1 INDICATIONS AND USAGE Doxycycline hyclate tablets and doxycycline hyclate capsules are tetracycline class drugs indicated for: Rickettsial infections ( 1.1 ) Sexually transmitted infections ( 1.2 ) Respiratory tract infections ( 1.3 ) Specific bacterial infections ( 1.4 ) Ophthalmic infections ( 1.5 ) Anthrax, including inhalational anthrax (post-exposure) ( 1.6 ) Alternative treatment for selected infections when penicillin is contraindicated ( 1.7 ) Adjunctive therapy for acute intestinal amebiasis and severe acne ( 1.8 ) Prophylaxis of malaria ( 1.9 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1.10 ) 1.1 Rickettsial Infections Doxycycline hyclate tablets and capsules 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 and capsules 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 .

1.3 Respiratory Tract Infections Doxycycline hyclate tablets and capsules 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 .

1.4 Specific Bacterial Infections Doxycycline hyclate tablets and capsules 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 and capsules 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.

1.5 Ophthalmic Infections Doxycycline hyclate tablets and capsules 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 .

1.6 Anthrax Including Inhalational Anthrax (Post-Exposure) Doxycycline hyclate tablets and capsules 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 and capsules 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.

1.8 Adjunctive Therapy for Acute Intestinal Amebiasis and Severe Acne In acute intestinal amebiasis, doxycycline hyclate tablets and capsules may be a useful adjunct to amebicides.

In severe acne, doxycycline hyclate tablets and capsules may be useful adjunctive therapy.

1.9 Prophylaxis of Malaria Doxycycline hyclate tablets and capsules 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 (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 and other antibacterial drugs, doxycycline hyclate 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.

6 ADVERSE REACTIONS The following adverse reactions have been identified during clinical trials or post-approval use of tetracycline-class drugs, including doxycycline.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, inflammatory lesions (with monilial overgrowth) in the anogenital region, and pancreatitis.

Hepatotoxicity has been reported.

These reactions have been caused by both the oral and parenteral administration of tetracyclines.

Superficial discoloration of the adult permanent dentition, reversible upon drug discontinuation and professional dental cleaning has been reported.

Permanent tooth discoloration and enamel hypoplasia may occur with drugs of the tetracycline class when used during tooth development [See Warnings and Precautions (5.1) ] .

Instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of drugs in the tetracycline-class.

Most of these patients took medications immediately before going to bed [see Dosage and Administration (2.1) ] .

Skin: Maculopapular and erythematous rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, and fixed drug eruption have been reported.

Photosensitivity has been reported [see Warnings and Precautions (5.4) ] .

Renal: Rise in BUN has been reported and is apparently dose-related [see Warnings and Precautions (5.7) ] .

Hypersensitivity reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, exacerbation of systemic lupus erythematosus, and drug reaction with eosinophilia and systemic symptoms (DRESS).

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

Intracranial Hypertension: Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines [see Warnings and Precautions (5.6) ] .

Thyroid Gland Changes: When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands.

No abnormalities of thyroid function are known to occur.

Psychiatric: Depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination.

Adverse reactions observed in patients receiving tetracyclines include anorexia, nausea, vomiting, diarrhea, rash, photosensitivity, urticaria, and hemolytic anemia.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC.

at 1-845-232-1683, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .