GENTAK SUMMARY
GENTAK® Gentamicin sulfate is a water-soluble antibiotic of the aminoglycoside group. Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution for ophthalmic use.
Gentamicin Sulfate Sterile 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 Gentak (Gentamicin Ophthalmic)
Side effects of postoperative administration of methylprednisolone and gentamicin into the posterior sub-Tenon's space. [2007.05]
PURPOSE: To assess the incidence of postoperative emetic side effects after the administration of methylprednisolone and gentamicin into the posterior sub-Tenon's space at the end of routine cataract surgery. SETTING: St. Luke's Hospital, Gwardamangia, Malta... CONCLUSIONS: The administration of methylprednisolone and gentamicin in the posterior sub-Tenon's space was related to a high incidence of side effects including nausea, vomiting, and headache. All adverse effects were self-limiting.
Horizontal head impulse test detects gentamicin vestibulotoxicity. [2009.04.21]
BACKGROUND: Parenteral antibiotic therapy with gentamicin, even in accepted therapeutic doses, can occasionally cause bilateral vestibular loss (BVL) due to hair cell toxicity. OBJECTIVE: To quantify in patients with gentamicin vestibulotoxicity (GVT) the extent of acceleration gain deficit of the horizontal vestibulo-ocular reflex at different accelerations with a graded head impulse test (HIT) in comparison with standard caloric and rotational testing. To characterize the corresponding HIT catch-up saccade pattern to provide the basis for its salience to clinicians... CONCLUSIONS: Head impulse testing is useful for early bedside detection of gentamicin vestibulotoxicity because most patients, even those with partial bilateral vestibular loss (BVL), have large overt saccades. Covert saccades, which can conceal the extent of BVL, are only approximately half as frequent as in unilateral patients, but may be present even in total BVL.
Gentamicin vestibulotoxicity impairs human electrically evoked vestibulo-ocular reflex. [2008.11.25]
BACKGROUND: Electrical vestibular stimulation is believed to directly activate the vestibular afferents to mediate an electrically evoked vestibulo-ocular reflex (eVOR). Gentamicin, an aminoglycoside antibiotic, induces vestibulotoxicity by hair cell damage and death. OBJECTIVE: To determine if human eVOR is impaired by hair cell damage and death in systemic gentamicin vestibulotoxicity (GV)... CONCLUSION: Impairment of evoked vestibulo-ocular reflex (eVOR) in gentamicin vestibulotoxicity (GV) suggests that vestibular hair cells, activated by electrical stimulation, mediate the eVOR. Abnormalities of the eVOR, especially the phasic component, might be a marker of vestibular injury in GV.
Gentamicin-induced macular infarction in transconjunctival sutureless 25-gauge vitrectomy. [2008.10]
PURPOSE: State Gentamicin antibiotic prophylaxis is contraindicated in 25 gauge Transconjunctival Sutureless Vitrectomy... CONCLUSION: Antibiotics, in particular gentamicin, have the potential to cause significant ocular toxicity when they gain access to the inside of the eye, through thinned sclera or sutureless sclerotomies of TSV.
Niosome-encapsulated gentamicin for ophthalmic controlled delivery. [2008]
The objective of the present research was to investigate the feasibility of using non-ionic surfactant vesicles (niosomes) as carriers for the ophthalmic controlled delivery of a water soluble local antibiotic; gentamicin sulphate. Niosomal formulations were prepared using various surfactants (Tween 60, Tween 80 or Brij 35), in the presence of cholesterol and a negative charge inducer dicetyl phosphate (DCP) in different molar ratios and by employing a thin film hydration technique...
Clinical Trials Related to Gentak (Gentamicin Ophthalmic)
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.
