Doxycycline Hyclate

Doxycycline Hyclate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Doxycycline Hyclate is an anti-bacterial agent that is FDA approved for the treatment of rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, tick fevers, respiratory tract infections caused by mycoplasma pneumoniae, lymphogranuloma venereum, psittacosis, trachoma, inclusion conjunctivitis, uncomplicated urethral, endocervical, or rectal infections in adults caused by chlamydia trachomatis, nongonococcal urethritis caused by ureaplasma urealyticum, relapsing fever, chancroid, plague, tularemia, cholera, campylobacter fetus infections, brucellosis, bartonellosis, granuloma inguinale. Common adverse reactions include photosensitivity, diarrhea, nasopharyngitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acinetobacter infection

• Dosing information

• IV route- usual dose: 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV in 1 or 2 divided doses depending on the severity of the infection. Infuse over 1 to 4 hours and continue therapy until 24 to 48 hours after symptoms and fever have subsided.

• Oral route: usual dose: 100 mg orally every 12 hours on day 1, then 100 mg/day in 1 or 2 divided doses thereafter. For more severe infection, doxycycline 100 mg orally every 12 hours is recommended.

Acne vulgaris (Severe); Adjunct

• Dosing information

• Oral route: usual dose: 100 mg orally every 12 hours on day 1, then 100 mg/day in 1 or 2 divided doses thereafter. For more severe infection, doxycycline 100 mg orally every 12 hours is recommended

Actinomycotic infection - Allergy to penicillin

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

• 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections

Amebic infection; Adjunct- Intestinal infectious disease

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

• 100 mg orally every 12 hours on day 1, then 100 mg/day in 1 or 2 divided doses thereafter. For more severe infection, doxycycline 100 mg orally every 12 hours is recommended

Anthrax

• Dosing information

• Initial, 100 mg IV every 12 hours in combination with 1 to 2 additional antibiotics (eg, rifampin, vancomycin, imipenem, chloramphenicol, penicillin, ampicillin, clindamycin, and clarithromycin); may switch to 100 mg ORALLY twice daily when clinically indicated; total treatment duration is 60 days (guideline dosing)

• 100 mg ORALLY every 12 hours for 60 days (guideline dosing)

Anthrax, Inhalational Postexposure ; Prophylaxis

• Dosing information

• Initial, 100 mg IV every 12 hours in combination with 1 to 2 additional antibiotics (eg, rifampin, vancomycin, imipenem, chloramphenicol, penicillin, ampicillin, clindamycin, and clarithromycin); may switch to 100 mg ORALLY twice daily when clinically indicated; total treatment duration is 60 days (guideline dosing)

• 100 mg IV/ORALLY every 12 hours for at least 60 days

Bartonellosis

• Dosing information

• Bartonellosis:(bacillary angiomatosis, peliosis hepatis, bacteremia, osteomyelitis in patients with HIV) 100 mg ORALLY/IV every 12 hours for at least 3 months (guideline dosing)

• Bartonellosis: (CNS infection or severe infections in patients with HIV) 100 mg ORALLY/IV every 12 hours, with or without rifampin 300 mg ORALLY/IV every 12 hours for 4 months (guideline dosing)

Brucellosis; Adjunct

• Dosing information

• 200 mg ORALLY daily for 6 weeks in combination with streptomycin (clinical trial dosing)

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided (manufacturer dosing)

• 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections (manufacturer dosing)

Chancroid

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

• Chancroid: 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections

Chlamydial infection

• Dosing information

• 100 mg ORALLY twice daily for 7 days (guideline dosing)

Cholera

• Dosing information

Clostridial infection- Allergy to penicillin -

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

• Cholera: 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections

Epididymitis

• Dosing information

• 100 mg ORALLY twice daily for 10 days plus ceftriaxone 250 mg IM as a single dose (guideline dosing)

Gonorrhea, Uncomplicated

• Dosing information

• Gonorrhea, Uncomplicated: (infections of the cervix, urethra, or rectum) 100 mg ORALLY twice daily for 7 days plus a single dose of either IM ceftriaxone 250 mg or ORAL cefixime 400 mg (guideline dosing)

