Furen Pharma


International Apex
Full Prescribing Info
Gentamicin sulfate.
Each ampoule contains: Gentamicin (as sulfate) 40 mg.
Pharmacology: Pharmacokinetics: Gentamicin is administered as a sulfate but its dosages and concentrations are expressed in terms of gentamicin. It is well absorbed by the body following parenteral administration. Following IM administration of a single dose of gentamicin, peak plasma gentamicin concentrations of 4-7.6 mcg/mL are attained within 30-90 minutes, whereas in IV infusion administration, similar peak plasma concentrations are attained in over 2 hours. In adults with normal renal function, 50-90% of a single dose of gentamicin is excreted unchanged by glomerular filtration within 24 hours. Complete recovery of the dose in urine requires approximately 10-20 days in patients with normal renal function.
Gentamicin is used in the short-term treatment of serious infections such as septicemia, bone and joints infections, skin and soft tissue infections, respiratory tract infections, and postoperative and intra-abdominal infections caused by susceptible strains of Gram-negative bacteria.
Dosage/Direction for Use
Gentamicin is administered by IM injection or IV infusion. Dosage of gentamicin sulfate is expressed in terms of gentamicin base. IM and IV dosage is identical and should be based in an estimate of ideal body weight. It is recommended for adults with normal renal function to be given 3 mg/kg daily in equally divided doses at 8 hours intervals. In life-threatening infections, up to 5 mg/kg may be administered daily in 3 to 4 equally divided doses; dosage should be reduced to 3 mg/kg daily as soon as clinically indicated. Children may receive 6-7.5 mg/kg daily given in equally divided doses at 8-intervals; premature or full term neonates, one week of age or less, should be given 2.5 mg/kg every twelve hours.
This product is contraindicated in pregnant women and patients with hypersensitivity to the preparation or any of its components.
Special Precautions
Caution should be observed in the elderly, premature and full-term neonates, and patients with neuromuscular disorders.
Adverse Reactions
Ototoxicity and nephrotoxicity are the most serious adverse effects of aminoglycosides therapy. Symptoms include dizziness, vertigo, ataxia, renal and electrolyte abnormalities, and auditory symptoms such as tinnitus, roaring in the ears, and varying degrees of hearing impairment. Hypersensitivity reactions including rash, stomatitis, muscle twitching, and fever may also occur.
Store at temperature not exceeding 30°C. Do not freeze.
MIMS Class
ATC Classification
J01GB03 - gentamicin ; Belongs to the class of other aminoglycosides. Used in the systemic treatment of infections.
Soln for inj (amp) 40 mg/mL x 2 mL x 10's.
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