Demeclocycline (Demeclocycline Hydrochloride) - Summary

DEMECLOCYCLINE SUMMARY

DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP
For ORAL USE

Demeclocycline hydrochloride is an antibiotic isolated from a mutant strain of Streptomyces aureofaciens.

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 immunofluorescence;

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 drugs 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 the 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 Fusobacterium fusiforme;

Actinomycosis caused by Actinomyces israelii;

Clostridial diseases 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.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline and other antibacterial drugs, demeclocycline 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.

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NEWS HIGHLIGHTS

Clinical Trials Related to Demeclocycline

Effects of Calcitriol Versus PTH Replacement Therapy in Patients With Hypoparathyroidism [Active, not recruiting]
This study will determine whether a synthetic form of human parathyroid hormone (PTH) can control hypoparathyroidism and will examine the drug's effects on bone. Blood calcium and phosphate levels in patients with hypoparathyroidism are difficult to control with the current standard treatment of calcitriol and calcium supplementation. Calcium levels in the urine may be elevated at the same time that blood calcium levels are normal. This spilling of excessive calcium into the urine can lead to kidney damage.

Patients between 9 and 55 years of age with hypoparathyroidism may be eligible for this study. Participants

take standard calcitriol therapy for the first year of the study and start PTH after 1 year. After 1 year on PTH, they are given the option to continue the drug for an additional 3 years.

Patients are admitted to the NIH Clinical Center for 4-6 days at the start of the study, at the end of the first year, and at the end of the second year (and at year 5 for those who continue on PTH for an additional 3 years) for the following procedures:

" Daily 24-hour urine collection.

" Daily blood draw for calcium and phosphorous levels and for calcium-regulating hormones.

" Blood draw every 2 hours for 24 hours to measure blood calcium, phosphorus, and magnesium levels (admission 3 only). For this test blood samples are collected through a catheter (plastic tube) placed in a vein in the arm or hand to avoid multiple needle sticks.

" Questionnaire and 6-minute walk test to determine fatigue

" Bone biopsy to test treatment response. Before the biopsy, patients are given a regimen of the antibiotic tetracycline or demeclocycline. The drug is absorbed by the bone, "labeling" it in a way that permits investigators to learn more about the bone's biology. For the biopsy, the patient is given a sedative to cause drowsiness. The skin over the hipbone is numbed with an injection of anesthetic into the skin, through the underlying tissues, and onto the surface of the bone. A larger needle is then inserted into the bone itself, and a sample of bone tissue is withdrawn through the needle. More sedative or anesthetic may be given to lessen any pain.

Every week for the first month of the study and then twice a month, patients go to a laboratory for a 24-hour urine collection. Every 6 months, they come to the NIH outpatient clinic for a physical exam, blood and urine tests, and a dual energy X-ray absorptiometry (DXA) scan to measure bone density.

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