Doxycycline Hyclate

Warnings and Precautions, Severe Skin Reactions (

Doxycycline hyclate is a tetracycline class drug indicated for:

• Rickettsial infections (
  1.1 Rickettsial Infections

  Doxycycline hyclate tablets are indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox, and tick fevers caused by

  Rickettsiae

  .
  )
• Sexually transmitted infections (
  1.2 Sexually Transmitted Infections

  Doxycycline hyclate tablets are indicated for treatment of the following sexually transmitted infections:

  • Uncomplicated urethral, endocervical or rectal infections caused by
    Chlamydia trachomatis
    .
  • Nongonococcal urethritis caused by
    Ureaplasma urealyticum
    .
  • Lymphogranuloma venereum caused by
    Chlamydia trachomatis
    .
  • Granuloma inguinale caused by
    Klebsiella granulomatis
    .
  • Uncomplicated gonorrhea caused by
    Neisseria gonorrhoeae
    .
  • Chancroid caused by
    Haemophilus ducreyi
    .
  )
• Respiratory tract infections (
  1.3 Respiratory Tract Infections

  Doxycycline hyclate tablets are indicated for treatment of the following respiratory tract infections:

  • Respiratory tract infections caused by
    Mycoplasma pneumoniae
    .
  • Psittacosis (ornithosis) caused by
    Chlamydophila psittaci
    .
  • Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.
  • Doxycycline is indicated for treatment of infections caused by the following microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:
  • Respiratory tract infections caused by
    Haemophilus influenzae
    .
  • Respiratory tract infections caused by
    Klebsiella species
    .
  • Upper respiratory infections caused by
    Streptococcus pneumoniae
    .
  )
• Specific bacterial infections (
  1.4 Specific Bacterial Infections

  Doxycycline hyclate tablets are indicated for treatment of the following specific bacterial infections:

  • Relapsing fever due to
    Borrelia recurrentis
    .
  • Plague due to
    Yersinia pestis
    .
  • Tularemia due to
    Francisella tularensis
    .
  • Cholera caused by
    Vibrio cholerae
    .
  • Campylobacter fetus infections caused by
    Campylobacter fetus
    .
  • Brucellosis due to
    Brucella
    species (in conjunction with streptomycin).
  • Bartonellosis due to
    Bartonella bacilliformis
    .

  Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.

  
  
  

  Doxycycline hyclate tablets are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:

  • Escherichia coli
  • Enterobacter aerogenes
  • Shigella
    species
  • Acinetobacter
    species
  • Urinary tract infections caused by
    Klebsiella
    species.
  )
• Ophthalmic infections (
  1.5 Ophthalmic Infections

  Doxycycline hyclate tablets are indicated for treatment of the following ophthalmic infections:

  • Trachoma caused by
    Chlamydia trachomatis
    , although the infectious agent is not always eliminated as judged by immunofluorescence.
  • Inclusion conjunctivitis caused by
    Chlamydia trachomatis
    .
  )
• Anthrax, including inhalational anthrax (post-exposure) (
  1.6 Anthrax Including Inhalational Anthrax (Post-Exposure)

  Doxycycline hyclate tablets are indicated for the treatment of Anthrax due to

  Bacillus anthracis

  , including inhalational anthrax (post-exposure); to reduce the incidence or progression of disease following exposure to aerosolized

  Bacillus anthracis

  .
  )
• Alternative treatment for selected infections when penicillin is contraindicated (
  1.7 Alternative Treatment for Selected Infections when Penicillin is Contraindicated

  Doxycycline hyclate tablets are indicted as an alternative treatment for the following selected infections when penicillin is contraindicated:

  • Syphilis caused by
    Treponema pallidum
    .
  • Yaws caused by
    Treponema pallidum
    subspecies
    pertenue.
  • Listeriosis due to
    Listeria monocytogenes
    .
  • Vincent’s infection caused by
    Fusobacterium fusiforme
    .
  • Actinomycosis caused by
    Actinomyces israelii
    .
  • Infections caused by
    Clostridium
    species.
  )
• Adjunctive therapy for acute intestinal amebiasis and severe acne (
  1.8 Adjunctive Therapy for Acute Intestinal Amebiasis and Severe Acne

  In acute intestinal amebiasis, doxycycline hyclate tablets may be a useful adjunct to amebicides.

  
  
  

  In severe acne, doxycycline hyclate tablets may be useful adjunctive therapy.
  )
• Prophylaxis of malaria (
  1.9 Prophylaxis of Malaria

  Doxycycline hyclate tablets are indicated for the prophylaxis of malaria due to

  Plasmodium falciparum

  in short-term travelers (less than 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains

  [see Dosage and Administration and Patient Counseling Information ]

  .
  )

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (

• Important Administration Instructions for Doxycycline Hyclate Tablets:
  • Doxycycline hyclate tablets (150 mg) can be broken into two-thirds or one-third to provide a 50 mg and 100 mg strength, respectively. (
    2.1 Important Administration Instructions

    • The usual dosage and frequency of administration of doxycycline hyclate tablets differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of adverse reactions.
    • Administer doxycycline hyclate tablets with adequate amounts of fluid to wash down the drugs and reduce the risk of esophageal irritation and ulceration
      [see Adverse Reactions ]
      .
    • If gastric irritation occurs, doxycycline hyclate tablets may be given with food or milk
      [see Clinical Pharmacology ]
    • Doxycycline hyclate tablets (150 mg) can be broken into two-thirds or one-third to provide a 100 mg and 50 mg strength, respectively
      [see FDA-approved patient labeling].
    )
• Dosage in Adults for Doxycycline Hyclate Tablets:
  • The usual dosage is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg daily. (
    2.1 Important Administration Instructions