Collagen-Gentamicin Implant in the Treatment of Contaminated Surgical Abdominal Wounds [Recruiting]
The investigators' hypothesis is that placement of CollatampG in the subcutaneous layer of
contaminated abdominal wounds is effective prophylaxis for superficial surgical site
infection (SSI). CollatampG is composed of highly purified type 1 collagen obtained from
bovine tendon, which acts as a vehicle for the aminoglycoside antibiotic, gentamicin. This
implant provides a high concentration of local gentamicin at the surgical wound to decrease
the local microorganism load. It has been shown that if a surgical site is contaminated with
> 10 to the power of 5 microorganisms per gram of tissue, the risk of infection is markedly
increased. When a gastrointestinal organ is the source of pathogens, gram-negative bacilli
(e. g., E. coli) are typical isolates, which are susceptible to gentamicin. Therefore, a high
local concentration of gentamicin at the contaminated surgical wound provided by the
CollatampG implant may prevent the local bacterial load from reaching levels high enough to
cause a clinical infection.
Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM1) [Recruiting]
This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial
comparing three creams in the treatment of impetiginous eczema:
- Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole and gentamicin
sulfate)
- Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream
- Arm C: Betamethasone diproprionate cream
At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1: 1:1
randomization ratio to receive one of the three possible treatments for a maximum period of
28 days or until 5 days after total remission of the signs and symptoms, but never more than
28 days. Assessments will be made of level of improvement of the target area in each
treatment group, number of days for total remission, and safety profile.
Treatment of Chorioamnionitis After Delivery [Recruiting]
Chorioamnionitis occurs in 1% to 5% of term pregnancies and may complicate up to 25% of
cases of preterm labor. The traditional regimen used to treat intra-amniotic infection is
intravenous ampicillin 2g every 6 hours and intravenous gentamicin 1. 5 mg/kg every 8 hrs
until delivery . In the past the recommendation has been that the antibiotics be continued
postpartum until 24-48 hours afebrile. More recent studies have looked at using a one time
dose of antibiotics after delivery vs treating until 24-48 hours afebrile. There have been
no studies comparing treatment of chorioamnionitis with antibiotics vs no treatment with
antibiotics postpartum. The aim of this study is to compare no treatment vs treatment with
one dose after a vaginal delivery and one dose of antibiotics vs a full course until 24
hours afebrile after a cesarean delivery complicated by chorioamnionitis. The hypothesis is
that there will be no difference in outcome between the two groups in each arm. This is a
randomized study. Once the patient delivers she will be randomized to one of two groups in
each arm. First arm (vaginal delivery) A: no treatment, B: treatment with a one time dose
of ampicillin/gentamicin; Second arm (c/s) A: one dose of ampicillin/gentamicin/clindamycin,
B: treatment with ampicillin/gentamicin and clindamycin until 24 hours afebrile. The goal
of the study is to determine the optimal postpartum management of chorioamnionitis.
Intradialytic Drug Removal by Short-Daily Hemodialysis [Recruiting]
Short-daily hemodialysis is increasingly becoming a preferred alternative to the
conventional intermittent (three times per week) hemodialysis schedule. Studies have shown
that short-daily dialysis improves a patient's quality of life, high blood pressure, anemia
and calcium-phosphorus balance. Infection, however, will likely remain a persistent problem
for dialysis patients regardless of the frequency of treatments. There is currently a
wealth of information to guide doctors on how much and how frequently to give an antibiotic
for patients who receive intermittent (thrice weekly) hemodialysis. However, there is very
little information on how to prescribe antibiotics for patient's receiving short-daily
hemodialysis. This study will develop drug dose guidelines for patients receiving
short-daily hemodialysis for three frequently used antibiotics, vancomycin, levofloxacin and
gentamicin. These guidelines will assist doctors so that patients receive the most
effective dose and frequency of an antibiotic to treat their infection.
The following is the study hypothesis which will be tested with two-sided, one sample
t-tests comparing the AUC observed to historical measures8.
1) Vancomycin, levofloxacin and gentamicin are removed to a greater extent by short-daily
hemodialysis than intermittent hemodialysis.
The following are the specific aims:
1. Determine the interdialytic pharmacokinetics of vancomycin, gentamicin, and
levofloxacin by short-daily HD.
2. Determine the extent of vancomycin removal when administered during the last hour of
short-daily HD.
3. Develop drug-dosing guidelines for vancomycin, gentamicin and levofloxacin for patients
receiving short-daily HD.
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Page last updated: 2009-10-20
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