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Tetracycline

Pronunciation

Class: Tetracyclines
VA Class: AM250
CAS Number: 60-54-8
Brands: Helidac Therapy, Sumycin

Introduction

Antibacterial; antibiotic derived from Streptomyces aureofaciensb c d or produced semisynthetically from oxytetracycline.b

Uses for Tetracycline

Respiratory Tract Infections

Treatment of respiratory tract infections caused by Mycoplasma pneumoniae.c d 104

Treatment of respiratory tract infections caused by Haemophilus influenzae, Streptococcus pneumoniae, or Klebsiella.c d 104 Should only be used for treatment of infections caused by these bacteria when in vitro susceptibility tests indicate the organism is susceptible.c d a

Acne

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

Actinomycosis

Treatment of actinomycosis caused by Actinomyces israelii;104 114 c d oral tetracyclines (usually doxycycline or tetracycline) used as follow-up after initial parenteral penicillin G.114

Amebiasis

Adjunct to amebicides for treatment of acute intestinal amebiasis.c d Tetracyclines not included in current recommendations for treatment of amebiasis caused by Entamoeba.112 114

Anthrax

Alternative to doxycycline for postexposure prophylaxis to reduce the incidence or progression of disease following suspected or confirmed exposure to aerosolized Bacillus anthracis spores (inhalational anthrax).122 Initial drug of choice for such prophylaxis is ciprofloxacin or doxycycline;114 122 123 127 doxycycline is the preferred tetracycline because of ease of administration and proven efficacy in monkey studies.122

Alternative to doxycycline for treatment of inhalational anthrax when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).c d 122 123 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.122 123 i

Balantidiasis

Treatment of balantidiasis caused by Balantidium coli; drug of choice.112 114

Bartonella Infections

Treatment of bartonellosis caused by Bartonella bacilliformis.c d

Brucellosis

Treatment of brucellosis;104 114 c d tetracyclines (usually doxycycline or tetracycline) considered drugs of choice.104 114 Used in conjunction with other anti-infectives (e.g., streptomycin or gentamicin and/or rifampin),114 especially for severe infections or when there are complications (e.g., endocarditis, meningitis, osteomyelitis).114

Burkholderia Infections

Treatment of glanders caused by Burkholderia mallei.104 m Experience is limited regarding treatment of human cases; optimum regimens not identified.123 m Some clinicians suggest streptomycin used in conjunction with tetracycline or chloramphenicol or imipenem monotherapy.104 Other clinicians suggest that, pending results of in vitro susceptibility tests, regimens used for treatment of melioidosis can be used for initial empiric treatment of glanders.123 Doxycycline is the preferred tetracycline for treatment of melioidosis caused by susceptible B. pseudomallei.123 m

Campylobacter Infections

Treatment of infections caused by Campylobacter.c d Tetracyclines (usually doxycycline) are alternatives,114 not drugs of choice for C. jejuni.104 114

Chancroid

Treatment of chancroid caused by Haemophilus ducreyi.c d Not included in CDC recommendations for treatment of chancroid;101 CDC and others recommend azithromycin, ceftriaxone, ciprofloxacin, or erythromycin.101 102

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Chlamydial Infections

Treatment of uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis.c d 102 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.c d 104 Consider that anti-infectives may not eliminate C. trachomatis in all cases of chronic trachoma.c d

Treatment of lymphogranuloma venereum (genital, inguinal, or anorectal infections) caused by C. trachomatis.c d 102 104 Doxycycline is the preferred tetracycline for these infections.101 114

Treatment of psittacosis (ornithosis) caused by C. psittaci.100 104 114 c d Doxycycline and tetracycline are drugs of choice.100 114 For initial treatment of severely ill patients, use IV doxycycline.100

Clostridium Infections

Alternative for treatment of infections caused by Clostridium.c d Tetracyclines are alternatives to metronidazole or penicillin G for adjunctive treatment of C. tetani infections.104

Dientamoeba fragilis Infections

Treatment of Dientamoeba fragilis infections.112 Drugs of choice are iodoquinol, paromomycin, tetracycline, or metronidazole.112

Enterobacteriaceae Infections

Treatment of infections caused by susceptible Escherichia coli, Enterobacter aerogenes, Klebsiella, or Shigella.c d Only use 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.a c d

Fusobacterium Infections

Alternative to penicillin G for the treatment of infections caused by Fusobacterium fusiforme (Vincent's infection).c d

Gonorrhea and Associated Infections

Alternative for treatment of uncomplicated gonorrhea caused by susceptible Neisseria gonorrhoeae.c d Tetracyclines are considered inadequate therapy and are not recommended by CDC for treatment of gonorrhea.101 a

Empiric treatment of epididymitis most likely caused by N. gonorrhoeae or C. trachomatis; used in conjunction with IM ceftriaxone.102

Granuloma Inguinale (Donovanosis)

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

Helicobacter pylori Infection and Duodenal Ulcer Disease

Treatment of Helicobacter pylori infection and duodenal ulcer (active or a history of duodenal ulcer);104 e eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.104 e

Used in a multiple-drug regimen that includes tetracycline, metronidazole, and bismuth subsalicylate and a histamine H2-receptor antagonist.e If initial 14-day regimen does not eradicate H. pylori, a retreatment regimen that does not include metronidazole should be used.e

Leptospirosis

Tetracyclines are alternatives to penicillin G for treatment of leptosporosis.104 Doxycycline is the preferred tetracycline for treatment or prevention of these infections.l

