DOXYCYCLINE HYCLATE

DOXYCYCLINE HYCLATE- doxycycline hyclate tablet, coated
EPIC PHARMA, LLC

1 INDICATIONS AND USAGE

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.

1.2 Sexually Transmitted Infections

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

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Uncomplicated urethral, endocervical or rectal infections caused by Chlamydia trachomatis.

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Nongonococcal urethritis caused by Ureaplasma urealyticum.

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Lymphogranuloma venereum caused by Chlamydia trachomatis.

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Granuloma inguinale caused by Klebsiella granulomatis.

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Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.

Chancroid caused by Haemophilus ducreyi.

1.3 Respiratory Tract Infections

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

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Respiratory tract infections caused by Mycoplasma pneumoniae.

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Psittacosis (ornithosis) caused by Chlamydophila psittaci.

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

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Doxycycline is indicated for treatment of infections caused by the following microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug.

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Respiratory tract infections caused by Haemophilus influenzae.

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Respiratory tract infections caused by Klebsiella species.

Upper respiratory infections caused by Streptococcus pneumoniae.

1.4 Specific Bacterial Infections

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

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Relapsing fever due to Borrelia recurrentis.

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Plague due to Yersinia pestis.

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Tularemia due to Francisella tularensis.

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Cholera caused by Vibrio cholerae.

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Campylobacter fetus infections caused by Campylobacter fetus.

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

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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:

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Escherichia coli

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Enterobacter aerogenes

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Shigella species

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Acinetobacter species

Urinary tract infections caused by Klebsiella species.

1.5 Ophthalmic Infections

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

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

Inclusion conjunctivitis caused by Chlamydia trachomatis.

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.

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:

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Syphilis caused by Treponema pallidum.

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Yaws caused by Treponema pallidum subspecies pertenue.

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Listeriosis due to Listeria monocytogenes.

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Vincent’s infection caused by Fusobacterium fusiforme.

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Actinomycosis caused by Actinomyces israelii.

Infections caused by Clostridium species.

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.

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 pyrimethaminesulfadoxine resistant strains [see Dosage and Administration (2.4) and Patient Counseling Information (17)].

1.10 Usage

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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

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The usual dosage and frequency of administration of doxycycline hyclate tablets differ from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of adverse reactions.

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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 (6)].

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If gastric irritation occurs, doxycycline hyclate tablets may be given with food or milk [see Clinical Pharmacology (12.3)].

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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].

2.2 Dosage in Adult Patients

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The usual dosage of doxycycline hyclate tablets are 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg daily. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours.

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In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

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For certain selected specific indications, the recommended duration or dosage and duration of doxycycline hyclate tablets in adult patients are as follows:

1.

Streptococcal infections, therapy should be continued for 10 days.

2.

Uncomplicated urethral, endocervical, or rectal infection caused by Chlamydia trachomatis: 100 mg by mouth twice-a-day for 7 days.

3.

Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice-a-day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose.

4.

Nongonococcal urethritis (NGU) caused by C. trachomatis and U. urealyticum: 100 mg by mouth twice-a-day for 7 days.

5.

Syphilis – early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 2 weeks.

6.

Syphilis of more than one year’s duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg by mouth twice-a-day for 4 weeks.

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Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg by mouth, twice-a-day for at least 10 days.

8.

Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice-a-day for at least 10 days.