• Gonorrhea, Uncomplicated: (infections of the pharynx) 100 mg ORALLY twice daily for 7 days in combination with a single dose of ceftriaxone 250 mg IM (guideline dosing)

• Gonorrhea, Uncomplicated: (alternative single visit dose) 300 mg ORALLY x 1 dose immediately followed by a second 300-mg dose in 1 hour (manufacturer dosing)

• Gonorrhea, Uncomplicated: 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided (manufacturer dosing)

Granuloma inguinale

• Dosing information

• 100 mg ORALLY twice daily for at least 21 days and lesions are healed completely (guideline dosing)

• 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections (manufacturer dosing)

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided (manufacturer dosing)

Inclusion conjunctivitis

• Dosing information

• 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections

Infection by Campylobacter fetus

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

• Infection by Campylobacter fetus: 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections

Infection due to Enterobacteriaceae

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

• 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections

Infection due to Escherichia coli

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

• 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections

Late latent syphilis, or latent syphilis of unknown duration; Penicillin allergy

• Dosing information

• Benzathine penicillin G is the drug of choice for late latent syphilis or latent syphilis of unknown duration and should always be utilized unless the patient has exhibited allergic reactions to penicillin; doxycycline is a secondary drug for treatment in nonpregnant, penicillin-allergic patients (guideline dosing)

• secondary treatment, 100 mg ORALLY twice daily for 28 days (guideline dosing)

Listeriosis- Allergy to penicillin -

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

• 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections

Lymphogranuloma venereum

• Dosing information

• 100 mg ORALLY twice daily for 21 days (guideline dosing)

• Sex partner, 100 mg ORALLY twice daily for 7 days (guideline dosing)

Malaria; Prophylaxis

• Dosing information

• Malaria; Adjunct: (uncomplicated) 100 mg ORALLY twice daily for 7 days; give in combination with quinine sulfate 650 mg ORALLY 3 times daily for 3 days (or 7 days if infection is acquired in Southeast Asia) (guideline dosing)

• Malaria; Adjunct: (severe) 100 mg IV/ORAL twice daily for 7 days; give in combination with quinidine gluconate 10 mg/kg IV loading dose over 1 to 2 hours then 0.02 mg/kg/min IV continuous infusion for at least 24 hours and continue for 3 days if infection acquired in Africa or South America or 7 days if infection is acquired in Southeast Asia, switch to oral doxycycline when patient can tolerate oral, switch to oral quinine once parasite density is less than 1% (guideline dosing)

• Malaria; Prophylaxis: 100 mg ORALLY once daily beginning 1 to 2 days prior to travel, continued during travel, and for 4 weeks after leaving malarious area

Meningococcal infectious disease- Allergy to penicillin

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

Nongonococcal urethritis

• Dosing information

• Nongonococcal cervicitis: 100 mg ORALLY twice daily for 7 days (guideline dosing)

• Nongonococcal urethritis due to Ureaplasma urealyticum: 100 mg ORALLY twice daily for 7 days

Plague

• Dosing information

• Plague, Postexposure: (treatment) 200 mg IV daily in 1 or 2 divided doses for 10 days (guideline dosing)

• Plague, Postexposure: (treatment) 100 mg ORALLY twice daily for 10 days (guideline dosing)

• Plague, Postexposure: (postexposure prophylaxis) 100 mg ORALLY twice daily for 7 days (guideline dosing)

Psittacosis

Q fever

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

• 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections

Relapsing fever

• Dosing information

Respiratory tract infection

• Dosing information

• Respiratory tract infection: (acute uncomplicated bacterial rhinosinusitis; initial empiric therapy alternative) 100 mg ORALLY twice daily OR 200 mg ORALLY daily for 5 to 7 days (guideline dosing)

• Respiratory tract infection: 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided (manufacturer dosing)

• Respiratory tract infection: 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections (manufacturer dosing)

Rocky Mountain spotted fever

Rosacea, inflammatory lesions (papules and pustules)

