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Name:Hydrocortisone And Acetic Acid
Manufacturer:Actavis Inc.
Category:Prescription Marketed Drugs


HYDROCORTISONE AND ACETIC ACID OTIC SOLUTION USP

HYDROCORTISONE AND ACETIC ACID  - hydrocortisone and acetic acid solution 
Actavis Inc.

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HYDROCORTISONE AND ACETIC ACID OTIC SOLUTION USP

DESCRIPTION

Hydrocortisone and Acetic Acid Otic Solution USP, is a solution containing hydrocortisone (1%) and acetic acid (2%), in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), sodium acetate (0.015%), and citric acid (0.2%). The molecular formulas for acetic acid and hydrocortisone are C2H4O2 and C21H30O5, with molecular weights of 60.05 and 362.46, respectively. The structural formulas are:

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Chemically, hydrocortisone is: Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-(11ß)-.

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This product is available as a nonaqueous otic solution buffered at pH 2 to 4 for use in the external ear canal.

CLINICAL PHARMACOLOGY

Acetic acid is anti-bacterial and anti-fungal; hydrocortisone is anti-inflammatory, anti-allergic and anti-pruritic; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues.

INDICATIONS AND USAGE

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients, herpes simplex, vaccinia and varicella. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

WARNINGS

Discontinue promptly if sensitization or irritation occurs.

PRECAUTIONS

Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

ADVERSE REACTIONS

Stinging or burning may be noted occasionally; local irritation has occurred very rarely.

DOSAGE AND ADMINISTRATION

Carefully remove all cerumen and debris to allow solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with the solution into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of solution 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.

HOW SUPPLIED

Hydrocortisone and Acetic Acid Otic Solution USP, 1%/2% is available in a 10 mL measured-drop, safety-tip plastic bottle.

Store at controlled room temperature 20°-25°C (68°-77°F).

Keep container tightly closed.

Distributed by:

Actavis Inc.

60 Columbia Rd., Bldg. B

Morristown, NJ 07960 USA

FORM NO. 412

Rev. 4/09

VC3353

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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HYDROCORTISONE AND ACETIC ACID 
hydrocortisone and acetic acid solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-412
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 3.15 g  in 100 mL
ACETIC ACID (ACETIC ACID) ACETIC ACID 2.41 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL  
BENZETHONIUM CHLORIDE  
SODIUM ACETATE  
CITRIC ACID MONOHYDRATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-412-61 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 10 mL in 1 BOTTLE This package is contained within the CARTON (45963-412-61)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087143 06/29/2009

Labeler - Actavis Inc. (145426388)

Revised: 09/2009 Actavis Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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