chloromycetin (chloramphenicol)  solution 
[Monarch Pharmaceuticals, Inc.]

Description

Each milliliter of Chloromycetin Otic contains 5 mg (0.5%) chloramphenicol in propylene glycol. Sterile.

The chemical names for chloramphenicol are:

1. Acetamide, 2,2-dichloro-N-[2-hydroxy-1-(hydroxymethyl)-2-(4-nitrophenyl) ethyl]-, and

2. D-threo-(—)-2,2-Dichloro-N-[β,-hydroxy-α-(hydroxymethyl)-p-nitrophenethyl] acetamide.

Chloramphenicol has the following empirical and structural formulas:

Clinical Pharmacology

Chloramphenicol is a broad-spectrum antibiotic originally isolated from Streptomyces venezuelae. It is primarily bacteriostatic and acts by inhibition of protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes. Development of resistance to chloramphenicol can be regarded as minimal for staphylococci and many other species of bacteria.

Indications and Usage

Chloromycetin (chloramphenicol) Otic is indicated for the treatment of surface infections of the external auditory canal caused by susceptible strains of various gram-positive and gram-negative organisms including: Staphylococcus aureus, Escherichia coli, Hemophilus influenzae, Pseudomonas aeruginosa, Aerobacter aerogenes, Klebsiella pneumoniae and Proteus species.

Deeper infections should be treated with appropriate systemic antibiotics.

Contraindications

This product is contraindicated in persons sensitive to any of its components.

Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

Warnings

SEE BOXED WARNING.

Discontinue promptly if sensitization or irritation occurs.

Precautions

The prolonged use of antibiotics may occasionally result in overgrowth of nonsusceptible organisms, including fungi. If new infections appear during medication, the drug should be discontinued and appropriate measures should be taken.

In all serious infections, the topical use of chloramphenicol should be supplemented by appropriate systemic medication.

The possibility of the occurrence of ototoxicity must be considered if this product is allowed to enter the middle ear.

Adverse Reactions

Signs of local irritation with subjective symptoms of itching or burning, angioneurotic edema, urticaria, vesicular and maculopapular dermatitis have been reported in patients sensitive to chloramphenicol and are causes for discontinuing the medication. Similar sensitivity reactions to other materials in topical preparations may also occur. Blood dyscrasias have been reported in association with the use of chloramphenicol (see WARNINGS).

Dosage and Administration

Instill 2 or 3 drops into the affected ear three times daily.

How Supplied

NDC 61570-331-31

Chloromycetin (chloramphenicol) Otic is supplied in 15 mL vials with droppers.

Store below 30°C (86°F).

Chloromycetin, brand of chloramphenicol, Reg US Pat Off.

Rx only.

Rev. 12/98

Manufactured by: Parkedale Pharmaceuticals, Inc., Rochester, MI 48307

Distributed by:Monarch Pharmaceuticals, Inc., Bristol, TN 37620

Chloromycetin (chloramphenicol)

PRODUCT INFO Product Code 61570-331 Dosage Form SOLUTION Route Of Administration AURICULAR (OTIC) DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength chloramphenicol (chloramphenicol) Active 5 MILLIGRAM  In 1 MILLILITER propylene glycol Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color Score Shape Symbol Imprint Code Coating Size

PACKAGING # NDC Package Description Multilevel Packaging 1 61570-331-31 15 MILLILITER In 1 VIAL None

Revised: 04/2007