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Basic Drug Info
Drug Name:Doxycycline
Manufacturer:Lannett Company, Inc.
Other Info:Manufactured by:LANNETT COMPANY, INC.Philadelphia, PA 19136Revised: 04/08-A



Clinical Trials:


Indications and Usage

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline 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.Doxycycline is indicated for the treatment of the following infections:  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.Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:  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.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 gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:  Escherichia coliEnterobacter aerogenes (formerly Aerobacter aerogenes)Shigella speciesAcinetobacter species (formerly Mima species and Herellea species)Respiratory tract infections caused by Haemophilus influenzae.Respiratory tract and urinary tract infections caused by Klebsiella species.Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:  Upper respiratory infections caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae).  Skin and skin structure infections caused by Staphylococcus aureus.  Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infections.When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:  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.In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.In severe acne, doxycycline may be useful adjunctive therapy.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Rocky Mountain Spotted Fever -- An acute febrile illness caused by RICKETTSIA RICKETTSII. It is transmitted to humans by bites of infected ticks and occurs only in North and South America. Characteristics include a sudden onset with headache and chills and fever lasting about two to three weeks. A cutaneous rash commonly appears on the extremities and trunk about the fourth day of illness.

TYPHUS -- group of acute, arthropod borne infections caused by rickettsiae; includes epidemic (classic or louse-borne) typhus, its recrudescent form, and murine (endemic or flea-borne) typhus; all are characterized by severe headache, chills, high fever, stupor, and rash.

Q Fever -- An acute infectious disease caused by COXIELLA BURNETII. It is characterized by a sudden onset of FEVER; HEADACHE; malaise; and weakness. In humans, it is commonly contracted by inhalation of infected dusts derived from infected domestic animals (ANIMALS, DOMESTIC).

Rickettsialpox --

Bovine Anaplasmosis -- A disease of cattle caused by parasitization of the red blood cells by bacteria of the genus ANAPLASMA.

Infection by Babesia bovis --

Tick fever --

respiratory infection -- Invasion of the host RESPIRATORY SYSTEM by microorganisms, usually leading to pathological processes or diseases.

Mycoplasma pneumonia -- Interstitial pneumonia caused by extensive infection of the lungs (LUNG) and BRONCHI, particularly the lower lobes of the lungs, by MYCOPLASMA PNEUMONIAE in humans. In SHEEP, it is caused by MYCOPLASMA OVIPNEUMONIAE. In CATTLE, it may be caused by MYCOPLASMA DISPAR.

Lymphogranuloma Venereum -- Subacute inflammation of the inguinal lymph glands caused by certain immunotypes of CHLAMYDIA TRACHOMATIS. It is a sexually transmitted disease in the U.S. but is more widespread in developing countries. It is distinguished from granuloma venereum (see GRANULOMA INGUINALE), which is caused by Calymmatobacterium granulomatis.

Trachoma -- A chronic infection of the CONJUNCTIVA and CORNEA caused by CHLAMYDIA TRACHOMATIS.

Inclusion conjunctivitis -- An infection of the eyes characterized by the presence in conjunctival epithelial cells of inclusion bodies indistinguishable from those of trachoma. It is acquired by infants during birth and by adults from swimming pools. The etiological agent is CHLAMYDIA TRACHOMATIS whose natural habitat appears to be the genito-urinary tract. Inclusion conjunctivitis is a less severe disease than trachoma and usually clears up spontaneously.

Nonspecific urethritis --

Relapsing Fever -- An acute infection characterized by recurrent episodes of PYREXIA alternating with asymptomatic intervals of apparent recovery. This condition is caused by SPIROCHETES of the genus BORRELIA. It is transmitted by the BITES of either the body louse (PEDICULUS humanus corporis), for which humans are the reservoir, or by soft ticks of the genus ORNITHODOROS, for which rodents and other animals are the principal reservoirs.

Chancroids -- Acute, localized autoinoculable infectious disease usually acquired through sexual contact. Caused by HAEMOPHILUS DUCREYI, it occurs endemically almost worldwide, especially in tropical and subtropical countries and more commonly in seaports and urban areas than in rural areas.

Plague -- An acute infectious disease caused by YERSINIA PESTIS that affects humans, wild rodents, and their ectoparasites. This condition persists due to its firm entrenchment in sylvatic rodent-flea ecosystems throughout the world. Bubonic plague is the most common form.

Tularemia -- A plague-like disease of rodents, transmissible to man. It is caused by FRANCISELLA TULARENSIS and is characterized by fever, chills, headache, backache, and weakness.

Cholera -- An acute diarrheal disease endemic in India and Southeast Asia whose causative agent is VIBRIO CHOLERAE. This condition can lead to severe dehydration in a matter of hours unless quickly treated.

