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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)

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).

Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4) [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.

Comparison of Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Intrapartum Chorioamnionitis: a Randomized Controlled Trial [Recruiting]
Chorioamnionitis is an infection of the placenta and amniotic membranes (bag of waters) surrounding the baby inside of a pregnant woman prior to delivery. This infection is somewhat common and is routinely treated with antibiotics given to the mother both before and after the baby is born. Currently it is not known what is the best choice of antibiotics to treat this type of infection, but commonly used treatments include Unasyn (ampicillin/sulbactam) or ampicillin/gentamicin. We plan to compare these two different antibiotic regimens to see if one is better than the other at treating and preventing bad outcomes from chorioamnionitis in women and babies.

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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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