Shigellosis

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

• 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections

Spotted fevers

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

• 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections

Staphylococcal infection of skin

• Dosing information

Syphilis, Primary, secondary, or early latent; Penicillin allergy

• Dosing information

• 300 mg/day IV in divided doses for at least 10 daysAll

• Early, 100 mg ORALLY twice daily for 14 days

• Infection for longer than 1 year, 100 mg ORALLY twice daily for 4 weeks

Tularemia, Postexposure

• Dosing information

• Treatment: 100 mg IV/ORALLY twice daily for 14 to 21 days (guideline dosing)

• Postexposure prophylaxis: 100 mg ORALLY twice daily for 14 days (guideline dosing)

Typhus group rickettsial disease

• Dosing information

Urinary tract infectious disease

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

• 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections

Vincent's infection- Allergy to penicillin

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

• 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections

Yaws- Allergy to penicillin

• Dosing information

• 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided

• 100 mg ORALLY every 12 hours on day 1, then 100 mg ORALLY daily in 1 to 2 divided doses OR 100 mg ORALLY every 12 hours for more severe infections

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Doxycycline Hyclate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxycycline Hyclate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Acinetobacter infection

• Dosing information

• Acinetobacter infection: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses OR 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses for at least 24 to 48 hours after symptoms subsided

• Acinetobacter infection: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses OR 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter for at least 24 to 48 hours after symptoms subsided

• Acinetobacter infection: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided

Acne vulgaris; Adjunct

• Dosing information

• Acne vulgaris (Severe); Adjunct: (older than 8 years, 45 kg or less) 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day in 1 to 2 divided doses

• Acne vulgaris (Severe); Adjunct: (older than 8 years, over 45 kg) 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter

• Acne vulgaris (Severe); Adjunct: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours

Actinomycotic infection

• Dosing information

• Actinomycotic infection - Allergy to penicillin: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses OR 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses for at least 24 to 48 hours after symptoms subsided

• Actinomycotic infection - Allergy to penicillin: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses OR 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter for at least 24 to 48 hours after symptoms subsided

• Actinomycotic infection - Allergy to penicillin: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided

Amebic infection - Intestinal infectious disease

• Dosing information

• Amebic infection; Adjunct - Intestinal infectious disease: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses OR 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses for at least 24 to 48 hours after symptoms subsided

• Amebic infection; Adjunct - Intestinal infectious disease: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses OR 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter for at least 24 to 48 hours after symptoms subsided

• Amebic infection; Adjunct - Intestinal infectious disease: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided

Anthrax

• Dosing information

• Anthrax: (inhalational anthrax OR cutaneous anthrax with systemic involvement, over 45 kg or older than 8 years) initial, 100 mg IV every 12 hours in combination with 1 to 2 additional antibiotics (eg, rifampin, vancomycin, imipenem, chloramphenicol, penicillin, ampicillin, clindamycin, and clarithromycin); may switch to 100 mg ORALLY twice daily when clinically indicated; total treatment duration is 60 days (guideline dosing)

• Anthrax: (cutaneous anthrax, over 45 kg or older than 8 years) 100 mg ORALLY every 12 hours for 60 days (guideline dosing)

• Anthrax: (inhalational anthrax OR cutaneous anthrax with systemic involvement, under 45 kg) initial, 2.2 mg/kg IV every 12 hours in combination with 1 to 2 additional antibiotics (eg, rifampin, vancomycin, imipenem, chloramphenicol, penicillin, ampicillin, clindamycin, and clarithromycin); may switch to 2.2 mg/kg ORALLY twice daily when clinically indicated; continue for a total treatment duration of 60 days (guideline dosing)

• Anthrax: (cutaneous anthrax, under 45 kg) 2.2 mg/kg ORALLY every 12 hours for 60 days (guideline dosing)

Bartonellosis

• Dosing information

• Dose:(cutaneous bacillary angiomatosis in patients with HIV) 2 to 4 mg/kg/day (MAX 100 to 200 mg/day) ORALLY or IV once daily or divided into 2 doses/day for 3 months (guideline dosing)

