Azithromycin

Name: Azithromycin

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Pregnancy & Lactation

Pregnancy category: B

Lactation: Unknown whether drug is excreted into breast milk; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

How supplied

Dosage Forms And Strengths

ZITHROMAX 600 mg tablets (engraved on front with “PFIZER” and on back with “308”) are supplied as white, modified oval-shaped, film-coated tablets containing azithromycin dihydrate equivalent to 600 mg azithromycin. These are packaged in bottles of 30 tablets.

ZITHROMAX for oral suspension 1000 mg/5 mL is supplied in single-dose packets containing azithromycin dihydrate equivalent to 1 gram of azithromycin.

Storage And Handling

ZITHROMAX 600 mg tablets (engraved on front with “PFIZER” and on back with “308”) are supplied as white, modified oval-shaped, film-coated tablets containing azithromycin dihydrate equivalent to 600 mg azithromycin. These are packaged in bottles of 30 tablets. ZITHROMAX tablets are supplied as follows:

Bottles of 30 NDC 0069-3080-30

Tablets should be stored at or below 30°C (86°F).

ZITHROMAX for oral suspension is supplied in single-dose packets containing azithromycin dihydrate equivalent to 1 gram of azithromycin as follows:

Boxes of 10 single-dose packets (1 g) NDC 0069-3051-07
Boxes of 3 single-dose packets (1 g) NDC 0069-3051-75

Store single-dose packets between 5° and 30°C (41° and 86°F).

Distributed by: Pfizer Labs Division of Pfizer Inc., NY, NY 10017. Revised: Dec 2015

Overdose

Adverse reactions experienced at higher than recommended doses were similar to those seen at normal doses. In the event of overdosage, general symptomatic and supportive measures are indicated as required.

Azithromycin Drug Class

Azithromycin is part of the drug class:

  • Macrolides

What is azithromycin?

Azithromycin is an antibiotic that fights bacteria.

Azithromycin is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, and sexually transmitted diseases.

Azithromycin may also be used for purposes not listed in this medication guide.

Cautions for Azithromycin

Contraindications

  • Known hypersensitivity to azithromycin, erythromycin, any macrolide, or any ketolide.1 10 196 302

Warnings/Precautions

Warnings

Severe Pneumonia

Should not be used orally for treatment of moderate to severe pneumonia or when there are risk factors that make oral therapy inappropriate (e.g., cystic fibrosis, nosocomial infection, known or suspected bacteremia, illness requiring hospitalization, geriatric or debilitated status, immunodeficiency or functional asplenia or other underlying conditions that may compromise ability to respond to treatment).1 10

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.1 10 196 302 Institute appropriate therapy if superinfection occurs.1 10 196

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 10 196 302 C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including azithromycin, and may range in severity from mild diarrhea to fatal colitis.1 10 196 302 Hyper toxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.1 10 196 302

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1 10 196 302 Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.1 10 263 264 265 266 267 302

If CDAD is suspected or confirmed, azithromycin may need to be discontinued.1 10 196 263 264 265 266 267 302 Some mild cases may respond to discontinuance alone.263 264 265 266 267 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.1 10 196 263 264 265 266 267 302

Sensitivity Reactions

Hypersensitivity and Dermatologic Reactions

Serious allergic and dermatologic reactions (e.g., angioedema, anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis) have occurred.1 10 196 302 Fatalities reported.1 10 196 302

If a hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).1 10 196 302

Despite initially successful symptomatic management of allergic reactions, symptoms have recurred soon after symptomatic treatment was discontinued; the relationship between these episodes and the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is unknown.1 10 196 302

General Precautions

Cardiac Effects

Prolonged cardiac repolarization and QT interval with risk of cardiac arrhythmia and torsades de pointes reported with some macrolides.1 10 196 302 Possibility of such effects with azithromycin cannot be completely ruled out in patients at increased risk for prolonged cardiac repolarization.1 10 196 302

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of azithromycin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1 10 196 302

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 10 196 302 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1 10 196 302

Because S. pyogenes (group A β-hemolytic streptococci) resistant to azithromycin have been reported, in vitro susceptibility tests should be performed when the drug is used for treatment of pharyngitis and tonsillitis.1

Sodium Content

Conventional tablets: Each 250- or 500-mg tablet contains 0.9 or 1.8 mg of sodium, respectively,1 and each 600 mg tablet contains 2.1 mg of sodium.10

Conventional oral suspension: Each 5 mL containing 100 or 200 mg of azithromycin contains 3.7 or 7.4 mg of sodium, respectively.1 The single-dose 1-g oral suspension contains 37 mg of sodium per package.10

Extended-release oral suspension: 2-g dose contains 148 mg (6.43 mEq) of sodium.302

IV infusion: Each vial contains 114 mg (4.96 mEq) of sodium.196 (See Geriatric Use under Cautions.)