Listeria Infections

Alternative for treatment of listeriosis caused by Listeria monocytogenes.c d Not usually considered a drug of choice or alternative for these infections.104 114

Malaria

Treatment of uncomplicated malaria caused by chloroquine-resistant Plasmodium falciparum or chloroquine-resistant P. vivax and when the plasmodial species has not been identified.112 129

CDC and others state treatments of choice for uncomplicated chloroquine-resistant P. falciparum malaria are a regimen of oral quinine in conjunction with oral doxycycline, tetracycline, or clindamycin or a regimen of atovaquone and proguanil.112 129 A regimen of quinine and doxycycline (or tetracycline) generally preferred over quinine and clindamycin,129 except for young children or pregnant women who should not receive tetracyclines.129 Quinine in conjunction with tetracycline (or doxycycline) also a regimen of choice for chloroquine-resistant P. vivax malaria.112 129

Treatment of severe malaria caused by P. falciparum;112 129 used in conjunction with IV quinidine gluconate initially and then oral quinine when an oral regimen is tolerated.112 129

Active only against asexual erythrocytic forms of Plasmodium (not exoerythrocytic stages) and cannot prevent delayed primary attacks or relapse of P. vivax malaria or provide a radical cure; primaquine usually also is indicated to eradicate hypnozoites and prevent relapse in patients treated for P. vivax malaria.112 129

Assistance with diagnosis or treatment of malaria available from the CDC Malaria Epidemiology Branch by contacting the CDC Malaria Hotline at 770-488-7788 from 8:00 a.m. to 4:30 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after hours, on weekends, and holidays.129

Nocardiosis

Tetracyclines are alternatives to co-trimoxazole for treatment of nocardiosis caused by Nocardia.104 114

Nongonococcal Urethritis

Treatment of nongonococcal urethritis (NGU) caused by Ureaplasma urealyticum, C. trachomatis, or Mycoplasma.c d 104 Doxycycline usually is the tetracycline of choice for NGU.101 102

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

Pasteurella multocida Infections

Treatment of infections caused by Pasteurella multocida.104 114 Tetracyclines (usually doxycycline) are alternatives to penicillin G.104 114

Plague

Treatment of plague caused by Yersinia pestis,c d 104 114 124 including naturally occurring or endemic bubonic, septicemic, or pneumonic plague and plague that occurs following exposure to Y. pestis in the context of biologic warfare or bioterrorism.124 Regimen of choice is streptomycin or gentamicin;104 114 123 124 alternatives are doxycycline, tetracycline, ciprofloxacin, or chloramphenicol.123 124 For plague meningitis, some experts recommend that chloramphenicol be included in the treatment regimen.123

Postexposure prophylaxis following a high-risk exposure to Y. pestis (e.g., household, hospital, or other close contact with an individual who has pneumonic plague; laboratory exposure to viable Y. pestis; confirmed exposure in the context of biologic warfare or bioterrorism).123 124 Doxycycline may be drug of choice;114 123 124 alternatives are tetracycline, ciprofloxacin, or chloramphenicol.123 Prophylaxis not required for asymptomatic contacts of individuals with bubonic plague, but observe such contacts for 1 week and initiate treatment if symptoms occur.123

Rat-bite Fever

Treatment of rat-bite fever caused by Streptobacillus moniliformis or Spirillum minus.104 114 Tetracyclines (usually doxycycline) are alternatives to penicillin G.104 114

Relapsing Fever

Treatment of relapsing fever caused by Borrelia recurrentis.104 c d Tetracyclines are drugs of choice.104

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.114 123 c d Doxycycline is the drug of choice for most rickettsial infections.114 a j

Syphilis

Alternative to penicillin G for treatment of primary, secondary, latent, or tertiary syphilis (not neurosyphilis) in nonpregnant adults and adolescents hypersensitive to penicillins.101 114 c d 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, including naturally occurring or endemic tularemia and tularemia that occurs following exposure to F. tularensis in the context of biologic warfare or bioterrorism.104 114 123 c d f Drugs of choice are streptomycin or gentamicin; alternatives are tetracyclines (usually doxycycline), ciprofloxacin, or chloramphenicol.104 114 f Risk of relapse and primary treatment failure may be higher with the alternatives.f

Postexposure prophylaxis of tularemia following a high-risk laboratory exposure to F. tularensis (e.g., spill, centrifuge accident, needlestick injury) or in individuals exposed to the organism in the context of biologic warfare or bioterrorism.123 f Drugs of choice are doxycycline, tetracycline, or ciprofloxacin.123 f Postexposure prophylaxis usually not recommended after exposure to natural or endemic tularemia (e.g., tick bite, rabbit or other animal exposure) and is unnecessary in close contacts of tularemia patients since human-to-human transmission does not occur.f

Vibrio Infections

Treatment of cholera caused by Vibrio cholerae.104 114 c d h Doxycycline and tetracycline are drugs of choice; used as an adjunct to fluid and electrolyte replacement in moderate to severe disease.104 114 c d h

Treatment of severe V. parahaemolyticus infection when anti-infective therapy is indicated in addition to supportive care.h

Treatment of infections caused by V. vulnificus.104 Optimum anti-infective therapy has not been identified; a tetracycline or third generation cephalosporin (e.g., cefotaxime, ceftazidime) is recommended.104 g h Because the case fatality rate associated with V. vulnificus is high, initiate anti-infective therapy promptly if indicated.g

Yaws

Alternative to penicillin G for treatment of yaws caused by Treponema pertenue.104 c d

Yersinia Infections

Treatment of plague or postexposure prophylaxis of plague.c d 104 114 123 124 (See Plague in Uses.)

Treatment of GI infections caused by Yersinia enterocolitica or Y. pseudotuberculosis.114 These GI infections usually are self-limited, but IDSA, AAP, and others recommend anti-infectives for severe infections or when septicemia or other invasive disease occurs.114 Some clinicians suggest the role of oral anti-infectives in management of enterocolitis, pseudoappendicitis syndrome, or mesenteric adenitis caused by Yersinia needs further evaluation.114

Tetracycline Dosage and Administration

Administration

Oral Administration

Administer orally.c d

Administer capsules and tablets with adequate amounts of fluid to reduce the risk of esophageal irritation and ulceration.c d

Dosage

Available as tetracyclined and tetracycline hydrochloride;c dosage expressed in terms of tetracycline hydrochloride.c d

Pediatric Patients

General Pediatric Dosage
Oral

Children >8 years of age: 25–50 mg/kg daily in 4 divided doses.c

Balantidiasis
Oral

Children ≥8 years of age: 40 mg/kg daily (up to 2 g) in 4 divided doses given for 10 days.112 114

Brucellosis
Oral

Children ≥8 years of age: 30–40 mg/kg daily (up to 2 g) in 4 divided doses.114 Duration of treatment usually is 4–6 weeks; more prolonged treatment may be necessary for severe infections or when there are complications.114

If infection is severe or if endocarditis, meningitis, or osteomyelitis are present, administer IM streptomycin or gentamicin during the first 7–14 days of tetracycline therapy.114 c d Rifampin can be administered concomitantly (with or without an aminoglycoside) to decrease the risk of relapse.114

Dientamoeba fragilis Infection
Oral

Children ≥8 years of age: 40 mg/kg daily (up to 2 g) in 4 divided doses given for 10 days.112

Malaria
Treatment of Uncomplicated Chloroquine-resistant P. falciparum Malaria
Oral

Children ≥8 years of age: 6.25 mg/kg 4 times daily given for 7 days; used in conjunction with oral quinine sulfate (10 mg/kg 3 times daily given for 3 days if infection was acquired in Africa or South America or for 7 days if acquired in Southeast Asia).112 129

Treatment of Uncomplicated P. vivax Malaria
Oral

Children ≥8 years of age: 6.25 mg/kg 4 times daily given for 7 days; used in conjunction with oral quinine sulfate (10 mg/kg 3 times daily given for 3 days if infection was acquired in Africa or South America or for 7 days if acquired in Southeast Asia).129

In addition, a 14-day regimen of oral primaquine (0.6 mg/kg once daily) also may be indicated to provide a radical cure and prevent delayed attacks or relapse of P. vivax malaria.129

Treatment of Severe P. falciparum Malaria
Oral

Children ≥8 years of age: 6.25 mg/kg 4 times daily given for 7 days; used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.129 If an IV tetracycline is necessary initially, use IV doxycycline until oral therapy can be tolerated.129

Plague
Treatment of Pneumonic Plague
Oral

Children >8 years of age: 25–50 mg/kg daily in 4 divided dosesb given for ≥10–14 days.123 124

Prompt initiation of treatment (within 18–24 hours of symptom onset) is essential.123 124 A parenteral regimen (e.g., IM streptomycin, IM or IV gentamicin, IV doxycycline) is preferred for initial treatment; an oral regimen may be substituted when the patient's condition improves or if a parenteral regimen is unavailable.123 124

Postexposure Prophylaxis following High-risk Exposure
Oral

Children >8 years of age: 25–50 mg/kg daily in 2 or 4 equally divided doses.b

Duration of prophylaxis following exposure to plague aerosol or a patient with suspected pneumonic plague is 7 days123 124 or the duration of exposure risk plus 7 days.123

Syphilis
Primary or Secondary Syphilis
Oral

Children >8 years of age: 500 mg 4 times daily given for 14 days.101 102 114

Latent Syphilis or Tertiary Syphilis (Except Neurosyphilis)
Oral

Children >8 years of age: 500 mg 4 times daily given for 14 days for early latent syphilis (duration <1 year) or 500 mg 4 times daily given for 28 days for late latent syphilis (duration≥1 year), latent syphilis of unknown duration, or tertiary syphilis.101 102 114

Vibrio Infections
Cholera
Oral

Children >8 years of age: 50 mg/kg daily in 4 divided doses given for 3 days.114

Adults

General Adult Dosage
Oral

1–2 g daily in 2–4 divided doses.c d

500 mg twice daily or 250 mg 4 times daily may be adequate for mild to moderate infections; severe infections may required 500 mg 4 times daily.c d

Respiratory Tract Infections
Mycoplasma pneumoniae Infections
Oral

1–2 g daily in 2–4 equally divided doses.b Duration of treatment usually is 1–4 weeks.b

Acne
Oral

1 g daily given in divided doses; when improvement occurs in 1–2 weeks, decrease slowly to a maintenance dosage of 125–500 mg daily.b c d Continue maintenance dosage until clinical improvement allows discontinuation of the drug.b

Actinomycosis
Oral

1–2 g daily for 6–12 months as follow-up to penicillin G.b

Anthrax
Postexposure Prophylaxis following Exposure in the Context of Biologic Warfare or Bioterrorism
Oral

500 mg every 6 hours given for ≥60 days.122

Optimum duration of postexposure prophylaxis after an inhalation exposure to B. anthracis spores is unclear,123 k but prolonged postexposure prophylaxis usually required.122 123 A duration of 60 days may be adequate for a low-dose exposure, but a duration >4 months may be necessary to reduce the risk following a high-dose exposure.k CDC recommends that postexposure prophylaxis following a confirmed exposure (including in laboratory workers with confirmed exposures to B. anthracis cultures) be continued for 60 days.122 123 The US Working Group on Civilian Biodefense and the US Army Medical Research Institute of Infectious Diseases (USAMRIID) recommends that postexposure prophylaxis be continued for at least 60 days in individuals who are not fully immunized against anthrax and when anthrax vaccine is unavailable or cannot be used for postexposure vaccination.123

Treatment of Inhalational Anthrax
Oral

500 mg every 6 hours.122

Initial parenteral regimen preferred; use oral regimen for initial treatment only when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).122 i Continue for total duration of ≥60 days if inhalational anthrax occurred as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.102 123 i

Balantidiasis
Oral

500 mg 4 times daily given for 10 days.112

Brucellosis
Oral

500 mg 4 times daily given for 3 weeks.c d

If infection is severe or if endocarditis, meningitis, or osteomyelitis are present, administer IM streptomycin or gentamicin during the first 7–14 days of tetracycline therapy.114 c d Rifampin can be administered concomitantly to decrease the risk of relapse (with or without an aminoglycoside).114

Burkholderia Infections
Melioidosis
Oral

2–3 g daily given for 1–3 months.b In severe cases, some clinicians recommend concomitant chloramphenicol during the first month.b In patients with extrapulmonary suppurative lesions, continue tetracycline therapy for 6–12 months.b

Campylobacter Infections
Campylobacter fetus Infections
Oral

1–2 g daily given for 10 days.b

Chancroid
Oral

1–2 g daily given for 2–4 weeks.b

Chlamydial Infections
Uncomplicated Urethral, Endocervical, or Rectal Infections
Oral

500 mg 4 times daily given for ≥7 days.102 c d

Psittacosis (Ornithosis)
Oral

500 mg 4 times daily given for ≥10–14 days after defervescence.100

Dientamoeba fragilis Infection
Oral

500 mg 4 times daily for 10 days.112

Gonorrhea and Associated Infections
Uncomplicated Gonorrhea
Oral

500 mg 4 times daily given for 7 days.c d No longer recommended for gonorrhea by CDC or other experts.101 102

Empiric Treatment of Epididymitis
Oral

500 mg 4 times daily given for 10 days; as follow-up to a single dose of IM ceftriaxone.102

Granuloma Inguinale (Donovanosis)
Oral

1–2 g daily given for 2–4 weeks.b

Helicobacter pylori Infection and Duodenal Ulcer Disease
Oral

500 mg in conjunction with metronidazole (250 mg) and bismuth subsalicylate (525 mg) 4 times daily (at meals and at bedtime) for 14 days; these drugs should be given concomitantly with usual dosage of an H2-receptor antagonist.110

Leptospirosis
Oral

1–2 g daily given for 5–7 days.b

Malaria
Treatment of Uncomplicated Chloroquine-resistant P. falciparum Malaria
Oral

250 mg 4 times daily given for 7 days; used in conjunction with quinine sulfate (650 mg 3 times daily given for 3 days if malaria was acquired in Africa or South America or for 7 days if acquired in Southeast Asia).112 129

Treatment of Uncomplicated P. vivax Malaria
Oral

250 mg 4 times daily given for 7 days; used in conjunction with oral quinine sulfate (650 mg 3 times daily given for 3 days if malaria was acquired in Africa or South America or for 7 days if acquired in Southeast Asia).129

In addition, a 14-day regimen of oral primaquine (30 mg once daily) also may be indicated to provide a radical cure and prevent delayed attacks or relapse of P. vivax malaria.129

Treatment of Severe P. falciparum Malaria
Oral

250 mg 4 times daily for 7 days; used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.129 If an IV tetracycline is necessary initially, use IV doxycycline until oral therapy can be tolerated.129

Plague
Treatment
Oral

2–4 g daily in 4 divided dosesb given for ≥10–14 days.b 123

Prompt initiation of treatment (within 18–24 hours of symptom onset) is essential.123 124 A parenteral regimen (e.g., IM streptomycin, IM or IV gentamicin, IV doxycycline) is preferred for initial treatment; an oral regimen may be substituted when the patient's condition improves or if a parenteral regimen is unavailable.123 124

Postexposure Prophylaxis following High-risk Exposure
Oral

1–2 g daily in 2 or 4 divided doses.123

Duration of prophylaxis following exposure to plague aerosol or a patient with suspected pneumonic plague is 7 days123 124 or the duration of exposure risk plus 7 days.123

Relapsing Fever
Oral

1–2 g daily until afebrile for 7 days.b A single 500-mg dose may be effective in some patients.b

Rickettsial Infections
Oral

1–2 g daily in 2–4 divided doses.b Duration of treatment usually is ≥3–7 days or until patients has been afebrile for approximately 2–3 days.b

Q Fever
Oral

500 mg every 6 hours given for ≥14 days for treatment of acute Q fever.123

For prophylaxis against Q fever, 500 mg every 6 hours given for ≥5–7 days may prevent clinical disease if initiated 8–12 days after exposure; such prophylaxis is not effective and may only prolong the onset of disease if given immediately (1–7 days) after exposure.123