• Dose: (bacillary peliosis, osteomyelitis, severe or CNS infections in patients with HIV) 2 to 4 mg/kg/day (MAX 100 to 200 mg/day) ORALLY or IV once daily or divided into 2 doses/day for 4 months; add rifampin 20 mg/kg (MAX 600 mg/day) ORALLY or IV once daily or divided into 2 doses/day for CNS and severe infections (guideline dosing)

Brucellosis; Adjunct

• Dosing information

• Older than 8 years: 2 to 4 mg/kg ORALLY per day in 2 divided doses for at least 6 weeks; MAX 200 mg/day; monotherapy not recommended, use in conjunction with rifampin (guideline dosing)

• Older than 8 years, 45 kg or less: 4.4 mg/kg IV in 1 to 2 divided doses OR 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses for at least 24 to 48 hours after symptoms subsided

• Older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses OR 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter for at least 24 to 48 hours after symptoms subsided

Chancroid

• Dosing information

• Chancroid: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses OR 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses for at least 24 to 48 hours after symptoms subsided

• Chancroid: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses OR 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter for at least 24 to 48 hours after symptoms subsided

• Chancroid: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided

Cholera

• Dosing information

• Cholera: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses [1] OR 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided dosesfor at least 24 to 48 hours after symptoms subsided

• Cholera: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses OR 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter for at least 24 to 48 hours after symptoms subsided

• Cholera: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided

Clostridial infection

• Dosing information

Inclusion conjunctivitis

• Dosing information

• Inclusion conjunctivitis: (older than 8 years, 45 kg or less) 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day in 1 to 2 divided doses

• Inclusion conjunctivitis: (older than 8 years, over 45 kg) 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter

• Inclusion conjunctivitis: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours

Infection by Campylobacter fetus

• Dosing information

• Infection by Campylobacter fetus: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses OR 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses for at least 24 to 48 hours after symptoms subsided

• Infection by Campylobacter fetus: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses OR 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter for at least 24 to 48 hours after symptoms subsided

• Infection by Campylobacter fetus: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided

Infection due to Enterobacteriaceae

• Dosing information

• Infection due to Enterobacteriaceae: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses OR 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses for at least 24 to 48 hours after symptoms subsided

• Infection due to Enterobacteriaceae: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses OR 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter for at least 24 to 48 hours after symptoms subsided

• Infection due to Enterobacteriaceae: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided

Infection due to Escherichia coli

• Dosing information

• Infection due to Escherichia coli: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses OR 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses for at least 24 to 48 hours after symptoms subsided

• Infection due to Escherichia coli: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses OR 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter for at least 24 to 48 hours after symptoms subsided

• Infection due to Escherichia coli: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided

Inhalational anthrax, Postexposure; Prophylaxis

• Dosing information

• Anthrax, Inhalational Postexposure ; Prophylaxis: (weight 45 kg or less) 2.2 mg/kg IV/ORALLY every 12 hours for at least 60 days, MAX 100 mg per dose (guideline dosing)

• Anthrax, Inhalational Postexposure ; Prophylaxis: (over 45 kg and older than 8 years) 100 mg IV/ORALLY every 12 hours for at least 60 days (guideline dosing)

Listeriosis

• Dosing information

Malaria; Prophylaxis

• Dosing information

• Malaria; Adjunct: (uncomplicated, 8 years or older) 2.2 mg/kg (MAX: 100 mg) ORALLY every 12 hours for 7 days in combination with quinine sulfate 10 mg/kg ORALLY 3 times daily for 3 days (or 7 days if infection is acquired in Southeast Asia) (guideline dosing)

• Malaria; Adjunct: (severe, 8 years or older, weight 45 kg or greater) 100 mg IV/ORAL twice daily for 7 days; give in combination with quinidine gluconate 10 mg/kg IV loading dose over 1 to 2 hours then 0.02 mg/kg/min IV continuous infusion for at least 24 hours and continue for 3 days if infection acquired in Africa or South America or 7 days if infection is acquired in Southeast Asia, switch to oral doxycycline when patient can tolerate oral, switch to oral quinine once parasite density is less than 1% (guideline dosing)

• Malaria; Adjunct: (severe, 8 years or older, weight less than 45 kg) 2.2 mg/kg IV/ORAL every 12 hours for 7 days; give in combination with quinidine gluconate 10 mg/kg IV loading dose over 1 to 2 hours then 0.02 mg/kg/min IV continuous infusion for at least 24 hours and continue for 3 days if infection acquired in Africa or South America or 7 days if infection is acquired in Southeast Asia, switch to oral doxycycline when patient can tolerate oral, switch to oral quinine once parasite density is less than 1% (guideline dosing)

• Malaria; Prophylaxis: (older than 8 years) 2 mg/kg ORALLY (up to 100 mg) once daily beginning 1 to 2 days prior to travel, continued during travel, and for 4 weeks after leaving malarious area

Plague

• Dosing information

• Plague, Postexposure: (treatment, less than 45 kg) 2.2 mg/kg IV/ORALLY twice daily for 10 days (guideline dosing)

• Plague, Postexposure: (treatment, greater than 45 kg) 100 mg IV/ORALLY twice daily for 10 days (guideline dosing)

• Plague, Postexposure: (postexposure prophylaxis, less than 45 kg) 2.2 mg/kg ORALLY twice daily for 7 days (guideline dosing)

• Plague, Postexposure: (postexposure prophylaxis, greater than 45 kg) 100 mg ORALLY twice daily for 7 days (guideline dosing)

Psittacosis

• Dosing information

Q fever

• Dosing information

• Q fever: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses OR 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses for at least 24 to 48 hours after symptoms subsided

• Q fever: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses OR 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter for at least 24 to 48 hours after symptoms subsided

• Q fever: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided

Relapsing fever

• Dosing information

• Louse-borne relapsing fever: (older than 8 years, 45 kg or less) 4.4 mg/kg ORALLY/IV in 1 or 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day ORALLY/IV in 1 or 2 divided doses for a total of 5 to 10 days (guideline dosing)

• Louse-borne relapsing fever: (older than 8 years, over 45 kg) 100 mg ORALLY/IV twice a day for a total of 5 to 10 days (guideline dosing)

Respiratory tract infection

• Dosing information

• Respiratory tract infection: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses OR 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses for at least 24 to 48 hours after symptoms subsided

• Respiratory tract infection: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses OR 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter for at least 24 to 48 hours after symptoms subsided

• Respiratory tract infection: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided

Rocky Mountain spotted fever

• Dosing information

Rosacea, inflammatory lesions (papules and pustules)

• Dosing information

Shigellosis

• Dosing information

• Shigellosis: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses OR 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses for at least 24 to 48 hours after symptoms subsided

• Shigellosis: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses OR 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter for at least 24 to 48 hours after symptoms subsided

• Shigellosis: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided

====Spotted fevers====

• Dosing information

• Spotted fevers: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses OR 4.4 mg/kg ORALLY in 2 divided doses on day 1, then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses for at least 24 to 48 hours after symptoms subsided

• Spotted fevers: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses OR 100 mg ORALLY every 12 hours on day 1, then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter for at least 24 to 48 hours after symptoms subsided

• Spotted fevers: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided

Staphylococcal infection of skin

• Dosing information

• Cellulitis, Purulent - Methicillin resistant Staphylococcus aureus infection: (older than 8 years, 45 kg or less) 4 mg/kg/day ORALLY divided every 12 hours (guideline dosing)

• Cellulitis, Purulent - Methicillin resistant Staphylococcus aureus infection: (older than 8 years, over 45 kg) 100 mg ORALLY every 12 hours (guideline dosing)

Syphilis, Primary, secondary, or early latent; Penicillin allergy

• Dosing information

Tularemia, Postexposure

• Dosing information

• Tularemia, Postexposure: (treatment, 45 kg or less) 2.2 mg/kg IV/ORALLY twice daily for 14 to 21 days (guideline dosing)

• Tularemia, Postexposure: (treatment, over 45 kg) 100 mg IV/ORALLY twice daily for 14 to 21 days (guideline dosing)