Specific Populations

Pregnancy

Category B.1 10 196 302

Lactation

Distributed into milk; 144 use with caution.1 10 196 302

Pediatric Use

Conventional tablets and oral suspension: Safety and efficacy not established for treatment of pharyngitis and tonsillitis in children <2 years of age1 or for treatment of AOM in children <6 months of age.1

Conventional tablets and oral suspension: Safety and efficacy of oral azithromycin not established for treatment of acute maxillary sinusitis in children <6 months of age.1 Use for sinusitis in those ≥6 months of age is supported by evidence from adequate and well-controlled studies in adults, similar pathophysiology of acute sinusitis in adults and pediatric patients, and studies of AOM in pediatric patients.1

Conventional tablets and oral suspension: Safety and efficacy of oral azithromycin not established for treatment of acute community-acquired pneumonia in children <6 months of age.1 Safety and efficacy for pneumonia caused by C. pneumoniae or M. pneumoniae were documented in pediatric trials; although safety and efficacy for pneumonia caused by H. influenzae or S. pneumoniae were not documented in pediatric trials, use for infections caused by these bacteria is supported by evidence from adequate and well-controlled studies in adults.1

Extended-release oral suspension: Safety and efficacy not established in pediatric patients.302

IV azithromycin: Safety and efficacy not established in children or adolescents <16 years of age.196

Manufacturer states that safety and efficacy of azithromycin not established for prevention or treatment of MAC infection in HIV-infected pediatric patients,10 but some experts recommend use of the drug for HIV-infected infants and children.234

Adverse effects reported in pediatric patients are similar to those reported in adults and generally involve the GI tract.1 10 Treatment-related reversible hearing impairment reported in some HIV-infected children receiving the drug for treatment of opportunistic infections.10

Geriatric Use

No overall differences in safety and efficacy of oral azithromycin in those ≥65 years of age compared with younger adults, but the possibility of increased sensitivity in some geriatric individuals cannot be ruled out.1 10 302

When used in a dosage >300 mg daily for a mean of 207 days for the treatment of various opportunistic infections (including MAC) in adults 65–94 years of age, adverse effect profile generally was similar to that in younger adults, except for a higher incidence of adverse GI effects and reversible hearing impairment.10

No overall differences in safety of IV azithromycin in those ≥65 years of age compared with younger adults; similar decreases in clinical response were noted with increasing age in both azithromycin- and comparator-treated patients.196

Azithromycin preparations contain sodium.1 10 196 302 (See Sodium Content under Cautions.) Patients receiving the usual IV dosage will receive 114 mg (4.96 mEq) of sodium per dose.196 Geriatric patients may respond to salt loading with blunted natriuresis,196 and the total sodium content from dietary and nondietary sources may be clinically important with regard to such diseases as congestive heart failure.196

Hepatic Impairment

Use caution.1 10 196 302

Pharmacokinetics not studied in hepatic impairment, but the drug is principally eliminated by the liver.1 10 196

Renal Impairment

Because of limited data, use caution if GFR <10 mL/minute.1 10 196 302

Clearance is decreased in severe renal impairment.1 10 196 (See Special Populations under Pharmacokinetics.)

Common Adverse Effects

Adverse GI effects, including diarrhea/loose stools, nausea, vomiting, abdominal pain.1 3 10 108 110 132 155 196 210 211 302 Adverse GI effects occur more frequently with single-dose regimens (1 or 2 g) than multiple-dose regimens.1 10

Adverse effects reported with long-term azithromycin used for prevention of MAC infection are similar to those reported with short-term dosage regimens but also included reversible hearing impairment.10

Local reactions (pain, inflammation) with IV administration.196

Uses For azithromycin

Azithromycin is used to treat certain bacterial infections in many different parts of the body. azithromycin may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.

Azithromycin belongs to the class of drugs known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, azithromycin will not work for colds, flu, or other virus infections.

azithromycin is available only with your doctor's prescription.

What is the most important information i should know about azithromycin?

You should not use this medication if you have ever had jaundice or liver problems caused by taking azithromycin. You should not use azithromycin if you are allergic to it or to similar drugs such as erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), clarithromycin (Biaxin), telithromycin (Ketek), or troleandomycin (Tao).

There are many other medicines that can interact with azithromycin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Azithromycin will not treat a viral infection such as the common cold or flu.

Avoid taking an antacid within 2 hours before or after you take azithromycin. Some antacids can make it harder for your body to absorb azithromycin.

