Doxycycline Calcium

Name: Doxycycline Calcium

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Doxycycline Calcium Dosage and Administration

Administration

Administer orally101 103 114 111 or by slow IV infusion.113 Also has been administered by intrapleural infusion.126 127 128 132 134 151 152

Do not administer IM or sub-Q.113

IV route recommended only when oral therapy is not indicated or feasible; oral should replace IV as soon as possible.113 Prolonged IV administration may result in thrombophlebitis; avoid extravasation.113

Oral Administration

Administer capsules and tablets with adequate amounts of fluid to reduce the risk of esophageal irritation and ulceration.103 114 111 123 Probably should not be given at bedtime or to patients with esophageal obstruction or compression.123 b

Administer with food or milk to minimize nausea and vomiting and if gastric irritation occurs;103 114 111 absorption not markedly influenced by simultaneous ingestion of food or milk.103 114 111 146 148 150

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.123

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.111

Doxycycline calcium oral suspension is administered as provided without further dilution and contains 50 mg/5 mL.111

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.155 156 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.155

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.113

Dilution

Reconstituted solution must be further diluted prior to administration.113 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.113 Concentrations <0.1 mg/mL or >1 mg/mL are not recommended.113

Rate of Administration

Administer by slow IV infusion, usually over 1–4 hours (depending on the dose).113 The minimum recommended time to infuse 100 mg in a solution containing 0.5 mg/mL is 1 hour.113

Intrapleural Administration

Reconstitution and Dilution

Dilute 500 mg of doxycycline with 25–30 mL of 0.9% sodium chloride injection.126 127 128 132 134 151 152

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).127 128 130 131 133

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.130 131 133

Instill diluted doxycycline solution into the pleural space through a thoracostomy tube; clamp tube and subsequently remove the fluid.126 127 128 132 134 151 152

Dosage

Available as doxycycline calcium,111 doxycycline hyclate,103 111 113 and doxycycline monohydrate;111 114 dosage expressed in terms of doxycycline.103 111 113 114

Pediatric Patients

General Pediatric Dosage Oral

Children >8 years of age weighing ≤45 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.103 111 114 For severe infections, up to 4.4 mg/kg daily.103 111 114

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.103 111 114 For more severe infections, 100 mg every 12 hours.103 111 114

Children >8 years of age weighing ≤45 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.113

Children >8 years of age weighing >45 kg: 200 mg on day 1 in 1 or 2 infusions followed by 100–200 mg daily.113

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

Children ≤8 years of age† or weighing <45 kg: 2.2 mg/kg (up to 100 mg) twice daily given for ≥60 days.141 147 c Because of concerns regarding long-term doxycycline use in infants and children, consider changing (after 10–14 days) to amoxicillin to complete the prophylaxis regimen if penicillin susceptibility is confirmed.102 104 141 147

Children >8 years of age weighing ≥45 kg: 100 mg twice daily given for ≥60 days.104 141 147 c

Optimum duration of postexposure prophylaxis after an inhalation exposure to B. anthracis spores is unclear,147 ff but prolonged postexposure prophylaxis usually required.102 147 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.ff CDC and US Working Group on Civilian Biodefense recommend that postexposure prophylaxis following a confirmed exposure (including in laboratory workers with confirmed exposures to B. anthracis cultures) be continued for 60 days.102 147 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.147

Treatment of Inhalational, GI, or Oropharyngeal Anthrax Oral

Children ≤8 years of age† or weighing <45 kg: 2.2 mg/kg twice daily (up to 200 mg daily).102 147 c

Children >8 years of age weighing ≥45 kg: 100 mg twice daily.102 c Some experts recommend an initial 200-mg dose, then 100 mg every 12 hours.147

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).102 147 Continue for total duration of ≥60 days if inhalational anthrax occurred as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.102 143 147 Because of concerns regarding long-term doxycycline use in infants and children, consider changing (after 10–14 days) to amoxicillin to complete the treatment regimen in children <8 years of age if penicillin susceptibility is confirmed.105

IV, then Oral

Children ≤8 years of age† or weighing <45 kg: 2.2 mg/kg (up to 100 mg) twice daily.102 143 147 d

Children >8 years of age weighing ≥45 kg: 100 mg twice daily.102 142 143 147 d

Used in conjunction with 1 or 2 other anti-infectives predicted to be effective.102 143 147 When clinical improvement occurs, switch IV doxycycline to oral doxycycline in the same dosage and continue for a total duration of ≥60 days.102 142 143 147 d Because of concerns regarding long-term doxycycline use in infants and children, consider changing (after 10–14 days) to amoxicillin to complete the treatment regimen in children <8 years of age if penicillin susceptibility is confirmed.105

Treatment of Cutaneous Anthrax Oral

Children ≤8 years of age† or weighing <45 kg: 2.2 mg/kg (up to 100 mg) twice daily.102 143 147

Children >8 years of age weighing ≥45 kg: 100 mg twice daily.102 143 147

For mild, uncomplicated cutaneous anthrax that occurs following natural or endemic exposure, 5–10 days of treatment has been recommended.102 143 147

For cutaneous anthrax that occurs following exposure in the context of biologic warfare or bioterrorism, duration of treatment is ≥60 days.102 143 147 Because of concerns regarding long-term doxycycline use in infants and children, consider changing (after 10–14 days) to amoxicillin to complete the treatment regimen in children <8 years of age if penicillin susceptibility is confirmed.105 143 147

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.102 105 143 147

IV, then Oral

Children ≤8 years of age† or weighing <45 kg: 2.2 mg/kg (up to 100 mg) twice daily.102 147

Children >8 years of age weighing ≥45 kg: 100 mg every 12 hours.102 142 143 147

Bartonella Infections Oral or IV

Adolescents with HIV infection: 100 mg every 12 hours for ≥3 months for bartonellosis (including CNS infections).160 Also consider doxycycline long-term suppressive therapy† in those with relapse or reinfection.160

Brucellosis Treatment of Brucellosis Oral

Children ≥8 years of age: 2–4 mg/kg daily (up to 200 mg daily) in 2 divided doses.109 Some experts recommend 2.2 mg/kg twice daily (up to 200 mg daily).147

Usual duration of therapy is 4–6 weeks;109 147 more prolonged therapy may be required for complicated disease (e.g., hepatitis, splenitis, meningoencephalitis, endocarditis, osteomyelitis).147 Meningoencephalitis and endocarditis should be treated for ≥90 days and may require ≥6 months of treatment.147

Usually used in conjunction with rifampin or other anti-infectives to decrease risk of relapse.109 147 If infection is severe or if endocarditis, meningitis, or osteomyelitis is present, administer IM streptomycin or gentamicin during the first 1–3 weeks of doxycycline therapy.109 147

Burkholderia Infections† Initial Treatment of Severe Disease† IV

Children <8 years of age† or weighing <45 kg: 2.2 mg/kg twice daily (up to 200 mg daily) given in conjunction with IV ceftazidime, imipenem, or meropenem.gg

Children ≥8 years of age or weighing ≥45 kg: 100 mg twice daily given in conjunction with IV ceftazidime, imipenem, or meropenem.gg

Initial IV regimen continued for ≥14 days and until clinical improvement occurs.147 gg When appropriate, switch to a prolonged oral maintenance regimen.147 gg

Follow-up Maintenance Regimen after Initial Treatment of Severe Disease† Oral

Children ≥8 years of age or weighing ≥45 kg: 100 mg twice daily given in conjunction with oral co-trimoxazole.147

Prolonged oral maintenance regimen recommended to reduce risk of relapse after initial treatment with IV ceftazidime, imipenem, or meropenem (with or without IV doxycycline).147 Maintenance regimen usually continued for ≥4–6 months;147 gg a duration of 6–12 months may be necessary depending on response to therapy and severity of illness.147 gg Lifelong follow-up recommended for all patients to identify relapse.147

Chlamydial Infections Uncomplicated Urethral, Endocervical, or Rectal Infections Oral

Children >8 years of age: 100 mg twice daily given for 7 days.107 109

Presumptive Treatment of Chlamydial Infection in Gonorrhea Patients Oral

Adolescents: 100 mg twice daily given for 7 days.107

Lymphogranuloma Venereum Oral

Adolescents: 100 mg twice daily given for 21 days.107 109

Ehrlichiosis† Oral or IV

AAP and CDC recommend 2.2 mg/kg (up to 100 mg) twice daily.109 cc Initiate promptly since delay can result in severe disease and fatal outcome.109 cc

Optimum duration of therapy not established.109 cc Usually continued ≥5–10 days and until patient is afebrile for ≥3 days and clinically improved.109 x cc Severe illness may require longer duration of therapy.109 cc CDC recommends a duration of 10–14 days in those with HGA since this provides an appropriate duration of therapy for possible concurrent early Lyme disease.cc

IV therapy generally indicated for hospitalized patients; oral therapy generally appropriate for patients with early disease, those treated as outpatients, or inpatients who are not vomiting or obtunded.109 cc

Gonorrhea and Associated Infections Empiric Treatment of Epididymitis Oral

Children ≥8 years of age: 100 mg twice daily given for 10 days; as follow-up to single-dose IM ceftriaxone.107 109

Granuloma Inguinale (Donovanosis) Oral

Adolescents: 100 mg twice daily given for ≥3 weeks or until all lesions have healed completely;107 consider adding IV aminoglycoside (e.g., gentamicin) if improvement is not evident within the first few days of therapy and in HIV-infected patients.107

Relapse can occur 6–18 months after apparently effective treatment.116

Lyme Disease† Early Localized or Early Disseminated Lyme Disease† Oral

Children ≥8 years of age: 1–2 mg/kg in 2 divided doses (up to 100 mg each dose).109 115 116 117 118 119 120 121 124 136 137 140

Duration of treatment is 14–21 days for most patients with early localized or early disseminated disease in the absence of neurologic involvement.109 115 116 117 118 119 120 121 124 136 140 Some experts recommend a duration of 21–28 days for early disseminated disease associated with mild carditis or isolated facial nerve palsy.109 115 136 140

Lyme Arthritis† Oral

Children ≥8 years of age: 1–2 mg/kg twice daily (up to 100 mg each dose) for 28 days.109 115 116 117 119 124 120 121 136

Malaria Prevention of Malaria Oral

Children ≥8 years of age: 2 mg/kg (up to 100 mg) once daily.122 123 139 153

Initiate prophylaxis 1–2 days prior to entering malarious area; continue during the stay and for 4 weeks after leaving area.111 122 123 139 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.123

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.122 123

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

Children ≥8 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).122 158

Treatment of Uncomplicated P. vivax Malaria† Oral

Children ≥8 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).158

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.158

Treatment of Severe P. falciparum Malaria† Oral

Children ≥8 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.158 159

IV, then Oral

Children ≥8 years of age weighing <45 kg: Initially 4 mg/kg daily in 2 equally divided doses IV; when oral therapy can be tolerated, 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.158 Used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.158

Children ≥8 years of age weighing ≥45 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.158 Used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.158

Presumptive Self-treatment of Malaria† Oral

Children ≥8 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).122 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.122

Not recommended for self-treatment of malaria in individuals currently taking the drug for prophylaxis.122

Nongonococcal Urethritis Oral

Adolescents: 100 mg twice daily given for 7 days.107

Pelvic Inflammatory Disease† Oral

Adolescents: 100 mg every 12 hours given for 14 days.107 Used in conjunction with and as follow-up to other anti-infectives (see Uses).107

IV, then Oral

Adolescents: 100 mg every 12 hours.107 Initially, IV doxycycline in conjunction with IV cefoxitin or cefotetan.107 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 ≥24 hours after clinical improvement occurs.107

Plague Treatment of Pneumonic Plague Occurring in Context of Biologic Warfare or Bioterrorism IV, then Oral

Children weighing <45 kg: 2.2 mg/kg twice daily (up to 200 mg daily).144

Children weighing ≥45 kg: 100 mg twice daily or 200 mg once daily.144

Prompt initiation of treatment (within 18–24 hours of symptom onset) is essential.144 147 Oral doxycycline may be substituted in the same dosage when the patient’s condition improves or if parenteral doxycycline is unavailable.144 147 Total duration of treatment is ≥10–14 days.144 147

Postexposure Prophylaxis Following High-risk Exposure† Oral

Children weighing <45 kg: 2.2 mg/kg twice daily (up to 200 mg daily).144

Children weighing ≥45 kg: 100 mg twice daily.144 Alternatively, 2–4 mg/kg daily in 2 equally divided doses.149

Duration of prophylaxis following exposure to plague aerosol or a patient with suspected pneumonic plague is 7 days144 147 or the duration of exposure risk plus 7 days.147