Syphilis
Primary or Secondary Syphilis
Oral

500 mg 4 times daily given for 14 days recommended by CDC and others.101 102 Manufacturer recommends a total dosage of 30–40 g in equally divided doses given over 10–15 days.c d

Latent Syphilis or Tertiary Syphilis (Except Neurosyphilis)
Oral

500 mg 4 times daily given for 14 days for early latent syphilis (duration <1 year) or 500 mg 4 times daily given for 28 days for late latent syphilis (duration≥1 year), latent syphilis of unknown duration, or tertiary syphilis.101 102

Tularemia
Treatment
Oral

500 mg 4 times daily123 given for ≥14–21 days.123 f Relapse may occur as long as 6 months after treatment with tetracycline; however, retreatment with the same dosage usually is curative.b

Postexposure Prophylaxis following High-risk Exposure
Oral

500 mg 4 times daily.123

Initiate postexposure prophylaxis within 24 hours of exposure and continue for ≥14 days.123 f

Vibrio Infections
Cholera
Oral

1–2 g daily given for 2–3 days.b 500 mg 4 times daily for 3 days also has been recommended.103

Yaws
Oral

1–2 g daily given for 10–14 days.b

Prescribing Limits

Pediatric Patients

Malaria
Treatment of Severe P. falciparum Malaria
Oral

Children ≥8 years of age: Maximum 1g daily.129

Special Populations

Renal Impairment

Adjust dosage by decreasing doses or increasing dosing interval.c d

Cautions for Tetracycline

Contraindications

  • Known hypersensitivity to any tetracycline.c d

  • Helidac Therapy (kit containing tetracycline, metronidazole, bismuth subsalicylate) contraindicated in pregnant or nursing women, pediatric patients, patients with hepatic or renal impairment, patients with known allergy to aspirin or salicylates, and those with known hypersensitivity to any component of the kit.e

Warnings/Precautions

Warnings

Dental and Bone Effects

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

Tetracyclines form a stable calcium complex in any bone-forming tissue.c d Reversible decrease in fibula growth rate has occurred in young animals receiving oral tetracycline.c d

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.114 c d (See Pediatric Use under Cautions.)

Fetal/Neonatal Morbidity

Animal studies indicate possible fetal toxicity (e.g., retardation of skeletal development) and embryotoxicity.c d If used during pregnancy or if patient becomes pregnant while receiving tetracycline, patient should be apprised of the potential hazard to the fetus.c d (See Pregnancy under Cautions.)

Renal Effects

Tetracyclines have antianabolic effects and may increase BUN.c d

In patients with impaired renal function, high serum tetracycline concentrations may result in azotemia, hyperphosphatemia, and acidosis.c d Excessive drug accumulation and possible liver toxicity may occur if usual dosage is used patients with renal impairment.c d (See Renal Impairment under Dosage and Administration.)

Do not use tetracycline preparations past their expiration dates.c d Outdated tetracycline preparations are highly nephrotoxic and have, on occasion, produced a Fanconi-like syndrome.c d

Laboratory Monitoring

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

Helidac Therapy

When the kit containing tetracycline, metronidazole, and bismuth subsalicylate (Helidac Therapy) is used for the treatment of H. pylori infection and duodenal ulcer disease, the cautions, precautions, and contraindications associated with metronidazole and bismuth subsalicylate must be considered in addition to those associated with tetracycline.e

Sensitivity Reactions

Photosensitivity Reactions

Photosensitivity, manifested by an exaggerated sunburn reaction, reported with tetracyclines.c d

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.c d

Hypersensitivity Reactions

Oral suspension contains sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.d

Cross-sensitization occurs among the various tetracyclines.c d

General Precautions

Superinfection

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

Nervous System Effects

Possibility of bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults.c d Effects usually resolve when drug discontinued, but possibility for permanent sequelae exists.c d

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of tetracycline and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.c d

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.c d In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.c d

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 tetracycline, in vitro susceptibility tests should be performed if the drug is used for treatment of infections caused by these bacteria.c d

Incision and drainage or other surgical procedures should be performed in conjunction with tetracycline therapy when indicated.c d

Specific Populations

Pregnancy

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

Should not be used in pregnant women unless, in the judgement of the clinician, it is essential for the welfare of the patient and benefits outweigh the risks.c d

CDC and others state tetracyclines can be used when necessary for treatment of inhalational anthrax in pregnant women.122 i Since adverse effects on developing teeth and bones are dose-related, CDC suggests the drug might be used for a short period (7–14 days) before 6 months of gestation;i some clinicians recommend periodic liver function testing if used in pregnant women.122

Malaria infection in pregnant women is associated with high risks of maternal and perinatal morbidity and mortality (e.g., miscarriage, premature delivery, low birth weight, congenital infection and/or perinatal death)129 CDC recommends prompt treatment with quinine and clindamycin for pregnant women with uncomplicated chloroquine-resistant P. falciparum malaria or with quinine alone for those with uncomplicated P. vivax malaria.129 However, CDC states a regimen of quinine in conjunction with doxycycline (or tetracycline) may be used for treatment of uncomplicated malaria in pregnant women in rare circumstances (e.g., if other treatment options are not available or not tolerated) if benefits outweigh risks.129

Lactation

Distributed into milk; discontinue nursing or the drug.c d

AAP states maternal use of tetracyclines usually is compatible with breast-feeding since absorption of the drugs by nursing infants is negligible.114

Pediatric Use

Should not be used in children <8 years of age unless other appropriate drugs are ineffective or are contraindicated.c d 114 (See Dental and Bone Effects under Cautions.)