What should i discuss with my healthcare provider before taking azithromycin?

You should not use this medication if you have ever had jaundice or liver problems caused by taking azithromycin. You should not use azithromycin if you are allergic to it or to similar drugs such as erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), clarithromycin (Biaxin), telithromycin (Ketek), or troleandomycin (Tao).

To make sure you can safely take azithromycin, tell your doctor if you have any of these other conditions:

  • liver disease;
  • kidney disease;
  • myasthenia gravis;
  • a heart rhythm disorder; or
  • a history of Long QT syndrome.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether azithromycin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 6 months old.

Older adults may be more likely to have side effects on heart rhythm, including a life-threatening fast heart rate.

What happens if i miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Usual Adult Dose for Nongonococcal Urethritis

Non-gonococcal urethritis and cervicitis:
-Immediate-release: 1 g orally once

Comment: A 1 g oral dose given once a week for 3 weeks may be effective in the treatment of lymphogranuloma venereum due to Chlamydia trachomatis.

Uses:
-Treatment of mild to moderate urethritis and cervicitis due to C trachomatis
-Treatment of nongonococcal urethritis, cervicitis, and chlamydial infections

Usual Adult Dose for Pelvic Inflammatory Disease

500 mg IV once a day for 1 or 2 days, followed by 250 mg (immediate-release formulation) orally once a day to complete a 7-day course of therapy

Comment: Antimicrobial drugs with anaerobic activity should be used concurrently if anaerobic microorganisms are suspected in contributing to the infection.

Use: Treatment of pelvic inflammatory disease due to C trachomatis, N gonorrhoeae, or Mycoplasma hominis

Usual Adult Dose for Bronchitis

Immediate-release: 500 mg orally once a day for 3 days OR 500 mg orally as a single dose on day 1, followed by 250 mg orally once a day on days 2 to 5

Uses:
-Mild to moderate acute bacterial exacerbations of COPD
-Treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis due to H influenzae, M catarrhalis, or S pneumoniae

Usual Adult Dose for Granuloma Inguinale

US CDC Recommendations:
Immediate-release: 1 g orally once a week OR 500 mg orally once a day for at least 3 weeks and until all lesions have completely healed

Comments:
-Patients diagnosed with granuloma inguinale should be tested for HIV.
-Patients should be monitored until all signs/symptoms have resolved.
-The patient's sexual partner(s) during the 60 days preceding the onset of symptoms should be evaluated and offered treatment.

Use: Treatment of granuloma inguinale/donovanosis caused by Klebsiella granulomatis

Usual Adult Dose for Pertussis

American Society for Blood and Marrow Transplantation (ASBMT) and IDSA Recommendations:
Immediate-release:
Immunization against pertussis:
-Alternative treatment: 250 mg orally once a day

Postexposure prophylaxis: 500 mg orally once on day 1, then 250 mg orally once a day for 4 days

Comments:
-Patients should receive the acellular pertussis vaccine after hematopoietic cell transplantation (HCT).
-Treatment with this drug may be given to patients with an incomplete vaccination series.

Uses:
-Immunization against pertussis for adult recipients after HCT
-Postexposure prophylaxis for HCT recipients, regardless of vaccination status
-Prophylaxis against bacterial infections

Usual Adult Dose for Lyme Disease - Erythema Chronicum Migrans

IDSA Recommendations:
Immediate-release:
Early Lyme disease: 500 mg orally once a day for 7 to 10 days

Comment: Use should be reserved for patients who are intolerant or should not take amoxicillin, doxycycline, and cefuroxime axetil.

Use: Alternative treatment for early Lyme disease

Usual Adult Dose for Babesiosis

IDSA Recommendations:
Immediate-release: 500 to 1000 mg orally once on day 1, followed by 250 mg orally once a day for a total of 7 to 10 days

Comments:
-This drug should be taken in combination with atovaquone.
-Immunocompromised patients may be given 600 to 1000 mg orally on day 1.

Use: Treatment of babesiosis

Usual Adult Dose for Shigellosis

NIH Recommendations:
Immediate-release:
Campylobacteriosis:
-Mild to moderate disease: 500 mg orally once a day for 5 days

Shigellosis:
-Alternative therapy: 500 mg orally once a day for 5 days

Comment: This drug should not be used to treat Shigella or Campylobacter bacteremia.