Rickettsial Infections Oral

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.103 111 114

Continue therapy for 3–10 days or until patient is afebrile for approximately 2–3 days.b Alternatively, a single 50-mg dose may be effective for louse-borne (epidemic) typhus, Brill-Zinsser disease, or scrub typhus.b

Rocky Mountain Spotted Fever (RMSF) Oral or IV

CDC recommends 2.2 mg/kg (up to 100 mg) twice daily.cc Initiate promptly since delay can result in severe disease and fatal outcome.109 cc

Usually continued ≥5–10 days and until patient is afebrile for ≥3 days and clinically improved.109 x cc Severe illness may require longer duration of therapy.109 cc

Q Fever Oral

CDC recommends 2.2 mg/kg every 12 hours for ≥14 days for treatment of acute Q fever.147

For prophylaxis against Q fever†, 2.2 mg/kg twice daily 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.147

Syphilis Primary or Secondary Syphilis Oral

Children >8 years of age: 100 mg twice daily given for 14 days.107 109 111 160

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 (duration≥1 year), latent syphilis of unknown duration, or tertiary syphilis.107 109 111 160

Tularemia Treatment IV, then Oral

Children weighing <45 kg: 2.2 mg/kg (up to 100 mg) twice daily.145 147

Children weighing ≥45 kg: 100 mg twice daily.145 147

Oral doxycycline may be substituted in the same dosage when the patient’s condition improves or if parenteral doxycycline is unavailable.145 Total duration of treatment is ≥14–21 days.145 147

Postexposure Prophylaxis Following High-risk Exposure† Oral

Children weighing <45 kg: 2.2 mg/kg (up to 100 mg) twice daily.145 147

Children weighing ≥45 kg: 100 mg twice daily.145 147

Initiate postexposure prophylaxis within 24 hours of exposure and continue for ≥14 days.145 147

Vibrio Infections Cholera Oral

Children ≥8 years of age: 6 mg/kg (maximum 300 mg) as a single dose.109

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.107

Adults

General Adult Dosage Oral

100 mg every 12 hours on day 1 followed by 100 mg daily in 1 or 2 divided doses.103 111

For more severe infections, 100 mg every 12 hours.103 111

200 mg on day 1 in 1 or 2 IV infusions followed by 100–200 mg daily.113

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.a

For severe infections, 100 mg every 12 hours.a

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

100 mg twice daily given for ≥60 days.102 141 147 c Some experts recommend an initial 200-mg dose, then 100 mg every 12 hours.147

Treatment of Inhalational, GI, or Oropharyngeal Anthrax Oral

100 mg twice daily.102 143 Some experts recommend an initial 200-mg dose, then 100 mg every 12 hours.147

IV, then Oral

100 mg twice daily.102 142 143 Some experts recommend an initial 200-mg dose, then 100 mg every 12 hours.147

Used in conjunction with 1 or 2 other anti-infectives predicted to be effective.102 143 When clinical improvement occurs, switch IV doxycycline to oral doxycycline in the same dosage and continue for a total duration of ≥60 days.102 142 143 147 d

Treatment of Cutaneous Anthrax Oral

100 mg twice daily.102 143 147

For mild, uncomplicated cutaneous anthrax that occurs following natural or endemic exposure, 5–10 days of treatment has been recommended.102 143 147

For cutaneous anthrax that occurs following exposure in the context of biologic warfare or bioterrorism, duration of treatment is ≥60 days.102 143 147

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.102 143 147

IV, then Oral

100 mg twice daily.d 143

Bartonella Infections Oral or IV

HIV-infected adults: 100 mg every 12 hours for ≥3 months for bartonellosis (including CNS infections).160 Also consider doxycycline long-term suppressive therapy† in those with relapse or reinfection.160

Burkholderia Infections† Treatment of Localized Disease† Oral

Mild, localized disease without toxicity: 100 mg twice daily for 60–150 days may be effective.147

Localized disease without toxicity: 100 mg twice daily for 20 weeks given in conjunction with oral co-trimoxazole.147

Initial Treatment of Severe Disease† IV

100 mg twice daily given in conjunction with IV ceftazidime, imipenem, or meropenem.147 gg

