NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)

Available from:

Citron Pharma LLC

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN 3.5 mg in 1 g

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is supplied in a tube of 1/8 oz (3.5 g) with an ophthalmic tip (NDC 57237-129-53). Caution: Federal law prohibits dispensing without a prescription. Store at 15° - 25°C (59°- 77°F). Rx only FOR OPHTHALMIC USE ONLY KEEP OUT OF REACH OF CHILDREN. Manufactured for: Citron Pharma LLC East Brunswick, NJ 08816 Issued: 04/2016 PIC12953-00 Made in Canada

Authorization status:

New Drug Application

Summary of Product characteristics

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC - NEOMYCIN AND
POLYMYXIN B SULFATES, BACITRACIN ZINC OINTMENT
CITRON PHARMA LLC
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NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OPHTHALMIC
OINTMENT USP (STERILE)
DESCRIPTION
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic
Ointment, USP is a sterile
antimicrobial ointment for ophthalmic use. Each gram contains:neomycin
sulfate equivalent to 3.5 mg
neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B
units, and bacitracin zinc
equivalent to 400 bacitracin units and petrolatum q.s.
Neomycin sulfate is the sulfate salt of neomycin B and C, which are
produced by the growth of
_Streptomyces fradiae _Waksman (Fam. Streptomycetaceae). It has a
potency equivalent of not less than 600
micrograms of neomycin standard per mg, calculated on an anhydrous
basis. The structural formulae
are:
Polymyxin B sulfate is the sulfate salt of polymyxin B and B which are
produced by the growth of
_Bacillus polymyxa _(Prazmowski) Migula (Fam. Bacillaceae). It has a
potency of not less than 6,000
polymyxin B units per mg, calculated on an anhydrous basis. The
structural formulae are:
Bacitracin zinc is the zinc salt of bacitracin, a mixture of related
cyclic polypeptides (mainly bacitracin
1
2
A) produced by the growth of an organism of the _licheniformis _group
of _Bacillus subtilis _var Tracy. It has
a potency of not less than 40 bacitracin units per mg. The structural
formula is:
CLINICAL PHARMACOLOGY
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 membran