Usual dosage range: Oral: 150 mg 4 times daily or 300 mg twice daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no specific dosage adjustments provided in the manufacturer’s labeling; dosage adjustment and/or increase in time interval between doses is recommended; use with caution. Tetracyclines are not removed in significant quantities by hemodialysis or peritoneal dialysis.
There are no specific dosage adjustments provided in the manufacturer’s labeling; dosage adjustment and/or increase in time interval between doses is recommended; use with caution.
Refer to adult dosing.
(For additional information see "Demeclocycline: Pediatric drug information")
Susceptible infections: Note: Although FDA approved, use of demeclocycline as an antibacterial agent is uncommon and rarely used; alternative tetracyclines are recommended (eg, doxycycline, minocycline, tetracycline).
Children ≥8 years and Adolescents: Oral: 7 to 13 mg/kg/day divided every 6 to 12 hours; maximum daily dose: 600 mg/day
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no specific dosage adjustments provided in the manufacturer’s labeling; dosage adjustment and/or increase in time interval between doses is recommended; use with caution. Tetracyclines are not removed in significant quantities by hemodialysis or peritoneal dialysis.
There are no specific dosage adjustments provided in the manufacturer’s labeling; dosage adjustment and/or increase in time interval between doses is recommended; use with caution.
The following adverse drug reactions are derived from product labeling unless otherwise specified. Reactions listed are based on reports for other agents in this same pharmacologic class and may not be specifically reported for demeclocycline.
Postmarketing:
Cardiovascular: Pericarditis
Dermatologic: Erythema multiforme, erythematous rash, exfoliative dermatitis, fixed drug eruption (Dodds 1985), maculopapular rash, nail discoloration (Demers 1968), onycholysis (Bethell 1977), phototoxicity, skin photosensitivity (Bethell 1977), skin pigmentation, Stevens-Johnson syndrome, urticaria
Endocrine & metabolic: Microscopic thyroid discoloration (brown/black), nephrogenic diabetes insipidus (Singer 1973), thyroid dysfunction
Gastrointestinal: Anorexia, Clostridioides difficile-associated diarrhea, diarrhea, discoloration of permanent tooth (infants, young children) (Demers 1968), dysphagia, enamel hypoplasia (infants, young children) (Demers 1968), enterocolitis, esophageal ulcer (Channer 1981), glossitis, mucous membrane hyperpigmentation, nausea, pancreatitis (Torosis 1987), vomiting
Genitourinary: Balanitis (Dodds 1985), inflammatory anogenital lesion (with monilial overgrowth)
Hematologic & oncologic: Eosinophilia, hemolytic anemia, Henoch-Schonlein purpura, neutropenia, thrombocytopenia
Hepatic: Hepatic failure, hepatitis, hepatotoxicity, increased liver enzymes
Hypersensitivity: Anaphylactic shock (Furey 1969), anaphylaxis (Furey 1969; Ogita 2011), angioedema (Steinbruegge 1980), nonimmune anaphylaxis (Barnett 1967)
Infection: Superinfection
Nervous system: Bulging fontanel (infants), dizziness, headache, intracranial hypertension (adults) (Walters 1981)
Neuromuscular & skeletal: Abnormal bone growth (fibula; premature infants) (Demers 1968), exacerbation of systemic lupus erythematosus, Lambert-Eaton syndrome, lupus-like syndrome (Lee 2013), polyarthralgia
Ophthalmic: Visual disturbance
Otic: Tinnitus
Renal: Acute kidney injury (Curtis 2002), increased blood urea nitrogen (Curtis 2002), renal failure syndrome (Carrilho 1977)
Respiratory: Pulmonary infiltrates
Hypersensitivity to demeclocycline, tetracyclines, or any component of the formulation
Concerns related to adverse effects:
• CNS effects: May cause dizziness, blurred vision, or lightheadedness, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).
• Diabetes insipidus syndrome: Dose-dependent nephrogenic diabetes insipidus is common with use (reversible on discontinuation).
• Increased BUN: May be associated with increases in BUN secondary to antianabolic effects; use caution in patients with renal impairment.
