Usual Adult Dose for Bacterial Infection

IV: 200 mg IV initially followed by 100 mg IV every 12 hours
Maximum dose: 400 mg/24 hours

Oral:
Most infections: 200 mg orally initially followed by 100 mg orally every 12 hours

• Alternative regimen (if more frequent dosing preferred): 100 to 200 mg orally initially followed by 50 mg orally 4 times a day

Uncomplicated urethral, endocervical, or rectal infections due to Chlamydia trachomatis or Ureaplasma urealyticum: 100 mg orally every 12 hours for at least 7 days

Comments:

• With trachoma, infectious agent is not always eliminated (as assessed by immunofluorescence).
• Coadministration with streptomycin recommended for brucellosis.
• For syphilis, the duration of therapy is 10 to 15 days; close follow-up (including laboratory tests) recommended.

Uses:

• For the treatment of the following infections: Rocky Mountain spotted fever, typhus fever, typhus group, Q fever, rickettsialpox, tick fevers due to rickettsiae; respiratory tract infections due to Mycoplasma pneumoniae; lymphogranuloma venereum, trachoma, or inclusion conjunctivitis due to C trachomatis; psittacosis (ornithosis) due to Chlamydophila psittaci; nongonococcal urethritis, endocervical, or rectal infections due to U urealyticum or C trachomatis; relapsing fever due to Borrelia recurrentis; plague due to Yersinia pestis; tularemia due to Francisella tularensis; cholera due to Vibrio cholerae; Campylobacter fetus infections; brucellosis due to Brucella species; bartonellosis due to Bartonella bacilliformis; granuloma inguinale due to Klebsiella granulomatis
• For the treatment of infections due to the following bacteria when bacteriologic testing shows suitable susceptibility to this drug: Escherichia coli; Enterobacter aerogenes; Shigella species; Acinetobacter species; respiratory tract infections due to Haemophilus influenzae; respiratory tract and urinary tract infections due to Klebsiella species; upper respiratory tract infections due to Streptococcus pneumoniae
• When penicillin is contraindicated, as an alternative agent for the treatment of the following infections: Syphilis due to Treponema pallidum subspecies pallidum; yaws due to T pallidum subspecies pertenue; listeriosis due to Listeria monocytogenes; anthrax due to Bacillus anthracis; Vincent's infection due to Fusobacterium fusiforme; actinomycosis due to Actinomyces israelii; clostridial infections
• As adjunctive therapy for: Acute intestinal amebiasis; severe acne

Usual Adult Dose for Acne

Extended-release formulations:
45 to 49 kg: 45 mg orally once a day
50 to 59 kg: 55 mg orally once a day
60 to 71 kg: 65 mg orally once a day
72 to 84 kg: 80 mg orally once a day
85 to 96 kg: 90 mg orally once a day
97 to 110 kg: 105 mg orally once a day
111 to 125 kg: 115 mg orally once a day
126 to 136 kg: 135 mg orally once a day

Duration of therapy: 12 weeks

Comments:

• Recommended dose is about 1 mg/kg once a day.
• This drug did not show any effect on non-inflammatory acne lesions.
• Safety not established beyond 12 weeks.

Use: To treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris

American Academy of Dermatology (AAD) Recommendations:
Immediate-release formulations: 50 mg orally once to 3 times a day

Comments:

• Recommended as adjunctive treatment of moderate to severe inflammatory acne
• This drug should not be used as monotherapy.
• Use should be limited to the shortest duration possible; reevaluation recommended at 3 to 4 months to minimize resistant bacteria developing.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Meningitis - Meningococcal

200 mg IV initially followed by 100 mg IV every 12 hours
Maximum dose: 400 mg/24 hours

Use: When penicillin is contraindicated, as an alternative agent for the treatment of meningitis due to Neisseria meningitidis

Usual Adult Dose for Meningococcal Meningitis Prophylaxis

100 mg orally every 12 hours for 5 days

Comments:

• Diagnostic laboratory studies (including serotyping and susceptibility testing) are recommended to establish the carrier state and the appropriate therapy.
• Prophylactic use of this drug is only recommended when risk of meningococcal meningitis is high.

