: ototoxicity (partial or complete bilateral deafness, ringing, buzzing or a feeling of “fullness” in the ears), vestibular and labyrinthine disorders (incoordination, dizziness, nausea, vomiting, unsteadiness).

From the urinary system: nephrotoxicity (oliguria, cylindruria, proteinuria, significant increase or decrease in the frequency of urination, polyuria; appearance of signs of renal failure – increased concentration of creatinine and urea nitrogen, thirst, decreased appetite, nausea, vomiting).

Allergic reactions: skin itching, skin hyperemia, rash, fever, angioedema, eosinophilia.

Laboratory parameters: hypocalcemia, hyponatremia, hypomagnesemia.

Contraindications

Hypersensitivity to tobramycin and other antibiotics of the aminoglycoside group; acoustic neuritis; severe chronic renal failure; pregnancy, breastfeeding period.

With caution

Renal failure, botulism, myasthenia gravis, parkinsonism, dehydration, hearing impairment, elderly patients.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use of tobramycin may cause impaired liver function.

Use in Renal Impairment

Contraindication: severe chronic renal failure. In mild to moderate renal failure, dosage adjustment is required.

Pediatric Use

The dosage regimen is established depending on the age and body weight of the patient.

Geriatric Use

In elderly patients, the dose should be reduced and the intervals between administrations increased.

Special Precautions

During treatment, it is necessary to monitor renal function, liver function, vestibular apparatus and hearing (at least once a week), monitor the concentration of tobramycin in the blood serum, which should not exceed 8 µg/ml.

If audiometric tests are unsatisfactory, the dose should be reduced or treatment discontinued.

The risk of oto- and nephrotoxicity increases significantly with persistently high plasma concentrations above 12 µg/ml.

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

During therapy, the development of superinfection may be observed.

In the absence of positive clinical dynamics, the possibility of the development of resistant microorganisms should be considered. In such cases, it is necessary to discontinue treatment and initiate appropriate therapy.

Drug Interactions

Tobramycin enhances the effect of non-depolarizing muscle relaxants.

Reduces the effect of antimyasthenic drugs.

Aminoglycosides, cephalosporins, vancomycin, polymyxin, diuretics increase the risk of oto- and nephrotoxicity.

Beta-lactam antibiotics weaken the effect.

Intravenous administration of indomethacin reduces the renal clearance of tobramycin, increasing its concentration in the blood and increasing T_1/2 (dose adjustment may be required).

Methoxyflurane increases the risk of adverse effects.

Drugs for inhalation general anesthesia (halogenated hydrocarbons), opioid analgesics, transfusion of large amounts of blood with citrate preservatives as anticoagulants, drugs that block neuromuscular transmission enhance neuromuscular blockade.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.