Hydrocortisone and Acetic Acid
Dosage Form: otic solution
Hydrocortisone and Acetic Acid Otic Solution, USP
Hydrocortisone and Acetic Acid 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 (0.05%). The empirical formulas for acetic acid and hydrocortisone are CH3COOH, and C21H30O5, with a molecular weight of 60.05 and 362.46, respectively. The structural formulas are:
Hydrocortisone and Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.
Hydrocortisone and Acetic Acid - Clinical Pharmacology
Acetic acid is antibacterial and antifungal; hydrocortisone is antiinflammatory, antiallergic and antipruritic; 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 Hydrocortisone and Acetic Acid
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.
Hypersensitivity to Hydrocortisone and Acetic Acid or 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.
Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.
Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Stinging or burning may be noted occasionally; local irritation has occurred very rarely.
Hydrocortisone and Acetic Acid Dosage and Administration
Carefully remove all cerumen and debris to allow Hydrocortisone and Acetic Acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Hydrocortisone and Acetic Acid 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 Hydrocortisone and Acetic Acid every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Hydrocortisone and Acetic Acid 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 is Hydrocortisone and Acetic Acid Supplied
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), is available in 10 mL, measured-drop, safety-tip plastic bottles (NDC 50383-901-10).
Store at room temperature, 20°- 25°C (68°-77°F). Keep container tightly closed.
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
Rev. 901:01 5/09
|Hydrocortisone and Acetic Acid
Hydrocortisone and Acetic Acid solution
|Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)|