• Intracranial hypertension (eg, pseudotumor cerebri): Intracranial hypertension (headache, blurred vision) has been associated with use. Usually resolves after discontinuation of treatment; however, permanent sequelae are possible.
• Photosensitivity: May cause photosensitivity; discontinue if skin erythema occurs. Use skin protection and avoid prolonged exposure to sunlight; do not use tanning equipment.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment; dose adjustment and/or adjustment to interval frequency recommended. Hepatotoxicity and hepatic failure have been reported rarely with use.
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment and/or adjustment to interval frequency recommended. Nephrotoxicity has also been reported with use, particularly in the setting of cirrhosis (Sherlock 2010).
Special populations:
• Pediatric: May cause tissue hyperpigmentation, enamel hypoplasia, or permanent tooth discoloration; use of tetracyclines should be avoided during tooth development (children <8 years of age) unless other drugs are not likely to be effective or are contraindicated.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as hydrochloride:
Generic: 150 mg, 300 mg
Yes
Tablets (Demeclocycline HCl Oral)
150 mg (per each): $6.64 - $18.80
300 mg (per each): $17.07 - $34.14
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Oral: Administer 1 hour before or 2 hours after food or milk. Administer with adequate amounts of fluid to decrease the risk of esophageal irritation and ulceration.
Oral: Administer 1 hour before or 2 hours after food or milk. Administer with adequate amounts of fluid to decrease the risk of esophageal irritation and ulceration.
Note: Although FDA-approved for treatment of the indications below, use of demeclocycline as an antibacterial agent is uncommon; alternative tetracycline agents (eg, doxycycline, minocycline, tetracycline) are preferred.
Acne: Adjunctive therapy in severe acne.
Actinomycosis: Treatment of actinomycosis caused by Actinomyces israelii when penicillin is contraindicated.
Acute intestinal amebiasis: Adjunct to amebicides in acute intestinal amebiasis.
Anthrax: Treatment of anthrax due to Bacillus anthracis when penicillin is contraindicated.
Cholera: Treatment of cholera caused by Vibrio cholerae.
Clostridium: Treatment of clostridial disease caused by Clostridium spp. when penicillin is contraindicated.
Gram-negative infections: Treatment of infections caused by Escherichia coli, Klebsiella aerogenes (formerly Enterobacter aerogenes), Shigella species, and Acinetobacter species.
Listeriosis: Treatment of listeriosis due to Listeria monocytogenes when penicillin is contraindicated.
Ophthalmic infections: Treatment of inclusion conjunctivitis or trachoma caused by Chlamydia trachomatis.
Plague: Treatment of plague due to Yersinia pestis.
Relapsing fever: Treatment of relapsing fever caused by Borrelia recurrentis.
Respiratory tract infections: Treatment of respiratory tract infections caused by Haemophilus influenzae, Klebsiella species, or Mycoplasma pneumoniae; treatment of upper respiratory tract infections caused by Streptococcus pneumoniae.
Rickettsial infections: Treatment of Rocky Mountain spotted fever, typhus fever, and the typhus group, Q fever, rickettsialpox and tick fevers caused by Rickettsiae.
Skin and skin structure infections: Treatment of skin and skin structure infections caused by Staphylococcus aureus.
Urinary tract infections: Treatment of urinary tract infections caused by Klebsiella species
Vincent infection: Treatment of Vincent infection caused by Fusobacterium fusiforme when penicillin is contraindicated.
Yaws: Treatment of yaws caused by Treponema pallidum subspecies pertenue when penicillin is contraindicated.
Zoonotic infections: Treatment of psittacosis (ornithosis) caused by Chlamydophila psittaci; tularemia caused by Francisella tularensis; brucellosis caused by Brucella species (in conjunction with streptomycin); bartonellosis caused by Bartonella bacilliformis; infections caused by Campylobacter fetus.
