Doxycycline (Systemic)

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Doxycycline
Doxycycline (Systemic)
Antibacterial; semisynthetic tetracycline antibiotic derived from oxytetracycline.
Class: Tetracyclines 8:12.24 (AHFS primary); AM250 (VA primary)
Brands*: Doryx; Doxy 100; Monodox; Vibramycin; Vibra-Tabs
*also available generically
Uses
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.
Empiric treatment of community-acquired pneumonia (CAP) in conjunction with
other anti-infectives. Tetracyclines provide coverage against C. pneumoniae, M.
pneumoniae, H. influenzae, and Legionella, but S. pneumoniae may be resistant.
Doxycycline is the preferred tetracycline for empiric treatment of CAP.
Alternative for treatment of infections caused by Legionella pneumophila†; used
with or without rifampin.
Acne
Adjunctive treatment of moderate to severe inflammatory acne. Not indicated for
treatment of noninflammatory acne.
Actinomycosis
Alternative to penicillin G for treatment of actinomycosis caused by Actinomyces
israelii.
Amebiasis
Adjunct to amebicides for treatment of acute intestinal amebiasis. Tetracyclines
generally not recommended for treatment of amebiasis caused by Entamoeba.
Anthrax
Postexposure prophylaxis to reduce the incidence or progression of disease following a suspected or confirmed exposure to aerosolized Bacillus anthracis spores
(inhalational anthrax). Initial drug of choice for such prophylaxis is ciprofloxacin or
doxycycline.
Treatment of inhalational anthrax. Monotherapy may be effective for anthrax that
occurs as the result of natural or endemic exposures, but a multiple-drug parenteral regimen (ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective) is recommended for inhalational anthrax that occurs as the
result of exposure to anthrax spores in the context of biologic warfare or bioterrorism. Although tetracyclines not usually used in children ⬍8 years of age or in
pregnant women, the benefits of doxycycline outweigh the risks and CDC and
others state doxycycline can be used when necessary for treatment of inhalational
anthrax in these individuals.
Treatment of GI and oropharyngeal anthrax. If occurring in the context of biologic
warfare or bioterrorism, use parenteral regimens recommended for inhalational anthrax.
Treatment of cutaneous anthrax. Multiple-drug regimen recommended for initial
treatment when there are signs of systemic involvement, extensive edema, or lesions on the head or neck or when cutaneous anthrax occurs in children ⬍2
years of age.
Bartonella Infections
Treatment of bartonellosis caused by Bartonella bacilliformis.
Treatment of infections caused by B. quintana†. Optimum anti-infective regimens
have not been identified; various drugs have been used, including doxycycline,
erythromycin, azithromycin, chloramphenicol, or cephalosporins.
Treatment of infections caused by B. henselae† (e.g., cat scratch disease, bacillary angiomatosis, peliosis hepatitis). Cat scratch disease generally is self-limited
in immunocompetent individuals and may resolve spontaneously in 2– 4 months;
some clinicians suggest that anti-infective therapy be considered for acutely or
severely ill patients with systemic symptoms, particularly those with hepatosplenomegaly or painful lymphadenopathy, and probably is indicated in immunocompromised patients. Anti-infectives also are indicated in patients with B. henselae infections who develop bacillary angiomatosis, neuroretinitis, or Parinaud’s
oculoglandular syndrome. Optimum regimens have not been identified; some clinicians recommend erythromycin, azithromycin, doxycycline, ciprofloxacin, rifampin,
co-trimoxazole, gentamicin, or third generation cephalosporins.
A drug of choice for treatment of bartonellosis in HIV-infected adults and adolescents, especially CNS bartonellosis. USPHS/IDSA and others suggest that longterm suppression with erythromycin or doxycycline should be considered to prevent recurrence of bartonellosis† in HIV-infected adults and adolescents with
relapse or reinfection.
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Brucellosis
Treatment of brucellosis; considered a drug 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).
Postexposure prophylaxis following a high-risk exposure to Brucella† (e.g., needlestick injury, inadvertent laboratory exposure, confirmed exposure in the context of
biologic warfare or bioterrorism). Postexposure prophylaxis not generally recommended after exposure to endemic brucellosis.
Burkholderia Infections
Treatment of glanders† caused by Burkholderia mallei; used in conjunction with
streptomycin.
Alternative for treatment of melioidosis† caused by susceptible B. pseudomallei;
used in a multiple-drug regimen with chloramphenicol and co-trimoxazole. Ceftazidime or imipenem monotherapy may be preferred. B. pseudomallei is difficult to
eradicate and relapse of melioidosis is common.
Campylobacter Infections
Treatment of infections caused by Campylobacter fetus. Not a drug of choice.
Chancroid
Treatment of chancroid caused by Haemophilus ducreyi. Not included in CDC recommendations for treatment of chancroid.
Chlamydial Infections
Treatment of uncomplicated urethral, endocervical, or rectal infections caused by
Chlamydia trachomatis. A drug of choice for 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. Recommended as drug of choice by CDC and others.
Treatment of psittacosis (ornithosis) caused by C. psittaci. A drug of choice recommended by CDC.
Clostridium Infections
Alternative for treatment of infections caused by Clostridium; not considered a
drug of choice. Recommended as an alternative to metronidazole or penicillin G
for adjunctive treatment of C. tetani infections.
Ehrlichia Infections
Treatment of ehrlichiosis† caused by Ehrlichia chaffeensis, E. canis, E. ewingii, or
E. phagocytophila; drug of choice.
Enterobacteriaceae Infections
Treatment of infections caused by susceptible Escherichia coli, Enterobacter aerogenes, Klebsiella, or Shigella. Should only be used 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 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. However, 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. CDC recommends doxycycline or co-trimoxazole as drugs of choice.
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Doxycycline
Leptospirosis
Pelvic Inflammatory Disease
Alternative to penicillin G for treatment of leptosporosis†.
Prevention of leptosporosis† in travelers to areas where leptospirosis is endemic
Treatment of acute pelvic inflammatory disease (PID); used in conjunction with
or epidemic who are at increased risk (e.g., those who engage in recreational water activities such as whitewater rafting, adventure racing, kayaking).
Can be used for combined prophylaxis in travelers at increased risk of leptospirosis who also require malaria chemoprophylaxis.
Listeria Infections
Alternative for treatment of listeriosis caused by Listeria monocytogenes. Not usually considered a drug of choice or alternative for these infections.
Lyme Disease
Treatment of early disseminated Lyme disease† associated with erythema migrans, in the absence of neurologic involvement or third-degree AV heart block.
IDSA, AAP, and others recommend oral doxycycline or oral amoxicillin as first-line
therapy for treatment of early localized or early disseminated Lyme disease when
oral therapy is appropriate.
Treatment of uncomplicated Lyme arthritis† without objective evidence of neurologic involvement (e.g., meningitis or radiculopathy).
Alternative for treatment of neurologic manifestations of Lyme disease† when ␤lactams (e.g., ceftriaxone, penicillin G) cannot be used.
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other anti-infectives. Doxycycline is included in PID regimens to provide coverage
against Chlamydia.
When a parenteral regimen is indicated for PID, CDC and others recommend IV
cefotetan (or cefoxitin) in conjunction with IV or oral doxycycline as a regimen of
choice. A regimen of IV ampicillin and sulbactam and IV doxycycline is an alternative since it provides good coverage against C. trachomatis, N. gonorrhoeae, and
anaerobes and is effective for tubo-ovarian abscess. Doxycycline also used as follow-up after a parenteral regimen of clindamycin and gentamicin.
When an oral regimen is indicated, CDC and others recommend a single IM dose
of ceftriaxone or cefoxitin (or other parenteral cephalosporin) followed by oral
doxycycline (with or without oral metronidazole) as a regimen of choice. Although
experience is limited, oral amoxicillin and clavulanate and oral doxycycline may be
an alternative oral regimen.
Plague
Treatment of plague caused by Yersinia pestis, including naturally occurring or en-
Malaria
demic 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) with or without doxycycline.
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).
Prevention (prophylaxis) of malaria caused by Plasmodium falciparum, including
Pleural Effusions
chloroquine-resistant strains. Recommended by CDC and others as a drug of
choice for prophylaxis in individuals traveling to areas where chloroquine-resistant
P. falciparum malaria has been reported; recommended by CDC as an alternative
in those traveling to areas where chloroquine-resistant P. falciparum has not been
reported and who are unable to take chloroquine or hydroxychloroquine.
Treatment of uncomplicated malaria† caused by chloroquine-resistant Plasmodium
falciparum or chloroquine-resistant P. vivax and when the plasmodial species has
not been identified. Used in conjunction with quinine; not effective alone.
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 with oral quinine when an oral regimen is
tolerated.
Presumptive self-treatment of malaria† in travelers who elect not to use prophylaxis, those who require or choose to use a prophylaxis regimen that may not
have optimal efficacy, or for long-term travelers receiving effective prophylaxis but
who plan to visit very remote areas; used in conjunction with quinine. Not recommended by CDC for presumptive self-treatment of malaria; CDC recommends the
fixed combination of atovaquone and proguanil.
Active only against the asexual erythrocytic forms of Plasmodium (not exoerythrocytic stages) and cannot prevent delayed primary attacks or relapse of P. ovale or
P. vivax malaria or provide a radical cure; primaquine usually also indicated to
eradicate hypnozoites and prevent relapse in patients exposed to or being treated
for P. ovale or P. vivax malaria.
Detailed recommendations regarding prevention of malaria available from CDC 24
hours a day from the voice information service (877-394-8747), fax information
service (888-232-3299), or Internet at http://www.cdc.gov/travel.
Assistance with diagnosis or treatment of malaria available from CDC Malaria Epidemiology Branch by contacting 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.
Mycobacterial Infections
Alternative for treatment of infections caused by Mycobacterium fortuitum†.
Treatment of cutaneous infections caused by M. marinum†; a drug of choice.
Nocardiosis
Alternative to co-trimoxazole for treatment of nocardiosis† caused by Nocardia.
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Management of pleural effusions† associated with metastatic tumors.
Relapsing Fever
Treatment of relapsing fever caused by Borrelia recurrentis. A drug 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. Drug of choice for treatment of most rickettsial infections.
Syphilis
Alternative to penicillin G benzathine for treatment of primary, secondary, latent,
or tertiary syphilis (not neurosyphilis) in nonpregnant adults and adolescents hypersensitive to penicillins, including HIV-infected patients. 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 or tularemia that occurs following exposure to F. tularensis in the context of biologic warfare or bioterrorism. Considered an alternative
to streptomycin (or gentamicin); risk of relapse and primary treatment failure may
be higher than with aminoglycosides.
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. 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. A drug 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
Nongonococcal Urethritis
Treatment of nongonococcal urethritis (NGU) caused by Ureaplasma urealyticum,
C. trachomatis, or Mycoplasma.
Consider that some cases of recurrent urethritis following doxycycline treatment
may be caused by tetracycline-resistant U. urealyticum.
Treatment of plague caused by Yersinia pestis. (See Plague under Uses.)
Treatment of GI infections caused by Yersinia enterocolitica† or Y. pseudotuberculosis†. These 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 suggest the role of oral anti-infectives in management of
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Doxycycline
enterocolitis, pseudoappendicitis syndrome, or mesenteric adenitis caused by Yersinia needs further evaluation.
Prophylaxis in Sexual Assault Victims
Empiric anti-infective prophylaxis in sexual assault victims†; used in conjunction
with a drug effective for gonorrhea (IM ceftriaxone) and a drug effective for bacterial vaginosis and trichomoniasis (oral metronidazole).
Dosage and Administration
Administration
Administer orally or by slow IV infusion. Also has been administered by intrapleural infusion.
Do not administer IM or sub-Q.
IV route recommended only when oral therapy is not indicated or feasible; oral
should replace IV as soon as possible. Prolonged IV administration may result in
thrombophlebitis; avoid extravasation.
Oral Administration
Administer capsules and tablets with adequate amounts of fluid to reduce the risk
of esophageal irritation and ulceration. Probably should not be given at bedtime or to
patients with esophageal obstruction or compression.
Administer with food or milk to minimize nausea and vomiting and if gastric irritation occurs; absorption not markedly influenced by simultaneous ingestion of food or
milk.
When used for prevention of malaria, CDC recommends taking the drug in the
evening (but not at bedtime), avoiding prolonged, direct exposure to the sun, and use
of sunscreens that absorb long-wave UVA radiation to minimize the risk of photosensitivity.
Reconstitution
Reconstitute doxycycline monohydrate powder for oral suspension at the time of
dispensing according to manufacturer’s directions to provide a suspension containing
25 mg/5 mL.
Doxycycline calcium oral suspension is administered as provided without further
dilution and contains 50 mg/5 mL.
If necessary because the commercial powder for oral suspension and oral suspension are not available, doxycycline film-coated tablets can be ground and mixed with
food or drinks. Ground doxycycline tablets are most palatable when mixed with chocolate pudding, regular or low-fat chocolate milk, simple syrup with sour apple flavor,
apple juice with table sugar, or low-fat milk; the bitterness of the drug is not masked
with grape or strawberry jellies or cherry yogurt.
IV Infusion
For solution and drug compatibility information, see Compatibility under Stability.
Reconstitution
Reconstitute vial containing 100 or 200 mg with 10 or 20 mL, respectively, of
sterile water for injection or a compatible IV infusion solution (see Compatibility under
Stability) to provide a solution containing 10 mg/mL.
Dilution
Reconstituted solution must be further diluted prior to administration. Each 100
mg should be diluted in 100 mL to 1 L of compatible IV infusion solution (see Compatibility under Stability) to provide solutions containing approximately 0.1– 1 mg/mL.
Concentrations ⬍0.1 mg/mL or ⬎1 mg/mL are not recommended.
Rate of Administration
Administer by slow IV infusion, usually over 1– 4 hours (depending on the dose).
The minimum recommended time to infuse 100 mg in a solution containing 0.5 mg/
mL is 1 hour.
Intrapleural Administration
Reconstitution and Dilution
Dilute 500 mg of doxycycline with 25– 30 mL of 0.9% sodium chloride injection.
Intrapleural Administration Technique
Prior to intrapleural instillation of doxycycline solution, drain the pleural cavity by
thoracentesis (needle aspiration) or via a thoracostomy tube by gravity or suction
(i.e., closed chest tube drainage).
Efficacy of the procedure may be reduced if fluid drainage from the chest tube is
⬎100 mL/24 hours when doxycycline is introduced into the pleural cavity.
Instill diluted doxycycline solution into the pleural space through a thoracostomy
tube; clamp tube and subsequently remove the fluid.
Dosage
Available as doxycycline calcium, doxycycline hyclate, and doxycycline monohydrate; dosage expressed in terms of doxycycline.
Pediatric Patients
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General Pediatric Dosage
Oral: Children ⬎8 years of age weighing ⱕ45 kg: 4.4 mg/kg in 2 divided
doses on day 1 followed by 2.2 mg/kg daily in 1 or 2 divided doses. For
severe infections, up to 4.4 mg/kg daily.
Children ⬎8 years of age weighing ⬎45 kg: 100 mg every 12 hours on
day 1 followed by 100 mg daily in 1 or 2 divided doses. For more severe
infections, 100 mg every 12 hours.
IV: Children ⬎8 years of age weighing ⱕ45 kg: 4.4 mg/kg in 1 or 2 divided doses on day 1 followed by 2.2– 4.4 mg/kg daily in 1 or 2 infusions.
Children ⬎8 years of age weighing ⬎45 kg: 200 mg on day 1 in 1 or 2
infusions followed by 100– 200 mg daily.
Anthrax
⬎Postexposure Prophylaxis Following Exposure in the Context of Biologic
Warfare or Bioterrorism
Oral: Children ⱕ8 years of age† or weighing ⬍45 kg: 2.2 mg/kg twice
daily given for 60 days. Because of concerns regarding long-term doxycycline use in infants and children, consider changing (after 10– 14 days) to
amoxicillin to complete the 60-day regimen if penicillin susceptibility is
confirmed.
Children ⬎8 years of age weighing ⱖ45 kg: 100 mg twice daily given for
60 days.
⬎Treatment of Inhalational, GI, or Oropharyngeal Anthrax
Oral: Children ⱕ8 years of age† or weighing ⬍45 kg: 2.2 mg/kg twice
daily.
Children ⬎8 years of age weighing ⱖ45 kg: 100 mg twice daily.
Initial parenteral regimen preferred; use oral regimen for initial treatment
only when a parenteral regimen is not available (e.g., when there are supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting). 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. Because of concerns regarding long-term doxycycline use in infants and children, consider changing (after 10– 14 days) to amoxicillin to complete the 60-day regimen in
children ⬍8 years of age if penicillin susceptibility is confirmed.
IV, then Oral: Children ⱕ8 years of age† or weighing ⬍45 kg: 2.2 mg/kg
twice daily.
Children ⬎8 years of age weighing ⱖ45 kg: 100 mg twice daily.
Used in conjunction with 1 or 2 other anti-infectives predicted to be effective. When clinical improvement occurs, switch IV doxycycline to oral
doxycycline in the same dosage and continue for a total duration of 60
days. Because of concerns regarding long-term doxycycline use in infants
and children, consider changing (after 10– 14 days) to amoxicillin to complete the 60-day regimen in children ⬍8 years of age if penicillin susceptibility is confirmed.
⬎Treatment of Cutaneous Anthrax
Oral: Children ⱕ8 years of age† or weighing ⬍45 kg: 2.2 mg/kg twice
daily.
Children ⬎8 years of age weighing ⱖ45 kg: 100 mg twice daily.
For mild, uncomplicated cutaneous anthrax that occurs following natural or
endemic exposure, 5– 10 days of treatment has been recommended.
For cutaneous anthrax that occurs following exposure in the context of
biologic warfare or bioterrorism, duration of treatment is 60 days. Because
of concerns regarding long-term doxycycline use in infants and children,
consider changing (after 10– 14 days) to amoxicillin to complete the 60day regimen in children ⬍8 years of age if penicillin susceptibility is confirmed.
Oral regimen should not be used for initial treatment of cutaneous anthrax
if there are signs of systemic involvement, extensive edema, or head and
neck lesions and should not be used for initial treatment in infants and
children ⬍2 years of age.
IV, then Oral: Children ⱕ8 years of age† or weighing ⬍45 kg: 2.2 mg/kg
twice daily.
Children ⬎8 years of age weighing ⱖ45 kg: 100 mg every 12 hours.
Used in conjunction with 1 or 2 other anti-infectives predicted to be effective. When clinical improvement occurs, switch IV doxycycline to oral
doxycycline in the same dosage and continue for a total duration of 60
days. Because of concerns regarding long-term doxycycline use in infants
and children, consider changing (after 10– 14 days) to amoxicillin to complete the 60-day regimen in children ⬍8 years of age if penicillin susceptibility is confirmed.
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Doxycycline
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Bartonella Infections
Oral or IV: Adolescents with HIV infection: 100 mg every 12 hours for ⱖ3
months for bartonellosis (including CNS infections). Also consider doxycycline long-term suppressive therapy† in those with relapse or reinfection.
switch to oral doxycycline in a dosage of 4 mg/kg daily in 2 equally divided doses (up to 200 mg daily) for a total duration of IV and oral doxycycline of 7 days. Used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3– 7 days.
Brucellosis
Oral: Children ⱖ8 years of age: 2– 4 mg/kg daily (up to 200 mg daily) in
2 divided doses given for 4– 6 weeks.
Children ⱖ8 years of age weighing ⱖ45 kg: Initially 100 mg of doxycycline IV every 12 hours; when oral therapy can be tolerated, switch to oral
doxycycline in a dosage of 100 mg every 12 hours for a total duration of
IV and oral doxycycline of 7 days. Used in conjunction with IV quinidine
gluconate (followed by oral quinine sulfate) given for a total duration of 3–
7 days.
Chlamydial Infections
⬎Uncomplicated Urethral, Endocervical, or Rectal Infections
Oral: Children ⬎8 years of age: 100 mg twice daily given for 7 days.
⬎Presumptive Treatment of Chlamydial Infection in Gonorrhea Patients
Oral: Adolescents: 100 mg twice daily given for 7 days.
⬎Lymphogranuloma Venereum
Oral: Adolescents: 100 mg twice daily given for 21 days.
Ehrlichia Infections†
Oral: Children ⱖ8 years of age: 3– 4 mg/kg daily in 2 divided doses. Duration of treatment is ⱖ5– 7 days; severe or complicated disease may require longer treatment.
Gonorrhea and Associated Infections
⬎Empiric Treatment of Epididymitis
Oral: Children ⱖ8 years of age: 100 mg twice daily given for 10 days; as
follow-up to single-dose IM ceftriaxone.
Granuloma Inguinale (Donovanosis)
Oral: Adolescents: 100 mg twice daily given for ⱖ3 weeks or until all lesions have healed completely; consider adding IV aminoglycoside (e.g.,
gentamicin) if improvement is not evident within the first few days of
therapy and in HIV-infected patients.
Relapse can occur 6– 18 months after apparently effective treatment.
Lyme Disease†
⬎Early Localized or Early Disseminated Lyme Disease†
Oral: Children ⱖ8 years of age: 1– 2 mg/kg in 2 divided doses (up to 100
mg each dose).
Duration of treatment is 14– 21 days for most patients with early localized
or early disseminated disease in the absence of neurologic involvement.
Some experts recommend a duration of 21– 28 days for early disseminated disease associated with mild carditis or isolated facial nerve palsy.
⬎Lyme Arthritis†
Oral: Children ⱖ8 years of age: 1– 2 mg/kg twice daily (up to 100 mg
each dose) for 28 days.
Malaria
⬎Prevention of Malaria
Oral: Children ⱖ8 years of age: 2 mg/kg (up to 100 mg) once daily.
Initiate prophylaxis 1– 2 days prior to entering malarious area; continue
during the stay and for 4 weeks after leaving area. If there are concerns
about tolerance or drug interactions, it may be advisable to initiate prophylaxis 3– 4 weeks prior to travel in individuals receiving other drugs to
ensure that the combination of drugs is well tolerated and to allow ample
time if a switch to another antimalarial is required.
Terminal prophylaxis with primaquine may be indicated during the final 2
weeks of doxycycline prophylaxis if exposure occurred in areas where P.
ovale or P. vivax are endemic.
⬎Treatment of Uncomplicated Chloroquine-resistant P. falciparum
Malaria†
Oral: Children ⱖ8 years of age: 4 mg/kg daily given in 2 equally divided
doses (up to 200 mg daily) 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 ⱖ8 years of age: 4 mg/kg daily in 2 equally divided doses
(up to 200 mg daily) 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)
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 ⱖ8 years of age: 4 mg/kg daily in 2 equally divided doses
(up to 200 mg 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.
IV, then Oral: Children ⱖ8 years of age weighing ⬍45 kg: Initially 4 mg/
kg daily in 2 equally divided doses IV; when oral therapy can be tolerated,
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⬎Presumptive Self-treatment of Malaria†
Oral: Children ⱖ8 years of age: 4 mg/kg daily in 2 equally divided doses
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). Initiate presumptive
self-treatment if malaria is suspected (fever, chills, or other influenza-like
illness) and professional medical care will not be available within 24
hours.
Not recommended for self-treatment of malaria in individuals currently taking the drug for prophylaxis.
Nongonococcal Urethritis
Oral: Adolescents: 100 mg twice daily given for 7 days.
Pelvic Inflammatory Disease†
Oral: Adolescents: 100 mg every 12 hours given for 14 days. Used in conjunction with and as follow-up to other anti-infectives (see Uses).
IV, then Oral: Adolescents: 100 mg every 12 hours. Initially, IV doxycycline in conjunction with IV cefoxitin or cefotetan. Switch IV doxycycline
to oral doxycycline in the same dosage as soon as possible and continue
for a total duration of 14 days; continue IV cephamycin for ⱖ24 hours
after clinical improvement occurs.
Plague
⬎Treatment of Pneumonic Plague Occurring in Context of Biologic
Warfare or Bioterrorism
IV, then Oral: Children ⬎8 years of age weighing ⬍45 kg: 2.2 mg/kg
every 12 hours (up to 200 mg daily).
Children ⬎8 years of age weighing ⱖ45 kg: 100 mg every 12 hours or
200 mg once daily.
Prompt initiation of treatment (within 18– 24 hours of symptom onset) is
essential. Oral doxycycline may be substituted in the same dosage when
the patient’s condition improves or if parenteral doxycycline is unavailable.
Total duration of treatment is 10– 14 days.
⬎Postexposure Prophylaxis Following High-risk Exposure†
Oral: Children ⬎8 years of age weighing ⬍45 kg: 2.2 mg/kg every 12
hours given for 7 days.
Children ⬎8 years of age weighing ⱖ45 kg: 100 mg every 12 hours given
for 7 days. Alternatively, 2– 4 mg/kg daily in 2 equally divided doses.
Rickettsial Infections
Oral: Children ⬎8 years of age weighing ⱕ45 kg: 4.4 mg/kg in 2 divided
doses on day 1 followed by 2.2 mg/kg daily in 1 or 2 divided doses. For
severe infections, up to 4.4 mg/kg daily.
Children ⬎8 years of age weighing ⬎45 kg: 100 mg every 12 hours on
day 1 followed by 100 mg daily in 1 or 2 divided doses. For severe infections, 100 mg every 12 hours.
