ERYTHROMYCIN ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)

Available from:

Padagis US LLC

INN (International Name):

ERYTHROMYCIN

Composition:

ERYTHROMYCIN 5 mg in 1 g

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin. For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis . The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrheae is not established. For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants. This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.

Product summary:

Sterile Erythromycin Ophthalmic Ointment USP, 5 mg/g as follows: 3.5 g (1/8 oz) tamper-evident tubes NDC 0574-4024 -35 24 x 3.5 g (1/8 oz) Hospital-Pak (for hospital use only) NDC 0574-4024 -39 Carton of fifty (50) Unit Dose 1 g tubes NDC 0574-4024 -50 Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERYTHROMYCIN- ERYTHROMYCIN OINTMENT
PADAGIS US LLC
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ERYTHROMYCIN OPHTHALMIC OINTMENT USP
STERILE
RX ONLY
DESCRIPTION:
Erythromycin Ophthalmic Ointment belongs to the macrolide group of
antibiotics. It is
basic and readily forms a salt when combined with an acid. The base,
as crystals or
powder, is slightly soluble in water, moderately soluble in ether, and
readily soluble in
alcohol or chloroform. Erythromycin
((3R*,4S*,5S*,6R*,7R*,9R*,11R*,12R*,13S*,14R*)-
4-[(2,6-dideoxy-3-_C_-methyl-3-_0_-methyl-α-L-_ribo_-hexopyranosyl)oxy]-14-ethyl-7,12,13-
trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-_xylo_-
hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione) is antibiotic
produced from a strain
of _Streptomyces erythraeus_. It has the following structural formula:
Each gram contains Erythromycin USP 5 mg in a sterile ophthalmic base
of mineral oil
and white petrolatum.
CLINICAL PHARMACOLOGY:
MICROBIOLOGY:
Erythromycin inhibits protein synthesis without affecting nucleic acid
synthesis.
Erythromycin is usually active against the following organisms _in
vitro _and in clinical
infections:
_Streptococcus pyogenes _(group A ß-hemolytic)
Alpha-hemolytic streptococci (viridans group)
_Staphylococcus aureus_, including penicillinase-producing strains
(methicillin-resistant
staphylococci are uniformly resistant to erythromycin)
_Streptococcus pneumonia_
_Mycoplasma pneumoniae _(Eaton Agent, PPLO)
_Haemophilus influenzae _(not all strains of this organism are
susceptible at the
erythromycin concentrations ordinarily achieved)
_Treponema pallidum_
_Corynebacterium diphtheriae_
_Neisseria gonorrhoeae_
_Chlamydia trachomatis_
INDICATIONS AND USAGE:
For the treatment of superficial ocular infections involving the
conjunctiva and/or cornea
caused by organisms susceptible to erythromycin.
For prophylaxis of ophthalmia neonatorum due to _N. gonorrhoeae _or
_C. trachomatis_.
The effectiveness of erythromycin in the prevention of ophthalmia
caused by
penicillinase-producing _N. gonorrheae _is not es