Dibekacin Meiji

Dibekacin sulfate.

Dibekacin is an aminoglycoside antibiotic.
Dibekacin sulfate occurs as a white to yellowish-white, odorless powder with a slightly bitter taste. It is very soluble in water, but practically insoluble in organic solvents eg, ethanol and acetone.
Dibekacin sulfate is very stable. When it is dissolved in physiological saline solution or water for injection and kept at 25°C for 7 days, no loss of potency is observed. Dibekacin sulfate has a molecular formula of C₁₈H₃₇N₅O₈·xH₂SO₄ (x) and a molecular weight of 451.54 (free base).

Dibekacin Meiji injection has potent bactericidal activity against gram-positive and -negative bacteria including Pseudomonas aeruginosa, Proteus sp, Klebsiella pneumoniae and multi-resistant strains of Escherichia coli and Staphylococci.
Therapeutic effect of Dibekacin Meiji injection has been confirmed in a large scale of clinical trials.
Dibekacin Meiji injection has the following characteristics: Bactericidal in its action against both gram-positive and gram-negative bacteria; produces therapeutic effect against infections caused by Pseudomonas aeruginosa and Proteus sp; also effective against infections due to Escherichia coli, Klebsiella pneumoniae and Staphylococci that have acquired multi-resistance to other drugs; rapidly absorbed into the blood and diffuses into the kidney and lung in high concentration after IM injection. It is excreted into the urine in active, unchanged form in high concentration.
Microbiology: Dibekacin exhibits strong antimicrobial activity against gram-negative bacteria including Pseudomonas aeruginosa and Proteus sp and against gram-positive bacteria as well. The MIC of Dibekacin Meiji injection against major pathogenic organisms is given as follows: See Table 1.


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Pharmacokinetics: Absorption and Excretion: A single IM injection of 50 mg and 100 mg (potency) produces peak blood concentrations of 5 mcg/mL and 7 mcg/mL around 30 min after injection. About 70-80% of the given dose is excreted into the urine within the first 8 hrs.

The following infections due to Pseudomonas aeruginosa and Proteus sp or caused by dibekacin-sensitive strains of Klebsiella pneumoniae, E. coli and Staphylococci that have acquired resistance to many drugs including kanamycin.
Septicemia, abscess, furuncle, furunculosis, phlegmon, tonsillitis, postoperative infections, pneumonia, bronchitis, peritonitis, pyelonephritis, cystitis, urethritis and otitis media.

The daily dosage is 100 mg (potency) for adults and 1-2 mg (potency)/kg of body weight for infants and children, given IM in 1 or 2 divided doses. The dosage may be adjusted according to age or severity of the infections.
IV Drip Infusion: Adults: 100 mg daily in 2 divided doses to be infused over a period of 30-60 min.
For reconstitution of Dibekacin Meiji injection, physiological saline solution or water for injection is used as solvent. The amount of the solvent is 1 mL for a 50-mg (potency) vial and 2 mL for 100-mg (potency) vial, respectively.
The modified dosage of Dibekacin Meiji injection for patients with impaired renal function is given as follows: See Table 2.


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Dibekacin Meiji injection should be administered by or under the supervision of a physician.

Hypersensitivity to dibekacin sulfate.

Administration of dibekacin may cause impairment of the auditory portion of the 8th nerve with symptoms eg, vertigo, tinnitus and hearing difficulty. Close observation for the signs of impairment is needed during therapy. It is desirable to discontinue administration once symptoms have occurred. In case continuous administration is inevitable, Dibekacin Meiji Injection should be given under careful observation.
Administration of dibekacin may rarely cause disturbance in liver or kidney function. Close observation for the disturbance is needed during therapy. If there is evidence of abnormality, administration should be discontinued. In case dibekacin is given to patients with impaired kidney function or to older patients, careful observation is needed.
The concurrent administration of blood substitutes eg, dextran and sodium alginate, should be avoided because of the possibility of intensifying the effects of these nephrotoxic drugs.
In case hypersensitivity reactions have occurred during therapy, administration should be discontinued. Dibekacin Meiji Injection should not be given to patients with history of hypersensitivity to aminoglycoside antibiotics eg, fradiomycin (neomycin), amikacin, kanamycin, streptomycin and gentamicin, and to bacitracin.
It is desirable to avoid administration to patients with past or family history of streptomycin- or any other drug-induced hearing difficulty. In case administration of dibekacin is inevitable, it should be given under careful observation.
Administration of dibekacin may cause respiratory depression due to its neuromuscular-blocking effect. Combined use with anesthetics or muscle-relaxing drugs should be carefully practiced.
Caution should be exercised in patients with poor oral nutrition.
Dibekacin Meiji Injection is for IM use and IV drip infusion.
Use in pregnancy: Administration to pregnant women may cause impairment of the auditory portion of the 8th nerve of their neonates. Dibekacin Meiji Injection should be given under careful observation.

Use in pregnancy: Administration to pregnant women may cause impairment of the auditory portion of the 8th nerve of their neonates. Dibekacin Meiji Injection should be given under careful observation.

Shock, ototoxicity and nephrotoxicity. Rarely, liver damage, deficiency of vitamins K and B; infrequently, gastrointestinal upsets and anorexia occur.

Concomitant use with blood substitutes and diuretics may intensify nephrotoxicity and ototoxicity effects. Possible inhibition of respiration with anesthetics or muscle relaxants.

Store at room temperature.

Aminoglycosides

J01GB09 - dibekacin ; Belongs to the class of other aminoglycosides. Used in the systemic treatment of infections.

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