• Tularemia, Postexposure: (postexposure prophylaxis, 45 kg or less) 2.2 mg/kg ORALLY twice daily for 14 days (guideline dosing)

• Tularemia, Postexposure: (postexposure prophylaxis, over 45 kg) 100 mg ORALLY twice daily for 14 days (guideline dosing)

Typhus group rickettsial disease

• Dosing information

Urinary tract infectious disease

• Dosing information

• Urinary tract infectious disease: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses [1] OR 4.4 mg/kg ORALLY in 2 divided doses on day 1 [2][3][4][5][6], then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses [2][3][4][5][6] for at least 24 to 48 hours after symptoms subsided [1]

Urinary tract infectious disease: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses [1] OR 100 mg ORALLY every 12 hours on day 1 [2][3][4][5][6], then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter [2][3][4][5][1][6] for at least 24 to 48 hours after symptoms subsided [1] Urinary tract infectious disease: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours [2][3][4][5][6] or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided [1]

Vincent's infection

• Dosing information

• Allergy to penicillin - Vincent's infection: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses [1] OR 4.4 mg/kg ORALLY in 2 divided doses on day 1 [2][3][4][5][6], then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses [2][3][4][5][6] for at least 24 to 48 hours after symptoms subsided [1]

Allergy to penicillin - Vincent's infection: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses [1] OR 100 mg ORALLY every 12 hours on day 1 [2][3][4][5][6], then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter [2][3][4][5][1][6] for at least 24 to 48 hours after symptoms subsided [1] Allergy to penicillin - Vincent's infection: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours [2][3][4][5][6] or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided [1]

Yaws

• Dosing information

• Allergy to penicillin - Yaws: (older than 8 years, 45 kg or less) 4.4 mg/kg IV in 1 to 2 divided doses [1] OR 4.4 mg/kg ORALLY in 2 divided doses on day 1 [2][3][4][5][6], then 2.2 to 4.4 mg/kg/day IV/ORALLY in 1 to 2 divided doses [2][3][4][5][6] for at least 24 to 48 hours after symptoms subsided [1]

Allergy to penicillin - Yaws: (older than 8 years, over 45 kg) 200 mg IV in 1 or 2 divided doses [1] OR 100 mg ORALLY every 12 hours on day 1 [2][3][4][5][6], then 100 mg IV/ORALLY daily in 1 to 2 divided doses thereafter [2][3][4][5][1][6] for at least 24 to 48 hours after symptoms subsided [1] Allergy to penicillin - Yaws: (older than 8 years, over 45 kg) severe infections, 100 mg ORALLY every 12 hours [2][3][4][5][6] or 200 mg IV daily in 1 or 2 divided doses for at least 24 to 48 hours after symptoms subsided [1]

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Doxycycline Hyclate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxycycline Hyclate in pediatric patients.

Contraindications

• This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Warnings

• THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drugs, but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, EXCEPT FOR ANTHRAX, INCLUDING INHALATIONAL ANTHRAX (POST-EXPOSURE), UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.

• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Doxycycline Hyclate Capsules, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

• C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following the use of antibacterial drugs. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

• If CDAD is suspected or confirmed, ongoing use of antibacterial drugs not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

• All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

• Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

• The antianabolic action of the tetracyclines may cause an increase in BUN. Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.

• Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.

PRECAUTIONS

General:

• As with other antibacterial drugs, use of Doxycycline may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, Doxycycline Hyclate Capsules should be discontinued and appropriate therapy instituted.

• Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including Doxycycline Hyclate Capsules. Clinical manifestations of IH include headache, blurred vision, diplopia, vision loss, and papilledema. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin and Doxycycline Hyclate Capsules should be avoided because isotretinoin is also known to cause pseudotumor cerebri.

• Although IH typically resolves after discontinuation of treatment, it is possible that permanent visual loss can occur. If visual symptoms develop during treatment, prompt ophthalmologic evaluation is warranted. Since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize.

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

• Doxycycline offers substantial but not complete suppression of the asexual blood stages of Plasmodium strains.

• Doxycycline does not suppress P. falciparum's sexual blood stage gametocytes. Subjects completing this prophylactic regimen may still transmit the infection to mosquitoes outside endemic areas.