Initial IV regimen continued for ≥14 days and until clinical improvement occurs.147 gg When appropriate, switch to a prolonged oral maintenance regimen.147 gg

Follow-up Maintenance Regimen after Initial Treatment of Severe Disease† Oral

100 mg twice daily given in conjunction with oral co-trimoxazole.147

Postexposure Prophylaxis† Oral

200 mg once daily in conjunction with oral rifampin.147 Optimum duration unknown; continue for ≥10 days.147

Brucellosis Treatment of Brucellosis Oral

Some experts recommend 100 mg twice daily.147

Usual duration is 4–6 weeks;109 147 more prolonged therapy may be required for complicated disease (e.g., hepatitis, splenitis, meningoencephalitis, endocarditis, osteomyelitis).147 Meningoencephalitis and endocarditis should be treated for ≥90 days and may require ≥6 months of treatment.147

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

200 mg once daily given for 3–6 weeks.147

Chlamydial Infections Uncomplicated Urethral, Endocervical, or Rectal Infections Oral

100 mg twice daily given for 7 days.103 107 108 111 114

Presumptive Treatment of Chlamydial Infection in Gonorrhea Patients Oral

100 mg twice daily given for 7 days.107 108 109

Acute Epididymo-orchitis or Proctitis caused by C. trachomatis Oral

100 mg twice daily given for ≥10 days.107 111

Lymphogranuloma Venereum Oral

100 mg twice daily given for 21 days.107 108

Psittacosis (Ornithosis) Oral

100 mg twice daily given for ≥10–14 days after defervescence.100

4.4 mg/kg daily in 2 divided doses for initial treatment of severely ill patients.100

Ehrlichiosis† Oral or IV

CDC and others recommend 100 mg twice daily.109 x cc Initiate promptly since delay can result in severe disease and fatal outcome.109 cc

Optimum duration of therapy not established.109 x cc Usually continued ≥5–10 days and until patient is afebrile for ≥3 days and clinically improved.109 x cc Severe illness may require longer duration of therapy.109 cc CDC recommends a duration of 10–14 days in those with HGA since this provides an appropriate duration of therapy for possible concurrent early Lyme disease.cc

IV therapy generally indicated for hospitalized patients; oral therapy generally appropriate for patients with early disease, not requiring hospitalization, or inpatients who are not vomiting or obtunded.109 cc

Gonorrhea and Associated Infections Uncomplicated Gonorrhea Oral

100 mg twice daily given for 7 days recommended by manufacturer.111 Alternatively, 300 mg followed by another 300-mg dose 1 hour later.111

No longer recommended for gonorrhea by CDC or other experts.107 108

Empiric Treatment of Epididymitis Oral

100 mg twice daily given for 10 days; as follow-up to a single dose of IM ceftriaxone.107 108 109

Epididymo-orchitis or Proctitis Oral

100 mg twice daily given for ≥10 days for acute epididymo-orchitis or for 7 days for proctitis.107 111

Granuloma Inguinale (Donovanosis) Oral

100 mg twice daily given for ≥3 weeks or until all lesions have healed completely;107 consider adding IV aminoglycoside (e.g., gentamicin) if improvement is not evident within the first few days of therapy and in HIV-infected patients.107

Relapse can occur 6–18 months after apparently effective treatment.116

Leptospirosis† Treatment† Oral

100 mg twice daily given for 7 days.b

Prevention† Oral

200 mg once weekly beginning 1–2 days prior to and continuing throughout the period of exposure.123 153

Lyme Disease† Early Localized or Early Disseminated Lyme Disease† Oral

100 mg twice daily.109 115 116 117 118 119 120 121 124 136 140

Lyme Arthritis† Oral

100 mg twice daily given for 28 days.109 115 116 117 118 119 120 121 124 136

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.109 115 136 140

Malaria Prevention of Malaria Oral

100 mg once daily.111 122 123 139 153

Initiate prophylaxis 1–2 days prior to entering malarious area; continue during the stay and for 4 weeks after leaving area.111 122 153 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.123

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.122 123

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).122 158

Treatment of Uncomplicated P. vivax Malaria† Oral

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.158

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.158

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.158

Used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.158

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).122 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.122

Not recommended for self-treatment of malaria in individuals currently taking the drug for prophylaxis.122

Mycobacterial Infections† Mycobacterium marinum Infections† Oral

100 mg twice daily given for ≥3 months recommended by ATS for treatment of cutaneous infections.106 A minimum of 4–6 weeks of treatment usually is necessary to determine whether the infection is responding.106

Nongonococcal Urethritis Oral

100 mg twice daily given for 7 days.103 107 108 111 114

Pelvic Inflammatory Disease† Oral

100 mg every 12 hours given for 14 days.107 108 Used in conjunction with and as follow-up to other anti-infectives (see Uses).107 108

IV, then Oral

100 mg every 12 hours.107 108 Initially, IV doxycycline in conjunction with IV cefoxitin or cefotetan.107 108 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 ≥24 hours after clinical improvement occurs.107 108

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.144 147

Postexposure Prophylaxis Following High-risk Exposure† Oral

100 mg every 12 hours.144 147 Alternatively, 100–200 mg daily in 2 equally divided doses.149

Duration of prophylaxis following exposure to plague aerosol or a patient with suspected pneumonic plague is 7 days144 147 or the duration of exposure risk plus 7 days.147

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).126 127 128 132 134 151 152 Procedure may be repeated to achieve control of the effusion,127 128 although repeated administration may have limited effects.126

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.129 Clamp tube for 24 hours and repeat entire procedure daily until the drainage volume approximates the amount of solution instilled.129

Rickettsial Infections Oral

100 mg every 12 hours on day 1 followed by 100 mg daily in 1 or 2 divided doses.103 111 114 For more severe infections, 100 mg every 12 hours.103 111 114

Continue therapy for 3–10 days or until patient is afebrile for approximately 2–3 days.b 109 Alternatively, a single dose of 100–200 mg may be effective for louse-borne (epidemic) typhus, Brill-Zinsser disease, or scrub typhus.b

Rocky Mountain Spotted Fever (RMSF) Oral or IV

CDC and others recommend 100 mg twice daily.x cc Initiate promptly since delay can result in severe disease and fatal outcome.x cc

Usually continued ≥5–10 days and until patient is afebrile for ≥3 days and clinically improved.109 x cc Severe illness may require longer duration of therapy.109 cc

Q Fever Oral

100 mg twice daily given for 2–3 weeks recommended by CDC and others for acute Q fever.112 123 147 157

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.157 Patients with chronic Q fever endocarditis should receive the doxycycline and hydroxychloroquine regimen for 1.5–3 years.157

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; such prophylaxis is not effective and may only prolong the onset of disease if given immediately (1–7 days) after exposure.147

Syphilis Primary or Secondary Syphilis Oral

100 mg twice daily given for 14 days.107 108 111 160

300 mg daily given for ≥10 days.113

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 (duration≥1 year), latent syphilis of unknown duration, or tertiary syphilis.107 108 109 111 160

Tularemia Treatment IV, then Oral

100 mg twice daily.145 147

Oral doxycycline may be substituted in the same dosage when the patient’s condition improves or if parenteral doxycycline is unavailable.145 Total duration of treatment is ≥14–21 days.145 147

Postexposure Prophylaxis Following High-risk Exposure† Oral

100 mg twice daily.145 147

Initiate postexposure prophylaxis within 24 hours of exposure and continue for ≥14 days.145 147

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.a For severe infections, 100 mg every 12 hours for 3 days.a

Alternatively, 300 mg as a single dose may be effective.110

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.107

Prescribing Limits

Pediatric Patients

General Pediatric Dosage Oral

Maximum 4.4 mg/kg daily for severe infections in children >8 years of age weighing ≤45 kg.111

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

Children ≥8 years of age: Maximum 200 mg daily.158

Treatment of Uncomplicated P. vivax Malaria† Oral

Children ≥8 years of age: Maximum 200 mg daily.158

Treatment of Severe P. falciparum Malaria† Oral or IV

Children ≥8 years of age: Maximum 200 mg daily.158

Special Populations

Renal Impairment

Dosage adjustments not necessary.111

Cautions for Doxycycline Calcium

Contraindications

Known hypersensitivity to doxycycline or any tetracycline.103 111 113 114

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.111 113 Effects are most common following long-term use, but may occur following repeated short-term use.111 113

Tetracyclines form a stable calcium complex in any bone-forming tissue.111 113 Reversible decrease in fibula growth rate has occurred in prematures receiving oral tetracycline.111 113

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, ehrlichiosis, RMSF) outweigh the risks.109 111 113 cc (See Pediatric Use under Cautions.)

Superinfection/Clostridium difficile-associated Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.111 113 Discontinue drug and institute appropriate therapy if superinfection occurs.111 113

Treatment with anti-infectives may permit overgrowth of clostridia.c Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.c

Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone.c r s t u v 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.c r s t u v

Fetal/Neonatal Morbidity

Animal studies indicate possible fetal toxicity (e.g., retardation of skeletal development) and embryotoxicity.111 113 If used during pregnancy or if patient becomes pregnant while receiving doxycycline, patient should be apprised of the potential hazard to the fetus.111 (See Pregnancy under Cautions.)

Renal Effects

Tetracyclines have antianabolic effects and may increase BUN.111 113 Dose-related increase in BUN reported.111

Studies to date indicate that increased BUN does not occur with use of usual doxycycline doses in patients with impaired renal function.111 113

Sensitivity Reactions

Photosensitivity Reactions

Photosensitivity, manifested by an exaggerated sunburn reaction, reported with tetracyclines.111 113

Photosensitivity reactions may develop within a few minutes to several hours after sun exposure and usually persist 1–2 days after discontinuance of the drug.a Most reactions result from accumulation of tetracyclines in skin and are phototoxic in nature; photoallergic reactions also may occur.a

Discontinue drug at first evidence of skin erythema.111 113

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.111

General Precautions

Nervous System Effects

Possibility of bulging fontanels in infants and benign intracranial hypertension in adults.111 Effects resolve when drug discontinued.111

Laboratory Monitoring

Periodically assess organ system function, including renal, hepatic and hematopoietic, during long-term therapy.111

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.c

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

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 doxycycline, in vitro susceptibility tests should be performed if the drug is used for treatment of infections caused by these bacteria.111 113

Incision and drainage or other surgical procedures should be performed in conjunction with doxycycline therapy when indicated.111

Specific Populations

Pregnancy

Category D.111 (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.113

CDC and others state doxycycline can be used when necessary for treatment of inhalational anthrax in pregnant women.102 143 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;143 some clinicians recommend periodic liver function testing if used in pregnant women.102

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).158 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.158 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.158

CDC states tetracyclines (e.g., doxycycline) may be warranted in pregnant women with life-threatening illness when clinical suspicion of ehrlichiosis (including HGA and HGE) or RMSF is high.cc

Lactation

Distributed into milk;111 113 discontinue nursing or the drug.111

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.c AAP states maternal use of tetracyclines usually is compatible with breast-feeding since absorption of the drugs by nursing infants is negligible.109

Pediatric Use

Should not be used in children <8 years of age unless other appropriate drugs are ineffective or are contraindicated.109 111 113 (See Dental and Bone Effects under Cautions.)

Manufacturer, AAP, and CDC state use of tetracyclines (e.g., doxycycline) in children <8 years of age can be considered in certain unusual circumstances when benefits outweigh the risks (e.g., treatment of inhalational anthrax).109 111 cc

Recommended by AAP and CDC as drug of choice for presumed or confirmed Rickettsial infections (including RMSF) or ehrlichiosis† (including HGA and HME) in children of any age.109 cc

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.158

Hepatic Impairment

Pharmacokinetics not studied.

Renal Impairment

Renal impairment does not appear to result in excessive accumulation of the drug.103 111 113

Common Adverse Effects

GI effects (nausea, vomiting, diarrhea, bulky loose stools, anorexia, glossitis, dysphagia); maculopapular and erythematous rash; photosensitivity.111 113 a

Stability

Storage

Oral

Capsules

Doxycycline hyclate capsules: <30°C in a tight, light-resistant container.111

Doxycycline monohydrate capsules: 15–30°C and protect from light.114

Doxycycline hyclate delayed-release capsules containing partially enteric-coated pellets: <25°C.103

For Suspension

<30°C in a tight, light-resistant container.111 After reconstitution, stable for 2 weeks at room temperature.b

Suspension

<30°C in a tight, light-resistant container.111

Tablets

Film-coated tablets: <30°C in a tight, light-resistant container.111

Tablets: 15–30°C in a tight, light-resistant container.101

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 (22–26°C) or refrigerated at 2–8°C; the ground tablets mixed with low-fat chocolate milk may be stable for 1 week when refrigerated.156 Ground tablets are stable for at least 6 days when wrapped in aluminum foil and stored at room temperature.156