Continue therapy for 3– 10 days or until patient is afebrile for approximately 2– 3 days. Alternatively, a single 50-mg dose may be effective for
louse-borne (epidemic) typhus, Brill-Zinsser disease, or scrub typhus.
Syphilis
⬎Primary or Secondary Syphilis
Oral: Children ⬎8 years of age: 100 mg twice daily given for 14 days.
⬎Latent Syphilis or Tertiary Syphilis (Except Neurosyphilis)
Oral: Children ⬎8 years of age: 100 mg twice daily given for 14 days for
early latent syphilis (duration ⬍1 year) or 100 mg twice daily given for 28
days for late latent syphilis (durationⱖ1 year), latent syphilis of unknown
duration, or tertiary syphilis.
Tularemia
⬎Treatment
IV, then Oral: Children ⬎8 years of age weighing ⬍45 kg: 2.2 mg/kg
every 12 hours.
Children ⬎8 years of age weighing ⱖ45 kg: 100 mg twice daily.
Oral doxycycline may be substituted in the same dosage when the patient’s condition improves or if parenteral doxycycline is unavailable. Total
duration of treatment is 14– 21 days.
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Doxycycline
⬎Postexposure Prophylaxis Following High-risk Exposure†
Oral: Children ⬎8 years of age weighing ⬍45 kg: 2.2 mg/kg every 12
hours given for 14 days.
Children ⬎8 years of age weighing ⱖ45 kg: 100 mg twice daily given for
14 days.
Vibrio Infections
⬎Cholera
Oral: Children ⱖ8 years of age: 6 mg/kg (maximum 300 mg) as a single
dose.
Prophylaxis in Sexual Assault Victims†
Oral: Adolescents: 100 mg twice daily given for 7 days; used in conjunction with single doses of IM ceftriaxone and oral metronidazole.
Adults
General Adult Dosage
Oral: 100 mg every 12 hours on day 1 followed by 100 mg daily in 1 or 2
divided doses.
For more severe infections, 100 mg every 12 hours.
IV: 200 mg on day 1 in 1 or 2 IV infusions followed by 100– 200 mg
daily.
Respiratory Tract Infections
⬎Legionella Infections†
Oral: 100 mg every 12 hours on the first day followed by 100 mg daily in
1 or 2 divided doses.
For severe infections, 100 mg every 12 hours.
Anthrax
⬎Postexposure Prophylaxis Following Exposure in the Context of Biologic
Warfare or Bioterrorism
Oral: 100 mg twice daily given for 60 days.
⬎Treatment of Inhalational, GI, or Oropharyngeal Anthrax
Oral: 100 mg twice daily given for 60 days.
Initial parenteral regimen preferred; use oral regimen for initial treatment
only when a parenteral regimen is not available (e.g., when there are supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting). 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.
IV, then Oral: 100 mg twice daily.
Used in conjunction with 1 or 2 other anti-infectives predicted to be effective. When clinical improvement occurs, switch IV doxycycline to oral
doxycycline in the same dosage and continue for a total duration of 60
days.
⬎Treatment of Cutaneous Anthrax
Oral: 100 mg twice daily.
For mild, uncomplicated cutaneous anthrax that occurs following natural or
endemic exposure, 5– 10 days of treatment has been recommended.
For cutaneous anthrax that occurs following exposure in the context of
biologic warfare or bioterrorism, duration of treatment is 60 days.
Oral regimen should not be used for initial treatment of cutaneous anthrax
if there are signs of systemic involvement, extensive edema, or head and
neck lesions.
IV, then Oral: 100 mg twice daily.
Used in conjunction with 1 or 2 other anti-infectives predicted to be effective. When clinical improvement occurs, switch IV doxycycline to oral
doxycycline in the same dosage and continue for a total duration of 60
days.
Bartonella Infections
Oral or IV: HIV-infected adults: 100 mg every 12 hours for ⱖ3 months for
bartonellosis (including CNS infections). Also consider doxycycline longterm suppressive therapy† in those with relapse or reinfection.
⬎Presumptive Treatment of Chlamydial Infection in Gonorrhea Patients
Oral: 100 mg twice daily given for 7 days.
⬎Acute Epididymo-orchitis or Proctitis caused by C. trachomatis
Oral: 100 mg twice daily given for ⱖ10 days.
⬎Lymphogranuloma Venereum
Oral: 100 mg twice daily given for 21 days.
⬎Psittacosis (Ornithosis)
Oral: 100 mg twice daily given for ⱖ10– 14 days after defervescence.
IV: 4.4 mg/kg daily in 2 divided doses for initial treatment of severely ill
patients.
Gonorrhea and Associated Infections
⬎Uncomplicated Gonorrhea
Oral: 100 mg twice daily given for 7 days recommended by manufacturer.
Alternatively, 300 mg followed by another 300-mg dose 1 hour later.
No longer recommended for gonorrhea by CDC or other experts.
⬎Empiric Treatment of Epididymitis
Oral: 100 mg twice daily given for 10 days; as follow-up to a single dose
of IM ceftriaxone.
⬎Epididymo-orchitis or Proctitis
Oral: 100 mg twice daily given for ⱖ10 days for acute epididymo-orchitis
or for 7 days for proctitis.
Granuloma Inguinale (Donovanosis)
Oral: 100 mg twice daily given for ⱖ3 weeks or until all lesions have
healed completely; consider adding IV aminoglycoside (e.g., gentamicin) if
improvement is not evident within the first few days of therapy and in
HIV-infected patients.
Relapse can occur 6– 18 months after apparently effective treatment.
Leptospirosis†
⬎Treatment†
Oral: 100 mg twice daily given for 7 days.
⬎Prevention†
Oral: 200 mg once weekly beginning 1– 2 days prior to and continuing
throughout the period of exposure.
Lyme Disease†
⬎Early Localized or Early Disseminated Lyme Disease†
Oral: 100 mg twice daily.
Duration of treatment is 14– 21 days for most patients with early localized
or early disseminated disease in the absence of neurologic involvement.
Some experts recommend a duration of 21– 28 days for early disseminated disease associated with mild carditis or isolated facial nerve palsy.
⬎Lyme Arthritis†
Oral: 100 mg twice daily given for 28 days.
⬎Acute Neurologic Manifestations (e.g., Meningitis, Radiculopathy)†
Oral or IV: 100– 200 mg twice daily given for 14– 28 days for patients
who are intolerant of cephalosporins and penicillin.
Malaria
⬎Prevention of Malaria
Oral: 100 mg once daily.
Initiate prophylaxis 1– 2 days prior to entering malarious area; continue
during the stay and for 4 weeks after leaving area. If there are concerns
about tolerance or drug interactions, it may be advisable to initiate prophylaxis 3– 4 weeks prior to travel in individuals receiving other drugs to
ensure that the combination of drugs is well tolerated and to allow ample
time if a switch to another antimalarial is required.
Terminal prophylaxis with primaquine may be indicated during the final 2
weeks of doxycycline prophylaxis if exposure occurred in areas where P.
ovale or P. vivax are endemic.
Brucellosis
Oral: 200 mg daily for 4 days followed by 100 mg daily for 6– 7 days.
Alternatively, dosage may be given for more prolonged periods (i.e., 4– 6
weeks).
⬎Treatment of Uncomplicated Chloroquine-resistant P. falciparum
Malaria†
Oral: 100 mg twice daily for 7 days; used in conjunction with oral quinine
sulfate (650 mg 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).
If infection is severe or if endocarditis, meningitis, or osteomyelitis is
present, administer IM streptomycin or gentamicin during the first 7– 14
days of doxycycline therapy. Rifampin can be administered concomitantly
to decrease the risk of relapse (with or without an aminoglycoside).
⬎Treatment of Uncomplicated P. vivax Malaria†
Oral: 100 mg twice daily 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).
Chlamydial Infections
⬎Uncomplicated Urethral, Endocervical, or Rectal Infections
Oral: 100 mg twice daily given for 7 days.
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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.
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Doxycycline
⬎Treatment of Severe P. falciparum Malaria†
Oral: 100 mg twice 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.
such prophylaxis is not effective and may only prolong the onset of disease if given immediately (1– 7 days) after exposure.
IV: 300 mg daily given for ⱖ10 days.
⬎Latent Syphilis or Tertiary Syphilis (Except Neurosyphilis)
Oral: 100 mg twice daily given for 14 days for early latent syphilis (duration ⬍1 year) or 100 mg twice daily given for 28 days for late latent
syphilis (durationⱖ1 year), latent syphilis of unknown duration, or tertiary
syphilis.
Used in conjunction with IV quinidine gluconate (followed by oral quinine
sulfate) given for a total duration of 3– 7 days.
⬎Presumptive Self-treatment of Malaria†
Oral: 100 mg twice daily 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). Initiate presumptive self-treatment if malaria is suspected (fever, chills, or
other influenza-like illness) and professional medical care will not be available within 24 hours.
Tularemia
⬎Treatment
IV, then Oral: 100 mg twice daily.
Oral doxycycline may be substituted in the same dosage when the patient’s condition improves or if parenteral doxycycline is unavailable. Total
duration of treatment is 14– 21 days.
Not recommended for self-treatment of malaria in individuals currently taking the drug for prophylaxis.
⬎Postexposure Prophylaxis Following High-risk Exposure†
Oral: 100 mg twice daily given for 14 days.
Mycobacterial Infections†
⬎Mycobacterium marinum Infections†
Oral: 100 mg twice daily given for ⱖ3 months recommended by ATS for
treatment of cutaneous infections. A minimum of 4– 6 weeks of treatment
usually is necessary to determine whether the infection is responding.
Vibrio Infections
⬎Cholera
Oral: 100 mg every 12 hours on the first day followed by 100 mg daily in
1 or 2 divided doses for 2 days. For severe infections, 100 mg every 12
hours for 3 days.
Nongonococcal Urethritis
Oral: 100 mg twice daily given for 7 days.
Alternatively, 300 mg as a single dose may be effective.
Prophylaxis in Sexual Assault Victims†
Oral: 100 mg twice daily for 7 days; used in conjunction with single
doses of IM ceftriaxone and oral metronidazole.
Pelvic Inflammatory Disease†
Oral: 100 mg every 12 hours given for 14 days. Used in conjunction with
and as follow-up to other anti-infectives (see Uses).
Prescribing Limits
Pediatric Patients
General Pediatric Dosage
Oral: Maximum 4.4 mg/kg daily for severe infections in children ⬎8 years
of age weighing ⱕ45 kg.
Plague
⬎Treatment of Pneumonic Plague Occurring in Context of Biologic
Warfare or Bioterrorism
IV, then Oral: 100 mg every 12 hours or 200 mg once daily.
Malaria
⬎Treatment of Uncomplicated Chloroquine-resistant P. falciparum
Malaria†
Oral: Children ⱖ8 years of age: Maximum 200 mg daily.
Prompt initiation of treatment (within 18– 24 hours of symptom onset) is
essential. Oral doxycycline may be substituted in the same dosage when
the patient’s condition improves or if parenteral doxycycline is unavailable.
Total duration of treatment is 10– 14 days.
⬎Postexposure Prophylaxis Following High-risk Exposure†
Oral: 100 mg every 12 hours for 7 days. Alternatively, 100– 200 mg daily
in 2 equally divided doses for 7 days.
⬎Treatment of Uncomplicated P. vivax Malaria†
Oral: Children ⱖ8 years of age: Maximum 200 mg daily.
⬎Treatment of Severe P. falciparum Malaria†
Oral or IV: Children ⱖ8 years of age: Maximum 200 mg daily.
Special Populations
Pleural Effusions†
Intrapleural: 500 mg (diluted with 25– 30 mL of 0.9% sodium chloride injection) instilled into the pleural space (see Intrapleural Administration
Technique under Dosage and Administration). Procedure may be repeated
to achieve control of the effusion, although repeated administration may
have limited effects.
Renal Impairment
For patients with recurrent malignant pleural effusions, administer a less
concentrated 500-mg solution (diluted with 250 mL of 0.9% sodium chloride injection) via chest tube lavage and drainage. Clamp tube for 24
hours and repeat entire procedure daily until the drainage volume approximates the amount of solution instilled.
Contraindications
Rickettsial Infections
Oral: 100 mg every 12 hours on day 1 followed by 100 mg daily in 1 or 2
divided doses. For more severe infections, 100 mg every 12 hours.
Continue therapy for 3– 10 days or until patient is afebrile for approximately 2– 3 days. Alternatively, a single dose of 100– 200 mg may be effective for louse-borne (epidemic) typhus, Brill-Zinsser disease, or scrub typhus.
⬎Q Fever
Oral: 100 mg twice daily given for 2– 3 weeks recommended by CDC and
others for acute Q fever.
For acute Q fever with preexisting valvular heart disease, CDC recommends 200 mg daily given in conjunction with hydroxychloroquine for 1
year to prevent progression of acute disease to endocarditis. Patients with
chronic Q fever endocarditis should receive the doxycycline and hydroxychloroquine regimen for 1.5– 3 years.
