Tetracycline Hydrochloride

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• TETRACYCLINE HYDROCHLORIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS & USAGE
• TETRACYCLINE HYDROCHLORIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• LABORATORY TESTS
• DRUG INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• LABOR & DELIVERY
• NURSING MOTHERS
• PEDIATRIC USE
• TETRACYCLINE HYDROCHLORIDE ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• STORAGE AND HANDLING
• ANIMAL PHARMACOLOGY & OR TOXICOLOGY
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

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

• ●     Vincent's infection caused by Fusobacterium fusiforme,

• ●     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

INFORMATION FOR PATIENTS

LABORATORY TESTS

DRUG INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

LABOR & DELIVERY

NURSING MOTHERS

PEDIATRIC USE

TETRACYCLINE HYDROCHLORIDE ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

ANIMAL PHARMACOLOGY & OR TOXICOLOGY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL