Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P)
Quality Care Products LLC
ACETIC ACID
ACETIC ACID 20.65 mg in 1 mL
AURICULAR (OTIC)
PRESCRIPTION DRUG
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial. Hypersensitivity to Acetic Acid or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal. Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Acetic Acid Otic Solution, USP containing 2% acetic acid, is available in 15 mL (NDC 55700-424-15) measured-drop, safety-tip plastic bottles.
New Drug Application
ACETIC ACID- ACETIC ACID SOLUTION QUALITY CARE PRODUCTS LLC ---------- ACETIC ACID OTIC SOLUTION, USP DESCRIPTION Acetic Acid Otic Solution, USP is a solution of acetic acid (2%), in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), and sodium acetate (0.015%). The empirical formula for acetic acid is CH COOH, with a molecular weight of 60.05. The structural formula is: Acetic Acid 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; 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 the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial. CONTRAINDICATIONS Hypersensitivity to Acetic Acid or any of the ingredients. 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. PRECAUTIONS Transient stinging or burning may be noted occasionally when the solution is first 3 instilled into the acutely inflamed ear. PEDIATRIC USE Safety and effectiveness in pediatric patients below the age of 3 years have not been established. 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 to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with 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 Acetic Acid every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to i Olvassa el a teljes dokumentumot