BACITRACIN ZINC AND POLYMYXIN B SULFATE ointment

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Rebel Distributors Corp

INN (Isem Internazzjonali):

BACITRACIN ZINC

Kompożizzjoni:

BACITRACIN ZINC 500 in 1 g

Rotta amministrattiva:

OPHTHALMIC

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP is available in tubes with an ophthalmic tip applicator in the following size: 3.5 gram tube - NDC 42254-154-35 DO NOT USE IF CAP AND NECKRING ARE NOT INTACT. Store between 15°-25°C (59°-77°F). KEEP TIGHTLY CLOSED. KEEP OUT OF REACH OF CHILDREN. Revised November 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9130700 (Folded) 9130600 (Flat) Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

BACITRACIN ZINC AND POLYMYXIN B SULFATE- BACITRACIN ZINC AND POLYMYXIN
B
SULFATE OINTMENT
REBEL DISTRIBUTORS CORP
----------
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 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: ACTIVES: Bacitracin Zinc equal to 500 bacitracin
units and Polymyxin B
Sulfate equal to 10,000 polymyxin B units; INACTIVES: White Petrolatum
and Mineral Oil.
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.
1
2
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