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Gentamicin (Gentamicin Sulfate Ophthalmic) - Summary

 
 



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)

Intratympanic Treatment of Intractable Unilateral Meniere Disease: Gentamicin or Dexamethasone? A Randomized Controlled Trial. [2011.11.18]
Objective. To determine the efficacy and safety of low-dose intratympanic gentamicin (ITG) compared with intratympanic dexamethasone (ITD) in patients with intractable unilateral Meniere disease (MD).Study Design.ITD offers poorer vertigo control rate, and hearing preservation is achieved only in cases with no vertigo recurrences.

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.

A randomized controlled trial of nebulized gentamicin in non-cystic fibrosis bronchiectasis. [2011.02.15]
RATIONALE: Bronchiectasis is a chronic debilitating disease with few evidence-based long-term treatments. OBJECTIVES: A randomized controlled trial assessing the efficacy of nebulized gentamicin therapy over 1 year in patients with non-cystic fibrosis bronchiectasis...

Local administration of antibiotics by gentamicin-collagen sponge does not improve wound healing or reduce recurrence rate after pilonidal excision with primary suture: a prospective randomized controlled trial. [2010.12]
BACKGROUND: Excision and primary suture for pilonidal disease is associated with a high rate of wound infection and recurrences. This randomized, controlled study was designed to analyze the effect of local application of a gentamicin-containing collagen sponge (Collatamp((R))) in reducing the wound infection rate and recurrences after excision of pilonidal sinus and wound closure with primary midline suture... CONCLUSIONS: This randomized, controlled study showed no significant differences in the rates of wound infection, wound healing, and recurrences when a gentamicin-collagen sponge was added to the surgical treatment of pilonidal disease with excision and primary midline suture. This does not support the use of gentamicin-collagen sponge for the surgical treatment of pilonidal disease.

Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery. [2010.09.09]
BACKGROUND: Despite the routine use of prophylactic systemic antibiotics, surgical-site infection continues to be associated with significant morbidity and cost after colorectal surgery. The gentamicin-collagen sponge, an implantable topical antibiotic agent, is approved for surgical implantation in 54 countries. Since 1985, more than 1 million patients have been treated with the sponges... CONCLUSIONS: Our large, multicenter trial shows that the gentamicin-collagen sponge is not effective at preventing surgical-site infection in patients who undergo colorectal surgery; paradoxically, it appears to result in significantly more surgical-site infections. (Funded by Innocoll Technologies; ClinicalTrials.gov number, NCT00600925.)

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Clinical Trials Related to Gentamicin (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.

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).

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).

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.

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Reports of Suspected Gentamicin (Gentamicin Ophthalmic) Side Effects

Renal Failure Acute (40)Renal Failure (23)Drug Rash With Eosinophilia and Systemic Symptoms (15)Drug Interaction (13)Septic Shock (13)Klebsiella Infection (9)Drug Hypersensitivity (9)Pyrexia (8)Fungaemia (8)Eosinophilia (8)more >>


Page last updated: 2011-12-09

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