Uses:
-Treatment of gastroenteritis caused by Shigella infection
-Treatment of mild to moderate campylobacteriosis

Usual Adult Dose for Upper Respiratory Tract Infection

ASBMT and IDSA Recommendations:
Immediate-release:
Bacterial infections within the first 100 days of HCT:
-Alternative treatment: 250 mg orally once a day

Use: Prevention of bacterial infections for HCT patients with anticipated neutropenic periods of at least 7 days

Usual Pediatric Dose for Mycoplasma Pneumonia

6 months and older:
Immediate-release: 10 mg/kg (maximum: 500 mg/dose) orally on day 1, followed by 5 mg/kg (250 mg/dose) orally once a day on days 2 to 5
Extended-release:
-Patients less than 34 kg: 60 mg/kg (maximum dose: 2 g/dose) orally as a single dose
-Patients 34 kg or greater: 2 g orally as a single dose

16 years and older:
Parenteral: 500 mg IV once a day as a single dose for at least 2 days, followed by 500 mg (immediate-release formulation) orally to complete a 7- to 10-day course of therapy

Comment: Extended-release formulations should be taken on an empty stomach.

Uses:
-Treatment of mild to moderate community acquired pneumonia due to C pneumoniae, H influenzae, M pneumonia, or S pneumoniae in patients appropriate for oral therapy
-Treatment of community-acquired pneumonia due to C pneumoniae, H influenzae, L pneumophila, M catarrhalis, M pneumoniae, or S pneumoniae in patients who require initial IV therapy

IDSA and Pediatric Infectious Disease Society (PIDS) Recommendations:
3 months to less than 5 years:
Parenteral: 10 mg/kg on days 1 and 2 of treatment, transitioning to oral treatment when possible
Oral: 10 mg/kg orally on day 1, then 5 mg/kg/day orally once a day on days 2 to 5

5 years and older:
Oral: 10 mg/kg (maximum: 500 mg/day) orally on day 1, followed by 5 mg/kg/day (maximum: 250 mg/day) orally on days 2 to 5

Comments:
-Oral therapy may be used in patients with mild infections and/or as outpatient empiric therapy for patients with presumed atypical pneumonia.
-Beta lactam antibiotics may be added to inpatients with presumed atypical pneumonia if diagnosis is in doubt.

Uses:
-Treatment of community-acquired pneumonia caused by M pneumoniae, C trachomatis, or C pneumoniae
-Treatment of presumed atypical pneumonia in outpatient and inpatient settings

Usual Pediatric Dose for Bacterial Infection

American Academy of Pediatrics (AAP) Recommendations:
Immediate-release:
Less than 1 month:
-IV: 10 mg/kg IV every 24 hours
-Oral: 10 to 20 mg/kg orally every 24 hours

1 month or older:
-Mild to moderate infections: 5 to 12 mg/kg orally once a day
-Severe infections: 10 mg/kg IV once a day

Comments:
-The single or total course dose for adult oral therapy is 1.5 to 2 g.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Gonococcal Infection - Uncomplicated

US CDC Recommendations:
Immediate-release:
Adolescents:
-Recommended regimen: 1 g orally once as a single dose plus ceftriaxone
-Alternative regimen: 1 g orally once as a single dose plus cefixime

Comments:
-The alternative regimen may be used for uncomplicated infections if ceftriaxone is unavailable.
-Arthritis and arthritis-dermatitis syndrome may be treated with 1 g orally once plus cefotaxime OR ceftizoxime.

Uses:
-Uncomplicated gonococcal infections of the pharynx, cervix, urethra, and rectum
-Treatment of gonococcal conjunctivitis
-Treatment of arthritis and arthritis-dermatitis syndrome caused by disseminated gonococcal infection
-Treatment of gonococcal meningitis and endocarditis

Usual Pediatric Dose for Chlamydia Infection

US CDC Recommendations:
Immediate-release:
30 days or younger:
-Ophthalmia neonatorum: 20 mg/kg orally (oral suspension) once a day for 3 days

1 to 3 months:
-Infant pneumonia: 20 mg/kg orally (oral suspension) once a day for 3 days

Children less than 8 years who weigh 45 kg or more, and patients 8 years or older: 1 g orally as a single dose

Comments:
-Neonates should be monitored for signs/symptoms of hypertrophic pyloric stenosis.
-Healthcare providers should follow-up to determine whether treatment was effective.

Uses:
-Alternative treatment of ophthalmia neonatorum caused by C trachomatis
-Alternative treatment of chlamydial pneumonia in infants
-Treatment of chlamydial infections in children

Precautions

Safety and efficacy of immediate-release formulations in the treatment of otitis media, acute bacterial sinusitis, and community-acquired pneumonia have not been established in patients younger than 6 months, and the safety and efficacy of immediate-release formulations in the treatment of tonsillitis/pharyngitis have not been established in patients younger than 2 years. Safety and efficacy of parenteral formulations have not been established in patients younger than 16 years.

Consult WARNINGS section for additional precautions.

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