Acetasol HC

Actavis Mid Atlantic LLC

HYDROCORTISONE AND ACETIC ACID OTIC SOLUTION USP FORM 0882 VC3300 Rev. 3/08

FULL PRESCRIBING INFORMATION

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:

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

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

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.

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 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.

Discontinue promptly if sensitization or irritation occurs.

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.

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.

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.

Manufactured by:
Actavis Mid Atlantic LLC
1877 Kawai Road
Lincolnton, NC 28092 USA

FORM NO. 0882
Rev. 3/08
VC3300