• Prescribing Doxycycline Hyclate Capsules in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions

Clinical Trials Experience

• Due to oral doxycycline's virtually complete absorption, side effects of the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines:

• Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported rarely. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of the drugs in the tetracycline class. Most of these patients took medications immediately before going to bed.

• Skin: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (See WARNINGS.)

• Renal toxicity: Rise in BUN has been reported and is apparently dose related.

• Immune: Hypersensitivity reactions including urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, exacerbation of systemic lupus erythematosus, and drug rash with eosinophilia and systemic symptoms (DRESS).

• Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

• Other: bulging fontanels in infants and intracranial hypertension in adults. (See PRECAUTIONS-General.)

• When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. No abnormalities of thyroid function studies are known to occur.

• To report suspected ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Postmarketing Experience

There is limited information regarding Doxycycline Hyclate Postmarketing Experience in the drug label.

Drug Interactions

• Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

• Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.

• Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.

• Absorption of tetracyclines is impaired by bismuth subsalicylate.

• Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

• The concurrent use of tetracycline and Penthrane® (methoxyflurane) has been reported to result in fatal renal toxicity.

• Concurrent use of tetracycline may render oral contraceptives less effective.

• Drug/Laboratory Test Interactions:

• False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): D

• There are no adequate and well-controlled studies on the use of doxycycline in pregnant women. The vast majority of reported experience with doxycycline during human pregnancy is short-term, first trimester exposure. There are no human data available to assess the effects of long-term therapy of doxycycline in pregnant women, such as that proposed for treatment of anthrax exposure. An expert review of published data on experiences with doxycycline use during pregnancy by TERIS -the Teratogen Information System -concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (the quantity and quality of data were assessed as limited to fair), but the data are insufficient to state that there is no riska. A case-control study (18,515 mothers of infants with congenital anomalies and 32,804 mothers of infants with no congenital anomalies) shows a weak but marginally statistically significant association with total malformations and use of doxycycline anytime during pregnancy. Sixty-three (0.19%) of the controls and fifty-six (0.30%) of the cases were treated with doxycycline. This association was not seen when the analysis was confined to maternal treatment during the period of organogenesis (i.e., in the second and third months of gestation) with the exception of a marginal relationship with neural tube defect based on only two exposed cases.b

• A small prospective study of 81 pregnancies describes 43 pregnant women treated for 10 days with doxycycline during early first trimester. All mothers reported their exposed infants were normal at 1 year of agec.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Doxycycline Hyclate in women who are pregnant.

Labor and Delivery

• The effect of tetracyclines on labor and delivery is unknown.

Nursing Mothers

• Tetracyclines are excreted in human milk; however, the extent of absorption of tetracyclines, including doxycycline, by the breastfed infant is not known. Short-term use by lactating women is not necessarily contraindicated; however, the effects of prolonged exposure to doxycycline in breast milk are unknownd. Because of the potential for serious adverse reactions in nursing infants from doxycycline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

• THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drugs, but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, EXCEPT FOR ANTHRAX, INCLUDING INHALATIONAL ANTHRAX (POST-EXPOSURE), UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.

Geriatic Use

There is no FDA guidance on the use of Doxycycline Hyclate in geriatric settings.

Gender

There is no FDA guidance on the use of Doxycycline Hyclate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Doxycycline Hyclate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Doxycycline Hyclate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Doxycycline Hyclate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Doxycycline Hyclate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Doxycycline Hyclate in patients who are immunocompromised.

Administration and Monitoring

Administration

• THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.

• Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day.

• In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

• For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections, up to 2 mg/lb of body weight may be used. For children over 100 lb the usual adult dose should be used.

• The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage.

• When used in streptococcal infections, therapy should be continued for 10 days.

• Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration.

• If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.

• Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of doxycycline in patients with renal impairment.

• Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required.

• Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg, by mouth twice a day for 7 days.

• Nongonococcal urethritis (NGU) caused by C. trachomatis or U. urealyticum: 100 mg by mouth, twice a day for 7 days.

• Syphilis - early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 2 weeks.

