Acetic Acid; Hydrocortisone (0088)
| Ingredients: |
Acetic Acid; Hydrocortisone |
| Indications: |
Infection, ear, external |
| Pregnancy Category: |
(none)
|
| FDA Approved: |
1981- 12- 01 |
| Classes: |
Anti- infectives, otic; Corticosteroids, otic; Otics |
| Brand Names: |
Acetasol HC
-
US
;
Earsol-HC
-
US
;
Oticot HC
-
US
;
Vasotate HC
-
US
;
Vosol HC
-
US; Canada, Us
;
|
| DEA schedules: |
(none)
|
DESCRIPTION
|
| |
Hydrocortisone and acetic acid otic solution 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 empirical formulas for acetic acid and hydrocortisone are CH3 COOH and C21 H30 O5 , with a molecular weight of 60.05 and 326.46, respectively.
Chemically, hydrocortisone is pregn- 4- ene- 3, 20- dione, 11, 17, 21- trihydroxy- 11β)- .
Acetic acid/ hydrocortisone is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.
|
CLINICAL PHARMACOLOGY
|
| |
Acetic acid is antibacterial and antifungal; hydrocortisone is anti- inflammatory, anti- allergic and anti- pruritic; propylene
glycol is hydrophilic and provides 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 caused by organisms susceptible to the action of the antimicrobial, complicated
by inflammation.
|
CONTRAINDICATIONS
|
| |
Hypersensitivity to hydrocortisone and acetic acid otic solution or any of the ingredients; herpes simplex, varicella. Perforated
tympanic membrane is frequently 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.
|
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 acetic acid/ hydrocortisone to contact infected surfaces directly. To promote
continuous contact, insert a wick saturated with this 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- 5 drops of hydrocortisone
and acetic acid otic solution every 4- 6 hours. The wick may be removed after 24 hours but the patient should continue to
instill 5 drops of the solution 3 or 4 times daily thereafter, for as long as indicated.
Storage: Store at room temperature; avoid excessive heat. Keep container tightly closed.
|
PRODUCT IDENTIFICATION
|
| |
None Available |
PRODUCT LISTING - RATED THERAPEUTICALLY EQUIVALENT
|
| |
| solution - otic - 2%- 1% -
|
| 10.0 ml |
$6.15 |
Vasotate HC
Major Pharmaceuticals Inc
|
00904031610 |
| 10.0 ml |
$8.27 |
Acetasol HC
IVAX Corporation
|
00182177663 |
| 10.0 ml |
$8.40 |
GENERIC
Bausch and Lomb
|
24208031910 |
| 10.0 ml |
$10.63 |
GENERIC
Sandoz Inc
|
00781631170 |
| 10.0 ml |
$12.00 |
GENERIC
Morton Grove Pharmaceuticals Inc
|
60432074001 |
| 10.0 ml |
$26.78 |
Acetasol HC
Alpharma USPD
|
00472088282 |
| 10.0 ml |
$26.79 |
GENERIC
Thames Pharmaceuticals Inc
|
49158019743 |
| 10.0 ml |
$75.87 |
Vosol HC
Allscripts Healthcare Solutions
|
54569089300 |
| 10.0 ml x 3.0 |
$241.29 |
Vosol HC
MedPointe Healthcare Inc
|
00037381112 |
|
PRODUCT LISTING - EQUIVALENTS NOT AVAILABLE
|
| |
| solution - otic - 2%- 1% -
|
| 10.0 ml |
$6.00 |
Oticot HC
Truxton Company Inc
|
00463805410 |
| 10.0 ml |
$6.34 |
GENERIC
Physicians Total Care
|
54868079901 |
| 10.0 ml |
$8.32 |
GENERIC
Prescript Pharmaceuticals
|
00247014310 |
| 10.0 ml |
$13.10 |
GENERIC
Direct Dispensing Inc
|
57866211070 |
| 10.0 ml |
$26.79 |
GENERIC
Allscripts Healthcare Solutions
|
54569124200 |
| 10.0 ml |
$35.30 |
GENERIC
Pharma Pac
|
52959031901 |
| 10.0 ml |
$38.70 |
GENERIC
Southwood Pharmaceuticals Inc
|
58016608101 |
| 30.0 ml |
$6.50 |
Earsol- HC
Parnell Pharmaceuticals Inc
|
50930027103 |
| 30.0 ml |
$10.75 |
Earsol- HC
Parnell Pharmaceuticals Inc
|
50930027203 |
|
|