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Tetracycline

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

Medically reviewed by Drugs.com on Jun 21, 2021. Written by ASHP.

Introduction

Antibacterial; antibiotic derived from Streptomyces aureofaciens or produced semisynthetically from oxytetracycline.

Uses for Tetracycline

Respiratory Tract Infections

Treatment of respiratory tract infections caused by Mycoplasma pneumoniae.

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

Acne

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

Actinomycosis

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

Amebiasis

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

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). Initial drug of choice for such prophylaxis is ciprofloxacin or doxycycline; doxycycline is the preferred tetracycline because of ease of administration and proven efficacy in monkey studies.

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). 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.

Balantidiasis

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

Bartonella Infections

Treatment of bartonellosis caused by Bartonella bacilliformis.

Brucellosis

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

Burkholderia Infections

Treatment of glanders caused by Burkholderia mallei. Experience is limited regarding treatment of human cases; optimum regimens not identified. Some clinicians suggest streptomycin used in conjunction with tetracycline or chloramphenicol or imipenem monotherapy. 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. Doxycycline is the preferred tetracycline for treatment of melioidosis caused by susceptible B. pseudomallei.

Campylobacter Infections

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

Chancroid

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

Chlamydial Infections

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

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

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

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

Clostridium Infections

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

Dientamoeba fragilis Infections

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

Enterobacteriaceae Infections

Treatment of infections caused by susceptible Escherichia coli, Enterobacter aerogenes, Klebsiella, or Shigella. Only use for treatment of infections caused by these common gram-negative bacteria when other appropriate anti-infectives are contraindicated or ineffective and when in vitro susceptibility tests indicate the organism is susceptible.

Fusobacterium Infections

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

Gonorrhea and Associated Infections

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

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

Granuloma Inguinale (Donovanosis)

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

Helicobacter pylori Infection and Duodenal Ulcer Disease

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

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

Leptospirosis

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

Listeria Infections

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

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.

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. A regimen of quinine and doxycycline (or tetracycline) generally preferred over quinine and clindamycin, except for young children or pregnant women who should not receive tetracyclines. Quinine in conjunction with tetracycline (or doxycycline) also a regimen of choice for chloroquine-resistant P. vivax malaria.

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

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.

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.

Nocardiosis

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

Nongonococcal Urethritis

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

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

Pasteurella multocida Infections

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

Plague

Treatment of plague caused by Yersinia pestis, 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. Regimen of choice is streptomycin or gentamicin; alternatives are doxycycline, tetracycline, ciprofloxacin, or chloramphenicol. For plague meningitis, some experts recommend that chloramphenicol be included in the treatment regimen.

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). Doxycycline may be drug of choice; alternatives are tetracycline, ciprofloxacin, or chloramphenicol. Prophylaxis not required for asymptomatic contacts of individuals with bubonic plague, but observe such contacts for 1 week and initiate treatment if symptoms occur.

Rat-bite Fever

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

Relapsing Fever

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

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. Doxycycline is the drug of choice for most rickettsial infections.

Syphilis

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

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. Drugs of choice are streptomycin or gentamicin; alternatives are tetracyclines (usually doxycycline), ciprofloxacin, or chloramphenicol. Risk of relapse and primary treatment failure may be higher with the alternatives.

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. Drugs of choice are doxycycline, tetracycline, or ciprofloxacin. 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.

Vibrio Infections

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

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

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

Yaws

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

Yersinia Infections

Treatment of plague or postexposure prophylaxis of plague. (See Plague in Uses.)

Treatment of GI infections caused by Yersinia enterocolitica or Y. pseudotuberculosis. 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. Some clinicians suggest the role of oral anti-infectives in management of enterocolitis, pseudoappendicitis syndrome, or mesenteric adenitis caused by Yersinia needs further evaluation.

Tetracycline Dosage and Administration

Administration

Oral Administration

Administer orally.

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

Dosage

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

Pediatric Patients

General Pediatric Dosage
Oral

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

Balantidiasis†
Oral

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

Brucellosis
Oral

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

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. Rifampin can be administered concomitantly (with or without an aminoglycoside) to decrease the risk of relapse.

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.

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).

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).

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.

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. If an IV tetracycline is necessary initially, use IV doxycycline until oral therapy can be tolerated.

Plague
Treatment of Pneumonic Plague
Oral

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

Prompt initiation of treatment (within 18–24 hours of symptom onset) is essential. 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.

Postexposure Prophylaxis following High-risk Exposure†
Oral

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

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

Syphilis
Primary or Secondary Syphilis
Oral

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

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.

Vibrio Infections
Cholera
Oral

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

Adults

General Adult Dosage
Oral

1–2 g daily in 2–4 divided doses.

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.

Respiratory Tract Infections
Mycoplasma pneumoniae Infections
Oral

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

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. Continue maintenance dosage until clinical improvement allows discontinuation of the drug.

Actinomycosis
Oral

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

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

500 mg every 6 hours given for ≥60 days.

Optimum duration of postexposure prophylaxis after an inhalation exposure to B. anthracis spores is unclear, but prolonged postexposure prophylaxis usually required. 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. 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. 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.

Treatment of Inhalational Anthrax
Oral

500 mg every 6 hours.

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). 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.

Balantidiasis†
Oral

500 mg 4 times daily given for 10 days.

Brucellosis
Oral

500 mg 4 times daily given for 3 weeks.

