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Basic Drug Info
Drug Name:Tetracycline Hydrochloride
Manufacturer:BARR LABORATORIES, INC.
Other Info:MANUFACTURED BYBARR LABORATORIES, INC.POMONA, NY 10970BR-010, 011



Clinical Trials:


Indications and Usage

Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:Upper respiratory tract infections caused by Streptococcuspyogenes, Streptococcuspneumoniae and Hemophilusinfluenzae.

Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible.Lower respiratory tract infections caused by Streptococcuspyogenes, Streptococcuspneumoniae, Mycoplasmapneumoniae (Eaton agent, and Klebsiellasp.)Skin and soft tissue infections caused by Streptococcuspyogenes, Staphylococcusaureaus.

(Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.)Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox.Psittacosis of ornithosis caused by Chlamydiapsittaci.Infections caused by Chlamydiatrachomatis such as uncomplicated urethral, endocervical, or rectal infections, inclusion conjunctivitis, trachoma and lymphogranuloma venereum.Granuloma inquinale caused by Calymmatobacteriumgranulomatis.Relapsing fever caused by Borrelia sp.Bartonellosis caused by Bartonellabacilli-formis.Chancroid caused by Hemophilus ducreyi.Tularemia caused by Francisella tularensis.Plaque caused by Yersiniapestis.Cholera caused by Vibriocholerae.Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside).Infections due to Campylobacterfetus.As adjunctive therapy in intestinal amebiasis caused by Entamoebahistolytica.Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc.Other infections caused by susceptible gram-negative organisms such as E.

coli, Enterobacteraerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp.In severe acne, adjunctive therapy with tetracycline may be useful.

When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections:syphilis and yaws caused by Treponema pallidumand pertenue, respectively,Vincent’s infection caused by Fusobacterium fusiforme,infections caused by Neisseria gonorrhoeae,anthrax caused by Bacillus anthracis,infections due to Listeria monocytogenes,actinomycosis caused by Actinomyces species,infections due to Clostridium species.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Upper Respiratory Infections --

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.

Lower respiratory tract infection --

SOFT TISSUE INFECTION -- Infections of non-skeletal tissue, i.e., exclusive of bone, ligaments, cartilage, and fibrous tissue. The concept is usually referred to as skin and soft tissue infections and usually subcutaneous and muscle tissue are involved. The predisposing factors in anaerobic infections are trauma, ischemia, and surgery. The organisms often derive from the fecal or oral flora, particularly in wounds associated with intestinal surgery, decubitus ulcer, and human bites. (From Cecil Textbook of Medicine, 19th ed, p1688)

SPONDYLOMETAEPIPHYSEAL DYSPLASIA, SHORT LIMB-HAND TYPE --

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

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 --

Psittacosis -- Infection with CHLAMYDOPHILA PSITTACI (formerly Chlamydia psittaci), transmitted to humans by inhalation of dust-borne contaminated nasal secretions or excreta of infected BIRDS. This infection results in a febrile illness characterized by PNEUMONITIS and systemic manifestations.

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.

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

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.

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.

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.

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.

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.

Dental Plaque -- A film that attaches to teeth, often causing DENTAL CARIES and GINGIVITIS. It is composed of MUCINS, secreted from salivary glands, and microorganisms.

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.

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.

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.

Klebsiella pneumonia --

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.

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

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.

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.

Actinomycosis -- Infections with bacteria of the genus ACTINOMYCES.

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 UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.All tetracyclines form a stable calcium complex in any bone forming tissue.

A decrease in fibula growth rate has been observed in premature infants 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 embryotoxicity has also been noted in animals treated early in pregnancy.

If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Tetracycline drugs should not be used during pregnancy unless absolutely necessary.If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulation of the drug and possible liver toxicity.

Under such conditions, lower than usual total doses are indicated, and, if therapy is prolonged, serum level determinations of the drug may be advisable.

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 lights should be advised that this reaction can occur with tetracycline drugs.

Treatment should be discontinued at the first evidence of skin erythema.The antianabolic action of the tetracyclines may cause an increase in BUN.

While this is not a problem in those with normal renal function, in patients with significantly impaired renal function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia and acidosis.
Branded Drugs
The following US Branded drugs contain Tetracycline Hydrochloride


HELIDAC -- PROMETHEUS LABORATORIES INC

ACHROMYCIN -- LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO

TETRACYN -- PFIZER LABORATORIES DIV PFIZER INC

ACHROMYCIN V -- HERITAGE PHARMACEUTICALS INC

BRISTACYCLINE -- BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO

CYCLOPAR -- WARNER CHILCOTT DIV WARNER LAMBERT CO

PANMYCIN -- PHARMACIA AND UPJOHN CO

RETET -- SOLVAY PHARMACEUTICALS

ROBITET -- WYETH AYERST LABORATORIES

SUMYCIN -- APOTHECON INC DIV BRISTOL MYERS SQUIBB

TETRACHEL -- ANGUS CHEMICAL CO

TETRACYN -- PFIPHARMECS DIV PFIZER INC

ACTISITE -- ON SITE THERAPEUTICS INC

TOPICYCLINE -- SHIRE DEVELOPMENT INC

ACHROMYCIN -- STORZ OPHTHALMICS INC SUB AMERICAN CYANAMID CO

ACHROMYCIN V -- LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO

SUMYCIN -- PAR PHARMACEUTICAL

TETRAMED -- IVAX PHARMACEUTICALS INC

SUMYCIN -- PAR PHARMACEUTICAL INC


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