BACITRACIN ZINC AND POLYMYXIN B SULFATE ointment

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Preferred Pharmaceuticals Inc.

Stjórnsýsluleið:

OPHTHALMIC

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Vörulýsing:

Bacitracin zinc and polymyxin B sulfate ophthalmic ointment, USP is available in tubes with an ophthalmic tip applicator in the following size: NDC 68788-7599-3 - 3.5 g tube Store between 15°C to 25°C (59°F to 77°F). KEEP TIGHTLY CLOSED. KEEP OUT OF REACH OF CHILDREN. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2022 Bausch & Lomb Incorporated or its affiliates Relabeled By: Preferred Pharmaceuticals Inc. Revised: May 2022 9130704 (Folded) 9130604 (Flat)

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

BACITRACIN ZINC AND POLYMYXIN B SULFATE- BACITRACIN ZINC AND POLYMYXIN
B SULFATE OINTMENT
PREFERRED PHARMACEUTICALS INC.
----------
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 formulated 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/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/mg, calculated on an
anhydrous basis. The
structural formulae are:
1
2
EACH GRAM CONTAINS: ACTIVES: bacitracin zinc equal to 500 bacitracin
units and
polymyxin B sulfate equal to 10,000 polymyxin B units; INACTIVES:
mineral oil and white
petrolatum.
CLINICAL PHARMACOLOGY
Polymyxin B sulfate attacks gram-negative bacilli, including virtually
all strains of
_Pseudomonas aeruginosa _and _Haemophilus influenzae _species.
Bacitracin is active against most gram-positive bacilli and cocci
including hemolytic
streptococci.
INDLCATLONS 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.
ADVERSE REACTIONS
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAUSCH &