Gentak (Gentamicin Sulfate Ophthalmic) - Summary

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.

NEWS HIGHLIGHTS

Published Studies Related to Gentak (Gentamicin Ophthalmic)

Effects of intracameral triamcinolone and gentamicin injections following cataract surgery. [2011.07]
CONCLUSION: Intracameral injections of triamcinolone acetonide and gentamicin appear to be a promising treatment option for the control of post-operative inflammation following cataract surgery.

Use of povidone-iodine drop instead of sub-conjunctival injection of dexamethasone and gentamicin combination at the end of phacoemulsification cataract surgery. [2010.04]
To evaluate the use of 5% povidone-iodine drop with subconjunctival injection of dexamethasone and gentamicin combination at the completion of phacoemulsification cataract surgery. This prospective randomized study was conducted at the department of Ophthalmology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh during the period of July, 2005 to June 2006...

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.

Intravitreal gentamicin-induced macular infarction: SD-OCT features. [2011.08.04]
A 75-year-old woman developed acute-onset endophthalmitis following phacoemulsification in the left eye. She was treated with intravitreal injections of vancomycin, ceftazidime, and gentamicin... This case demonstrates SD-OCT features in macular infarction following intravitreal gentamicin, specifically changes involving the inner retina with a relatively intact outer retina.

Severe ocular reactions after neonatal ocular prophylaxis with gentamicin ophthalmic ointment. [2011.02]
In this study, we report 4 infants who developed severe ocular reactions after neonatal ocular prophylaxis with gentamicin ophthalmic ointment during a period of erythromycin ophthalmic ointment shortage.

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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.

Local Gentamicin Application to Reduce Postoperative Infection Rate [Recruiting]
The majority of elderly patients with a displaced fracture of the proximal femur are now treated with a hemiarthroplasty. Prosthetic joint infection is a devastating complication, and the infection rate is high in this group of elderly patients. Local application of gentamicin produces high antibiotic concentrations in the wound. The aim of this study is to determine whether locally administered collagen-gentamicin in the joint perioperatively in addition to routine IV prophylaxis with beta-lactam antibiotics can reduce the early postoperative infection rate (< 4 weeks postoperative)after hemiarthroplasty in proximal femoral fractures.

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, Efficacy, and PK of Topical Paromomycin/Gentamicin Cream for Treatment of Cutaneous Leishmaniasis [Recruiting]
The objectives of the study are to evaluate the safety, pharmacokinetics (PK), and efficacy of open label treatment with WR 279,396 (Topical Paromomycin/Gentamicin Cream)in subjects with cutaneous leishmaniasis (CL).

Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama [Recruiting]
The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in subjects with cutaneous leishmaniasis (CL).

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