NEO POLYCIN HC- neomycin and polymyxin b sulfates, bacitracin zinc and hydrocortisone acetate 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 ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

Padagis US LLC

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN 3.5 mg in 1 g

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Neo-Polycin® HC Ophthalmic Ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (see CLINICAL PHARMACOLOGY: Microbiology ). The particular anti-infective drugs in this product are active against the following common bacterial eye

Product summary:

Neo-Polycin® HC Ophthalmic Ointment is supplied in 3.5 g (1/8 oz) sterile tamper evident tube with ophthalmic tip. NDC 0574-4144 -35 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] Neo-Polycin® HC is a Registered Trademark of Perrigo Company

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEO POLYCIN HC- NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND
HYDROCORTISONE ACETATE OINTMENT
PADAGIS US LLC
----------
NEO-POLYCIN® HC NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC,
AND
HYDROCORTISONE ACETATE OPHTHALMIC OINTMENT USP
STERILE RX ONLY
DESCRIPTION:
Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone
acetate
ophthalmic ointment is a sterile antimicrobial and anti-inflammatory
ointment for
ophthalmic use. Each gram contains: 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 acetate 10 mg (1
%), in a white
petrolatum and mineral oil base.
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:
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 B1 and B2, 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:
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
case. When a decision to
administer both a corticosteroid and antimicrobials is made, the
administr