BACITRACIN ZINC AND POLYMYXIN B SULFATE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Bacitracin Zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I), polymyxin B sulfate (UNII: 19371312D4) (polymyxin B - UNII:J2VZ07J96K)

Available from:

E. FOUGERA & CO., A division of Nycomed US Inc.

INN (International Name):

Bacitracin Zinc

Composition:

Bacitracin Zinc 500 in 1 g

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bacitracin Zinc and Polymyxin B Sulfate 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. Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

Product summary:

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP, is supplied as follows:                                 NDC 0168-0273-38                                3.5 gram tubes Store between 15° and 25°C (59° and 77°F). E. FOUGERA & CO. A division of Nycomed US Inc. MELVILLE, NEW YORK 11747 I273A R10/07

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BACITRACIN ZINC AND POLYMYXIN B SULFATE- BACITRACIN ZINC AND POLYMYXIN
B
SULFATE OINTMENT
E. FOUGERA & CO., A DIVISION OF NYCOMED US INC.
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BACITRACIN ZINC AND POLYMYXIN B SULFATE OPHTHALMIC OINTMENT, USP
STERILE
Rx only
DESCRIPTION
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP, is a
sterile antimicrobial ointment
for ophthalmic use. Each gram contains: bacitracin zinc equivalent to
500 bacitracin units, polymyxin B
sulfate equivalent to 10,000 polymyxin B units, mineral oil, and white
petrolatum.
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 mg. The structural
formula for bacitracin A is:
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:
CLINICAL PHARMACOLOGY
A wide range of antibacterial action is provided by the overlapping
spectra of bacitracin and polymyxin
B sulfate.
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.
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.
MICROBIOLOGY: Bacitracin zinc and polymyxin B sulfate together are
considered active against the
1
2
following microorganisms: _Staphylococcus aureus_, streptococci
including _Streptococcus pneumoniae,_
_Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter_
species, _Neisseria_ species, and
_Pseudomonas aeruginosa_. The product does