the variety [8:<8 years of age unless other appropriate drugs are ineffective or are contraindicated or unless the benefits in certain indications (e.g., anthrax) outweigh the risks. 100 (See Pediatric Use under Cautions.) Fetal/Neonatal Morbidity Animal studies indicate possible fetal toxicity (e.g., retardation of skeletal development) and embryotoxicity. 100 If used during pregnancy or if patient becomes pregnant while receiving demeclocycline, patient should be apprised of the potential hazard to the fetus. 100 (See Pregnancy under Cautions.) Nervous System Effects Possibility of adverse CNS effects (light-headedness, dizziness, vertigo) that may impair ability to drive vehicles or operate hazardous machinery. 100 Benign intracranial hypertension (pseudotumor cerebri) in adults reported with tetracyclines; usually manifested as headache and blurred vision. 100 Bulging fontanels reported in infants. 100 Effects usually resolve when drug discontinued, but possibility for permanent sequelae exists. 100 Renal Effects Tetracyclines have antianabolic effects and may increase BUN. 100 In patients with impaired renal function, high serum demeclocycline concentrations may result in azotemia, hyperphosphatemia, and acidosis. 100 Excessive drug accumulation and possible liver toxicity may occur if usual dosage is used patients with renal impairment. 100 (See Renal Impairment under Dosage and Administration.) Diabetes Insipidus Syndrome Diabetes insipidus syndrome (polyuria, polydipsia and weakness) reported with long-term demeclocycline therapy. 100 Syndrome is nephrogenic, dose-dependent, and reversible when drug discontinued. 100 Laboratory Monitoring Periodically assess organ system function, including renal, hepatic and hematopoietic, during long-term therapy. 100 Sensitivity Reactions Photosensitivity Reactions Photosensitivity, manifested by an exaggerated sunburn reaction, reported with tetracyclines. 100 Photosensitivity reactions may develop within a few minutes to several hours after sun exposure and usually persist 1 2 days after discontinuance of the drug. a Most reactions result from accumulation of tetracyclines in skin and are phototoxic in nature; photoallergic reactions may also occur. a Discontinue drug at first evidence of skin erythema. 100 General Precautions Superinfection Possible emergence and overgrowth of nonsusceptible bacteria or fungi. 100 Discontinue drug and institute appropriate therapy if superinfection occurs. 100 Selection and Use of Anti-infectives Because many strains of Acinetobacter , Bacteroides , Enterobacter , E. coli , Klebsiella , Shigella , S. pyogenes (group A β-hemolytic streptococci), S. pneumoniae , enterococci, and α-hemolytic streptococci are resistant to tetracyclines (including demeclocycline), in vitro susceptibility tests should be performed if the drug is used for treatment of infections caused by these bacteria. 100 Incision and drainage or other surgical procedures should be performed in conjunction with demeclocycline therapy when indicated. 100 Specific Populations Pregnancy Category D. 100 (See Fetal/Neonatal Morbidity under Cautions.) Lactation Distributed into milk; 100 discontinue nursing or the drug. 100 AAP states maternal use of tetracyclines usually is compatible with breast-feeding since absorption of the drugs by nursing infants is negligible. d Pediatric Use Should not be used in children> <8 years of age unless benefits outweigh the risks. 100 (See Adverse Dental and Bone Effects under Cautions.) Hepatic Impairment Use with caution. 100 Reduce dosage. 100 Renal Impairment Use with caution. 100 Reduce dosage. 100 Because usual dosage of doxycycline can be used in patients with impaired renal function, it may preferred when a tetracycline is indicated in a patient with impaired renal function. b Common Adverse Effects GI effects (anorexia, nausea, vomiting, diarrhea); maculopapular and erythematous rash; dose-related BUN increase; hypersensitivity reactions. 100 Interactions for Declomycin Specific Drugs Drug Interaction Comments Antacids (aluminum-, calcium-, or magnesium-containing) Decreased demeclocycline absorption 100 Administer antacids containing aluminum, calcium, or magnesium 1 2 hours before or after demeclocycline a Anticoagulants, oral Possible increased anticoagulant effect; 100 tetracyclines may impair utilization of prothrombin or decrease vitamin K production by intestinal bacteria a Monitor PT carefully; adjust anticoagulant dosage as needed a 100 Hormonal contraceptives Possible decreased effectiveness of oral contraceptives 100 Use alternative nonhormonal contraceptives a Iron-containing preparations Possible decreased absorption of demeclocycline 100 Administer demeclocycline 2 hours before or 3 hours after an oral iron preparation a Methoxyflurane Possible fatal nephrotoxicity 100 Concomitant use not recommended a Penicillins Possible antagonism 100 Concomitant use not recommended a Declomycin Pharmacokinetics Absorption Bioavailability Approximately 60 80% of a dose absorbed from the GI tract in fasting adults. b Peak serum concentrations attained within 2 4 hours. b c Food Food and/or milk decrease GI absorption by 50%. b c Distribution Extent Well distributed into body tissues and fluids. c Plasma Protein Binding 36 91%. a c Elimination Metabolism Does not appear to be metabolized. a Elimination Route Excreted into the GI tract via bile and by nonbiliary routes. a Excreted in urine by glomerular filtration. a c 44% of a 150-mg oral dose excreted in urine and 13 46% excreted in feces as unchanged drug. b c Half-life Adults with normal renal function: 10 17 hours. b c Special Populations Patients with severe renal impairment: half-life 42 68 hours. b Stability Storage Oral Tablets 20 25 C. 100 Actions and Spectrum Usually bacteriostatic, 100 a but may be bactericidal in high concentrations or against highly susceptible