CDC states that children <8 years of age with uncomplicated chloroquine-resistant P. falciparum malaria, uncomplicated P. vivax malaria, or severe P. falciparum malaria may receive a regimen that includes a tetracycline if other treatment options are not available or not tolerated and if potential benefits outweigh risks.129

Safety and efficacy of the kit containing tetracycline, metronidazole, and bismuth subsalicylate (Helidac Therapy) for treatment of H. pylori infection and duodenal ulcer disease have not been established in pediatric patients.e

Geriatric Use

Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults to concomitant use of tetracycline, metronidazole, and bismuth subsalicylate (Helidac Therapy) for treatment of H. pylori infection and duodenal ulcer disease.e Age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy should be considered.e

Renal Impairment

High serum tetracycline concentrations may result in azotemia, hyperphosphatemia, and acidosis.c d Excessive drug accumulation and possible liver toxicity may occur if usual dosage is used patients with renal impairment.c d

Dosage adjustment necessary in patients with impaired renal function.c d Serum tetracycline concentrations should be monitored if therapy is prolonged.c d

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, epigastric distress, nausea, vomiting, diarrhea); rash; dose-related BUN increases.c d

Interactions for Tetracycline

Specific Drugs

Drug

Interaction

Comments

Antacids (aluminum-, calcium-, or magnesium-containing)

Decreased tetracycline absorptionc d

Administer antacids containing aluminum, calcium, or magnesium 1–2 hours before or after tetracyclinea

Anticoagulants, oral

Possible increased anticoagulant effect;c d tetracyclines may impair utilization of prothrombin or decrease vitamin K production by intestinal bacteriaa

Monitor PT carefully; adjust anticoagulant dosage as neededa c d

Atovaquone

Decreased plasma atovaquone concentrations131

Closely monitor parasitemia131

Didanosine

Decreased tetracycline concentrations with buffered didanosine preparations130

Caution if used with buffered didanosine preparations130

Hormonal contraceptives

Possible decreased effectiveness of oral contraceptivesc d

Use alternative nonhormonal contraceptivesa

Iron-containing preparations

Possible decreased absorption of tetracyclinec d

Administer tetracycline 2 hours before or 3 hours after an oral iron preparationa

Methoxyflurane

Possible fatal nephrotoxicityc d

Concomitant use not recommendeda

Penicillins

Possible antagonisma c d

Concomitant use not recommendeda c d

Tetracycline Pharmacokinetics

Absorption

Bioavailability

75–80% absorbed from GI tract in fasting adults;b peak serum concentrations attained within 2–4 hours.b c d

Food

GI absorption reduced by ≥50% by food and/or milk.b

Divalent and trivalent cations, including aluminum, calcium, iron, magnesium, and zinc may decrease oral absorption as a result of chelation with the drug.b

Distribution

Extent

Widely distributed into body tissues and fluids.a c d

Only small amounts diffuse into CSF.a

Readily crosses the placentaa and is distributed into milk.a c d

Plasma Protein Binding

20–67%.a c d

Elimination

Metabolism

Does not appear to be metabolized.a

Elimination Route

Eliminated in urine by glomerular filtration; 48–60% of a dose excreted in urine as active drug.b Also eliminated in bile and feces.a c d

Half-life

Adults with normal renal function: 6–12 hours.b

Special Populations

Patients with severe hepatic impairment or biliary obstruction: Serum concentrations and half-life may be increased.a

Severe renal impairment: 57–120 hours.b

Stability

Storage

Oral

Tablets

Room temperature in tight, light-resistant container.c Avoid excessive heat.c

Suspension

<30°C in tight container; protect from light.d

Tetracycline Combinations

Kit containing tetracycline, metronidazole, and bismuth subsalicylate: 20–25°C.e

Actions and Spectrum

  • Usually bacteriostatic,a c d but may be bactericidal in high concentrations or against highly susceptible organisms.a

  • Inhibits protein synthesisc d in susceptible organisms by reversibly binding to 30S and 50S ribosomal subunits.a

  • The complete mechanisms by which tetracyclines reduce acne lesions have not been fully elucidated.a The effects appear to result in part from the antibacterial activity of the drugs, but other mechanisms also are involved.a

  • Spectrum of activity includes many gram-positive and -negative bacteria and various other organisms (e.g., Rickettsia, Chlamydia, Mycoplasma, spirochetes).a c d Inactive against fungi and viruses.a

  • Gram-positive aerobes and anaerobes: Active against Actinomyces israelii, Bacillus anthracis, Clostridium perfringens, C. tetani, Nocardia, Propionibacterium acnes, and some streptococci.a c d Many strains of S. pyogenes and Enterococci are resistant.a c d

  • Gram-negative aerobes and anaerobes: Active against Bartonella bacilliformis, Brucella, Calymmatobacterium granulomatis, Francisella tularensis, Haemophilus ducreyi, H. influenzae, Neisseria gonorrhoeae, Vibrio cholerae, Y. enterocolitica, and Y. pestis.a c d Many strains of Acinetobacter, E. aerogenes, E. coli, Klebsiella, and Shigella and nearly all strains of Proteus and Pseudomonas are resistant.a c d

