(dem e kloe SYE kleen)
- Demeclocycline Hydrochloride
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as hydrochloride:
Generic: 150 mg, 300 mg
- Antibiotic, Tetracycline Derivative
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; inhibits the action of ADH in patients with chronic SIADH
66%; extent of absorption is reduced by food and by certain antacids and dairy products containing aluminum, calcium, magnesium, or iron
Urine (44% as unchanged drug); feces (13% to 46% as unchanged drug)
Onset of Action
SIADH: 2-5 days
Time to Peak
Serum: ~4 hours
40% to 90%
Use: Labeled Indications
Treatment of susceptible bacterial infections (eg, acne, urinary tract infections, respiratory infections) caused by both gram-negative and gram-positive organisms
Note: Use of demeclocycline as an antibacterial agent is uncommon; alternative tetracycline agents (eg, doxycycline, minocycline, tetracycline) are generally preferred.
Treatment of chronic syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
Hypersensitivity to demeclocycline, tetracyclines, or any component of the formulation
Susceptible infections: Manufacturer’s labeling:
Children >8 years: Oral: 7 to 13 mg/kg/day (maximum: 600 mg/day) divided every 6 to 12 hours
Adults: Oral: 150 mg 4 times/day or 300 mg twice daily
SIADH (off-label use): Adults: Oral: 600 to 1,200 mg/day (Goh, 2004; Gross, 2008, Verbalis, 2013). Note: Limited high quality evidence exists to define the clinical role, if any, of demeclocycline in this condition. European clinical practice guidelines recommend against the use of demeclocycline for the management of hyponatremia in patients with SIADH (Spasovski, 2014).
Dosage adjustment in renal impairment: Use with caution; dosage adjustment and/or increase in time interval between doses recommended in manufacturer’s labeling; no specific adjustment recommendations provided.
Dosage adjustment in hepatic impairment: Use with caution; dosage adjustment and/or increase in time interval between doses recommended in manufacturer’s labeling; no specific adjustment recommendations provided.
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.
Due to potential for decreased absorption, administer 1 hour before or 2 hours after food or milk.
Store at controlled room temperature at 20°C to 25°C (68°F to 77°F).
Antacids: May decrease the absorption of Tetracycline Derivatives. Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Bile Acid Sequestrants: May decrease the absorption of Tetracycline Derivatives. Consider therapy modification
Bismuth Subcitrate: May decrease the serum concentration of Tetracycline Derivatives. 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. Consider therapy modification
Bismuth Subsalicylate: May decrease the serum concentration of Tetracycline Derivatives. Management: Consider dosing tetracyclines 2 hours before or 6 hours after bismuth. The need to separate doses during Helicobacter pylori eradication regimens is questionable. Consider therapy modification
Calcium Salts: May decrease the serum concentration of Tetracycline Derivatives. Management: If coadministration of oral calcium with oral tetracyclines can not be avoided, consider separating administration of each agent by several hours. Consider therapy modification
Desmopressin: Demeclocycline may diminish the therapeutic effect of Desmopressin. Monitor therapy
Iron Salts: Tetracycline Derivatives may decrease the absorption of Iron Salts. Iron Salts may decrease the serum concentration of Tetracycline Derivatives. Exceptions: Ferric Carboxymaltose; Ferric Gluconate; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Consider therapy modification
Lanthanum: May decrease the serum concentration of Tetracycline Derivatives. Management: Administer oral tetracycline antibiotics at least two hours before or after lanthanum. Consider therapy modification
Magnesium Dimecrotate: May interact via an unknown mechanism with Tetracycline Derivatives. Monitor therapy
Magnesium Salts: May decrease the absorption of Tetracycline Derivatives. Only applicable to oral preparations of each agent. Consider therapy modification
Mecamylamine: Tetracycline Derivatives may enhance the neuromuscular-blocking effect of Mecamylamine. Avoid combination
Mipomersen: Tetracycline Derivatives may enhance the hepatotoxic effect of Mipomersen. Monitor therapy
Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Tetracycline Derivatives. Management: If coadministration of a polyvalent cation-containing multivitamin with oral tetracyclines can not be avoided, separate administration of each agent by several hours. Consider therapy modification
Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Tetracycline Derivatives. Management: If coadministration of a polyvalent cation-containing multivitamin with oral tetracyclines can not be avoided, separate administration of each agent by several hours. Consider therapy modification
Neuromuscular-Blocking Agents: Tetracycline Derivatives may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Penicillins: Tetracycline Derivatives may diminish the therapeutic effect of Penicillins. Consider therapy modification
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy
