VA Class:AM250
AHFS Class:
Generic Name(s):
- Demeclocycline Hydrochloride
Demeclocycline is a tetracycline antibiotic.
Administration 
Demeclocycline hydrochloride is administered orally.100,106,107
Because food and/or milk reduce GI absorption of demeclocycline hydrochloride, the drug should be given 1 hour before or 2 hours after meals and/or milk.100,106,107
To reduce the risk of esophageal irritation and ulceration, demeclocycline hydrochloride tablets should be administered with adequate amounts of fluid100 and probably should not be given at bedtime or to patients with esophageal obstruction or compression.
Dosage
General Adult Dosage
The usual adult dosage of demeclocycline hydrochloride is 600 mg daily administered in 2 or 4 divided doses.100,106,107
General Pediatric Dosage
The usual dosage of demeclocycline hydrochloride for children older than 8 years of age is 7-13 mg/kg daily (up to 600 mg daily) given in 2 or 4 divided doses.100,106
Gonorrhea
The manufacturers state that uncomplicated gonorrhea in adults may be treated with an initial 600-mg dose of demeclocycline hydrochloride, followed by 300 mg every 12 hours for 4 days for a total of 3 g.100,106,107
Tetracyclines are not included in current US Centers for Disease Control and Prevention (CDC) guidelines for the treatment of gonorrhea101 and doxycycline is the preferred tetracycline for presumptive treatment of coexisting chlamydial infections in patients with gonorrhea.101
Syndrome of Inappropriate Antidiuretic Hormone Secretion
In the treatment of the chronic form of the syndrome of inappropriate antidiuretic hormone secretion† (SIADH), a demeclocycline hydrochloride dosage of 600 mg to 1.2 g daily given in 3 or 4 divided doses has been effective in inhibiting the action of ADH in a dose-dependent manner. Diuresis usually occurs within 5 days after initiation of therapy and reverses within 2-6 days after discontinuation of the drug.
Dosage in Renal and Hepatic Impairment
If demeclocycline hydrochloride is used in patients with impaired renal function, doses and/or frequency of administration must be modified in response to the degree of renal impairment.100,106,107
If demeclocycline hydrochloride is used in patients with impaired hepatic function, some manufacturers state that doses and/or frequency of administration must be modified in response to the degree of hepatic impairment.106
Photosensitivity reactions occur more frequently and are more severe with demeclocycline than with other currently available tetracyclines. Demeclocycline also causes a reversible, dose-related diabetes insipidus syndrome which does not occur with other currently available tetracyclines. For a more complete discussion of these and other cautions associated with the use of demeclocycline, see Cautions in the Tetracyclines General Statement 8:12.24.
Pharmacokinetics
Absorption
Approximately 60-80% of an oral dose of demeclocycline hydrochloride is absorbed from the GI tract in fasting adults. Following oral administration of tablets containing demeclocycline hydrochloride in fasting adults with normal renal function, peak serum concentrations of demeclocycline were attained within 3-4 hours and averaged 0.9-1.2 mcg/mL following a single 150-mg dose and 1.5-1.7 mcg/mL following a single 300-mg dose.
Food and/or milk reduce GI absorption of the drug by 50% or more.100,106 Because tetracyclines readily chelate divalent or trivalent cations including aluminum, calcium, iron, and magnesium, concurrent oral administration of antacids and other drugs containing these cations may also decrease oral absorption of demeclocycline hydrochloride.100,106,107 Of the currently available tetracyclines, demeclocycline has the greatest affinity for calcium ions.
Elimination
The serum half-life of demeclocycline is 10-17 hours in adults with normal renal function and is reported to be 42-68 hours in patients with severe renal impairment. In one study in adults with normal renal function, the half-life of demeclocycline was 11 hours following a single dose and 15 hours following multiple doses.
In one study in adults with normal renal function, 44% of a single 150-mg oral dose of demeclocycline hydrochloride was excreted in urine and 31% was excreted in feces within 48 hours as active drug.
Chemistry and Stability
Chemistry
Demeclocycline is a tetracycline antibiotic derived from a mutant strain of Streptomyces aureofaciens .100,106,107 Demeclocycline is commercially available as the hydrochloride salt which occurs as a yellow, crystalline powder having a bitter taste and is sparingly soluble in water and slightly soluble in alcohol.
Stability
Demeclocycline hydrochloride tablets should be stored at a controlled room temperature of 20-25°C100,106 in tight, light-resistant containers.106
Additional Information
For further information on chemistry and stability, mechanism of action, spectrum, resistance, pharmacokinetics, uses, cautions, drug interactions, laboratory test interferences, and dosage and administration of demeclocycline hydrochloride, see the Tetracyclines General Statement 8:12.24.
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.
Demeclocycline Hydrochloride
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|
Bulk | Powder* | | | |
Oral | Tablets, film-coated | 150 mg* | Declomycin® | Glades |
| | | Demeclocycline Tablets | |
| | 300 mg* | Declomycin® | Glades |
| | | Demeclocycline Tablets | |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
AHFS® Drug Information. © Copyright, 1959-2024, Selected Revisions January 1, 2009. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
100. Lederle Pharmaceuticals. Declomycin® (demeclocycline hydrochloride) tablets prescribing information. Pearl River, NY. 2003 Jun.
101. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2006. MMWR Morb Mortal Wkly Rep . 2006; 55(No. RR-11):1-96. [PubMed 16410759]
102. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.
103. Anon. Choice of antibacterial drugs. Med Lett Treat Guid . 2004; 2:18-26.
104. 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]
105. 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]
106. Barr Laboratories. Demeclocycline tablets, USP for oral use prescribing information. Pomona, NY; 2004 Aug.
107. Global Pharmaceuticals. Demeclocycline hydrochloride tablets, USP prescribing information. Philadelphia, PA; 2001 Oct.