KIDs List: Demeclocycline, when used pediatric patients <8 years of age, is identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be used with caution due to risk of tooth discoloration (strong recommendation; high quality of evidence) (PPA [Meyers 2020]).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Antacids: May decrease the absorption of Tetracyclines. Management: Separate administration of antacids and oral tetracycline derivatives by several hours when possible to minimize the extent of this potential interaction. Monitor for decreased therapeutic effects of tetracyclines. Risk D: Consider therapy modification
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Bile Acid Sequestrants: May decrease the absorption of Tetracyclines. Risk C: Monitor therapy
Bismuth Subcitrate: May decrease the serum concentration of Tetracyclines. Management: Avoid administration of oral tetracyclines within 30 minutes of bismuth subcitrate administration. This is of questionable significance for at least some regimens intended to treat H. pylori infections. Risk D: Consider therapy modification
Bismuth Subsalicylate: May decrease the serum concentration of Tetracyclines. Management: Consider dosing tetracyclines 2 hours before or 6 hours after bismuth. The need to separate doses during Helicobacter pylori eradication regimens is questionable. Risk D: Consider therapy modification
Calcium Salts: May decrease the serum concentration of Tetracyclines. Management: If coadministration of oral calcium with oral tetracyclines cannot be avoided, consider separating administration of each agent by several hours. Risk D: Consider therapy modification
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Desmopressin: Demeclocycline may diminish the therapeutic effect of Desmopressin. Risk C: Monitor therapy
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Iron Preparations: Tetracyclines may decrease the absorption of Iron Preparations. Iron Preparations may decrease the serum concentration of Tetracyclines. Management: Avoid this combination if possible. Administer oral iron preparations at least 2 hours before, or 4 hours after, the dose of the oral tetracycline derivative. Monitor for decreased therapeutic effect of oral tetracycline derivatives. Risk D: Consider therapy modification
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Lanthanum: May decrease the serum concentration of Tetracyclines. Management: Administer oral tetracycline antibiotics at least 2 hours before or after lanthanum. Risk D: Consider therapy modification
Lithium: Tetracyclines may increase the serum concentration of Lithium. Risk C: Monitor therapy
Magnesium Dimecrotate: May interact via an unknown mechanism with Tetracyclines. Risk C: Monitor therapy
Magnesium Salts: May decrease the absorption of Tetracyclines. Only applicable to oral preparations of each agent. Management: Avoid coadministration of oral magnesium salts and oral tetracyclines. If coadministration cannot be avoided, administer oral magnesium at least 2 hours before, or 4 hours after, oral tetracyclines. Monitor for decreased tetracycline therapeutic effects. Risk D: Consider therapy modification
Mecamylamine: Tetracyclines may enhance the neuromuscular-blocking effect of Mecamylamine. Risk X: Avoid combination
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Methoxyflurane: Tetracyclines may enhance the nephrotoxic effect of Methoxyflurane. Risk X: Avoid combination
Mipomersen: Tetracyclines may enhance the hepatotoxic effect of Mipomersen. Risk C: Monitor therapy
Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Tetracyclines. Management: Avoid this combination if possible. If coadministration cannot be avoided, administer the polyvalent cation-containing multivitamin at least 2 hours before or 4 hours after the tetracycline derivative. Monitor for decreased tetracycline effects. Risk D: Consider therapy modification
Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Tetracyclines. Management: If coadministration of a polyvalent cation-containing multivitamin with oral tetracyclines cannot be avoided, administer the polyvalent cation-containing multivitamin either 2 hours before or 4 hours after the tetracycline product. Risk D: Consider therapy modification
Neuromuscular-Blocking Agents: Tetracyclines may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
Penicillins: Tetracyclines may diminish the therapeutic effect of Penicillins. Risk C: Monitor therapy
Polyethylene Glycol-Electrolyte Solution: May decrease the absorption of Tetracyclines. Management: Give oral tetracyclines at least 2 hours before or at least 6 hours after polyethylene glycol-electrolyte solutions that contain magnesium sulfate (Suflave brand). Other products without magnesium do not require dose separation. Risk D: Consider therapy modification
