CORTISPORIN- neomycin sulfate, polymyxin b sulfate, and hydrocortisone acetate cream

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Доступна з:

Pfizer Laboratories Div Pfizer Inc

ІПН (Міжнародна Ім'я):

NEOMYCIN SULFATE

Склад:

NEOMYCIN 3.5 mg in 1 g

Адміністрація маршрут:

TOPICAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 lesions of the skin (herpes simplex, vaccinia, and varicella). This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Огляд продуктів:

Tube of 7.5 g (NDC 61570-032-75). Store at 15° to 25°C (59° to 77°F).

Статус Авторизація:

New Drug Application

Характеристики продукта

CORTISPORIN- NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND HYDROCORTISONE
ACETATE CREAM
PFIZER LABORATORIES DIV PFIZER INC
----------
CORTISPORIN CREAM
(NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE ACETATE CREAM,
USP)
DESCRIPTION
CORTISPORIN Cream (neomycin and polymyxin B sulfates and
hydrocortisone acetate cream, USP) is
a topical antibacterial cream. Each gram contains: neomycin sulfate
equivalent to 3.5 mg neomycin base,
polymyxin B sulfate equivalent to 10,000 polymyxin B units, and
hydrocortisone acetate 5 mg (0.5%).
The inactive ingredients are liquid petrolatum, white petrolatum,
propylene glycol, polyoxyethylene
polyoxypropylene compound, emulsifying wax, purified water, and 0.25%
methylparaben added as a
preservative. Sodium hydroxide or sulfuric acid may be added to adjust
pH.
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:
®
1
2
Hydrocortisone acetate is the acetate ester of hydrocortisone, an
anti-inflammatory hormone. Its
chemical name is 21-(acetyloxy)-
11β,17-dihydroxypregn-4-ene-3,20-dione. Its structural formula is:
The base is a smooth vanishing cream with a pH of approximately 5.0.
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 includ