CORTOMYCIN neomycin sulfate and polymyxin b bacitracin zinc hydrocortisone ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)

Available from:

Major Pharmaceuticals

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN SULFATE 3.5 mg in 1 g

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CORTOMYCIN- NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC
AND
HYDROCORTISONE OINTMENT
MAJOR PHARMACEUTICALS
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NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE
OPHTHALMIC OINTMENT,
USP
(STERILE)
DESCRIPTION:
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone
Ophthalmic Ointment, USP is
a sterile antimicrobial and anti-inflammatory ointment for ophthalmic
use.
EACH GRAM CONTAINS: ACTIVES: Neomycin sulfate (equivalent to 3.5 mg
neomycin base), Polymyxin
B Sulfate equivalent to 10,000 polymyxin B units, Bacitracin Zinc
equivalent to 400 bacitracin units,
Hydrocortisone 10 mg (1%); INACTIVES: White Petrolatum, Mineral Oil.
Neomycin sulfate is the sulfate salt of neomycin B and C, which are
produced by the growth of
_Streptomyces fradiae _Waksman (Fam. Streptomycetaceae). It has a
potency equivalent of not less than 600
mcg of neomycin standard per mg, calculated on an anhydrous basis.
The structural formulae are:
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:
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 is:
1
2
Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20-dione, is an
anti-inflammatory hormone.
Its structural formula is:
CLINICAL PHARMACOLOGY:
Corticosteroids suppress the inflammatory response to a variety of
agents and they probably delay or
slow healing. Since corticosteroids may inhibit the body’s defense
mechanism against infection,
concomitant antimicrobial drugs may be used when this inhibition is
considered to be clinically
significant in a particular ca