HYDROCORTISONE AND ACETIC ACID solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P), HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Inapatikana kutoka:

Akorn Operating Company LLC

INN (Jina la Kimataifa):

ACETIC ACID

Tungo:

ACETIC ACID 20.75 mg in 1 mL

Njia ya uendeshaji:

AURICULAR (OTIC)

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 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.

Bidhaa muhtasari:

Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), is available in 10 mL, measured-drop, safety-tip plastic bottles (NDC 50383-901-10).

Idhini hali ya:

New Drug Application

Tabia za bidhaa

HYDROCORTISONE AND ACETIC ACID- HYDROCORTISONE AND ACETIC
ACID SOLUTION
AKORN OPERATING COMPANY LLC
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HYDROCORTISONE AND ACETIC ACID OTIC SOLUTION, USP
DESCRIPTION
Hydrocortisone and Acetic Acid Otic Solution, USP is a solution
containing
hydrocortisone (1%) and acetic acid (2%), in a propylene glycol
vehicle containing
benzethonium chloride (0.02%), citric acid (0.05%), propylene glycol
diacetate (3%) and
sodium acetate (0.015%). The empirical formulas for acetic acid and
hydrocortisone are
CH COOH, and C
H
O , with a molecular weight of 60.05 and 362.46, respectively.
The structural formulas are:
Hydrocortisone and 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; hydrocortisone is
antiinflammatory, 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
3
21
30
5
organisms susceptible to the action of the antimicrobial, complicated
by inflammation.
CONTRAINDICATIONS
Hypersensitivity to Hydrocortisone and Acetic Acid 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
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 Hydrocortisone and
Acetic Acid to
contact infe