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:

Physicians Total Care, Inc.

INN (International Name):

BACITRACIN ZINC

Composition:

BACITRACIN ZINC 500 [USP'U] in 1 g

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate. This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Product summary:

Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment USP, sterile, each gram contains bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, in a tube of 3.5 g (1/8 oz) with ophthalmic tip. NDC 54868-1199-0

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BACITRACIN ZINC AND POLYMYXIN B SULFATE - BACITRACIN ZINC AND
POLYMYXIN B
SULFATE OINTMENT
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
DESCRIPTION
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is a
sterile antimicrobial ointment for
ophthalmic use.
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:
Each gram contains: Bacitracin zinc equal to 500 bacitracin units and
polymyxin B sulfate equal to
10,000 polymyxin B units, white petrolatum and mineral oil.
CLINICAL PHARMACOLOGY
Polymyxin B attacks gram-negative bacilli, including virtually all
strains of _Pseudomonas aeruginosa_ and
_H influenzae_ species.
Bacitracin is active against most gram-positive bacilli and cocci
including hemolytic streptococci.
1
2
INDICATIONS AND USAGE
For the treatment of superficial ocular infections involving the
conjunctiva and/or cornea caused by
organisms susceptible to bacitracin zinc and polymyxin B sulfate.
CONTRAINDICATIONS
This product is contraindicated in those individuals who have shown
hypersensitivity to any of its
components.
WARNINGS
Ophthalmic ointments may retard corneal healing.
PRECAUTIONS
As with other antibiotic preparations, prolonged use may result in
overgrowth of nonsusceptible
organisms, including fungi. Appropriate measures should be taken if
this occurs.
DOSAGE AND ADMINISTRATION
Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on
the severity of the infection.
HOW SUPPLIED
Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment