POLYCIN- bacitracin zinc and polymyxin b sulfates 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:

RPK Pharmaceuticals, Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Polycin® 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. Polycin® Ophthalmic Ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

Product summary:

Product: 53002-9270 NDC: 53002-9270-1 3.5 g in a TUBE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POLYCIN- BACITRACIN ZINC AND POLYMYXIN B SULFATES OINTMENT
RPK PHARMACEUTICALS, INC.
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POLYCIN®
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
1
2
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
following microorganisms: _Staphylococcus aureus_, streptococci
including _Streptococcus_
_pneumoniae_, _Escherichia coli_, _Haemophilus influenzae_,
_Klebsiella/Enterobacter _species,
_Neisseria _