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Quinapril: May decrease the serum concentration of Tetracyclines. Risk C: Monitor therapy
Retinoic Acid Derivatives: Tetracyclines may enhance the adverse/toxic effect of Retinoic Acid Derivatives. The development of pseudotumor cerebri is of particular concern. Risk X: Avoid combination
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Strontium Ranelate: May decrease the serum concentration of Tetracyclines. Management: In order to minimize any potential impact of strontium ranelate on tetracycline antibiotic concentrations, it is recommended that strontium ranelate treatment be interrupted during tetracycline therapy. Risk X: Avoid combination
Sucralfate: May decrease the absorption of Tetracyclines. Management: Administer most tetracycline derivatives at least 2 hours prior to sucralfate in order to minimize the impact of this interaction. Administer oral omadacycline 4 hours prior to sucralfate. Risk D: Consider therapy modification
Sucroferric Oxyhydroxide: May decrease the serum concentration of Tetracyclines. Management: Administer oral/enteral doxycycline at least 1 hour before sucroferric oxyhydroxide. Specific dose separation guidelines for other tetracyclines are not presently available. No interaction is anticipated with parenteral administration of tetracyclines. Risk D: Consider therapy modification
Sulfonylureas: Tetracyclines may enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Vasopressin: Drugs Suspected of Causing Diabetes Insipidus may diminish the therapeutic effect of Vasopressin. Specifically, the pressor and antidiuretic hormone effects of vasopressin may be decreased. Risk C: Monitor therapy
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Tetracyclines may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Zinc Salts: May decrease the absorption of Tetracyclines. Only a concern when both products are administered orally. Management: Separate administration of oral tetracycline derivatives and oral zinc salts by at least 2 hours to minimize this interaction. Risk D: Consider therapy modification
Demeclocycline serum levels may be decreased if taken with food, milk, or dairy products. Management: Administer 1 hour before or 2 hours after food, milk, or dairy products.
Demeclocycline crosses the placenta (Gibbons 1960).
Tetracycline-class antibiotics may cause fetal harm following maternal use in pregnancy. Tetracyclines accumulate in developing teeth and long tubular bones (Mylonas 2011). Permanent discoloration of teeth (yellow, gray, brown) can occur following in utero exposure and is more likely to occur following long-term or repeated exposure.
As a class, tetracyclines are generally considered second-line antibiotics in pregnant women and their use should be avoided (Mylonas 2011). Demeclocycline is not recommended for the treatment of Rocky Mountain Spotted Fever (Biggs 2016), Q fever (Anderson 2013), or anthrax infection (Meaney-Delman 2014) in pregnant women. When systemic antibiotics are needed for dermatologic conditions in pregnant women, other agents are preferred (Kong 2013; Murase 2014).
Tetracyclines are present in breast milk.
According to the manufacturer, due to the potential for adverse events, the decision to continue or discontinue breastfeeding during therapy should consider the risk of exposure to the infant and the benefits of treatment to the mother.
As a class, tetracyclines have generally been avoided in nursing women due to theoretical concerns that they may permanently stain the teeth of the breastfeeding infant (Chung 2002). Some sources note that breastfeeding can continue during tetracycline therapy (Chung 2002; WHO 2002) but recommend use of alternative medications when possible (WHO 2002). Other sources note that short-term exposure may be acceptable; however, long-term use of tetracyclines (eg, for the treatment of acne) should be avoided in breastfeeding women (Pugashetti 2013). In general, antibiotics that are present in breast milk may cause nondose-related modification of bowel flora. Monitor infants for GI disturbances (Chung 2002; WHO 2002).
Due to potential for decreased absorption, administer 1 hour before or 2 hours after food or milk.
CBC, renal and hepatic function
Inhibits protein synthesis by binding with the 30S and possibly the 50S ribosomal subunit(s) of susceptible bacteria; may also cause alterations in the cytoplasmic membrane.
Absorption: 66% (Agwuh 2006); extent of absorption is reduced by food and by certain antacids and dairy products containing aluminum, calcium, magnesium, or iron.
Distribution: 1.7 L/kg (Agwuh 2006).
Protein binding: ~40% to 90%.
Metabolism: None.
Half-life elimination: 10 to 16 hours.
Time to peak, serum: ~4 hours.
Excretion: Urine (44% as unchanged drug); feces (13% to 46% as unchanged drug).
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