Tetracycline Hydrochloride

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• TETRACYCLINE HYDROCHLORIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS & USAGE
• TETRACYCLINE HYDROCHLORIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• TETRACYCLINE HYDROCHLORIDE ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• ANIMAL PHARMACOLOGY & OR TOXICOLOGY
• INACTIVE INGREDIENT
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

TETRACYCLINE HYDROCHLORIDE DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS & USAGE

• ●Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible.

• ●Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.)

• ●Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.)

• ●Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox.

• ●Psittacosis or ornithosis caused by Chlamydia Psittaci.

• ●Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum.

• ●Granuloma inquinale caused by Calymmatobacterium granulomatis.

• ●Relapsing fever caused by Borrelia sp.

• ●Bartonellosis caused by Bartonella bacilliformis.

• ●Chancroid caused by Hemophilus ducreyi.

• ●Tularemia caused by Francisella tularensis.

• ●Plaque caused by Yersinia pestis.

• ●Cholera caused by Vibrio cholerae.

• ●Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside).

• ●Infections due to Campylobacter fetus.

• ●As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica.

• ●Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc.

• ●Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp.

• ●In severe acne, adjunctive therapy with tetracycline may be useful.

• ●When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections:

• ●syphilis and yaws caused by Treponema pallidum and pertenue, respectively,

• ●infections caused by Neisseria gonorrhoeae,

• ●anthrax caused by Bacillus anthracis,

• ●infections due to Listeria monocytogenes,

• ●actinomycosis caused by Actinomyces species,

• ●infections due to Clostridium species.

• ●

TETRACYCLINE HYDROCHLORIDE CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

TETRACYCLINE HYDROCHLORIDE ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

ANIMAL PHARMACOLOGY & OR TOXICOLOGY

INACTIVE INGREDIENT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION