Drug Catalog - Product Detail
NEOMYCIN/BACITRACIN/POLYMYXIN-B OPHTH/HYDROCORTISONE OINT USP OINT 3.5/400/5GM 3.5GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00574-4144-35 | PADAGIS | 3 | 1% | OINTMENT |
PACKAGE FILES
Generic Name
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE ACETATE
Substance Name
BACITRACIN ZINC
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Application Number
ANDA062166
Description
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: Chemical Structure Chemical Structure Chemical Structure
How Supplied
HOW SUPPLIED: 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
Indications & Usage
INDICATIONS AND USAGE: 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 pathogens: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species , Neisseria species , and Pseudomonas aeruginosa . The product does not provide adequate coverage against Serratia marcescens .
Dosage and Administration
DOSAGE AND ADMINISTRATION: Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition. Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.