    • The usual dosage and frequency of administration of doxycycline hyclate tablets differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of adverse reactions.
    • Administer doxycycline hyclate tablets with adequate amounts of fluid to wash down the drugs and reduce the risk of esophageal irritation and ulceration
      [see Adverse Reactions ]
      .
    • If gastric irritation occurs, doxycycline hyclate tablets may be given with food or milk
      [see Clinical Pharmacology ]
    • Doxycycline hyclate tablets (150 mg) can be broken into two-thirds or one-third to provide a 100 mg and 50 mg strength, respectively
      [see FDA-approved patient labeling].
    )
  • In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended. (
    2.1 Important Administration Instructions

    • The usual dosage and frequency of administration of doxycycline hyclate tablets differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of adverse reactions.
    • Administer doxycycline hyclate tablets with adequate amounts of fluid to wash down the drugs and reduce the risk of esophageal irritation and ulceration
      [see Adverse Reactions ]
      .
    • If gastric irritation occurs, doxycycline hyclate tablets may be given with food or milk
      [see Clinical Pharmacology ]
    • Doxycycline hyclate tablets (150 mg) can be broken into two-thirds or one-third to provide a 100 mg and 50 mg strength, respectively
      [see FDA-approved patient labeling].
    )
• Dosage in Pediatric Patients for Doxycycline Hyclate Tablets:
  • For all pediatric patients weighing less than 45 kg with severe or life-threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dose is 2.2 mg per kg of body weight administered every 12 hours. Pediatric patients weighing 45 kg or more should receive the adult dose. (
    2.3 Dosage in Pediatric Patients

    • For all pediatric patients weighing less than 45 kg with severe or life threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dosage of doxycycline hyclate tablets is 2.2 mg per kg of body weight administered every 12 hours. Pediatric patients weighing 45 kg or more should receive the adult dose
      [see Warnings and Precautions ]
      .
    • For pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the recommended dosage schedule of doxycycline hyclate tablets is 4.4 mg per kg of body weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.2 mg per kg of body weight (given as a single daily dose or divided into twice daily doses). For pediatric patients weighing over 45 kg, the usual adult dose should be used.
    )
  • For pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the recommended dose is 4.4 mg per kg of body weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.2 mg per kg of body weight (given as a single daily dose or divided into two doses. For pediatric patients weighing over 45 kg, the usual adult dose should be used. (
    2.3 Dosage in Pediatric Patients

    • For all pediatric patients weighing less than 45 kg with severe or life threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dosage of doxycycline hyclate tablets is 2.2 mg per kg of body weight administered every 12 hours. Pediatric patients weighing 45 kg or more should receive the adult dose
      [see Warnings and Precautions ]
      .
    • For pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the recommended dosage schedule of doxycycline hyclate tablets is 4.4 mg per kg of body weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.2 mg per kg of body weight (given as a single daily dose or divided into twice daily doses). For pediatric patients weighing over 45 kg, the usual adult dose should be used.
    )
• See Full Prescribing Information for additional indication specific dosage information and important administration instructions for doxycycline hyclate tablets. (
  2.1 Important Administration Instructions

  • The usual dosage and frequency of administration of doxycycline hyclate tablets differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of adverse reactions.
  • Administer doxycycline hyclate tablets with adequate amounts of fluid to wash down the drugs and reduce the risk of esophageal irritation and ulceration
    [see Adverse Reactions ]
    .
  • If gastric irritation occurs, doxycycline hyclate tablets may be given with food or milk
    [see Clinical Pharmacology ]
  • Doxycycline hyclate tablets (150 mg) can be broken into two-thirds or one-third to provide a 100 mg and 50 mg strength, respectively
    [see FDA-approved patient labeling].
  ,
  2.4 Dosage for Prophylaxis of Malaria

  For adults, the recommended dose of doxycycline hyclate tablets is 100 mg daily.

  
  
  

  For pediatric patients 8 years of age and older, the recommended dosage of doxycycline hyclate tablets is 2 mg per kg of body weight administered once daily. Pediatric patients weighing 45 kg or more should receive the adult dose.

  Prophylaxis should begin 1 or 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.
  ,
  2.5 Dosage for Inhalational Anthrax (Post-Exposure)

  For adults, the recommended dosage is 100 mg, of doxycycline hyclate tablets, by mouth, twice-a-day for 60 days.

  
  
  

  For pediatric patients weighing less than 45 kg, the recommended dosage of doxycycline hyclate tablets is 2.2 mg per kg of body weight, by mouth, twice-a-day for 60 days. Pediatric patients weighing 45 kg or more should receive the adult dose.
  )

Doxycycline Hyclate Tablets, USP 75 mg are blue colored, round-shaped, biconvex, film-coated tablets with ‘DY’ debossed on one side of the tablet and ‘2’ debossed on the other (each tablet contains 75 mg doxycycline, USP as 86.6 mg doxycycline hyclate, USP).

Doxycycline Hyclate Tablets, USP 150 mg are yellowish-green to green colored, capsule-shaped, biconvex, film-coated tablets. Each side of the functionally scored tablet has two parallel score lines for splitting into 3 equal portions with ‘D’ or ‘Y’ or ‘1’ debossed on either portion of one side of the tablet, and no debossing on the other (each tablet contains 150 mg doxycycline, USP as 173.2 mg doxycycline hyclate, USP).

• Lactation: Breastfeeding is not recommended. (
  8.2 Lactation

  Risk Summary

  
  
  Based on available published data, doxycycline is present in human milk. There are no data that inform the levels of doxycycline in breastmilk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during treatment with doxycycline hyclate and for 5 days after the last dose.
  )