AK-POLY-BAC- bacitracin zinc and polymyxin b sulfate ointment

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

קנה את זה

הורד מאפייני מוצר (SPC)
19-12-2017

מרכיב פעיל:

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

זמין מ:

A-S Medication Solutions

INN (שם בינלאומי):

BACITRACIN ZINC

הרכב:

BACITRACIN 500 [USP'U] in 1 g

מסלול נתינה (של תרופות):

OPHTHALMIC

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.

leaflet_short:

Product: 50090-0447 NDC: 50090-0447-0 3.5 g in a TUBE

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

                                AK-POLY-BAC- BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT
A-S MEDICATION SOLUTIONS
----------
BACITRACIN ZINC AND POLYMYXIN B SULFATE OPHTHALMIC OINTMENT USP,
STERILE
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.
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.
1
2
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:
Product: 50
                                
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