organisms. a Inhibits protein synthesis 100 in susceptible organisms by reversibly binding to 30S and 50S ribosomal subunits. a The complete mechanisms by which tetracyclines reduce acne lesions have not been fully elucidated. a The effects appear to result in part from the antibacterial activity of the drugs, but other mechanisms also are involved. a Spectrum of activity includes many gram-positive and -negative bacteria and various other organisms (e.g., Rickettsia , Chlamydia , Mycoplasma , spirochetes). a c Inactive against fungi and viruses. a Gram-positive aerobes and anaerobes: active against Actinomyces israelii , Bacillus anthracis , Clostridium , Propionibacterium acnes , and some staphylococci and streptococci. a c Many strains of S. pyogenes and Enterococci are resistant. a Gram-negative aerobes and anaerobes: active against Bartonella bacilliformis , Brucella , Calymmatobacterium granulomatis , Francisella tularensis , Haemophilus ducreyi , H. influenzae , Neisseria gonorrhoeae , Vibrio cholerae , and Y. pestis . 100 Many strains of Acinetobacter , E. aerogenes , E. coli , Klebsiella , and Shigella and nearly all strains of Proteus and Pseudomonas are resistant. a c Other organisms: active against Rickettsia , Coxiella burnetii , Chlamydia psittaci , C. trachomatis , Mycoplasma hominis , M. pneumoniae , Ureoplasma urealyticum , B. recurrentis , Leptospira , Treponema pallidum , and T. pertenue . a c Complete cross-resistance usually occurs between demeclocycline and other tetracyclines (doxycycline, minocycline, oxytetracycline, tetracycline). a c Advice to Patients Importance of drinking sufficient quantities of fluids when taking tablets to reduce the risk of esophageal irritation and ulceration. 100 Advise patients that absorption of demeclocycline may be reduced when taken with foods, especially those containing calcium, and that tablets should be taken at least 1 hour before or 2 hours after meals and/or milk. 100 Advise patients that adverse CNS effects (light-headedness, dizziness, vertigo) may occur and caution should be used when driving vehicles or operating hazardous machinery. 100 Advise patients to avoid excessive sunlight or artificial UV light and to discontinue the drug at the first sign of skin erythema; 100 consider use of sunscreen or sunblock. a Advise patients that demeclocycline may decrease effectiveness of oral contraceptives and that alternative nonhormonal contraceptive measures should be used. 100 Advise patients that unused supplies of demeclocycline should be discarded by the expiration date. 100 Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 100 (See Fetal/Neonatal Morbidity under Cautions.) Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs. 100 Importance of informing patients of other important precautionary information. (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name Demeclocycline Hydrochloride Routes Dosage Forms Strengths Brand Names Manufacturer Bulk Powder* Oral Tablets, film-coated 150 mg* Declomycin Glades Demeclocycline Tablets Barr, Impax 300 mg* Declomycin Glades Demeclocycline Tablets Barr, Impax AHFS DI Essentials. Copyright 2017, Selected Revisions July 1, 2006. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Use is not currently included in the labeling approved by the US Food and Drug Administration. References Only references cited for selected revisions after 1984 are available electronically. 100. Lederle Pharmaceuticals. Declomycin (demeclocycline hydrochloride) for oral use prescribing information. Pearl River, NY. 2002 Mar 14. 101. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2002. MMWR Morb Mortal Wkly Rep . 2002; 51(No. RR-6):1-78. a. AHFS Drug Information 2004. McEvoy GK, ed. Tetracyclines General Statement. American Society of Health-System Pharmacists; 2004:433-49. b. AHFS Drug Information 2004. McEvoy GK, ed. Demeclocycline hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2004:449. c. Lederle Pharmaceuticals. Declomycin (demeclocycline hydrochloride) tablets prescribing information. Pearl River, NY. 2003 Jun. d. Committee on Infectious Diseases, American Academy of Pediatrics. 2000 Red book: report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics: 2000:187-8,192-3,374-9,547-59. e. Anon. The choice of antibacterial drugs. Med Lett Drugs Ther . 2001; 43:69-78. [PubMed 11518876] f. Inglesby TV, O Toole T, Henderson DA et al for the Working Group on Civilian Biodefense. Anthrax as a biological weapon, 2002. Updated recommendations for management. JAMA . 2002; 287:2236-52. [PubMed 11980524] g. Dennis DT, Inglesby TV, Henderson DA et al for the Working Group on Civilian Biodefense. Tularemia as a biological weapon: medical and public health management. JAMA . 2001; 285:2763-73. [PubMed 11386933] Next Interactions Print this page Add to My Med List More about Declomycin (demeclocycline) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Compare Alternatives Support Group En Español 2 Reviews Add your own review/rating Drug class: tetracyclines Consumer resources Declomycin Professional resources Demeclocycline Hydrochloride (AHFS Monograph) Demeclocycline (FDA) Related treatment guides Bacterial Infection SIADH> ]} Antibiotics 101 Everything you need to know about antibiotics: List of Common Antibiotics & Types Antibiotics & Drinking Alcohol - Is it Safe? Antibiotics For UTI - What Are My Options? FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Tetracyclines Related Drugs SIADH demeclocycline , conivaptan , Vaprisol , More... Bacterial Infection ciprofloxacin , amoxicillin , azithromycin , doxycycline , cephalexin , metronidazole , Augmentin , Zithromax , Levaquin , Keflex , levofloxacin , More... Declomycin Rating 2 User Reviews 9.0 /10 2 User Reviews 9.0 Rate it! Declomycin Images Declomycin 150 mg (LL D 11) View larger images} } practice
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