Description.

Injection: 1 ml contains 40 mg of N in an aqueous solution.

Pharmacotherapeutic group:

Aminoglycoside Antibiotic for

- Intravenous Injection or Infusion

- Intramuscular Injection

Actions

The drug acts by inhibiting protein synthesis in susceptible microorganisms. It is active against a wide variety of pathogenic Gram-negative and Gram-positive bacteria, including

- Escherichia coli

- Proteus sp. (indole-positive and indole-negative)

- Pseudomonas aeruginosa

- Klebsiella-Enterobacter-Serratia Group sp.

- Citrobacter sp. Providencia sp.

- Staphylococcus sp. (coagulase-positive and coagulase-negative, including penicillin-and methicillin-resistant strains)

- Neisseria gonorrhoeae

Indications

The drug is indicated in the treatment of infections caused by the above mentioned susceptible microorganisms:

- septicemia, bacteremia, neonatal sepsis;

- infection of the kidney and genito-urinary tract (including pelvic);

- respiratory tract infections (see adjunctive inhalation use);

- skin, bone or soft tissue infections (including infected burns and wounds);

- intra-abdominal infections (including peritonitis);

- infections of the gastro-intestinal tract;

- serious infections of the central nervous system (including meningitis);

- ocular infections.

The drug may be considered as initial therapy in suspected or confirmed Gram-negative infection. In serious infections, when the causative microorganisms are unknown the drug may be administered as initial therapy in conjunction with a penicillin-orcephalosporin-type drug. Depending on the identification and susceptibility of the organisms appropriate therapy should then be continued. If anaerobic micro-organisms are suspected, suitable anti­microbial therapy should be used in conjunction with the drug.

The drug has been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group D streptococci. The same combination is usually indicated in the neonate with sepsis or staphylocoсcal pneumonia.

The drug has been used effectively in combination with carbenicillin or ticarcillin for the treatment of life-threate­ning infections caused by Pseudomonas aeruginosa.

The drug has been shown to be effective in the treatment of serious staphylococcal infections.

In the perioperative period it may be started preoperatively and continued postoperatively for treatment of suspected or proven infection due to susceptible microorganisms.

Subconjunctival administration of the drug is recommended for the treatment of endophtalmitis caused by sensi­tive microorganisms. It may be used prophilactically in patients undergoing high risk intraocular surgery, especially if preoperative cultures or smears contain Gram-negative microorganisms.

The drug may also be administered by direct endotracheal instillation or by nebulization as an adjunct to systemic therapy in the treatment of serious pulmonary infections.

Dosage and administration

The drug should not be physically premixed with other drugs but should be administered separately in accordan­ce with the recommended route of administration.

The usual duration of treatment is seven to ten days. In complicated infections, a longer course of therapy may be necessary. In such cases monitoring of renal, auditory and vestibular functions is recommended, since toxicity is more likely to occur with treatment extended over ten days. Dosage should be reduced if clinically indicated.

Contraindications

Hypersensitivity or serious toxic reactions to the drug or other aminoglycosides contraindicate its use.

Usage in pregnancy

It is not know whether the drug can cause fetal harm when administered to pregnant women or can affect reproduction capacity.

Interactions

The concurrent use of the drug with potent diuretics, such as ethacrynic acid or furosemide, should be avoided since these diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance aminoglycoside toxicity by altering the antibiotic concentration in serum and tissue.

Overdosage information

In the event of overdose or toxic reactions, hemodialysis will aid in the removal of the drug from the blood. The rate of removal of the drug is considerably less by peritoneal dialysis than it is by hemodialysis. In the newborn infant, exchange transfusions may be considered. These procedures are of particular importance for patients with impaired renal function.

Storage

Store at 30º C

How supplied

Injection: Ampules of 80 mg (2 ml). Ampules of 40 mg (1 ml). Pediatric Injection: Ampules of 20 mg (2 ml).

Вариант№24