GENTAMICIN SUMMARY
GENTAMICIN SULFATE
Ophthalmic Solution, USP 0.3%
Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group. Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered with dibasic sodium phosphate and monobasic sodium phosphate to approximately pH 7 (pH range 6.5 - 7.5) for ophthalmic use. Each mL contains gentamicin sulfate, USP (equivalent to 3 mg gentamicin base), sodium chloride; and benzalkonium chloride (0.1 mg) as a preservative. Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C1, C2, and C1A. All three components appear to have similar antimicrobial activities. Gentamicin Sulfate occurs as a white powder and is soluble in water and insoluble in alcohol.
Gentamicin Sulfate Ophthalmic Solution is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis caused by susceptible strains of the following microorganisms:
Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
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NEWS HIGHLIGHTS
Published Studies Related to Gentamicin (Gentamicin Ophthalmic)
Collagen-gentamicin implant for prevention of sternal wound infection; long-term follow-up of effectiveness. [2009.09]
In a previous randomized controlled trial (LOGIP trial) the addition of local collagen-gentamicin reduced the incidence of postoperative sternal wound infections (SWI) compared with intravenous prophylaxis only. Consequently, the technique with local gentamicin was introduced in clinical routine at the two participating centers...
Initial low-dose gentamicin for Staphylococcus aureus bacteremia and endocarditis is nephrotoxic. [2009.03.15]
BACKGROUND:The safety of adding initial low-dose gentamicin to antistaphylococcal penicillins or vancomycin for treatment of suspected Staphylococcus aureus native valve endocarditis is unknown. This study evaluated the association between this practice and nephrotoxicity... CONCLUSIONS:Initial low-dose gentamicin as part of therapy for S. aureus bacteremia and native valve infective endocarditis is nephrotoxic and should not be used routinely, given the minimal existing data supporting its benefit.
Daptomycin versus vancomycin plus gentamicin for treatment of bacteraemia and endocarditis due to Staphylococcus aureus: subset analysis of patients infected with methicillin-resistant isolates. [2008.12]
OBJECTIVES: In a prospective, randomized trial, daptomycin was non-inferior to standard therapy for Staphylococcus aureus bacteraemia and right-sided endocarditis. Since rates of infection due to methicillin-resistant S. aureus (MRSA) infection are increasing and treatment outcomes for bacteraemia caused by MRSA are generally worse than those observed with methicillin-susceptible S. aureus bacteraemia, clinical characteristics and treatment results in the trial's pre-specified subset of patients with MRSA were analysed... CONCLUSIONS: Daptomycin was an effective alternative to vancomycin/gentamicin for MRSA bacteraemia or right-sided endocarditis.
Intratympanic gentamicin therapy for control of vertigo in unilateral Menire's disease: a prospective, double-blind, randomized, placebo-controlled trial. [2008.08]
CONCLUSIONS: Intratympanic application of gentamicin is a relatively safe and efficient treatment for the reduction of complaints of vertigo attacks associated with Meniere's disease. The treatment also reduces the severity of the perceived aural fullness. OBJECTIVE: To investigate the effectiveness of intratympanic gentamicin treatment in patients with unilateral Meniere's disease. SUBJECTS AND METHODS: In a prospective, double-blind, randomized, placebo-controlled clinical trial subjects scored vertigo complaints, aural fullness and tinnitus, before, during and up to 1 year after treatment. Hearing loss was monitored with pure tone audiometry. RESULTS: Gentamicin treatment resulted in a significant reduction of the score for vertigo complaints and the score for perceived aural fullness. A small increase in hearing loss (average 8 dB) was measured in the gentamicin group.
Surgical treatment of hidradenitis suppurativa with gentamicin sulfate: a prospective randomized study. [2008.02]
CONCLUSION: This study shows that enclosure of gentamicin after primary excision of hidradenitis suppurativa reduces the number of complications 1 week postoperatively. Furthermore, in 65% of the patients treated with gentamicin, the wound was completely healed within 2 months. There is no effect on the long term recurrence rate, as expected.
Clinical Trials Related to Gentamicin (Gentamicin Ophthalmic)
Gentamicin Treatment of Muscular Dystrophy [Completed]
This study will evaluate the antibiotic gentamicin for treating patients with muscular
dystrophy caused by a specific genetic abnormality known as a nonsense mutation. In studies
of mice with this type of muscular dystrophy, gentamicin treatment produced positive changes
in muscle tissue.
Patients with Duchenne or Becker muscular dystrophy caused by nonsense mutations by may be
eligible for this 2-week study. Before starting treatment, patients will have evaluations of
muscle strength and general well being. Two muscle tissue samples will be taken by needle
biopsy, under local anesthetic and sedation. Because of potential risks of hearing loss and
kidney toxicity associated with gentamicin, patients will also have a hearing test and blood
and urine tests for kidney function before starting treatment. (Currently, gentamicin is
commonly prescribed for serious infections of the lungs, heart, and digestive and urinary
tracts; adverse effects of hearing loss and kidney toxicity can occur with excessively high
drug doses.)
Patients will be hospitalized during drug treatment. Gentamicin will be given intravenously
(through a vein) once a day for 14 days. Blood samples will be collected daily to monitor
drug levels and determine dosage adjustments, if necessary. Urine samples will be collected
to assess kidney function. Hearing tests will be done on days 7 and 10.
On the last day of the study, hearing, kidney function, and muscle strength will be tested
and the results compared with pre-treatment levels. Blood and muscle samples will also be
taken again for pre-treatment comparison. Hearing, blood, urine, and muscle strength tests
will be repeated one month after treatment ends for comparison with previous results.
Determination of Gentamicin Dosing in Neonatal Patients [Active, not recruiting]
The purpose of this study is to determine what dosage of gentamicin for use in one-time
administration device (Uniject) is appropriate.
Topical Gentamicin Cream Versus Alternating Gentamicin and Mupirocin Cream in Peritoneal Dialysis [Not yet recruiting]
Catheter-related infection, namely exit site infection and peritonitis, is the commonest
complication of peritoneal dialysis. This complication causes significant morbidity and
mortality in patients requiring peritoneal dialysis. Topical application of mupirocin 2%
cream was first proven to be effective in reduction of staphylococcus-related catheter
infection in 1990s. Subsequent randomized trial published in 2005 showed that gentamicin
cream was superior to mupirocin 2% cream in reducing both Gram's positive and Gram's
negative related catheter infection. However, a retrospective report published in 2007 puts
the use of prophylactic antibiotic cream into a question. It reported an emergency of
non-tuberculous mycobacterial infection in a dialysis center in Hong Kong after practising
prophylactic application of gentamicin cream at the catheter exit site. The following
prospective, randomized and open-label study aims to find out an optimal regimen of topical
antibiotic prophylaxis in patients requiring peritoneal dialysis.
Six Month Study of Gentamicin in Duchenne Muscular Dystrophy With Stop Codons [Recruiting]
The purpose of this study is to determine the safety of giving intravenous (IV) gentamicin to
boys with Duchenne muscular dystrophy who have stop codon mutations.
Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis [Active, not recruiting]
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Page last updated: 2009-10-20
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