• Syphilis of more than one year's duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks.

• Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.

• Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.

• For prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1-2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.

Inhalational anthrax (post-exposure)

• ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days.
• CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.

Monitoring

There is limited information regarding Doxycycline Hyclate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Doxycycline Hyclate and IV administrations.

Overdosage

• In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage.

Pharmacology

Mechanism of Action

There is limited information regarding Doxycycline Hyclate Mechanism of Action in the drug label.

Structure

There is limited information regarding Doxycycline Hyclate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Doxycycline Hyclate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Doxycycline Hyclate Pharmacokinetics in the drug label.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

• Long-term studies in animals to evaluate carcinogenic potential of doxycycline have not been conducted. However, there has been evidence of oncogenic activity in rats in studies with the related antibacterial drugs, oxytetracycline (adrenal and pituitary tumors), and minocycline (thyroid tumors).

• Likewise, although mutagenicity studies of doxycycline have not been conducted, positive results in in vitro mammalian cell assays have been reported for related antibacterial drugs (tetracycline, oxytetracycline).

• Doxycycline administered orally at dosage levels as high as 250 mg/kg/day had no apparent effect on the fertility of female rats. Effect on male fertility has not been studied.

Animal pharmacology and toxicology

• Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4, and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4, and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.

• Minocycline, tetracycline PO4, methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.

• Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetracycline); and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

Clinical Studies

There is limited information regarding Doxycycline Hyclate Clinical Studies in the drug label.

How Supplied

• Doxycycline Hyclate Capsules, USP 50 mg are available as a blue and white capsule filled with yellow powder, imprinted with "2984", containing Doxycycline Hyclate, equivalent to 50 mg *Doxycycline; 100 mg are available as a light blue capsule filled with yellow powder imprinted with "2985" containing Doxycycline Hyclate, equivalent to 100 mg of doxycycline.

File:Doxycycline how supplied.png

• Dispense in a tight, light resistant container as defined in the USP, with a child resistant closure (as required).

Storage

• Store at 20° to 25° C (68° to 77° F) (see USP controlled room temperature).

Images

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Patient Counseling Information

Information For Patients

Patients taking doxycycline for malaria prophylaxis should be advised:

• that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria.
• to avoid being bitten by mosquitoes by using personal protective measures that help avoid contact with mosquitoes, especially from dusk to dawn (e.g., staying in well-screened areas, using mosquito nets, covering the body with clothing, and using an effective insect repellent).
• that doxycycline prophylaxis:

• should begin 1-2 days before travel to the malarious area,
• should be continued daily while in the malarious area and after leaving the malarious area,
• should be continued for 4 further weeks to avoid development of malaria after returning from an endemic area,
• should not exceed 4 months.

All patients taking doxycycline should be advised:

• to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (e.g., skin eruption, etc.) occurs. Sunscreen or sunblock should be considered. (See WARNINGS.)
• to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.)
• that the absorption of tetracyclines is reduced when taken with foods, especially those which contain calcium. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. (See DRUG INTERACTIONS.)
• that the absorption of tetracyclines is reduced when taking bismuth subsalicylate. (See DRUG INTERACTIONS.)
• that the use of doxycycline might increase the incidence of vaginal candidiasis.

• Patients should be counseled that antibacterial drugs, including Doxycycline Hyclate Capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Doxycycline Hyclate Capsules is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Doxycycline Hyclate Capsules or other antibacterial drugs in the future.

• Diarrhea is a common problem caused by antibacterial drugs, which usually ends when the antibacterials are discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.

• Laboratory Tests:

• In venereal disease, when co-existent syphilis is suspected, dark field examinations should be done before treatment is started and the blood serology repeated monthly for at least 4 months.

• In long-term therapy, periodic laboratory evaluation of organ systems, including hematopoietic, renal, and hepatic studies, should be performed.

Precautions with Alcohol

Alcohol-Doxycycline Hyclate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Atridox Doryx Doxy 100 Periostat Vibra-Tabs Vibramycin Hyclate Alodox Oraxyl

Look-Alike Drug Names

There is limited information regarding Doxycycline Hyclate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.