For prophylaxis against Q fever†, 100 mg every 12 hours given for 5– 7
days may prevent clinical disease if initiated 8– 12 days after exposure;
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Syphilis
⬎Primary or Secondary Syphilis
Oral: 100 mg twice daily given for 14 days.
IV, then Oral: Initially, 100 mg of doxycycline IV every 12 hours; when
oral therapy can be tolerated, switch to oral doxycycline in a dosage of
100 mg every 12 hours for a total duration of IV and oral doxycycline of 7
days.
IV, then Oral: 100 mg every 12 hours. Initially, IV doxycycline in conjunction with IV cefoxitin or cefotetan. Switch IV doxycycline to oral doxycycline in the same dosage as soon as possible and continue for a total
duration of 14 days; continue IV cefoxitin or cefotetan for ⱖ24 hours after
clinical improvement occurs.
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Dosage adjustments not necessary.
Cautions
•
Known hypersensitivity to doxycycline or any tetracycline.
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 prematures 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.)
Superinfection/Clostridium difficile-associated Colitis
Possible emergence and overgrowth of nonsusceptible bacteria or fungi. Discontinue drug and institute appropriate therapy if superinfection occurs.
Treatment with anti-infectives may permit overgrowth of clostridia. Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.
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Doxycycline
Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone. Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or
vancomycin) recommended if colitis is severe.
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 doxycycline, 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. Dose-related increase in BUN reported.
Studies to date indicate that increased BUN does not occur with use of usual
doxycycline doses in patients with impaired renal function.
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 also may 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.
General Precautions
Nervous System Effects
Possibility of bulging fontanels in infants and benign intracranial hypertension in
adults. Effects resolve when drug discontinued.
Laboratory Monitoring
Periodically assess organ system function, including renal, hepatic and hematopoietic, during long-term therapy.
Selection and Use of Anti-infectives
To reduce development of drug-resistant bacteria and maintain effectiveness of
doxycycline 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 ␤-hemolytic streptococci), S. pneumoniae, enterococci, and ␣-hemolytic streptococci are resistant to doxycycline, 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 doxycycline therapy when indicated.
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.)
Use in children ⬍8 years of age can be considered in certain unusual circumstances when benefits outweigh the risks (e.g., treatment of inhalational anthrax).
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 doxycycline (or tetracycline) if other
treatment options are not available or not tolerated and the potential benefits outweigh risks.
Hepatic Impairment
Pharmacokinetics not studied.
Renal Impairment
Renal impairment does not appear to result in excessive accumulation of the drug.
Common Adverse Effects
GI effects (nausea, vomiting, diarrhea, bulky loose stools, anorexia, glossitis, dysphagia); maculopapular and erythematous rash; photosensitivity.
Interactions
Specific Drugs
Drug
Interaction
Comments
Antacids (aluminum-, calcium-, or magnesiumcontaining)
Decreased doxycycline absorption
Avoid concomitant use
Administer antacids containing aluminum, calcium, or
magnesium 1– 2 hours
before or after doxycycline
Anticoagulants, oral
Possible increased anticoagu- Monitor PT carefully; adjust
lant effect; doxycycline
anticoagulant dosage as
may impair utilization of
needed
prothrombin or decrease
vitamin K production by
intestinal bacteria
Anticonvulsants (carbamazepine, barbiturates, phenytoin)
Possible decreased doxycycline half-life
Demeclocycline, oxytetracycline, or tetracycline may
be preferred when a tetracycline is indicated in a
patient receiving carbamazepine, barbiturates, or
phenytoin
Bismuth subsalicylate
Possible decreased absorption of doxycycline
Concomitant use not recommended
Hormonal contraceptives
Possible decreased effective- Use alternative nonhormonal
ness of oral contraceptives
contraceptives
Iron-containing preparations
Possible decreased absorption of doxycycline
Avoid concomitant use
Administer doxycycline 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
Specific Populations
Pregnancy
Category D. (See Fetal/Neonatal Morbidity under Cautions.)
Should not be used in pregnant women unless, in the judgment of the clinician, it
is essential for the welfare of the patient and benefits outweigh the risks.
CDC and others state doxycycline 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 the 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.
Short-term use in lactating women is not necessarily contraindicated, but the effects of prolonged exposure to doxycycline in breast milk (e.g., 60-day regimen for
inhalational anthrax) are unknown. AAP states maternal use of tetracyclines usually is
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Pharmacokinetics
Absorption
Bioavailability
90– 100% absorbed from GI tract in fasting adults; peak serum concentrations attained within 1.5– 4 hours.
Food
GI absorption reduced up to 20% by food and/or milk; effect not considered clinically important.
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Divalent and trivalent cations, including aluminum, calcium, iron, and magnesium,
may decrease oral absorption as a result of chelation with the drug.
warmed, take care to avoid heating after thawing is complete. Do not refreeze after
thawing.
Distribution
Compatibility
Extent
For information on systemic interactions resulting from concomitant use, see Interactions.
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
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Parenteral
Solution Compatibility
Compatible
25– 93%.
Elimination
Metabolism
Does not appear to be metabolized in the liver, but is partially inactivated in the
intestine by chelate formation.
Dextrose 5% in Ringer’s injection, lactated
Dextrose 5% in water
Invert sugar 10% in water
Normosol M in dextrose 5%
Normosol R in dextrose 5%
Drug Compatibility
⬎Admixture Compatibility
Elimination Route
Excreted into the GI tract via bile and by nonbiliary routes. 20– 26% of an oral or
IV dose excreted in urine and 20– 40% excreted in feces.
Compatible
Half-life
Variable
14– 17 hours after a single dose and 22– 24 hours after multiple doses.
Plasma-Lyte 56 or 148 in dextrose 5%
Ringer’s injection
Ringer’s injection, lactated
Sodium chloride 0.9%
Ranitidine HCl
Meropenem
⬎Y-site Compatibility
Special Populations
Patients with severe hepatic impairment or biliary obstruction: Serum concentrations and half-life may be increased.
Patients with severe renal impairment: Half-life 18– 26 hours after a single dose
and 20– 30 hours after multiple doses.
Stability
Storage
Oral
Capsules
Doxycycline hyclate capsules: ⬍30C in a tight, light-resistant container.
Doxycycline monohydrate capsules: 15– 30C and protect from light.
Doxycycline hyclate delayed-release capsules containing partially enteric-coated
pellets: ⬍25C.
