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0.4% 10 ml Ophthalmic Medication Gentamicin Sulfate Ear Drops / Gentamycin Eye Drops

0.4% 10 ml Ophthalmic Medication Gentamicin Sulfate Ear Drops / Gentamycin Eye Drops

0.4% 10 ml Ophthalmic Medication Gentamicin Sulfate Ear Drops / Gentamycin Eye Drops

Product Details:

Place of Origin: China
Brand Name: Newlystar
Certification: GMP
Model Number: 0.4% 10ml

Payment & Shipping Terms:

Minimum Order Quantity: 200, 000 bottles
Price: Negotiation
Packaging Details: one bottle/box
Delivery Time: 45 days
Payment Terms: L/C, T/T
Supply Ability: 400, 000 bottles per day
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Detailed Product Description
Strength: 0.4% 10ml Packing: One Bottle/box
Dosage Form: Eye Drop Active Ingredients: Gentamycin Sulfate

0.4% 10 ml Ophthalmic Medication Gentamicin Sulfate Ear Drops / Gentamycin Eye Drops

 

 

Product : Gentamycin Sulfate Eye & Ear Drops,

Doage and strength : Drops, 0.4% 10ml

Packaging : 1bottle/box

Standard : USP/BP

Dossier : Ready to submit

 

Description :

Gentamicin Sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived by the growth of Micromonospora purpurea, an actinomycete.

 

Indication

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.

 

DOSAGE & ADMINISTRATION

Gentamicin Sulfate sterile ophthalmic solution; Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops once every hour.

 

PRECAUTIONS

General

Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.

If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation and appropriate therapy should be instituted.

 

Information for patients

To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non mutagenic.

 

Pregnancy

Pregnancy Category C

 

Gentamicin has been shown to depress body weights, kidney weights and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

 

Pediatric Use

Safety and effectiveness in neonates have not been established.

 

Pharmacodynamics

Gentamicin is a broad spectrum aminoglycoside antibiotic. Aminoglycosides work by binding to the bacterial 30S ribosomal subunit, causing misreading of t-RNA, leaving the bacterium unable to synthesize proteins vital to its growth. Aminoglycosides are useful primarily in infections involving aerobic, Gram-negative bacteria, such as Pseudomonas, Acinetobacter, and Enterobacter. In addition, some mycobacteria, including the bacteria that cause tuberculosis, are susceptible to aminoglycosides. Infections caused by Gram-positive bacteria can also be treated with aminoglycosides, but other types of antibiotics are more potent and less damaging to the host. In the past the aminoglycosides have been used in conjunction with penicillin-related antibiotics in streptococcal infections for their synergistic effects, particularly in endocarditis. Aminoglycosides are mostly ineffective against anaerobic bacteria, fungi and viruses.

 

Mechanism of action

Aminoglycosides like gentamicin "irreversibly" bind to specific 30S-subunit proteins and 16S rRNA. Specifically gentamicin binds to four nucleotides of 16S rRNA and a single amino acid of protein S12. This interferes with decoding site in the vicinity of nucleotide 1400 in 16S rRNA of 30S subunit. This region interacts with the wobble base in the anticodon of tRNA. This leads to interference with the initiation complex, misreading of mRNA so incorrect amino acids are inserted into the polypeptide leading to nonfunctional or toxic peptides and the breakup of polysomes into nonfunctional monosomes.

 

Contact Details
Newlystar (Ningbo) Medtech Co.,Ltd.

Contact Person: Luke Liu

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