Drug Catalog - Product Detail
NEOMYCIN/POLYMYXIN B/HC OTIC SOL SOL 5/10/1MG/ML 10ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 61314-0646-10 | SANDOZ | 10 | 3.5-10000-1 | SOLUTION |
PACKAGE FILES
Generic Name
NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE
Substance Name
HYDROCORTISONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
AURICULAR (OTIC)
Application Number
ANDA062423
Description
DESCRIPTION Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution, USP is a sterile antibacterial and anti-inflammatory solution for otic use. Each mL contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). The vehicle contains potassium metabisulfite 0.1% (added as a preservative) and the inactive ingredients glycerin, propylene glycol, hydrochloric acid, and Water for Injection. 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: Neomycin B (R 1 =H, R 2 =CH 2 NH 2 ) Neomycin C (R 1 =CH 2 NH 2 , R 2 =H) Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 , 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: Hydrocortisone, 11β,17,21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is: structure1 structure2 polymyxin hydrocortisone
How Supplied
HOW SUPPLIED Bottle of 10 mL with sterilized dropper NDC 61314-646-10 Store at 15 ° to 25 ° C (59 ° to 77 ° F). Also Available: Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, USP in a bottle containing 10 mL NDC 61314-645-11.
Indications & Usage
INDICATIONS AND USAGE For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.
Dosage and Administration
DOSAGE AND ADMINISTRATION Therapy with this product should be limited to 10 consecutive days. The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator. For adults, four drops of the solution should be instilled into the affected ear 3 or 4 times daily. For infants and children, three drops are suggested because of the smaller capacity of the ear canal. The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the solution. This wick should be kept moist by adding further solution every 4 hours. The wick should be replaced at least once every 24 hours.