For Suspension
⬍30C in a tight, light-resistant container. After reconstitution, stable for 2 weeks
at room temperature.
Suspension
⬍30C in a tight, light-resistant container.
Tablets
Film-coated tablets: ⬍30C in a tight, light-resistant container.
Tablets: 15– 30C in a tight, light-resistant container.
Film-coated tablets that have been ground and extemporaneously mixed with food
or drinks (chocolate pudding, regular or low-fat chocolate milk, apple juice with table
sugar, low-fat milk) are stable for 24 hours at room temperature (22– 26C) or refrigerated at 2– 8C; the ground tablets mixed with low-fat chocolate milk may be stable
for 1 week when refrigerated. Ground tablets are stable for at least 6 days when
wrapped in aluminum foil and stored at room temperature.
Parenteral
Powder for Infusion
IV solutions containing 0.1– 1 mg/mL prepared using sodium chloride or 5% dextrose injection are stable for 48 hours at 25C when protected from direct sunlight or
up to 72 hours when refrigerated and protected from both sunlight and artificial light.
Once removed from refrigeration, these solutions must be completely infused within
12 hours and any unused solution discarded.
IV solutions containing 0.1– 1 mg/mL prepared using Ringer’s injection, invert
sugar in 10% dextrose injection, Normosol-M or Normosol-R in 5% dextrose injection, or Plasma-Lyte 56 or Plasma-Lyte 148 in 5% dextrose injection are stable for
up 12 hours at room temperature or up to 72 hours when refrigerated and protected
from sunlight and artificial light. Once removed from refrigeration, these solutions
must be completely infused within 12 hours and any unused solution discarded.
IV solutions prepared using lactated Ringer’s injection or 5% dextrose in lactated
Ringer’s injection must be completely infused within 6 hours after reconstitution and
any unused solution discarded. These solutions must be protected from direct sunlight
during infusion.
Solutions containing 10 mg/mL prepared using sterile water for injection may be
frozen immediately after preparation and stored for up to 8 weeks at ⫺20C. If
Compatible
Acyclovir sodium
Amifostine
Amiodarone HCl
Aztreonam
Bivalirudin
Cyclophosphamide
Dexmedetomidine HCl
Diltiazem HCl
Docetaxel
Etoposide phosphate
Fenoldopam mesylate
Filgrastim
Fludarabine phosphate
Gemcitabine HCl
Granisetron HCl
Hetastarch in lactated electrolyte injection
(Hextend)
Hydromorphone HCl
Linezolid
Magnesium sulfate
Melphalan HCl
Meperidine HCl
Morphine sulfate
Ondansetron HCl
Perphenazine
Propofol
Remifentanil HCl
Sargramostim
Tacrolimus
Teniposide
Theophylline
Thiotepa
Vinorelbine tartrate
Incompatible
Allopurinol sodium
Heparin sodium
Piperacillin sodium and tazobactam sodium
Variable
Hetastarch in 0.9% sodium chloride
Meropenem
Actions and Spectrum
•
•
•
•
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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.
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AHFS Essentials
14
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ASHPI
BATCH
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Doxycycline
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 doxycycline and other tetracyclines (demeclocycline, minocycline, oxytetracycline, tetracycline).
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Advise patients that antibacterials (including doxycycline) 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 doxycycline 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 doxycycline absorption is reduced when taken with foods,
especially those containing calcium, but is not markedly influenced by simultaneous ingestion with food or milk.
Advise patients that doxycycline may increase the incidence of vaginal candidiasis.
Advise patients that doxycycline 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 and if phototoxicity (e.g., skin eruption)
occurs; consider use of sunscreen or sunblock.
Advise patients using the drug for malaria prevention that no antimalarial agent
(including doxycycline) guarantees protection against malaria. Importance of using
personal protective measures to avoid mosquito bites (e.g., staying in wellscreened areas, using mosquito nets, covering body with clothing, using an effective insect repellent), especially from dusk to dawn.
Advise patients using the drug for malaria prevention that such prophylaxis should
begin 1– 2 days before travel to the malarious area, be taken daily while in the
malarious area, and continued for 4 weeks (but not ⬎4 weeks) after leaving the
area.
Advise travelers who plan presumptive self-treatment in the event of a possible
malarial infection to keep an amount of doxycycline and quinine sufficient for selftreatment in their possession during travel and to take the regimen promptly in
the event of a febrile illness during or after their travel if professional medical care
is not readily available.
Advise travelers that presumptive self-treatment of malaria is an interim measure
and that they should seek medical evaluation as soon as possible.
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 therapy, including
prescription and OTC drugs, and any concomitant illnesses.
Importance of informing patients of other important precautionary information.
(See Cautions.)
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Parenteral
For injection, for
IV use only
100 mg (of doxycycline)
Doxy 100 (with ascorbic acid
480 mg and mannitol 300 mg),
American Pharmaceutical Partners
Vibramycin Hyclate Intravenous (with ascorbic acid 480
mg), Pfizer
200 mg (of doxycycline)
Advice to Patients
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Vibramycin Hyclate Intravenous (with ascorbic acid 960
mg), Pfizer
*available generically
Doxycycline Monohydrate
Oral
Capsules
For suspension
50 mg (of doxycycline)*
Doxycycline Monohydrate Capsules, Eon, Par, Ranbaxy, Watson
Monodox, Oclassen
100 mg (of doxycycline)*
Doxycycline Monohydrate Capsules, Eon, Par, Ranbaxy, Watson
Monodox, Oclassen
25 mg (of doxycycline) per 5 mL
Vibramycin Monohydrate (with
parabens), Pfizer
*available generically
†Use is not currently included in the labeling approved by the US Food and Drug Administration
Selected Revisions July 2005, Copyright, May 2004, American Society of Health-System Pharmacists, Inc.
Preparations
Doxycycline Calcium
Oral
Suspension
50 mg (of doxycycline) per 5 mL
Vibramycin Calcium Syrup
(with parabens, povidone, propylene glycol, and sodium metabisulfite), Pfizer
Doxycycline Hyclate
Oral
Capsules
Capsules, delayed-release
(containing partially entericcoated pellets)
Tablets, filmcoated
50 mg (of doxycycline)*
100 mg (of doxycycline)*
100 mg (of doxycycline)
100 mg (of doxycycline)*
Vibramycin Hyclate, Pfizer
Vibramycin Hyclate, Pfizer
Doryx (with povidone), Warner
Chilcott
Vibra-Tabs (with propylene glycol), Pfizer
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