CORTISPORIN- neomycin and polymyxin b sulfates, bacitracin zinc, and hydrocortisone ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I), HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

Pfizer Laboratories Div Pfizer Inc

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN 3.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the treatment of corticosteroid-responsive dermatoses with secondary infection. It has not been demonstrated that this steroid-antibiotic combination provides greater benefit than the steroid component alone after 7 days of treatment. (See WARNINGS.) Not for use in the eyes or in the external ear canal if the eardrum is perforated. This product is contraindicated in tuberculous, fungal, or viral (for example, herpes simplex or varicella zoster) lesions of the skin. This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Product summary:

Tube of 1/2 oz with applicator tip (NDC 61570-031-50). Store at 15° to 25°C (59° to 77°F).

Authorization status:

New Drug Application

Summary of Product characteristics

CORTISPORIN- NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND
HYDROCORTISONE OINTMENT
PFIZER LABORATORIES DIV PFIZER INC
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CORTISPORIN OINTMENT
(NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND
HYDROCORTISONE OINTMENT, USP)
DESCRIPTION
CORTISPORIN Ointment (neomycin and polymyxin B sulfates, bacitracin
zinc, and hydrocortisone
ointment, USP) is a topical antibacterial ointment. Each gram
contains: neomycin sulfate equivalent to 3.5
mg neomycin base, polymyxin B sulfate equivalent to 5,000 polymyxin B
units, bacitracin zinc
equivalent to 400 bacitracin units, hydrocortisone 10 mg (1%), and
white petrolatum, qs.
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
µg 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_ (Fam.
Bacillaceae). 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
Corticoids suppress the inflammatory response to a variety of agents
and they may delay healing. Since
corticoids may inhibit the body's defense mechanism against infection,
a concomitant antimicrobial drug
may be used when this inhibition is considered to be clinically
significant in a particular case.
The anti-infective components in the combination are incl