NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC- neomycin and polymyxin b sulfates, bacitracin zinc_ointment

A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and bacitracin. Neomycin is bactericidal for many gram-positive and 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. Bacitracin is bactericidal for a variety of gram-positive and gram-negative organisms. It interferes with bacterial cell wall synthesis by inhibition of the regeneration of phospholipid receptors involved in peptidoglycan synthesis. Microbiology Neomycin sulfate, polymyxin B sulfate and bacitracin zinc together are considered active against the following microorganisms: Staphylococcus aureus Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter Neisseria Pseudomonas aeruginosa Serratia marcescens

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

Adverse reactions have occurred with the anti-infective components of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment. The exact incidence is not known. Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema ( see WARNINGS Local irritation on instillation has also been reported. To report SUSPECTED ADVERSE REACTIONS, contact Casper Pharma LLC. at 1-844-5-CASPER (1-844-522-7737) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

PREGNANCY
Teratogenic Effects
NURSING MOTHERS
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 neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is administered to a nursing woman.
PEDIATRIC USE
Safety and effectiveness in children have not been established.

WARNINGS
NOT FOR INJECTION INTO THE EYE. Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing. see PRECAUTIONS: General
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Treatment of cultured human lymphocytes in vitro Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, litter size or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet.

Casper Pharma LLC

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC- neomycin and polymyxin b sulfates, bacitracin zinc_ointment Product manual source documgent