NEOMYCIN AND POLYMYXIN B SULFATES AND 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:

Physicians Total Care, Inc.

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN SULFATE 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 those 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 3.5 g tube with an ophthalmic tip. Prod. No. 03534 NDC 54868-2971-1 DO NOT USE IF CAP AND NECKRING ARE NOT INTACT. FOR OPHTHALMIC USE ONLY Store between 15° - 30°C (59°- 86°F). KEEP OUT OF REACH OF CHILDREN. Revised November 2007 Bausch & Lomb Incorporated Tampa, FL    33637 Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC - NEOMYCIN AND
POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT
PHYSICIANS TOTAL CARE, INC.
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NEOMYCIN AND POLYMYXIN B SULFATES AND
BACITRACIN ZINC OPHTHALMIC OINTMENT USP (STERILE)
RX ONLY
DESCRIPTION:
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic
Ointment USP is a sterile
antimicrobial ointment for ophthalmic use.
EACH GRAM CONTAINS:
ACTIVES: 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; INACTIVES: White
Petrolatum, Mineral Oil.
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 milligram, 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 milligram, 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
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 milligram.
1
2
The structural formula for bacitracin A 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 permeabi