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Demeclocycline: Drug information

Demeclocycline: Drug information
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For additional information see "Demeclocycline: Patient drug information" and "Demeclocycline: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Pharmacologic Category
  • Antibiotic, Tetracycline Derivative
Dosing: Adult
Susceptible infection

Susceptible infection: Note: Although FDA approved, use of demeclocycline as an antibacterial agent is uncommon and rarely used; alternative tetracyclines are recommended (eg, doxycycline, minocycline, tetracycline).

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.

Dosing: Kidney Impairment: Adult

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.

Dosing: Liver Impairment: Adult

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.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Demeclocycline: Pediatric drug information")

Susceptible infection

Susceptible infection: 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.

Dosing: Kidney Impairment: Pediatric

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.

Dosing: Liver Impairment: Pediatric

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.

Adverse Reactions

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

Contraindications

Hypersensitivity to demeclocycline, tetracyclines, or any component of the formulation

Warnings/Precautions

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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as hydrochloride:

Generic: 150 mg, 300 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Demeclocycline HCl Oral)

150 mg (per each): $6.64 - $18.80

300 mg (per each): $17.07 - $34.14

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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.

Administration: Pediatric

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.

Use: Labeled Indications

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.

Sexually transmitted infections: Treatment of lymphogranuloma venereum caused by C. trachomatis; granuloma inguinale caused by Klebsiella granulomatis; chancroid caused by Haemophilus ducreyi; nongonococcal urethritis caused by Ureaplasma urealyticum or C. trachomatis. When penicillin is contraindicated: Treatment of uncomplicated urethritis in males caused by Neisseria gonorrhea and other uncomplicated gonococcal infections; infections in females caused by N. gonorrhea and syphilis caused by Treponema pallidum subspecies pallidum.

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 T. 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.

Medication Safety Issues
Pediatric patients: High-risk medication:

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]).

Metabolism/Transport Effects

None known.

Drug Interactions

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminolevulinic Acid (Systemic): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Systemic). Risk X: Avoid

Aminolevulinic Acid (Topical): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Topical). Risk C: Monitor

Antacids: May decrease 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 decrease therapeutic effects 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 decrease therapeutic effects of BCG (Intravesical). Risk X: Avoid

BCG Vaccine (Immunization): Antibiotics may decrease therapeutic effects of BCG Vaccine (Immunization). Risk C: Monitor

Bile Acid Sequestrants: May decrease absorption of Tetracyclines. Risk C: Monitor

Bismuth Subcitrate: May decrease 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 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 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 decrease therapeutic effects 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

Desmopressin: Demeclocycline may decrease therapeutic effects of Desmopressin. Risk C: Monitor

Fecal Microbiota (Live) (Oral): May decrease therapeutic effects of Antibiotics. Risk X: Avoid

Fecal Microbiota (Live) (Rectal): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Rectal). Risk X: Avoid

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor

Iron Preparations: Tetracyclines may decrease absorption of Iron Preparations. Iron Preparations may decrease 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 decrease therapeutic effects of Lactobacillus and Estriol. Risk C: Monitor

Lanthanum: May decrease 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 serum concentration of Lithium. Risk C: Monitor

Magnesium Dimecrotate: And Tetracyclines may interact via an unclear mechanism. Risk C: Monitor

Magnesium Salts: May decrease 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 increase neuromuscular-blocking effects of Mecamylamine. Risk X: Avoid

Methotrexate: Tetracyclines may increase serum concentration of Methotrexate. Risk C: Monitor

Methoxsalen (Systemic): Photosensitizing Agents may increase photosensitizing effects of Methoxsalen (Systemic). Risk C: Monitor

Methoxyflurane: Tetracyclines may increase nephrotoxic effects of Methoxyflurane. Risk X: Avoid

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease 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 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

Mycophenolate: Antibiotics may decrease active metabolite exposure of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor

Neuromuscular-Blocking Agents: Tetracyclines may increase neuromuscular-blocking effects of Neuromuscular-Blocking Agents. Risk C: Monitor

Penicillins: Tetracyclines may decrease therapeutic effects of Penicillins. Risk C: Monitor

Polyethylene Glycol-Electrolyte Solution: May decrease 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 increase photosensitizing effects of Porfimer. Risk X: Avoid

Quinapril: May decrease serum concentration of Tetracyclines. Risk C: Monitor

Retinoic Acid Derivatives: Tetracyclines may increase adverse/toxic effects of Retinoic Acid Derivatives. The development of pseudotumor cerebri is of particular concern. Risk X: Avoid

Sodium Bicarbonate (Systemic): May decrease serum concentration of Tetracyclines. Risk C: Monitor

Sodium Picosulfate: Antibiotics may decrease therapeutic effects 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 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

Sucralfate: May decrease 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 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 increase hypoglycemic effects of Sulfonylureas. Risk C: Monitor

Typhoid Vaccine: Antibiotics may decrease therapeutic effects 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 decrease therapeutic effects of Vasopressin. Specifically, the pressor and antidiuretic hormone effects of vasopressin may be decreased. Risk C: Monitor

Verteporfin: Photosensitizing Agents may increase photosensitizing effects of Verteporfin. Risk C: Monitor

Vitamin K Antagonists: Tetracyclines may increase anticoagulant effects of Vitamin K Antagonists. Risk C: Monitor

Zinc Salts: May decrease 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

Food Interactions

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.

Pregnancy Considerations

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).

Breastfeeding Considerations

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).

Dietary Considerations

Due to potential for decreased absorption, administer 1 hour before or 2 hours after food or milk.

Monitoring Parameters

CBC, renal and hepatic function

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

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).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Ledermycin;
  • (FR) France: Demeclocycline | Ledermycine;
  • (GB) United Kingdom: Ledermycin;
  • (GR) Greece: Ledermycin;
  • (IN) India: Ledermycin;
  • (IT) Italy: Ledermicina;
  • (PR) Puerto Rico: Declomycin | Demeclocycline HCL
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