Use: In the treatment of asymptomatic carriers of N meningitidis to eliminate meningococci from the nasopharynx

Usual Adult Dose for Skin or Soft Tissue Infection

IV: 200 mg IV initially followed by 100 mg IV every 12 hours
Maximum dose: 400 mg/24 hours

Oral:
Infection due to Staphylococcus aureus: 200 mg orally initially followed by 100 mg orally every 12 hours

• Alternative regimen (if more frequent dosing preferred): 100 to 200 mg orally initially followed by 50 mg orally 4 times a day

Infection due to Mycobacterium marinum: 100 mg orally every 12 hours for 6 to 8 weeks

Comments:

• Not the drug of choice for any type of staphylococcal infection
• The optimal dose has not been established to treat M marinum infections; the recommended dose has been successful in limited cases.

Uses: For the treatment of skin and skin structure infections due to S aureus when bacteriologic testing shows suitable susceptibility to this drug; for the treatment of infections due to M marinum

Infectious Diseases Society of America (IDSA) Recommendations: 100 mg orally twice a day

Comments:

• Recommended for skin and soft tissue infections due to methicillin-susceptible and methicillin-resistant S aureus
• After an initial dose of 200 mg, recommended for purulent cellulitis (cellulitis associated with purulent drainage/exudate without a drainable abscess) due to methicillin-resistant S aureus
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Skin and Structure Infection

IV: 200 mg IV initially followed by 100 mg IV every 12 hours
Maximum dose: 400 mg/24 hours

Oral:
Infection due to Staphylococcus aureus: 200 mg orally initially followed by 100 mg orally every 12 hours

• Alternative regimen (if more frequent dosing preferred): 100 to 200 mg orally initially followed by 50 mg orally 4 times a day

Infection due to Mycobacterium marinum: 100 mg orally every 12 hours for 6 to 8 weeks

Comments:

• Not the drug of choice for any type of staphylococcal infection
• The optimal dose has not been established to treat M marinum infections; the recommended dose has been successful in limited cases.

Uses: For the treatment of skin and skin structure infections due to S aureus when bacteriologic testing shows suitable susceptibility to this drug; for the treatment of infections due to M marinum

Infectious Diseases Society of America (IDSA) Recommendations: 100 mg orally twice a day

Comments:

• Recommended for skin and soft tissue infections due to methicillin-susceptible and methicillin-resistant S aureus
• After an initial dose of 200 mg, recommended for purulent cellulitis (cellulitis associated with purulent drainage/exudate without a drainable abscess) due to methicillin-resistant S aureus
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Chancroid

200 mg orally initially followed by 100 mg orally every 12 hours

• Alternative regimen (if more frequent dosing preferred): 100 to 200 mg orally initially followed by 50 mg orally 4 times a day

Use: For the treatment of chancroid due to H ducreyi

Usual Adult Dose for Gonococcal Infection - Uncomplicated

Urethritis in men: 100 mg orally every 12 hours for 5 days
Infections other than urethritis and anorectal infections in men: 200 mg orally initially followed by 100 mg orally every 12 hours for at least 4 days

Comments:

• For infections other than urethritis and anorectal infections in men, posttherapy cultures are recommended within 2 to 3 days.

Uses: When penicillin is contraindicated, as an alternative agent for the treatment of the following infections: Uncomplicated urethritis in men due to N gonorrhoeae and other gonococcal infections; infection in women due to N gonorrhoeae

Usual Pediatric Dose for Bacterial Infection

Older than 8 years: 4 mg/kg orally or IV initially followed by 2 mg/kg orally or IV every 12 hours
Maximum dose: 200 mg/dose initially followed by 200 mg/day

Comments:

• With trachoma, infectious agent is not always eliminated (as assessed by immunofluorescence).
• Coadministration with streptomycin recommended for brucellosis.
• For syphilis, the duration of therapy is 10 to 15 days; close follow-up (including laboratory tests) recommended.