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 25°C when protected from direct sunlight or up to 72 hours when refrigerated and protected from both sunlight and artificial light.113 Once removed from refrigeration, these solutions must be completely infused within 12 hours and any unused solution discarded.113

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.113 Once removed from refrigeration, these solutions must be completely infused within 12 hours and any unused solution discarded.113

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.113 These solutions must be protected from direct sunlight during infusion.113

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 -20°C.113 If warmed, take care to avoid heating after thawing is complete.113 Do not refreeze after thawing.113

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility

Compatible
Dextrose 5% in Ringer’s injection, lactated113
Dextrose 5% in water113 HID
Invert sugar 10% in water113
Normosol M in dextrose 5%113 HID
Normosol R in dextrose 5%113 HID
Plasma-Lyte 56 or 148 in dextrose 5%113 HID
Ringer’s injection113 HID
Ringer’s injection, lactated113
Sodium chloride 0.9%113 HID

Drug Compatibility Admixture CompatibilityHID

Compatible
Ranitidine HCl
Variable
Meropenem

Y-site CompatibilityHID

Compatible
Acyclovir sodium
Amifostine
Amiodarone HCl
Aztreonam
Bivalirudin
Cisatracurium besylate
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
Propofol
Remifentanil HCl
Sargramostim
Tacrolimus
Telavancin HCl
Teniposide
Theophylline
Thiotepa
Vinorelbine tartrate
Incompatible
Allopurinol sodium
Heparin sodium
Pemetrexed disodium
Piperacillin sodium and tazobactam sodium
Variable
Hetastarch in 0.9% sodium chloride
Meropenem

Advice to Patients

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).c
Importance of completing full course of therapy, even if feeling better after a few days.111 c
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.c
Importance of drinking sufficient quantities of fluids when taking capsules or tablets to reduce the risk of esophageal irritation and ulceration.111
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.111
Advise patients that doxycycline may increase the incidence of vaginal candidiasis.111
Advise patients that doxycycline may decrease effectiveness of oral contraceptives and that alternative nonhormonal contraceptive measures should be used.a
Advise patients to avoid excessive sunlight or artificial UV light and to discontinue the drug at the first sign of skin erythema and if phototoxicity (e.g., skin eruption) occurs;111 consider use of sunscreen or sunblock.111
Advise patients using the drug for malaria prevention that no antimalarial agent (including doxycycline) guarantees protection against malaria.111 Importance of using personal protective measures to avoid mosquito bites (e.g., staying in well-screened areas, using mosquito nets, covering body with clothing, using an effective insect repellent), especially from dusk to dawn.111
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.111
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 self-treatment 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.122 158
Advise travelers that presumptive self-treatment of malaria is an interim measure and that they should seek medical evaluation as soon as possible.122 158
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.111 (See Fetal/Neonatal Morbidity under Cautions.)
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, and any concomitant illnesses.111
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.

Doxycycline Calcium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Suspension	50 mg (of doxycycline) per 5 mL	Vibramycin Calcium Syrup	Pfizer

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

Doxycycline Hyclate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	50 mg (of doxycycline)*	Vibramycin Hyclate	Pfizer
		100 mg (of doxycycline)*	Vibramycin Hyclate	Pfizer
	Capsules, delayed-release (containing partially enteric-coated pellets)	100 mg (of doxycycline)	Doryx	Warner Chilcott
	Tablets, film-coated	100 mg (of doxycycline)*	Vibra-Tabs	Pfizer
Parenteral	For injection, for IV use only	100 mg (of doxycycline)	Doxy 100	American Pharmaceutical Partners
			Vibramycin Hyclate Intravenous	Pfizer
		200 mg (of doxycycline)	Vibramycin Hyclate Intravenous	Pfizer

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

Doxycycline Monohydrate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	50 mg (of doxycycline)*	Doxycycline Monohydrate Capsules
			Monodox	Oclassen
		100 mg (of doxycycline)*	Doxycycline Monohydrate Capsules
			Monodox	Oclassen
	For suspension	25 mg (of doxycycline) per 5 mL	Vibramycin Monohydrate	Pfizer

Doxycycline Calcium