Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3458
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Doxycycline (Tablet, Film Coated)
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| dailymed-instance:dosage |
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.<br/>Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours or 50 mg every 6 hours) followed by a maintenance dose of 100 mg/day. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.<br/>For Pediatric Patients Above Eight Years of Age: The recommended dosage schedule for pediatric patients weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For pediatric patients over 100 pounds the usual adult dose should be used. Uncomplicated Gonococcal Infections in Adults (Except Anorectal Infections in Men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. Acute Epididymo-Orchitis Caused by N. Gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days. Primary and Secondary Syphilis: 300 mg a day in divided doses for at least 10 days. Uncomplicated Urethral, Endocervical, or Rectal Infection in Adults Caused by Chlamydia Trachomatis: 100 mg, by mouth, twice a day for at least 7 days. Nongonococcal Urethritis Caused by C. Trachomatis and U. Urealyticum: 100 mg, by mouth, twice a day for at least 7 days. Acute Epididymo-Orchitis Caused by C. Trachomatis: 100 mg, by mouth, twice a day for at least 10 days.<br/>Inhalational Anthrax (Postexposure): Adults: 100 mg of doxycycline, by mouth, twice a day for 60 days. Children: Weighing less than 100 pounds (45 kg): 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 pounds or more should receive the adult dose. When used in streptococcal infections, therapy should be continued for 10 days. Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline-class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. If gastric irritation occurs, doxycycline may be given with food. Ingestion of a high fat meal has been shown to delay the time to peak plasma concentrations by an average of one hour and 20 minutes. However, in the samestudy, food enhanced the average peak concentration by 7.5% and the area under the curve by 5.7%.
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| dailymed-instance:descripti... |
Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. Doxycycline 50 mg, 75 mg, 100 mg and 150 mg film-coated tablets contain doxycycline monohydrate equivalent to 50 mg, 75 mg, 100 mg or 150 mg of doxycycline for oral administration. Inactive ingredients include colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. Each tablet also contains the following colorant agents: hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin. In addition, the doxycycline 50 mg and 100 mg tablets contain: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 2 aluminum lake, and FD&C Yellow No. 6 aluminum lake. The 75 mg and 150 mg tablets contains yellow iron oxide and red iron oxide. Its molecular weight is 462.45. The chemical designation of the light yellow to pale yellow crystalline powder is 2-Naphthacenecarboxamide, 4-(dimethylamino)-1, 4,4a,5, 5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-,[4S-(4��,4a��,5��,5a��,6��,12a��)]-, monohydrate. Structural formula: Doxycycline, USP has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.
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Tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form. Doxycycline is virtually completely absorbed after oral administration. Following a 200 mg dose of doxycycline monohydrate, 24 normal adult volunteers averaged the following serum concentration values: Excretion of doxycycline by the kidney is about 40%/72 hours in individuals with normal function (creatinine clearance about 75 mL/min). This percentage excretion may fall as low as 1 to 5%/72 hours in individuals with severe renal insufficiency (creatinine clearance below 10 mL/min). Studies have shown no significant difference in serum half-life of doxycycline (range 18 to 22 hours) in individuals with normal and severely impaired renal function. Hemodialysis does not alter serum half-life.<br/>Microbiology: The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including doxycycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative microorganisms. Cross-resistance of these microorganisms to tetracyclines is common. Doxycycline 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.<br/>Aerobic Gram-Positive Microorganisms: Because many strains of the following groups of gram-positive microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended: Bacillus anthracisListeria monocytogenesStaphylococcus aureus Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used to treat streptococcal infections unless the microorganism has been demonstrated to be susceptible. Streptococcus pneumoniae<br/>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 recommended: Acinetobacter speciesEnterobacter aerogenesEscherichia coliKlebsiella speciesShigella species<br/>Anaerobic Microorganisms: Actinomyces israeliiClostridium speciesFusobacterium fusiforme<br/>Other Microorganisms: Borrelia recurrentisChlamydia psittaciChlamydia trachomatisMycoplasma pneumoniaeRickettsiaeTreponema pallidumTreponema pertenue<br/>Susceptibility Tests:<br/>Anaerobic Techniques: For anaerobic bacteria, the susceptibility to tetracycline as MICs can be determined by standardized test methods.The MIC values obtained should be interpreted according to the following criteria. Interpretation is identical to that stated above for results using dilution techniques. As with other susceptibility techniques, the use of laboratory control microorganisms is required to control the technical aspects of the laboratory standardized procedures. Standardized tetracycline powder should provide the following MIC values:
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This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
