HYDROCORTISONE AND ACETIC ACID solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ), Acetic Acid (UNII: Q40Q9N063P) (Acetic Acid - UNII:Q40Q9N063P)

Tillgänglig från:

Taro Pharmaceuticals U.S.A., Inc.

INN (International namn):

Hydrocortisone

Sammansättning:

Hydrocortisone 10.4 mg in 1 mL

Administreringssätt:

AURICULAR (OTIC)

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation. 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.

Produktsammanfattning:

Hydrocortisone 1% and acetic acid 2% otic solution is available in 10 mL plastic, controlled dropper tip bottle. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

HYDROCORTISONE AND ACETIC ACID- HYDROCORTISONE AND ACETIC ACID
SOLUTION
TARO PHARMACEUTICALS U.S.A., INC.
----------
HYDROCORTISONE 1%
AND ACETIC ACID 2%
OTIC SOLUTION
(HYDROCORTISONE AND ACETIC ACID OTIC SOLUTION, USP)
RX ONLY
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 COOH with molecular weight
of 60.05. The structural
formula is:
ACETIC ACID
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
H O with molecular weight 362.46. The structural formula is:
HYDROCORTIS ONE
Hydrocortisone and acetic acid is available as a non-aqueous otic
solution buffered at pH (2.0 to 4.0)
3
21
30
5
for use in the external ear canal.
CLINICAL PHARMACOLOGY
Acetic acid is anti-bacterial and antifungal; hydrocortisone is
anti-inflammatory, antiallergic and
antipruritic; 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, complicated by
inflammation.
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.
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.
PEDIATRIC USE
Safet