ERYTHROMYCIN ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

H.J. Harkins Company, Inc.

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. gonorrhoeae 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:

Erythromycin Ophthalmic Ointment USP, 0.5% is available in the following sizes: 1/8 oz. (3.5 g) tamper-resistant tube – 09234 DO NOT USE IF CAP AND NECKRING ARE NOT INTACT. 1 g tin container (in cartons of 50) DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED. Store between 15°-30°C (59°-86°F). KEEP OUT OF REACH OF CHILDREN. Revised February 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated H.J. Harkins Company, Inc. Nipomo, CA 93444 9043401 (Folded) 9043501 (Flat)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERYTHROMYCIN - ERYTHROMYCIN OINTMENT
H.J. HARKINS COMPANY, INC.
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ERYTHROMYCIN OPHTHALMIC OINTMENT USP, 0.5% (STERILE)
RX ONLY
DESCRIPTION:
Erythromycin Ophthalmic Ointment USP belongs to the macrolide group of
antibiotics. The sterile
ophthalmic ointment flows freely over the conjunctiva. Erythromycin
base, as crystals or powder, is
slightly soluble in water, moderately soluble in ether, and readily
soluble in alcohol or chloroform.
Erythromycin is an antibiotic produced from a strain of _Streptomyces
erythraeus. _It is basic and readily
forms a salt when combined with an acid. It has the following
structural formula:
C
H NO
Mol. Wt. 733.94
Chemical Name: (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)-_β_-D-_xylo_-hexopyranosyl]oxy]oxacyclotetradecane-2,
10-dione
Each Gram Contains: ACTIVE: Erythromycin, USP 5 mg (0.5%); INACTIVES:
White Petrolatum,
Mineral Oil.
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 β-hemolytic), Alpha-hemolytic streptococci (viridans group);
_Staphylococcus aureus,_
including penicillinase-producing strains (methicillin-resistant
staphylococci are uniformly resistant to
erythromycin); _Streptococcus pneumoniae; 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._
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INDICATIONS AND USAGE:
For the treatment of superficial ocular infections involving the
conjunctiva and/or cornea caused by
organisms susceptible to erythromycin.
For