POLYCIN- bacitracin zinc and polymyxin b sulfates ointment

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

NuCare Pharmaceuticals,Inc.

INN (Nome Internazionale):

BACITRACIN ZINC

Composizione:

BACITRACIN 500 [USP'U] in 1 g

Via di somministrazione:

OPHTHALMIC

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Polycin® Ophthalmic Ointment is supplied in 3.5 g (1/8 oz) sterile tamper evident tubes with ophthalmic tip. NDC 66267-925-35 Box of 3.5 g Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Polycin® is a Registered Trademark of Perrigo Company Manufactured For Perrigo, Minneapolis, MN 55427 R1113 Ini1113 6U200 RC J1 Rev 12-13 A

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

POLYCIN- BACITRACIN ZINC AND POLYMYXIN B SULFATES OINTMENT
NUCARE 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 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
1
2
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_, _Haemophilusinfluenzae_, _Klebsiella/Enterobacter_species,
_Neisseria _species and _Pseudomonas_
_aeruginosa_. The product does not provide adequate coverage agains