Brucellosis -- Infection caused by bacteria of the genus BRUCELLA mainly involving the MONONUCLEAR PHAGOCYTE SYSTEM. This condition is characterized by fever, weakness, malaise, and weight loss.

Bartonella Infections -- Infections by the genus BARTONELLA. Bartonella bacilliformis can cause acute febrile anemia, designated Oroya fever, and a benign skin eruption, called verruga peruana. BARTONELLA QUINTANA causes TRENCH FEVER, while BARTONELLA HENSELAE is the etiologic agent of bacillary angiomatosis (ANGIOMATOSIS, BACILLARY) and is also one of the causes of CAT-SCRATCH DISEASE in immunocompetent patients.

Granuloma Inguinale -- Anogenital ulcers caused by Calymmatobacterium granulomatis as distinguished from lymphogranuloma inguinale (see LYMPHOGRANULOMA VENEREUM) caused by CHLAMYDIA TRACHOMATIS. Diagnosis is made by demonstration of typical intracellular Donovan bodies in crushed-tissue smears.

Urinary tract infection -- Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.

Upper Respiratory Infections --

Lobar Pneumonia --

skin infection -- Skin diseases caused by bacteria, fungi, parasites, or viruses.

Anthrax disease -- An acute infection caused by the spore-forming bacteria BACILLUS ANTHRACIS. It commonly affects hoofed animals such as sheep and goats. Infection in humans often involves the skin (cutaneous anthrax), the lungs (inhalation anthrax), or the gastrointestinal tract. Anthrax is not contagious and can be treated with antibiotics.

Pulmonary anthrax --

Disease Progression -- The worsening of a disease over time. This concept is most often used for chronic and incurable diseases where the stage of the disease is an important determinant of therapy and prognosis.

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

SPONDYLOMETAEPIPHYSEAL DYSPLASIA, SHORT LIMB-HAND TYPE --

Staphylococcal Infections -- Infections with bacteria of the genus STAPHYLOCOCCUS.

Gonorrhea -- Acute infectious disease characterized by primary invasion of the urogenital tract. The etiologic agent, NEISSERIA GONORRHOEAE, was isolated by Neisser in 1879.

Syphilis -- A contagious venereal disease caused by the spirochete TREPONEMA PALLIDUM.

Yaws -- A systemic non-venereal infection of the tropics caused by Treponema pallidum subspecies pertenue.

Listeriosis -- Infections with bacteria of the genus LISTERIA.

Necrotizing Ulcerative Gingivitis -- An acute or chronic GINGIVITIS characterized by redness and swelling, NECROSIS extending from the interdental papillae along the gingival margins, PAIN; HEMORRHAGE, necrotic odor, and often a pseudomembrane. The condition may extend to the ORAL MUCOSA; TONGUE; PALATE; or PHARYNX. The etiology is somewhat unclear, but may involve a complex of FUSOBACTERIUM NUCLEATUM along with spirochetes BORRELIA or TREPONEMA.

Actinomycosis -- Infections with bacteria of the genus ACTINOMYCES.

Amebic colitis -- DYSENTERY caused by intestinal PROTOZOA infection, chiefly with ENTAMOEBA HISTOLYTICA. This condition may be associated with amebic infection of the LIVER and other distant sites.

Acne -- chronic inflammatory disease of the pilosebaceous apparatus marked by an increase in sebum secretions causing lesions most frequently occurring on the face, chest, and back; the inflamed glands may form small pink papules, which sometimes surround comedones so that they have black centers (blackheads), or form pustules or cysts (whiteheads).

Acne Vulgaris -- A chronic disorder of the pilosebaceous apparatus associated with an increase in sebum secretion. It is characterized by open comedones (blackheads), closed comedones (whiteheads), and pustular nodules. The cause is unknown, but heredity and age are predisposing factors.

Contraindications
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN).

This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses.

Enamel hypoplasia has also been reported.

TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, EXCEPT FOR ANTHRAX, INCLUDING INHALATIONAL ANTHRAX (POST-EXPOSURE), UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including doxycycline tablets, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.

difficile.C.

difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of C.

difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.

difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.

difficile, and surgical evaluation should be instituted as clinically indicated.All tetracyclines form a stable calcium complex in any bone-forming tissue.

A decrease in the fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every six hours.

This reaction was shown to be reversible when the drug was discontinued.Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development).

Evidence of embryo toxicity has been noted in animals treated early in pregnancy.

If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus.The antianabolic action of the tetracyclines may cause an increase in BUN.

Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines.

Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.
Branded Drugs
The following US Branded drugs contain Doxycycline


ORACEA -- GALDERMA LABORATORIES LP

MONODOX -- WATSON PHARMACEUTICALS INC

DOXYCHEL -- RACHELLE LABORATORIES INC

VIBRAMYCIN -- PFIZER LABORATORIES DIV PFIZER INC


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