Uses:

• For the treatment of the following infections: Rocky Mountain spotted fever, typhus fever, typhus group, Q fever, rickettsialpox, tick fevers due to rickettsiae; respiratory tract infections due to M pneumoniae; lymphogranuloma venereum, trachoma, or inclusion conjunctivitis due to C trachomatis; psittacosis (ornithosis) due to C psittaci; relapsing fever due to B recurrentis; plague due to Y pestis; tularemia due to F tularensis; cholera due to V cholerae; C fetus infections; brucellosis due to Brucella species; bartonellosis due to B bacilliformis; granuloma inguinale due to K granulomatis
• For the treatment of infections due to the following bacteria when bacteriologic testing shows suitable susceptibility to this drug: E coli; E aerogenes; Shigella species; Acinetobacter species; respiratory tract infections due to H influenzae; respiratory tract and urinary tract infections due to Klebsiella species; upper respiratory tract infections due to S pneumoniae
• When penicillin is contraindicated, as an alternative agent for the treatment of the following infections: Syphilis due to T pallidum subspecies pallidum; yaws due to T pallidum subspecies pertenue; listeriosis due to L monocytogenes; anthrax due to B anthracis; Vincent's infection due to F fusiforme; actinomycosis due to A israelii; clostridial infections
• As adjunctive therapy for: Acute intestinal amebiasis; severe acne

American Academy of Pediatrics Recommendations: 2 mg/kg orally or IV twice a day
Maximum dose: 200 mg/day

Comments:

• Routine use only recommended for children 8 years or older.
• Recommended for mild, moderate, or severe infections
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Acne

12 years or older:
Extended-release formulations:
45 to 49 kg: 45 mg orally once a day
50 to 59 kg: 55 mg orally once a day
60 to 71 kg: 65 mg orally once a day
72 to 84 kg: 80 mg orally once a day
85 to 96 kg: 90 mg orally once a day
97 to 110 kg: 105 mg orally once a day
111 to 125 kg: 115 mg orally once a day
126 to 136 kg: 135 mg orally once a day

Duration of therapy: 12 weeks

Comments:

• Recommended dose is about 1 mg/kg once a day.
• This drug did not show any effect on non-inflammatory acne lesions.
• Safety not established beyond 12 weeks.

Use: To treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris

AAD Recommendations:
Immediate-release formulations:

• Children older than 8 years: 4 mg/kg orally initially followed by 2 mg/kg orally every 12 hours

Comments:

• Recommended as adjunctive treatment of moderate to severe inflammatory acne
• This drug should not be used as monotherapy.
• Use should be limited to the shortest duration possible; reevaluation recommended at 3 to 4 months to minimize resistant bacteria developing.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Skin or Soft Tissue Infection

Older than 8 years: 4 mg/kg orally or IV initially followed by 2 mg/kg orally or IV every 12 hours
Maximum dose: 200 mg/dose initially followed by 200 mg/day

Comments:

• Not the drug of choice for any type of staphylococcal infection

Use: For the treatment of skin and skin structure infections due to S aureus when bacteriologic testing shows suitable susceptibility to this drug

IDSA Recommendations: 4 mg/kg orally initially followed by 2 mg/kg orally every 12 hours
Maximum dose: 200 mg/dose initially followed by 200 mg/day

Comments:

• Recommended for purulent cellulitis (cellulitis associated with purulent drainage/exudate without a drainable abscess) due to methicillin-resistant S aureus
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Skin and Structure Infection

Older than 8 years: 4 mg/kg orally or IV initially followed by 2 mg/kg orally or IV every 12 hours
Maximum dose: 200 mg/dose initially followed by 200 mg/day

Comments:

• Not the drug of choice for any type of staphylococcal infection

Use: For the treatment of skin and skin structure infections due to S aureus when bacteriologic testing shows suitable susceptibility to this drug

IDSA Recommendations: 4 mg/kg orally initially followed by 2 mg/kg orally every 12 hours
Maximum dose: 200 mg/dose initially followed by 200 mg/day

Comments:

• Recommended for purulent cellulitis (cellulitis associated with purulent drainage/exudate without a drainable abscess) due to methicillin-resistant S aureus
• Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Immediate-release formulations:

• CrCl less than 80 mL/min: Dose adjustments may be required; however, no specific guidelines have been suggested.

Maximum dose: 200 mg/24 hours

Extended-release formulations:

• Renal dysfunction: Dose reductions and/or extended dosing intervals are recommended; however, no specific guidelines have been suggested.

Liver Dose Adjustments

Liver dysfunction: Caution recommended.

Precautions

This drug is not recommended for use in patients younger than 8 years unless the expected benefits outweigh the risks.

• Extended-release: Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:

• This drug is not significantly removed by hemodialysis or peritoneal dialysis.

Other Comments

Administration advice:

• IV: Infuse over 60 minutes; avoid rapid administration.
• IV: If the same IV line is used for sequential infusion of other drugs, flush the line with a compatible infusion solution before and after infusion of this drug.
• Only use parenteral therapy when oral therapy is not adequate/tolerated; start oral therapy as soon as possible.
• Oral: May administer without regard to food
• Oral: Administer immediate-release formulations with adequate amounts of fluids to reduce risk of esophageal irritation and ulceration; for extended-release formulations, this risk may be reduced when administered with food.
• Oral: Swallow capsules or tablets whole; do not chew, crush, or split.
• Since decomposed tetracyclines may cause potentially fatal nephrotoxicity (Fanconi's syndrome), discard outdated or decomposed medications.

Storage requirements:

• IV injection: Prior to reconstitution, store at 20C to 25C (68F to 77F); after dilution, may store at room temperature up to 4 hours or refrigerated at 2C to 8C (36F to 46F) up to 24 hours
• Oral formulations: Store at 20C to 25C (68F to 77F); protect from light, moisture, and excessive heat.

Reconstitution/preparation techniques:

• IV: The manufacturer product information should be consulted.

IV compatibility:

• Compatible solutions: Sterile Water for Injection USP; Sodium Chloride Injection USP; Dextrose Injection USP; Dextrose and Sodium Chloride Injection USP; Lactated Ringers Injection USP
• Incompatible: Other solutions containing calcium (especially neutral and alkaline solutions); additives or other medications

General:

• This drug is for the treatment of infections due to susceptible isolates of the designated bacteria.
• Extended-release formulations have not been evaluated for the treatment of infections.
• The usual dose and dosing frequency of this drug are different from other tetracyclines; side effects may occur more often if recommended dose exceeded.
• Thrombophlebitis may occur if IV therapy prolonged.
• Incision and drainage or other surgical procedures may be indicated in addition to antibiotic therapy.

Monitoring:

• General: Organ systems (periodically); serum magnesium levels in patients with renal dysfunction using IV injection
• Hematologic: Hematopoietic studies (periodically)
• Hepatic: Hepatic studies (periodically)
• Renal: Renal studies (periodically); BUN and creatinine in patients with renal dysfunction

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Drink plenty of fluids.
• Avoid missing doses and complete the entire course of therapy.
• Lightheadedness, dizziness, and vertigo reported; do not drive or operate machinery if these symptoms develop.
• Avoid or minimize exposure to natural or artificial sunlight; use sun protection (e.g., protective clothing, sunscreen) if sun exposure cannot be avoided. Stop therapy at first sign of skin erythema.
• Consult physician at once if watery and bloody stools (with or without stomach cramps and fever) develop.
• Do not use this drug if it is outdated or decomposed; discard this drug by the expiration date.