Doxycycline Hyclate description, usages, side effects, indications, overdosage, supplying and lots more!

Doxycycline Hyclate

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DESCRIPTION



DESCRIPTION









CLINICAL PHARMACOLOGY






MICROBIOLOGY



Gram-Negative Bacteria
  • ●      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

Gram-Positive Bacteria

  • ●     Streptococcus pyogenes
  • ●     Streptococcus pneumoniae
  • ●     Enterococcus group (Streptococcus faecalis and Streptococcus faecium)
  • ●     Alpha-hemolytic streptococci (viridans group)

Other Microorganisms
  • ●      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



Treatment:

  • ●     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.



Prophylaxis:
DOSAGE AND ADMINISTRATIONInformation For PatientsPRECAUTIONS

CONTRAINDICATIONS



WARNINGS










PRECAUTIONS

General







INFORMATION FOR PATIENTS


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WARNINGS
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ADVERSE REACTIONS
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Drug Interactions
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Drug Interactions
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LABORATORY TESTS




DRUG INTERACTIONS









DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY

Teratogenic effects. Pregnancy Category D:


WARNINGS

LABOR & DELIVERY



NURSING MOTHERS

WARNINGS

PEDIATRIC USE

WARNINGSDOSAGE AND ADMINISTRATION

ADVERSE REACTIONS


DOSAGE AND ADMINISTRATION
WARNINGS
WARNINGS


PRECAUTIONSGeneral


OVERDOSAGE



DOSAGE & ADMINISTRATION






ADVERSE REACTIONS



















HOW SUPPLIED






STORAGE AND HANDLING



ANIMAL PHARMACOLOGY & OR TOXICOLOGY





REFERENCES









PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Doxycycline Hyclate

Doxycycline Hyclate CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-949(NDC:0591-5440)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Doxycycline Hyclate DOXYCYCLINE HYCLATE 100 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
SILICON DIOXIDE
SODIUM LAURYL SULFATE
titanium dioxide
MAGNESIUM STEARATE
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
blue 22 mm DAN;5440 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-949-04 14 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062031 2012-03-29


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