VOSOL acetic acid solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P)

Sẵn có từ:

ECR Pharmaceuticals Co., Inc.

INN (Tên quốc tế):

ACETIC ACID

Thành phần:

ACETIC ACID 20.65 mg in 1 mL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

VOSOL- ACETIC ACID SOLUTION
ECR PHARMACEUTICALS CO., INC.
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VŌSOL
OTIC SOLUTION
(ACETIC ACID OTIC SOLUTION, USP)
RX ONLY
DESCRIPTION
VōSoL (Acetic acid otic solution, USP) is a solution containing
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:
VōSoL 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 VōSoL 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 instilled into the
acutely inflamed ear.
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3
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 VōSoL to contact
infected surfaces directly. To
promote continuous contact, insert a wick of cotton saturated with
VōSoL 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 VōSoL every 4 to 6 hours. The
wick may be removed after 24
hours but the patie