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Doxycycline Tablets are available as 50 mg, 75 mg, 100 mg, or 150 mg tablets. The 50 mg tablet is a light yellow film-coated, round, unscored tablet debossed with M on one side of the tablet and D21 on the other side. They are available as follows: NDC 0378-6021-01bottles of 100 tablets NDC 0378-6021-05bottles of 500 tablets The 75 mg tablet is an orange film-coated, round, unscored tablet debossed with M on one side of the tablet and D22 on the other side. They are available as follows: NDC 0378-6022-01bottles of 100 tablets NDC 0378-6022-05bottles of 500 tablets The 100 mg tablet is a light yellow film-coated, round, unscored tablet debossed with M on one side of the tablet and D23 on the other side. They are available as follows: NDC 0378-6023-89bottles of 50 tablets NDC 0378-6023-25bottles of 250 tablets The 150 mg tablet is an orange film-coated, round tablet debossed with M on one side of the tablet and D above the score and 24 below the score on the other side. They are available as follows: NDC 0378-6124-93bottles of 30 tablets NDC 0378-6124-01bottles of 100 tablets NDC 0378-6124-05bottles of 500 tablets Store at 20��to 25��C (68��to 77��F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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| dailymed-instance:inactiveI... |
dailymed-ingredient:D&C_yellow_#10_lake,
dailymed-ingredient:FD&C_blue_#2_aluminum_lake,
dailymed-ingredient:FD&C_yellow_#6_aluminum_lake,
dailymed-ingredient:colloidal_silicon_dioxide,
dailymed-ingredient:crospovidone,
dailymed-ingredient:hypromellose,
dailymed-ingredient:magnesium_stearate,
dailymed-ingredient:microcrystalline_cellulose,
dailymed-ingredient:polydextrose,
dailymed-ingredient:polyethylene_glycol,
dailymed-ingredient:titanium_dioxide,
dailymed-ingredient:triacetin
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General: Prescribing doxycycline tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted. Bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving tetracyclines. These conditions disappeared when the drug was discontinued. Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy when indicated.<br/>Information for Patients: Patients should be counseled that antibacterial drugs, including doxycycline tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When doxycycline tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by doxycycline tablets or other antibacterial drugsin the future.<br/>Laboratory Tests: In venereal disease when coexistent syphilis is suspected, a dark-field examination should be done before treatment is started and the blood serology repeated monthly for at least 4 months. In long-term therapy, periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies should be performed.<br/>Drug Interactions: Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron containing preparations. Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. Concurrent use of tetracycline may render oral contraceptives less effective.<br/>Drug/Laboratory Test Interactions: False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals to evaluate the carcinogenic potential of doxycycline have not been conducted. However, there has been evidence of oncogenic activity in rats in studies with related antibiotics, oxytetracycline (adrenal and pituitary tumors) and minocycline (thyroid tumors). Likewise, although mutagenicity studies of doxycycline have not been conducted, positive results in in vitro mammalian cell assays have been reported for related antibiotics (tetracycline, oxytetracycline). Doxycycline administered orally at dosage levels as high as 250 mg/kg/day had no apparent effect on the fertility of female rats. Effect on male fertility has not been studied.<br/>Pregnancy:<br/>Teratogenic Effects:<br/>Labor and Delivery: The effect of tetracyclines on labor and delivery is unknown.<br/>Nursing Mothers: Tetracyclines are excreted in human milk, however, the extent of absorption of tetracyclines, including doxycycline, by the breastfed infant is not known. Short-term use by lactating women is not necessarily contraindicated; however, the effects of prolonged exposure to doxycycline in breast milk are unknown. Because of the potential for adverse reactions in nursing infants from doxycycline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.<br/>Pediatric Use: See WARNINGS and DOSAGE AND ADMINISTRATION sections.
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In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life, and it would not be of benefit in treating cases of overdosage.
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Doxycycline
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Doxycycline (Tablet, Film Coated)
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Due to oral doxycycline's virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines. Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of drugs in the tetracycline-class. Most of these patients took medications immediately before going to bed. Skin: Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. Renal Toxicity: Rise in BUN has been reported and is apparently dose related. Hypersensitivity Reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, and exacerbation of systemic lupus erythematosus. Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported with tetracyclines. Other: Bulging fontanels in infants and intracranial hypertension in adults. When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. No abnormalities of thyroid function are known to occur.
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To reduce the development of drug-resistant bacteria and maintain the 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 beconsidered 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: Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: 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: Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: 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: In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.
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Doxycycline
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