Generic Name: Tetracycline
Class: Tetracyclines
VA Class: AM250
CAS Number: 60-54-8
Introduction
Antibacterial; antibiotic derived from Streptomyces aureofaciensb c d or produced semisynthetically from oxytetracycline.b
Uses for Sumycin
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
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
Sumycin 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 Sumycin
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)1
