GENTAMICIN SULFATE 40mg/ml Injection

Gentamicin Sulfate 40 mg / ml

COMPOSITION : 

Gentamicin Sulfate Injection 80 mg/2 ml, each ml contains : Gentamicin sulfate equivalent to Gentamicin 40 mg.

 

DESCRIPTIONS : 

Gentamicin Sulfate with Gentamicin sulfate (equivalent to Gentamicin) as active ingredient is available in injection 80 mg/2 ml.

 

INDICATIONS : 

Gentamicin injection is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms such as Pseudomonas aeruginosa, Proteus sp. (indole-positive and indole-negative), E. coli, Klebsiella, Enterobacter, Serratia sp., Citrobacter sp., and Staphylococcus sp. (coagulase-positive and negative).

Effective in bacterial neonatal sepsis, bacterial septicemia and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue including burns.

 

DOSAGE AND ADMINISTRATIONS : 

Gentamicin injection may be given intramuscularly or intravenously.

Patients with normal renal function

Adults : 3 – 4 mg/kgBW per day, administered in divided dose every 6 – 8 hours.

Children : 6 – 7.5 mg/kgBW per day, administered in divided dose every 8 hours.

Infants and neonates : 7.5 mg/kgBW per day, administered in divided doses every 8 hours.

Premature or full term neonates one week of age or less : 5 mg/kgBW per day, administered in divided doses every 12 hours.

Patients with impaired renal function

Dosage must be adjusted related to renal impairment severity and serum concentration of Gentamicin should be monitored. One method of dosage adjustment is to increase the interval between administration of the usual doses.

Since the serum creatinine concentration has a high correlation with the serum half-life of Gentamicin this laboratory test may provide guidance for adjusment of the interval between doses. The interval between doses (in hours) may be approximated by multiplying the serum creatinine level (mg/100 ml) by 8. In systemic infections it is better to administered more frequently at a reduced dose than normal sparing dose. The guideline to determine the dose reduction at 8 hour intervals is by divided the recommended dose with serum creatinine level.

In adults with renal failure undergoing hemodialysis, the amount of Gentamicin removed from the blood may vary depending upon several factors including the dialysis method used and the duration of dialysis. An eight-hour hemodialysis may reduce serum concentrations of Gentamicin by approximately 50%. The recommended dose at the end of each dialysis period is 1 – 1.7 mg/kgBW depending upon the serverity of infection. In children, a dose of 2 mg/kgBW may be administered.

For intravenous administration 

Particularly useful for treating patients with bacterial septicemia, patients with congestive heart failure, hematologic disorders, severe burns or those in shock. 

In adults, a single dose of 40 mg/ml, may be diluted in 50 – 200 ml of sterile NaCl 0.9% solution or in Dextrose 5% sterile solution in water (in infants and children, the volume of diluent should be less).

The solution may be infused over a period of 1.5 – 2 hours.

 

CONTRAINDICATIONS

Patients with hypersensitive to Gentamicin and have history of hypersensitive or severe toxicity against aminoglycoside.

 

WARNINGS AND PRECAUTIONS : 

  • Patients treated with aminoglycoside must be under tight clinical observation. 
  • Urine analysis, BUN, creatinine serum or creatinine clearence should be monitored periodically to see nephrotoxicity or ototoxicity which require adjustment dosage or termination therapy. 
  • Drug levels in the blood should always be monitored to prevent toxic levels, avoid peak levels above 12 mcg/ml and the valley levels below 2 mcg/ml.
  • There have been found cross allergy between aminoglycoside.
  • Beware the usage at patients with impaired neuromuscular (such as myasthenia gravis, parkinsonism or botulism infants).
  • In long-term use or high doses, especially in patients with impaired renal function should be monitored renal function and cranial nerves.
  • The growth of insensitive microorganisms can occur and once a super-infection occurs, give appropriate therapy.
  • The risk of toxicity is increased in dehydration, old age and intravenous diuretic administration.
  • Fanconi like syndrome with aminoaciduria and metabolic acidosis can occur in children and adults.
  • During therapy patients must be properly hydrated.
  • In patients with hypomagnesemia, hypocalcemia and hypokalemia, during treatment with Gentamicin, symptoms of paresthesias, tetany and Chvostek can be positive.
  • In nursing mothers the use of this drug must consider the benefit of giving to mothers and the risks for babies who are breastfeeding or breastfeeding to babies are stopped while the mother is undergoes therapy.
  • In pregnant women, the safety of the use of this drug is not yet clearly known.

 

ADVERSE REACTIONS

  • In patients with impaired kidney function, the use of these drugs with high doses or long-term side effects may occur in cranial nerves with symptoms of dizziness, vertigo, tinnitus, ataxia, ringing in the ears and hearing loss.
  • Side effects to the blood include anemia, leukopenia, granulocytopenia, transient agranulocytosis, eosinophilia and thrombocytopenia.
  • Other side effects include respiratory depression, lethargy, convulsions, depression, visual disturbances, weight loss, decreased appetite, hypotension, hypertension, rashes, itching, urticaria, fever, headache, nausea, vomiting, stomatitis, purpura, alopecia, joint pain, transient hepatomegaly and splenomegaly.
  • Laryngeal edema, anaphylactoid reactions, increased salivation, cerebral pseudotumor, acute organic brain syndrome, pulmonary fibrosis, peripheral neuropathy or encephalopathy.
  • Laboratory abnormalities that may be related to Gentamicin include increased serum transaminases (SGOT, SGPT), serum LDH and bilirubin, decreased serum calcium, magnesium, Na and K.

 

PRESENTATION :

Gentamicin Sulfate Injection 80 mg/2 ml Box, 10 ampoules @ 2 ml

 

STORAGE :

STORE BELOW 30ºC

 

ON MEDICAL PRESCRIPTION ONLY