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Basic Drug Info
Drug Name:Demeclocycline Hydrochloride
Manufacturer:Global Pharmaceuticals
Other Info:

Mfg.

by:IMPAX Laboratories, Inc.Hayward, CA 94544Dist.

by:Global PharmaceuticalsDivision of IMPAX Laboratories, Inc.Philadelphia, PA 19124Rev.

233-041/2004



Clinical Trials:


Indications and Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets and other antibacterial drugs, demeclocycline hydrochloride 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.Demeclocycline Hydrochloride is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: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 due to Chlamydia trachomatis;Psittacosis (Ornithosis) due to Chlamydia psittaci;Trachoma due to Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescense; Inclusion conjunctivitis caused by Chlamydia trachomatis;Nongonococcal urethritis in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis;Relapsing fever due to Borrelia recurrentis;Chancroid caused by Haemophilus ducreyi;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;Granuloma inguinale caused by Calymmatobacterium granulomatis;Demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:Escherichia coli; Enterobacter aerogenes;Shigella species;Acinetobacter species;Respiratory tract infections caused by Haemophilus influenzae;Respiratory tract and urinary tract infections caused by Klebsiella species.Demeclocycline hydrochloride 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;Skin and skin structure infections caused by Staphylococcus aureus.

(Note: Tetracyclines, including demeclocycline, are not the drug of choice in the treatment of any type of staphylococcal infection.)When penicillin is contraindicated, tetracyclines, including demeclocycline hydrochloride, are alternative drugs in the treatment of the following infections:Uncomplicated urethritis in men due to Neisseria gonorrhoeae, and for treatment of other uncomplicated gonococcal infections;Infections in women caused by Neisseria gonorrhoeae;Syphilis caused by Treponema pallidum subspecies pallidum;Yaws caused by Treponema pallidum subspecies pertenue;Listeriosis due to Listeria monocytogenes;Anthrax due to Bacillus anthracis;Vincent's infection caused by Fusibacterium fusiforme;Actinomycosis caused by Actinomyces israelii;Clostridial disease caused by Clostridium species.In acute intestinal amebiasis, demeclocycline hydrochloride may be a useful adjunct to amebicides.In severe acne, demeclocycline hydrochloride may be a 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.

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.

Nongonococcal urethritis [NGU] due to Chlamydia trachomatis --

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 --

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

SPONDYLOMETAEPIPHYSEAL DYSPLASIA, SHORT LIMB-HAND TYPE --

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

Nonspecific urethritis --

Urethritis -- Inflammation involving the URETHRA. Similar to CYSTITIS, clinical symptoms range from vague discomfort to painful urination (DYSURIA), urethral discharge, or both.

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.

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.

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.

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 or any of the components of the product formulation.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

DEMECLOCYCLINE HYDROCHLORIDE, LIKE OTHER TETRACYCLINE-CLASS ANTIBIOTICS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN.

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 OF THE FETUS.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 DURING TOOTH DEVELOPMENT 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 human 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.The anti-anabolic 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 function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis.

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.

Phototoxic reactions can occur in individuals taking demeclocycline, and are characterized by severe burns of exposed surfaces resulting from direct exposure of patients to sunlight during therapy with moderate or large doses of demeclocycline.

Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur, and treatment should be discontinued at the first evidence of erythema of the skin.

Administration of demeclocyline hydrochloride has resulted in appearance of the diabetes insipidus syndrome (polyuria, polydipsia and weakness) in some patients on long-term therapy.

The syndrome has been shown to be nephrogenic, dose-dependent and reversible on discontinuance of therapy.Patients who are experiencing central nervous system symptoms associated with demeclocycline therapy, should be cautioned about driving vehicles or using hazardous machinery while on demeclocycline therapy.
Branded Drugs
The following US Branded drugs contain Demeclocycline Hydrochloride


DECLOMYCIN -- LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO

DECLOMYCIN -- STIEFEL LABORATORIES INC


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