16 . July , 2018 - Monday
Check todays hot topics or new products

Find a Drug: Advanced

Please Sign in or Register

All about: Chloromycetin ophthalmic ointment

Big Image
Generic Name: chloramphenicol
Dosage Form: Ophthalmic ointment

WARNING

Bone marrow hypoplasia including aplastic anemia and death has been reported following topical application of chloramphenicol. Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.

Description

Each gram of Chloromycetin Ophthalmic Ointment, 1% contains 10 mg of chloramphenicol in a special base of liquid petrolatum and polyethylene. It contains no preservatives. Sterile ointment.

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. It has been noted that chloramphenicol is found in measurable amounts in the aqueous humor following local application to the eye. Development of resistance to chloramphenicol can be regarded as minimal for staphylococci and many other species of bacteria.

Indications and Usage

Chloramphenicol should be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated. Bacteriological studies should be performed to determine the causative organisms and their sensitivity to chloramphenicol (see Boxed Warning).

Chloromycetin Ophthalmic Ointment, 1% (Chloramphenicol Ophthalmic Ointment, USP) is indicated for the treatment of surface ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms.

The particular antiinfective drug in this product is active against the following common bacterial eye pathogens:

Staphylococcus aureus

Streptococcus, including Streptococcus pneumoniae

Escherichia coli

Haemophilus influenzae

Klebsiella/Enterobacter species

Moraxella lucunata

    (Morax-Axenfeld bacillus)

Neisseria species

This product does not provide adequate coverage against:

Pseudomonas aeruginosa

Serratia marcescens

Contraindications

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

Warnings

SEE BOXED WARNING

Ophthalmic ointments may retard corneal wound healing.

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.

Adverse Reactions

Blood dyscrasias have been reported in association with the use of chloramphenicol (see WARNINGS).

Allergic or inflammatory reactions due to individual hypersensitivity and occasional burning or stinging may occur with the use of Chloromycetin Ophthalmic Ointment.

Dosage and Administration

A small amount of ointment placed in the lower conjunctival sac every three hours, or more frequently if deemed advisable by the prescribing physician. Administration should be continued day and night the first 48 hours, after which the interval between applications may be increased. Treatment should be continued for at least 48 hours after the eye appears normal.

How Supplied

N 0071–3070–07

Chloromycetin Ophthalmic Ointment, 1% (Chloramphenicol Ophthalmic Ointment, USP) is supplied, sterile, in ophthalmic ointment tubes of 3.5 grams.

Chloromycetin, brand of chloramphenicol. Reg US Pat Off

Caution—Federal law prohibits dispensing without prescription.

March 1997

©1997, Warner-Lambert Co.

PARKE-DAVIS

Div of Warner-Lambert Co/Morris Plains, NJ 07950 USA


Chloromycetin (chloramphenicol)
PRODUCT INFO
Product Code 0071-3070 Dosage Form OINTMENT
Route Of Administration OPHTHALMIC DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
chloramphenicol (chloramphenicol) Active 10 MILLIGRAM  In 1 GRAM
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0071-3070-07 3.5 GRAM In 1 TUBE None

Revised: 10/2006

Recent Drug Updates at DrugIndexOnline:





Actidose-Aqua Actidose-Aqua
Some commonly used brand names are: In the U.S.— Actidose-Aqua 1 Actidose with Sorbitol 2 CharcoAid 2 CharcoAid G 1 CharcoAid 2000 1 Insta-Char in an Aqueous Base 1 Insta-Char in an Aqueous Base with Cherry Flavor 1 Insta-Char Pediatric in an Aqueous Base with Cherry Flavor 1 Insta-Char P more...

Alprazolam Intensol Solution Alprazolam Intensol Solution
Generic Name: Alprazolam Oral Solution (al-PRAY-zoe-lam) Brand Name: Alprazolam IntensolAlprazolam Intensol Solution is used for:Treating anxiety and panic disorder. It may also be used to treat other conditions as determined by your doctor. Alprazolam Intensol Solution is a benzodiazepine. It w more...

Amoxil Pediatric Drops Amoxil Pediatric Drops
Generic Name: amoxicillin (am OKS i sil in) Brand Names: Amoxicot, Amoxil, Amoxil Pediatric Drops, Biomox, Dispermox, Trimox, Wymox What is Amoxil Pediatric Drops (amoxicillin)? Amoxicillin is an antibiotic in the penicillin group of drugs. It fights bacteria in your body. Amoxicillin more...

Cefaclor Capsules Cefaclor Capsules
Generic Name: Cefaclor Capsules (SEFF-uh-klor) Brand Name: Generic only. No brands available.Cefaclor Capsules is used for:Treating infections caused by certain bacteria. Cefaclor Capsules is a cephalosporin antibiotic. It kills sensitive bacteria by interfering with formation of the bacteria's c more...

Lansoÿl Lansoÿl
Some commonly used brand names are: In the U.S.— Agoral 35 Alophen 25 Alphamul 30 Alramucil Orange 7 Alramucil Regular 7 Bisac-Evac 25 Black-Draught 26 Black-Draught Lax-Senna 32 Carter's Little Pills 25 Cholac 14 Citroma 16 Citrucel Orange Flavor 3 Citrucel Sugar-Free Orange Flavor 3 Col more...

Nizoral Shampoo Nizoral Shampoo
Generic Name: Ketoconazole Shampoo 2% (kee-toe-KOE-na-zole) Brand Name: NizoralNizoral Shampoo is used for:Treating tinea (pityriasis) versicolor. It may also be used for other conditions as determined by your doctor. Nizoral Shampoo is an imidazole antifungal. It works by killing sensitive fung more...

Nizoral Nizoral
Generic name: Ketoconazole Brand names: Nizoral Why is Nizoral prescribed? Nizoral, a broad-spectrum antifungal drug available in tablet form, may be given to treat several fungal infections within the body, including oral thrush and candidiasis. It may also be given to treat severe, hard-to-tre more...

Premphase Premphase
Generic Name: Conjugated Estrogens/Medroxyprogesterone (ESS-troe-jenz/me-DROX-ee-proe-JESS-te-rone) Brand Name: Examples include Premphase and PremproDo not use Premphase to prevent heart disease, heart attacks, strokes, or dementia. Premphase may increase the risk of heart disease (including more...