Hydrocortisone And Acetic Acid
FDA Drug Information • Also known as: Hydrocortisone And Acetic Acid
- Brand Names
- Hydrocortisone And Acetic Acid
- Drug Class
- Corticosteroid [EPC]
- Route
- AURICULAR (OTIC)
- Dosage Form
- SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Hydrocortisone and Acetic Acid Otic Solution, USP contains Hydrocortisone (1%) and acetic acid, glacial (2%) in a propylene glycol vehicle containing benzethonium chloride (0.02%), citric acid (0.2%), propylene glycol diacetate (3%) and sodium acetate (0.015%). Acetic acid has a molecular formula of CH 3 COOH with molecular weight of 60.05. The structural formula is: Hydrocortisone is a Synthetic Steroid used as an anti-inflammatory and antipruritic agent. Its chemical name is Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-, (11β)-. Hydrocortisone has a molecular formula of C 21 H 30 O 5 with molecular weight 362.46. The structural formula is: Hydrocortisone and acetic acid is available as a non-aqueous otic solution buffered at pH (2.0 to 4.0) for use in the external ear canal. Chemical Structure Chemical Structure
What Is Hydrocortisone And Acetic Acid Used For?
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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Carefully remove all cerumen and debris to allow hydrocortisone 1% and acetic acid 2% otic 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 the solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops 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.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS Stinging or burning may be noted occasionally; local irritation has occurred very rarely.
Warnings and Precautions
WARNINGS Discontinue promptly if sensitization or irritation occurs.
Contraindications
CONTRAINDICATIONS Hypersensitivity to hydrocortisone and acetic acid otic solution 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.
How Supplied
HOW SUPPLIED Hydrocortisone 1% and acetic acid 2% otic solution is available in 10 mL plastic, controlled dropper tip bottle. 10 mL bottle NDC 51672-3007-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.