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. Rifampin can be administered concomitantly to decrease the risk of relapse (with or without an aminoglycoside).

Burkholderia Infections†
Melioidosis†
Oral

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

Campylobacter Infections
Campylobacter fetus Infections
Oral

1–2 g daily given for 10 days.

Chancroid
Oral

1–2 g daily given for 2–4 weeks.

Chlamydial Infections
Uncomplicated Urethral, Endocervical, or Rectal Infections
Oral

500 mg 4 times daily given for ≥7 days.

Psittacosis (Ornithosis)
Oral

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

Dientamoeba fragilis Infection†
Oral

500 mg 4 times daily for 10 days.

Gonorrhea and Associated Infections
Uncomplicated Gonorrhea
Oral

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

Empiric Treatment of Epididymitis†
Oral

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

Granuloma Inguinale (Donovanosis)
Oral

1–2 g daily given for 2–4 weeks.

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.

Leptospirosis†
Oral

1–2 g daily given for 5–7 days.

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).

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).

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.

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. If an IV tetracycline is necessary initially, use IV doxycycline until oral therapy can be tolerated.

Plague
Treatment
Oral

2–4 g daily in 4 divided doses given for ≥10–14 days.

Prompt initiation of treatment (within 18–24 hours of symptom onset) is essential. 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.

Postexposure Prophylaxis following High-risk Exposure†
Oral

1–2 g daily in 2 or 4 divided doses.

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

Relapsing Fever
Oral

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

Rickettsial Infections
Oral

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

Q Fever
Oral

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

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.

Syphilis
Primary or Secondary Syphilis
Oral

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

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.

Tularemia
Treatment
Oral

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

Postexposure Prophylaxis following High-risk Exposure†
Oral

500 mg 4 times daily.

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

Vibrio Infections
Cholera
Oral

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

Yaws
Oral

1–2 g daily given for 10–14 days.

Prescribing Limits

Pediatric Patients

Malaria
Treatment of Severe P. falciparum Malaria†
Oral

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

Special Populations

Renal Impairment

Adjust dosage by decreasing doses or increasing dosing interval.

Cautions for Tetracycline

Contraindications

  • Known hypersensitivity to any tetracycline.

  • 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.

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. Effects are most common following long-term use, but may occur following repeated short-term use.

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

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. (See Pediatric Use under Cautions.)

Fetal/Neonatal Morbidity

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

Renal Effects

Tetracyclines have antianabolic effects and may increase BUN.

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

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

Laboratory Monitoring

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

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.

Sensitivity Reactions

Photosensitivity Reactions

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

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. Most reactions result from accumulation of tetracyclines in skin and are phototoxic in nature; photoallergic reactions may also occur.

Discontinue drug at first evidence of skin erythema.

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.

Cross-sensitization occurs among the various tetracyclines.

General Precautions

Superinfection

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

Nervous System Effects

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

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.

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

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.

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

Specific Populations

Pregnancy

Category 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.

CDC and others state tetracyclines can be used when necessary for treatment of inhalational anthrax in pregnant women. 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; some clinicians recommend periodic liver function testing if used in pregnant women.

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) 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. 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.

Lactation

Distributed into milk; discontinue nursing or the drug.

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

Pediatric Use

Should not be used in children <8 years of age unless other appropriate drugs are ineffective or are contraindicated. (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.

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.

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. Age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy should be considered.

Renal Impairment

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

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

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.

Common Adverse Effects

GI effects (anorexia, epigastric distress, nausea, vomiting, diarrhea); rash; dose-related BUN increases.

Interactions for Tetracycline

Specific Drugs

Drug

Interaction

Comments

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

Decreased tetracycline absorption

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

Anticoagulants, oral

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

Monitor PT carefully; adjust anticoagulant dosage as needed

Atovaquone

Decreased plasma atovaquone concentrations

Closely monitor parasitemia

Didanosine

Decreased tetracycline concentrations with buffered didanosine preparations

Caution if used with buffered didanosine preparations

Hormonal contraceptives

Possible decreased effectiveness of oral contraceptives

Use alternative nonhormonal contraceptives

Iron-containing preparations

Possible decreased absorption of tetracycline

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

Methoxyflurane

Possible fatal nephrotoxicity

Concomitant use not recommended

Penicillins

Possible antagonism

Concomitant use not recommended

Tetracycline Pharmacokinetics

Absorption

Bioavailability

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

Food

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

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

Distribution

Extent

Widely distributed into body tissues and fluids.

Only small amounts diffuse into CSF.

Readily crosses the placenta and is distributed into milk.

Plasma Protein Binding

20–67%.

Elimination

Metabolism

Does not appear to be metabolized.

Elimination Route

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

Half-life

Adults with normal renal function: 6–12 hours.

Special Populations

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

Severe renal impairment: 57–120 hours.

Stability

Storage

Oral

Tablets

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

Suspension

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

Tetracycline Combinations

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

Actions and Spectrum

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

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

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

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

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

  • 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. Many strains of Acinetobacter, E. aerogenes, E. coli, Klebsiella, and Shigella and nearly all strains of Proteus and Pseudomonas are resistant.

  • 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. Active against asexual erythrocytic forms of Plasmodium falciparum, but is not gametocidal and not active against exoerythrocytic forms of P. falciparum.

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

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).

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

  • 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.

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

  • 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.

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

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

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. (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.

  • 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.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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

AHFS DI Essentials™. © Copyright 2022, Selected Revisions July 1, 2006. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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

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