  • Other organisms: Active against Rickettsia, Coxiella burnetii, Chlamydia psittaci, C. trachomatis, Helicobacter pylori, Mycoplasma hominis, M. pneumoniae, Ureoplasma urealyticum, Borrelia burgdorferi, B. recurrentis, Leptospira, Treponema pallidum, T. pertenue, and Mycobacterium fortuitum.a c d Active against asexual erythrocytic forms of Plasmodium falciparum, but is not gametocidal and not active against exoerythrocytic forms of P. falciparum.a

  • Complete cross-resistance usually occurs between tetracycline and other tetracyclines (demeclocycline, doxycycline, minocycline, oxytetracycline).a c d

Advice to Patients

  • Advise patients that antibacterials (including tetracycline) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).c d

  • Importance of completing full course of therapy, even if feeling better after a few days.c d

  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with tetracycline or other antibacterials in the future.c d

  • Importance of drinking sufficient quantities of fluids when taking capsules or tablets to reduce the risk of esophageal irritation and ulceration.c

  • Advise patients that tetracycline absorption is reduced when taken with foods, especially those containing calcium, and doses should be taken 1 hour before or 2 hours after meals and/or milk.b

  • Advise patients that tetracycline may decrease effectiveness of oral contraceptives and that alternative nonhormonal contraceptive measures should be used.a

  • Advise patients to avoid excessive sunlight or artificial UV light and to discontinue the drug at the first sign of skin erythema;a c d consider use of sunscreen or sunblock.a

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.c d (See Fetal/Neonatal Morbidity under Cautions.)

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.c d

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Tetracycline

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension

equivalent to 125 mg tetracycline hydrochloride per 5 mL

Sumycin Syrup (with sodium metabisulfite)

Par

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Tetracycline Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

250 mg*

Tetracycline Hydrochloride Capsules

Barr, Teva

500 mg*

Tetracycline Hydrochloride Capsules

Barr, Teva

Tablets, film-coated

250 mg

Sumycin (with povidone)

Par

500 mg

Sumycin (with povidone)

Par

Tetracycline Hydrochloride Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Kit

4 Capsules, Tetracycline Hydrochloride 500 mg

4 Tablets, Metronidazole 250 mg

8 Tablets, chewable Bismuth Subsalicylate

Helidac Therapy (available as 14 dose cards/carton)

Prometheus

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Tetracycline HCl 500MG Capsules (WATSON LABS): 100/$19.99 or 200/$28.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Centers for Disease Control and Prevention. Compendium of measures to control Chlamydia psittaci infection among humans (psittacosis) and pet birds (avian chlamydiosis), 2000. MMWR Morb Mortal Wkly Rep. 2000; 49(No. RR-8):1-17. [IDIS 439515] [PubMed 10993565]

101. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2002. MMWR Morb Mortal Wkly Rep. 2002; 51(No. RR-6):1-78.

102. Anon. Drugs for sexually transmitted infections. Med Lett Treat Guid. 2004; 2:67-74.

103. Guerrant RL, Gilder TV, Steiner TS et al. Practice guidelines for the management of infectious diarrhea. Clin Infect Dis. 2001; 32:331-50. [IDIS 466024] [PubMed 11170940]

104. Anon. The choice of antibacterial drugs. Med Lett Treat Guid. 2004; 2:13-26.

105. Blaser MJ. Helicobacter pylori: its role in disease. Clin Infect Dis. 1992; 15:386-91. [IDIS 301064] [PubMed 1520782]

106. Chiba N, Rao BV, Rademaker JW et al. Meta-analysis of the efficacy of antibiotic therapy in eradicating Helicobacter pylori. Am J Gastroenterol. 1992; 87:1716-27. [IDIS 307322] [PubMed 1449132]

107. Soll AH. Medical treatment of peptic ulcer disease. JAMA. 1996; 275:622-9. [IDIS 361115] [PubMed 8594244]

108. Lind T, Veldhuyzen van Zanten S, Unge P et al. Eradication of Helicobacter pylori using one-week triple therapies combining omeprazole with two antimicrobials: the MACH I study. Helicobacter. 1996; 1:138-44. [PubMed 9398894]

109. Luft BJ, Gorevic PD, Halperin JJ et al. A perspective on the treatment of Lyme borreliosis. Rev Infect Dis. 1989; 11(Suppl 6)::S1518-25.

110. Procter & Gamble Pharmaceuticals. Helidac Therapy (bismuth subsalicylate 262.4-mg chewable tablets, metronidazole 250-mg tablets, and tetracycline hydrochloride 500-mg capsules) prescribing information. Cincinnati, OH; 1997 Aug.

111. Reviewers’ comments (personal observations).

112. Anon. Drugs for parasitic infections. Med Lett Drugs Ther. Aug 2004. From the Medical Letter website (). Accessed 2005 Feb 2.

113. Rahn DW, Malawista SE. Lyme disease: recommendations for diagnosis and treatment. Ann Intern Med, 1991; 114:472-81.

114. Committee on Infectious Diseases, American Academy of Pediatrics. Red book: 2003 report of the Committee on Infectious Diseases. 26th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2003.

115. Ateshkadi A, Lam NP, Johnson CA. Helicobacter pylori and peptic ulcer disease. Clin Pharm. 1993; 12:34-48. [IDIS 307044] [PubMed 8428432]

116. Marshall BJ. Treatment strategies for Helicobacter pylori infection. Gastroenterol Clin North Am. 1993; 22:183-98. [PubMed 8449566]

117. Graham DY, Lew GM, Evans DG et al. Effect of triple therapy (antibiotics plus bismuth) on duodenal ulcer healing: a randomized controlled trial. Ann Intern Med. 1991; 115:266-9. [IDIS 284354] [PubMed 1854110]

118. Nadelman RB, Wormser GP. Erythema migrans and early Lyme disease. Am J Med. 1995; 98(4A):15-23S.

119. Hackelsberger A, Malfertheiner P. A risk-benefit assessment of drugs used in the eradication of Helicobacter pylori infection. Drug Saf. 1996; 15:30-52. [PubMed 8862962]

120. Anon. Treatment of Lyme disease. Med Lett Drugs Ther. 2000; 42:37-9. [PubMed 10825919]

121. Wormser GP, Nadelman RB, Dattwyler R, et al. Infectious Diseases Society of America. Practice guidelines for the treatment of Lyme disease. Clin Infect Dis. 2000; 31(Suppl 1):1-14. [PubMed 10982743]

122. 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. [IDIS 480001] [PubMed 11980524]

123. US Army Medical Research Institute of Infectious Disease. USAMRIID’s medical management of biologic casualties handbook. 5th ed. USAMRIID: Fort Detrick, MD; 2004 Aug.

124. Inglesby TV, Dennis DT, Henderson DA et al for the Working Group on Civilian Biodefense. Plague as a biological weapon: medical and public health management. JAMA. 2000; 283:2281-90. [IDIS 446671] [PubMed 10807389]

125. Centers for Disease Control and Prevention. Use of anthrax vaccine in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2000; 49(No RR-15): 1-22.

126. Pfizer. Vibramycin calcium (doxycycline calcium) syrup, Vibramycin hyclate (doxycycline hyclate) capsules, Vibramycin monohydrate (doxycycline monohydrate) for oral suspension, Vibra-tabs (doxycycline hyclate) film-coated tablets prescribing information. New York, NY. 2001 Nov.

127. Centers for Disease Control and Prevention. Update: Investigation of anthrax associated with intentional exposure and interim public health guidelines, October 2001. MMWR. 2001; 50:889-893. [IDIS 471389] [PubMed 11686472]

128. Centers for Disease Control and Prevention. Update: interim recommendations for antimicrobial prophylaxis for children and breastfeeding mothers and treatment of children and mothers. MMWR Morb Mortal Wkly Rep. 2001; 50:1014–6.

129. Centers for Disease Control and Prevention. CDC treatment guidelines: Treatment of malaria (guidelines for clinicians). 2004 Jun 28. From the CDC website. Accessed 2004 Oct 25.

130. Bristol-Myers Squibb. Videx (didanosine) chewable/dispersible buffered tablets, buffered powder for oral solution, pediatric powder for oral solution prescribing information. Princeton, NJ; 2003 Feb.

131. GlaxoSmithKline. Malarone (atovaquone and proguanil hydrochloride) tablets and pediatric tablets prescribing information. Research Triangle Park, NC; 2005 Mar.

a. AHFS Drug Information 2004. McEvoy GK, ed. Tetracyclines General Statement. American Society of Health-System Pharmacists; 2004:433-49.

b. AHFS Drug Information 2004. McEvoy GK, ed. Tetracycline, Tetracycline Hydrochloride. American Society of Health-System Pharmacists; 2004: 455-7.

c. Par. Sumycin '250' tablets and '500' tablets (tetracycline hydrochloride) tablets prescribing information. Spring Valley, NY. 2004 Mar.

d. Par. Sumycin syrup (tetracycline) oral suspension prescribing information. Spring Valley, NY. 2004 Mar.

e. Prometheus Laboratories. Helidac therapy (bismuth subsalicylate 262.4-mg chewable tablets, metronidazole 250-mg tablets, and tetracycline hydrochloride 500-mg capsules) prescribing information. San Diego, CA; 2003 Jan.

f. 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. [IDIS 465175] [PubMed 11386933]

g. Centers for Disease Control and Prevention. Vibrio vulnificus infections associated with eating raw oysters—Los Angeles, 1996. MMWR Morb Mortal Wkly Rep. 1996; 45:621-4. [PubMed 8965788]

h. Centers for Disease Control and Prevention. Vibrio vulnificus infections associated with eating raw oysters—Los Angeles, 1996. MMWR Morb Mortal Wkly Rep. 1996; 45:621-4. [PubMed 8965788]

i. Centers for Disease Control and Prevention. Update: investigation of bioterrorism-related anthrax and interim guidelines for exposure management and antimicrobial therapy, October 2001. MMWR Morb Mortal Wkly Rep. 2001; 50:909-19. [IDIS 471910] [PubMed 11699843]

j. Centers for Disease Control and Prevention. Diagnosis and management of tickborne rickettsial diseases: Rocky Mountain spotted fever, ehrlichioses, and anaplasmosis -United States: a practical guide for physicians and other health-care and public health professionals.. MMWR Morb Mortal Wkly Rep. 2006; 55(No RR-4): 1-27.

k. Brookmeyer R, Johnson E, Bollinger R. Modeling the optimum duration of antibiotic prophyalxis in an anthrax outbreak. Proc Natl Acad Sci. 2003; 100:10129-32. [PubMed 12890865]

l. Centers for Disease Control and Prevention. Health information for international travel, 2005–2006. Atlanta, GA: US Department of Health and Human Services; 2005. Updates available from CDC website ().

m. Bossi P, Tegnell A, Baka A et al. BICHAT guidelines for the clinical management of glanders and melioidosis and bioterrorism-related glanders and melioidosis. Euro Surveill. 2004; 9:1-6.

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