Doxycycline Hyclate

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

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

FULL PRESCRIBING INFORMATION

DOXYCYCLINE HYCLATE DESCRIPTION

CLINICAL PHARMACOLOGY

MICROBIOLOGY

• ●      Neisseria gonorrhoeae

• ●     Calymmatobacterium granulomatis

• ●     Haemophilus ducreyi

• ●     Haemophilus influenzae

• ●     Yersinia pestis (formerly Pasteurella pestis)

• ●     Francisella tularensis (formerly Pasteurella tularensis)

• ●     Vibrio cholera (formerly Vibrio comma)

• ●     Bartonella bacilliformis

• ●     Brucella species

• ●     Escherichia coli

• ●     Klebsiella species

• ●     Enterobacter aerogenes

• ●     Shigella species

• ●     Acinetobacter species (formerly Mima species and Herellea species)

• ●     Bacteroides species

• ●     Streptococcus pyogenes

• ●     Streptococcus pneumoniae

• ●     Enterococcus group (Streptococcus faecalis and Streptococcus faecium)

• ●     Alpha-hemolytic streptococci (viridans group)

• ●      Rickettsiae

• ●     Chlamydia psittaci

• ●     Chlamydia trachomatis

• ●     Mycoplasma pneumoniae

• ●     Ureaplasma urealyticum

• ●     Borrelia recurrentis

• ●     Treponema pallidum

• ●     Treponema pertenue

• ●     Clostridium species

• ●     Fusobacterium fusiforme

• ●     Actinomyces species

• ●     Bacillus anthracis

• ●     Propionibacterium acnes

• ●     Entamoeba species

• ●     Balantidium coli

• ●     Plasmodium falciparum

INDICATIONS & USAGE

• ●     Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.

• ●     Respiratory tract infections caused by Mycoplasma pneumoniae.

• ●     Lymphogranuloma venereum caused by Chlamydia trachomatis.

• ●     Psittacosis (ornithosis) caused by Chlamydia psittaci.

• ●     Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.

• ●     Inclusion conjunctivitis caused by Chlamydia trachomatis.

• ●     Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis.

• ●     Nongonococcal urethritis caused by Ureaplasma urealyticum.

• ●     Relapsing fever due to Borrelia recurrentis.

• ●     Chancroid caused by Haemophilus ducreyi.

• ●     Plague due to Yersinia pestis (formerly Pasteurella pestis).

• ●     Tularemia due to Francisella tularensis (formerly Pasteurella tularensis).

• ●     Cholera caused by Vibrio cholerae (formerly Vibrio comma).

• ●     Campylobacter fetus infections caused by Campylobacter fetus (formerly Vibrio fetus).

• ●     Brucellosis due to Brucella species (in conjunction with streptomycin).

• ●     Bartonellosis due to Bartonella bacilliformis.

• ●     Granuloma inguinale caused by Calymmatobacterium granulomatis.

• ●     Escherichia coli.

• ●     Enterobacter aerogenes (formerly Aerobacter aerogenes).

• ●     Shigella species.

• ●     Acinetobacter species (formerly Mima species and Herellea species).

• ●     Respiratory tract infections caused by Haemophilus influenzae.

• ●     Respiratory tract and urinary tract infections caused by Klebsiella species.

• ●     Upper respiratory infections caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae).

• ●     Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.

• ●     Syphilis caused by Treponema pallidum.

• ●     Yaws caused by Treponema pertenue.

• ●     Listeriosis due to Listeria monocytogenes.

• ●     Vincent's infection caused by Fusobacterium fusiforme.

• ●     Actinomycosis caused by Actinomyces israelii.

• ●     Infections caused by Clostridium species.

DOXYCYCLINE HYCLATE CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

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LABORATORY TESTS

DRUG INTERACTIONS

DRUG & OR LABORATORY TEST INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

LABOR & DELIVERY

NURSING MOTHERS

PEDIATRIC USE

DOXYCYCLINE HYCLATE ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

ANIMAL PHARMACOLOGY & OR TOXICOLOGY

REFERENCES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION