Declomycin

Demeclocycline is used to treat infections caused by bacteria includingpneumonia and other respiratory tract infections;; certain infections of the skin, eye, lymphatic, intestinal, genital, and urinary systems; and certain other infections that are spread by ticks, lice, mites, and infected animals. It is also used along with other medications to treat acne. Demeclocycline is also used to treat plague and tularemia (serious infections that may be spread on purpose as part of a bioterror attack). Demeclocycline can also be used in patients who cannot be treated with penicillin to treat certain types of food poisoning and anthrax (a very serious infection that may be spread on purpose as part of a bioterror attack), Demeclocycline is in a class of medications called tetracycline antibiotics. It works by preventing the growth and spread of bacteria.

Antibiotics such as demeclocycline will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Demeclocycline is also sometimes used to treat syndrome of inappropriate antidiuretic hormone (SIADH; condition in which the body produces too much of a certain natural substance that causes the body to retain water). Talk to your doctor about the risks of using this medication for your condition.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Declomycin is a prescription medication used to treat infections caused by bacteria, including respiratory tract infections (such as pneumonia), and infections of the skin, acne, genital, and urinary systems.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Amneal Pharmaceuticals, LLC

• Acne (Pimples)

You should not take this medication if you are allergic to demeclocycline or to similar antibiotics such as doxycycline (Adoxa, Alodox, Avidoxy, Oraxyl, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap).

Do not use demeclocycline if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Demeclocycline can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking demeclocycline.

Demeclocycline passes into breast milk and may affect bone and tooth development in a nursing baby. You should not breast-feed while you are taking demeclocycline.

Do not give demeclocycline to a child younger than 8 years old. Demeclocycline can affect a child's growth or cause permanent yellowing or graying of the teeth.

Avoid exposure to sunlight or tanning beds. Demeclocycline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking demeclocycline. Also avoid a product that contains bismuth subsalicylate (such as Pepto-Bismol) within 2 hours before or after taking demeclocycline. These medications can make it harder for your body to absorb demeclocycline.

Throw away any unused demeclocycline after the expiration date on the label has passed.

You should not take this medication if you are allergic to demeclocycline or to similar antibiotics such as doxycycline (Adoxa, Alodox, Avidoxy, Oraxyl, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap).

To make sure you can safely take demeclocycline, tell your doctor if you have any of these other conditions:

• kidney disease;

• liver disease; or

• diabetes.

If you are being treated for gonorrhea, your doctor may test you to make sure you do not also have syphilis, another sexually transmitted disease.

FDA pregnancy category D. Do not use demeclocycline if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Demeclocycline can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking demeclocycline.

Demeclocycline passes into breast milk and may affect bone and tooth development in a nursing baby. You should not breast-feed while you are taking demeclocycline.

Do not give demeclocycline to a child younger than 8 years old. Demeclocycline can affect a child's growth or cause permanent yellowing or graying of the teeth.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Antibacterial; tetracycline antibiotic derived from Streptomyces aureofaciens.100

Respiratory Tract Infections

Treatment of respiratory tract infections caused by Mycoplasma pneumoniae.100

Treatment of respiratory tract infections caused by Haemophilus influenzae, Streptococcus pneumoniae, or Klebsiella.100 Should only be used for treatment of infections caused by these bacteria when in vitro susceptibility tests indicate the organism is susceptible.100 a

Acinetobacter Infections

Treatment of infections caused by Acinetobacter;100 minocycline may be the preferred tetracycline for use as an alternative to imipenem or meropenem.e

Acne

Adjunctive treatment of moderate to severe inflammatory acne.100 Not indicated for treatment of noninflammatory acne.a

Actinomycosis

Treatment of actinomycosis caused by Actinomyces israelii;100 oral tetracyclines used as follow-up after initial parenteral treatment with penicillin G.d

Amebiasis

Adjunct to amebicides for treatment of acute intestinal amebiasis.100 Tetracyclines generally not recommended for treatment of amebiasis caused by Entamoeba.d

Anthrax

Alternative to doxycycline for treatment of inhalational anthrax when a parenteral regimen is not available (e.g., when there are supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).100 A multiple-drug parenteral regimen (ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective) is preferred for treatment of inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.f

Bartonella Infections

Treatment of infections caused by Bartonella bacilliformis.100

Brucellosis

Treatment of brucellosis;100 tetracyclines considered drugs of choice.d e Used in conjunction with other anti-infectives (e.g., streptomycin or gentamicin and/or rifampin),100 d e especially for severe infections or when there are complications (e.g., endocarditis, meningitis, osteomyelitis).d

Campylobacter Infections

Treatment of infections caused by Campylobacter.100 Tetracyclines are alternatives, not drugs of choice.d e

Chancroid

Treatment of chancroid caused by Haemophilus ducreyi.100 Not included in CDC recommendations for treatment of chancroid.101

Chlamydial Infections

Treatment of uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis.100 Doxycycline is the preferred tetracycline for treatment of these infections, including presumptive treatment of chlamydial infections in patients with gonorrhea.101

Treatment of trachoma and inclusion conjunctivitis caused by C. trachomatis.100 Consider that anti-infectives may not eliminate C. trachomatis in all cases of chronic trachoma.100

Treatment of lymphogranuloma venereum (genital, inguinal, or anorectal infections) caused by C. trachomatis.100 Doxycycline is the preferred tetracycline for these infections.101 d

Treatment of psittacosis (ornithosis) caused by C. psittaci.100 Doxycycline and tetracycline are drugs of choice.a d For initial treatment of severely ill patients, use IV doxycycline.a

Clostridium Infections

Alternative for treatment of infections caused by Clostridium.100 Tetracyclines are alternatives to metronidazole or penicillin G for adjunctive treatment of C. tetani infections.e

Enterobacteriaceae Infections

Treatment of infections caused by susceptible Escherichia coli, Enterobacter aerogenes, Klebsiella, or Shigella.100 Should only be used for treatment of infections caused by these common gram-negative bacteria when other appropriate anti-infectives are contraindicated or ineffectivea and when in vitro susceptibility tests indicate the organism is susceptible.100 a

Fusobacterium Infections

Alternative to penicillin G for the treatment of infections caused by Fusobacterium fusiforme (Vincent’s infection).100

Gonorrhea and Associated Infections

Alternative for treatment of uncomplicated gonorrhea (including urethritis) caused by susceptible Neisseria gonorrhoeae.100 However, tetracyclines are considered inadequate therapy and are not recommended by CDC for treatment of gonorrhea.101 a

Granuloma Inguinale (Donovanosis)

Treatment of granuloma inguinale (donovanosis) caused by Calymmatobacterium granulomatis.100 Doxycycline is the tetracycline recommended as drug of choice by CDC.101

Listeria Infections

Alternative for treatment of listeriosis caused by Listeria monocytogenes.100 Not usually considered a drug of choice or alternative for these infections.d e

Nongonococcal Urethritis

Treatment of nongonococcal urethritis (NGU) caused by Ureaplasma urealyticum, C. trachomatis, or Mycoplasma.100 Doxycycline usually is the tetracycline of choice for NGU.101

Consider that some cases of recurrent urethritis following treatment may be caused by tetracycline-resistant U. urealyticum.101

Plague

Treatment of plague caused by Yersinia pestis.100 Regimen of choice is streptomycin or gentamicin (with or without doxycycline).d e

Relapsing Fever

Treatment of relapsing fever caused by Borrelia recurrentis.100 Tetracyclines are drugs of choice.e

Rickettsial Infections

Treatment of rickettsial infections including Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.100 Tetracyclines are drugs of choice for treatment of most rickettsial infections; doxycycline usually is the preferred tetracycline.a d

Syndrome of Inappropriate Antidiuretic Hormone Secretion

Treatment of syndrome of inappropriate antidiuretic hormone secretion† (SIADH).a Only limited value in patients with acute water intoxication caused by excess ADH secretion, but may be effective in inhibiting the action of ADH in patients with chronic form of the disease.a

Also has been used to treat hyponatremia and water retention† in patients with congestive heart failure or cirrhosis, but a high incidence of renal failure has been reported and the drug probably should not be used in these patients.a

Syphilis

Alternative to penicillin G for treatment of primary, secondary, latent, or tertiary syphilis (not neurosyphilis) in nonpregnant adults and adolescents hypersensitive to penicillins.100 Doxycycline and tetracycline are the preferred tetracyclines in patients hypersensitive to penicillins.101 Use tetracyclines only if compliance and follow-up can be ensured since efficacy not well documented.101

Tularemia

Treatment of tularemia caused by Francisella tularensis.100 Tetracyclines considered alternatives to streptomycin (or gentamicin);d e g risk of relapse and primary treatment failure may be higher than with aminoglycosides.g

Vibrio Infections

Treatment of cholera caused by Vibrio cholerae.100 Doxycycline and tetracycline are drugs of choice; used as an adjunct to fluid and electrolyte replacement in moderate to severe disease.d e

Yaws

Alternative to penicillin G for treatment of yaws caused by Treponema pertenue.100

Contraindications

• Known hypersensitivity to demeclocycline, other tetracyclines, or any ingredient in the formulation.100

Warnings/Precautions

Warnings

Use during tooth development (e.g., pregnancy, children <8 years of age) may cause permanent yellow-gray to brown discoloration of teeth and enamel hypoplasia100 Effects are most common following long-term use, but may occur following repeated short-term use.100

Tetracyclines form a stable calcium complex in any bone-forming tissue.100 Reversible decrease in fibula growth rate has occurred in prematures receiving tetracycline.100

Use not recommended in children <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.)

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.)

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

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 (polyuria, polydipsia and weakness) reported with long-term demeclocycline therapy.100 Syndrome is nephrogenic, dose-dependent, and reversible when drug discontinued.100

Periodically assess organ system function, including renal, hepatic and hematopoietic, during long-term therapy.100

Sensitivity 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

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.100 Discontinue drug and institute appropriate therapy if superinfection occurs.100

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

Category D.100 (See Fetal/Neonatal Morbidity under Cautions.)

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

Should not be used in children <8 years of age unless benefits outweigh the risks.100 (See Adverse Dental and Bone Effects under Cautions.)

Use with caution.100 Reduce dosage.100

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

Specific Drugs

(Not approved by FDA)

Initial dose: 600 to 1200 mg/day orally in 3 or 4 divided doses
Maintenance dose: 600 to 900 mg/day orally or the lowest effective dosage to prevent hyponatremia

Demeclocycline is not significantly removed by hemodialysis or peritoneal dialysis. Caution and dose reduction or interval prolongation should be considered in patients with renal impairment.

There are no data on the excretion of demeclocycline into human milk; however, tetracyclines are excreted into human milk in small amounts. Concentrations of tetracycline in milk have averaged 0.6 mcg/mL when the blood level was approximately 1.2 mcg/mL. The theoretical risks of dental staining and inhibition of bone growth exist, although they are unlikely. In one study, tetracycline levels were undetectable in nursing infants. Tetracycline, a related drug, is considered compatible with breast-feeding by the American Academy of Pediatrics. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

LactMed Record Number

81

Last Revision Date

20150310

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