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Demeclocycline Hydrochloride (Tablet, Film Coated)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1540

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Demeclocycline Hydrochloride (Tablet, Film Coated)
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Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided. Concomitant therapy: Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and by iron-containing preparations. Foods and some dairy products also interfere with absorption. Oral forms of tetracycline should be given at least 1 hour before or 2 hours after meals. In patients with renal impairment: Tetracyclines should be used cautiously in patients with impaired renal function. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses. In patients with liver impairment: Tetracyclines should be used cautiously in patients with impaired liver function. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses. Administration of adequate amounts of fluid with the oral formulations of tetracyclines is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. Adults: Usual daily dose--Four divided doses of 150 mg each or two divided doses of 300 mg each. For pediatric patients above eight years of age: Usual daily dose, 7 to 13 mg per kg body weight per day, depending upon the severity of the disease, divided into two to four doses not to exceed adult dosage of 600 mg per day. Gonorrhea patients sensitive to penicillin may be treated with demeclocycline administered as an initial oral dose of 600 mg followed by 300 mg every 12 hours for four days to a total of 3 grams.
dailymed-instance:descripti...
Demeclocycline hydrochloride is an antibiotic isolated from a mutant strain of Streptomyces aureofaciens. Chemically it is 7-Chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12, 12a-pentahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is: The molecular weight is 501.32 and the empirical formula is CHCINO���HCI. Each film-coated tablet contains demeclocycline hydrochloride 150 mg or 300 mg. In addition, each tablet contains the following inactive ingredients: alginic acid, colloidal silicon dioxide, crosscarmellose sodium, lactose monohydrate, microcrystalline cellulose, magnesium stearate, and povidone. The film coating material, contains FD&C Red #40, hypromellose 3cP, hypromellose 6cP, hypromellose 50cP, macrogol, polydextrose, titanium dioxide and triacetin.
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Pharmacokinetics: The absorption of demeclocycline is slower than that of tetracycline. The time to reach the peak concentration is about 4 hours. After a 150 mg oral dose of demeclocycline tablet, the mean concentrations at 1 hour and 3 hours are 0.46 and 1.22 mcg/mL (n = 6), respectively. The serum half-life ranges between 10 and 16 hours. When demeclocycline hydrochloride is given concomitantly with some dairy products, or antacids containing aluminum, calcium, or magnesium, the extent of absorption is reduced by more than 50%. Demeclocycline hydrochloride penetrates well into various body fluid and tissues. The percent of demeclocycline hydrochloride bound to plasma protein is about 40% using a dialysis equilibrium method and 90% using an ultra-filtration method. Demeclocycline hydrochloride, like other tetracyclines, is concentrated in the liver and excreted into the bile where it is found in much higher concentrations than in the blood. The rate of demeclocycline hydrochloride renalclearance (35 mL/min/1.73 m) is less than half that of tetracycline. Following a single 150 mg dose of demeclocycline hydrochloride in normal volunteers, 44% (n = 8) was excreted in urine and 13% and 46%, respectively, were excreted in feces in two patients within 96 hours as active drug.<br/>Microbiology: The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including demeclocycline, have a similar antimicrobial spectrum of activity against a wide range of gram-negative and gram-positive organisms. Cross-resistance of these organisms to tetracyclines is common. Demeclocycline has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. AEROBIC GRAM-POSITIVE MICROORGANISMS:Bacillus anthracisListeria monocytogenesStaphylococcus aureusStreptococcus pneumoniae AEROBIC GRAM-NEGATIVE MICROORGANISMS:Bartonella bacilliformisBrucella speciesCalymmatobacterium granulomatisCampylobacter fetusFrancisella tularensisHaemophilus ducreyiHaemophilus influenzaeNeisseria gonorrhoeaeVibrio choleraeYersinia pestis Because many strains of the following groups of gram-negative microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are especially recommended: Acinetobacter speciesEnterobacter aerogenesEscherichia coliKlebsiella speciesShigella species OTHER MICROORGANISMS:Actinomyces israeliiBorrelia recurrentisChlamydia psittaciChlamydia trachomatisClostridium speciesEntamoeba speciesFusobacterium fusiformeMycoplasma pneumoniaePropionibacterium acnesRickettsiaeTreponema pallidum subspecies pallidumTreponema pallidum subspecies pertenueUreaplasma urealyticum<br/>Susceptibility Tests:<br/>Dilution Techniques: Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of demeclocycline hydrochloride or tetracycline powder.The MIC values should be interpreted according to the following criteria: For organisms other than Haemophilus species, Neisseria gonorrhoeae and Streptococcus species: For Haemophilus and Streptococcus species: For Neisseria gonorrhoeae: A report of "Susceptible" indicates that the pathogen is likely to be inhibited by usually achievable concentrations of the antimicrobial compound in blood. A report of "Intermediate" indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zonewhich prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that usually achievable concentrations of the antimicrobial compound in the blood are unlikely to be inhibitory and that other therapy should be selected. Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard demeclocycline or tetracycline powder should provide the following MIC values:<br/>Diffusion Techniques: Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure requires the use of standardized inoculum concentrations.This procedure uses paper disks impregnated with 30-mcg tetracycline (as a class disk) or a 30-mcg demeclocycline hydrochloride disk to test the susceptibility of microorganisms to demeclocycline. Reports from the laboratory providing results of the standard single-disk susceptibility test with either a 30-mcg tetracycline-class disk or a 30-mcg demeclocycline disk should be interpreted according to the following criteria: For organisms other than Haemophilus species, Neisseria gonorrhoeae and Streptococcus species: For Haemophilus species: For N. gonorrhoeae: For Streptococcus species: Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for demeclocycline hydrochloride or tetracycline. As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. For the diffusion technique, the 30-mcg demeclocycline hydrochloride disk or the 30-mcg tetracycline-class disk should provide the following zone diameters in these laboratory test quality control strains:
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This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the components of the product formulation.
dailymed-instance:supply
Demeclocyline Hydrochloride Tablets USP, 150 mg are red, round, convex tablets debossed with "G" on one side and "2111" on the other side Bottles of 100............................................................................. NDC 0115-2111-01Bottles of 500............................................................................. NDC 0115-2111-02 Demeclocyline Hydrochloride Tablets USP, 300 mg are red, round, convex tablets debossed with "G" on one side and "2122" on the other side Bottles of 48............................................................................... NDC 0115-2122-14Bottles of 100............................................................................. NDC 0115-2122-01Bottles of 500............................................................................. NDC 0115-2122-02 Store at 20 to 25��C (68 to 77��F). (See USP Controlled Room Temperature)Dispense in a tightly-closed, light-resistant container (USP).
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In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Tetracyclines are not removed in significant quantities by hemodialysis or peritoneal dialysis.
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Demeclocycline Hydrochloride
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Demeclocycline Hydrochloride (Tablet, Film Coated)
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The following reactions have been reported in patients receiving tetracyclines: Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, pancreatitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region, increases in liver enzymes, and hepatic toxicity has been reported rarely. Rarely, hepatitis and liver failure have been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Instances of esophageal ulcerations have been reported in patients receiving oral tetracyclines. Most of the patients were reported to have taken the medication immediately before lying down. Skin: Maculopapular and erythematous rashes, erythema multiforme. Exfoliative dermatitis has been reported but is uncommon. Fixed drug eruptions and Stevens-Johnson syndrome have been reported rarely. Lesions occurring on the glans penis have caused balanitis. Pigmentation of the skin and mucous membranes has also been reported. Photosensitivity is discussed above. Renal toxicity: Acute renal failure. Rise in BUN has been reported and is apparently dose related. Nephrogenic diabetes insipidus . Hypersensitivity reactions: Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus, lupus-like syndrome, pulmonary infiltrates with eosinophilia. Hematologic: Hemolytic anemia, thrombocytopenia, neutropenia and eosinophilia have been reported. CNS: Pseudotumor cerebri (benign intracranial hypertension) in adults and bulging fontanels in infants . Dizziness, headache, tinnitus, and visual disturbances have been reported. Myasthenic syndrome has been reported rarely. Other: When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function studies are known to occur. Very rare cases of abnormal thyroid function have been reported. Tooth discoloration has occurred in pediatric patients less than 8 years of age , and also has been reported rarely in adults.
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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.
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Demeclocycline Hydrochloride