Acetasol HC

Name: Acetasol HC

Uses For Acetasol HC

Corticosteroid and acetic acid combinations are used to treat certain problems of the ear canal. They also help relieve the redness, itching, and swelling that may accompany these conditions.

These medicines may also be used for other conditions as determined by your doctor.

Corticosteroid and acetic acid combinations are available only with your doctor's prescription.

Proper Use of hydrocortisone and acetic acid

This section provides information on the proper use of a number of products that contain hydrocortisone and acetic acid. It may not be specific to Acetasol HC. Please read with care.

To use:

  • Lie down or tilt the head so that the affected ear faces up. Gently pull the ear lobe up and back for adults (down and back for children) to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several (about 5) minutes to allow the medicine to run to the bottom of the ear canal. A sterile cotton plug may be gently inserted into the ear opening to prevent the medicine from leaking out. At first, your doctor may want you to put more medicine on the cotton plug during the day to keep it moist.

To keep the medicine as germ-free as possible, avoid touching the dropper or applicator tip to any surface as much as possible (including the ear). Also, always keep the container tightly closed.

For patients using hydrocortisone and acetic acid ear drops:

  • Do not wash the dropper or applicator tip, because water may get into the medicine and make it weaker. If necessary, you may wipe the dropper or applicator tip with a clean tissue.

Do not use corticosteroids more often or for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Do not use any leftover medicine for future ear problems without first checking with your doctor. This medicine should not be used if certain kinds of infections are present. To do so may make the infection worse.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    For hydrocortisone and acetic acid
  • For ear drops dosage form:
    • For ear infections:
      • Adults and children over 3 years of age—Use 3 to 5 drops in the affected ear every four to six hours for the first twenty-four hours, then 5 drops three to four times daily.
      • Children under 3 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Do not stop treatment abruptly.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Uses of Acetasol HC

  • It is used to treat ear infections.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad ear pain.
  • Very bad skin irritation.

Acetasol HC 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:

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.

Acetasol HC - 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 Acetasol HC

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.

Package label.principal display panel

Acetasol HC 
hydorcortisone and acetic acid solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0472-0882
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1.1 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  
Packaging
# Item Code Package Description
1 NDC:0472-0882-82 1 BOTTLE (BOTTLE) in 1 CARTON
1 10 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087143 09/10/2002
Labeler - Actavis Mid Atlantic LLC (809515898)
Revised: 04/2009   Actavis Mid Atlantic LLC
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