Novasorin

Novasorin

neomycin + polymyxin b + gramicidin

Manufacturer:

Vendiz

Distributor:

Ashford Pharma
Full Prescribing Info
Contents
Gramicidin, neomycin sulfate, polymyxin-B sulfate.
Description
Each mL contains: Polymyxin B Sulfate 5,000 Units, Neomycin (as Sulfate) 1,700 Units, Gramicidin 25 Units.
Action
Pharmacology: A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and gramicidin.
Neomycin is bactericidal for many gram-negative organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.
Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.
Gramicidin is bactericidal for a variety of gram-positive organisms. It increases the permeability of the bacterial cell membrane to inorganic cations by forming a network of channels through the normal lipid bilayer of the membrane.
Indications/Uses
Novasorin is indicated for the prophylaxis and treatment of external bacterial infections of the eye including conjunctivitis, blepharitis, keratitis, corneal ulcers, styes, abrasions and lacerations.
Dosage/Direction for Use
Instill one or two drops into the affected eye every 4 hours for 7 to 10 days, or as directed by the physician. In severe infections, dosage maybe increased to as much as two drops every hour, or as directed by the physician.
Contraindications
Contraindicated in individuals who have shown hypersensitivity to any of the components of Novasorin Eye Drops.
Warnings
For external use only.
Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. The manifestations of sensitization to topical antibiotics are usually itching, reddening and edema of the conjunctiva and eyelid.
Special Precautions
General: As with other antibiotic preparations, prolonged use of this product may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated.
Bacterial resistance to this product may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.
Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.
Information for Patients: Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.
Patient should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. If the condition persists or get worse, or if rash or other allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if patient is allergic to any of the listed ingredients.
Keep tightly closed when not in use.
Use in Pregnancy: Teratogenic Effects: Pregnancy Category C: Adequate animal reproductive studies have not been conducted with neomycin, polymyxin B or gramicidin. It is also not known whether this product can cause fetal harm when administered to a pregnant women or can affect reproductive capacity. This product should be given to a pregnant woman only if clearly needed.
Use in Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
Use In Pregnancy & Lactation
Use in Pregnancy: Teratogenic Effects: Pregnancy Category C: Adequate animal reproductive studies have not been conducted with neomycin, polymyxin B or gramicidin. It is also not known whether this product can cause fetal harm when administered to a pregnant women or can affect reproductive capacity. This product should be given to a pregnant woman only if clearly needed.
Use in Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
Storage
Store below 25°C.
Protect from light.
ATC Classification
S01AA30 - combinations of different antibiotics ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
Presentation/Packing
Ophth soln (bottle) (clear, colorless, odorless liquid, free from visible impurities) 10 mL x 1's.
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