Quinapril: May decrease the serum concentration of Tetracycline Derivatives. Management: Separate doses of quinapril and oral tetracycline derivatives by at least 2 hours in order to reduce the risk of interaction. Monitor for reduced efficacy of the tetracycline if these products are used concomitantly. Consider therapy modification
Retinoic Acid Derivatives: Tetracycline Derivatives may enhance the adverse/toxic effect of Retinoic Acid Derivatives. The development of pseudotumor cerebri is of particular concern. Exceptions: Adapalene; Bexarotene (Topical); Tretinoin (Topical). 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. Consider therapy modification
Strontium Ranelate: May decrease the serum concentration of Tetracycline Derivatives. 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. Avoid combination
Sucralfate: May decrease the absorption of Tetracycline Derivatives. Management: Administer the tetracycline derivative at least 2 hours prior to sucralfate in order to minimize the impact of this interaction. Consider therapy modification
Sucroferric Oxyhydroxide: May decrease the serum concentration of Tetracycline Derivatives. Management: Administer oral/enteral doxycycline at least 1 h before sucroferric oxyhydroxide. Specific dose separation guidelines for other tetracyclines are not presently available. No interaction is anticipated with parenteral administration of tetracyclines. Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy
Vitamin K Antagonists (eg, warfarin): Tetracycline Derivatives may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy
Zinc Salts: May decrease the absorption of Tetracycline Derivatives. Only a concern when both products are administered orally. Management: Consider doxycycline as a noninteracting tetracycline derivative. Separate dose administration of oral tetracycline derivative and oral zinc salts by at least 2 hours to minimize interaction. Exceptions: Zinc Chloride. Consider therapy modification
Frequency not defined.
Central nervous system: Bulging fontanels (infants), dizziness, headache, pseudotumor cerebri (adults)
Dermatologic: Angioedema, anogenital inflammatory lesions (with monilial overgrowth), erythema multiforme, erythematous rash, exfoliative dermatitis (rare), maculopapular rash, photosensitivity, pigmentation of skin, Stevens-Johnson syndrome (rare), urticaria
Endocrine & metabolic: Microscopic discoloration of thyroid gland (brown/black), nephrogenic diabetes insipidus, thyroid dysfunction (rare)
Gastrointestinal: Anorexia, diarrhea, dysphagia, enterocolitis, esophageal ulcerations, glossitis, nausea, pancreatitis, vomiting
Hematologic: Eosinophilia, neutropenia, hemolytic anemia, thrombocytopenia
Hepatic: Hepatitis (rare), hepatotoxicity (rare), liver enzymes increased, liver failure (rare)
Neuromuscular & skeletal: Myasthenic syndrome, polyarthralgia, tooth discoloration (children <8 years, rarely in adults)
Ocular: Visual disturbances
Renal: Acute renal failure, BUN increased
Respiratory: Pulmonary infiltrates
Miscellaneous: Anaphylaxis, anaphylactoid purpura, fixed drug eruptions (rare), lupus-like syndrome, superinfection, systemic lupus erythematosus exacerbation
Concerns related to adverse effects:
• Diabetes insipidus syndrome: Dose-dependent nephrogenic diabetes insipidus is common with use; however, this adverse event of demeclocycline has been used as a therapeutic advantage in the off-label use of hyponatremia associated with SIADH.
• Increased BUN: May be associated with increases in BUN secondary to antianabolic effects; use caution in patients with renal impairment.
• Photosensitivity: May cause photosensitivity; discontinue if skin erythema occurs. Use skin protection and avoid prolonged exposure to sunlight; do not use tanning equipment.
• Pseudotumor cerebri: Has been (rarely) reported with tetracycline use; usually resolves with discontinuation.
• 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.
• 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 recommended. Nephrotoxicity has also been reported with use, particularly in the setting of cirrhosis.
Concurrent drug therapy issues:
• Methoxyflurane: Concurrent use of tetracyclines and methoxyflurane (not available in the U.S.) is not recommended; fatal renal toxicity has been reported with concurrent use.
• 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.
• Pregnancy: Do not use during pregnancy. In addition to affecting tooth development, tetracycline use has been associated with retardation of skeletal development and reduced bone growth.
CBC, renal and hepatic function
Pregnancy Risk Factor
Tetracyclines, including demeclocycline, cross the placenta and accumulate in developing teeth and long tubular bones. Tetracyclines may discolor fetal teeth following maternal use during pregnancy; the specific teeth involved and the portion of the tooth affected depends on the timing and duration of exposure relative to tooth calcification. As a class, tetracyclines are generally considered second-line antibiotics in pregnant women and their use should be avoided (Gibbons, 1960; Mylonas, 2011).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience diarrhea, dizziness, nausea, or lack of appetite. Have patient report immediately to prescriber vision changes, urinary retention, oliguria, severe headache, ecchymosis, hemorrhaging, considerable asthenia, or signs of pseudomembranous colitis (rare) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
More about demeclocycline
- Other brands: Declomycin