terra-cortril- oxytetracycline hydrochloride and hydrocortisone acetate suspension

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

oxytetracycline hydrochloride (UNII: 4U7K4N52ZM) (oxytetracycline - UNII:X20I9EN955), hydrocortisone acetate (UNII: 3X7931PO74) (hydrocortisone - UNII:WI4X0X7BPJ)

Tilgjengelig fra:

Roerig

INN (International Name):

oxytetracycline hydrochloride and hydrocortisone acetate

Legemiddelform:

SUSPENSION

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical radiation, thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: - Staphylococcus aureus - Streptococci , including Streptococcus pneumoniae - Escherichia

Produkt oppsummering:

Terra-Cortril Ophthalmic Suspension (NDC 0049-0670-48) is supplied in 5 ml vials with separate sterile dropper.

Preparatomtale

TERRA-CORTRIL- OXYTETRACYCLINE HYDROCHLORIDE AND HYDROCORTISONE
ACETATE SUSPENSION
ROERIG
----------
TERRA-CORTRIL®
TERRAMYCIN® (OXYTETRACYCLINE HCL)
—CORTRIL® (HYDROCORTISONE ACETATE)
OPHTHALMIC SUSPENSION
DESCRIPTION
Terra-Cortril suspension combines the antibiotic, oxytetracycline HCl
(C
H N O •HCl) and the
adrenocorticoid, hydrocortisone acetate (C
H O ). EACH ML OF TERRA-CORTRIL CONTAINS TERRAMYCIN
(OXYTETRACYCLINE HCL) EQUIVALENT TO 5 MG OF OXYTETRACYCLINE, AND 15 MG
OF CORTRIL (HYDROCORTISONE
ACETATE) INCORPORATED IN MINERAL OIL WITH ALUMINUM TRISTEARATE.
_FOR OPHTHALMIC USE ONLY._
CLINICAL PHARMACOLOGY
Corticosteroids suppress the inflammatory response to a variety of
agents and they probably delay or
slow healing. Since corticoids may inhibit the body's defense
mechanism against infection, a
concomitant antimicrobial drug may be used when this inhibition is
considered to be clinically
significant in a particular case.
The anti-infective component in the combination is included to provide
action against specific
organisms susceptible to it.
Terramycin is considered active against the following microorganisms:
Rickettsiae (Rocky Mountain spotted fever, typhus fever and the typhus
group, Q fever,
rickettsialpox and tick fevers),
_Mycoplasma pneumoniae_ (PPLO, Eaton Agent),
Agents of psittacosis and ornithosis,
Agents of lymphogranuloma venereum and granuloma inguinale,
The spirochetal agent of relapsing fever _(Borrelia recurrentis)_.
The following gram-negative microorganisms:
_Haemophilus ducreyi_ (chancroid),
_Pasteurella pestis_ and _Pasteurella tularensis_,
_Bartonella bacilliformis,_
_Bacteroides_ species,
_Vibrio comma_ and _Vibrio fetus_,
_Brucella_ species (in conjunction with streptomycin).
Because many strains of the following groups of microorganisms have
been shown to be resistant to
tetracyclines, culture and susceptibility testing are recommended.
Oxytetracycline is indicated for treatment of infections caused by the
following gram-negative
microorganisms, when bacteriologic testing in