Zithromax azithromycin dihydrate

Get an overview of ZITHROMAX (azithromycin dihydrate powder, for suspension), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Zithromax can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Zithromax.

Drug Basics

Brand Name: Zithromax

Generic Name: AZITHROMYCIN DIHYDRATE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: POWDER, FOR SUSPENSION

Data Current As Of: 2020-01-20

indications & usage

ZITHROMAX (azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)]

ZITHROMAX is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:

  • Acute bacterial exacerbations of chronic bronchitis in adults (1.1)
  • Acute bacterial sinusitis in adults (1.1)
  • Uncomplicated skin and skin structure infections in adults (1.1)
  • Urethritis and cervicitis in adults (1.1)
  • Genital ulcer disease in men (1.1)
  • Acute otitis media in pediatric patients (6 months of age and older) (1.2)
  • Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2)
  • Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2)

Limitation of Use:

Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. (1.3)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (azithromycin) should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.4)

adult patients

  • Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
  • Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis. or Streptococcus pneumoniae.
  • Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.
  • Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
  • Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae.
  • Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.
  • Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.

pediatric patients

[see Use in Specific Populations (8.4) and Clinical Studies (14.2)]

  • Acute otitis media (>6 months of age) caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
  • Community-acquired pneumonia (>6 months of age) due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.
  • Pharyngitis/tonsillitis (>2 years of age) caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.

limitations of use

Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:

  • patients with cystic fibrosis,
  • patients with nosocomial infections,
  • patients with known or suspected bacteremia,
  • patients requiring hospitalization,
  • elderly or debilitated patients, or
  • patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).

usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (azithromycin) should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

drug interactions

  • Nelfinavir: Close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. (7.1)
  • Warfarin: Use with azithromycin may increase coagulation times; monitor prothrombin time. (7.2)

nelfinavir

Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations. Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. [see Adverse Reactions (6)]

warfarin

Spontaneous postmarketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly.

potential drug-drug interaction with macrolides

Interactions with digoxin, colchicine or phenytoin have not been reported in clinical trials with azithromycin. No specific drug interaction studies have been performed to evaluate potential drug-drug interaction. However, drug interactions have been observed with other macrolide products. Until further data are developed regarding drug interactions when digoxin, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised.

patient counseling information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

General Patient Counseling

ZITHROMAX tablets and oral suspension can be taken with or without food.

Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously.

The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur.

Direct parents or caregivers to contact their physician if vomiting and irritability with feeding occurs in the infant.

Patients should be counseled that antibacterial drugs including ZITHROMAX (azithromycin) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ZITHROMAX (azithromycin) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of the 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 ZITHROMAX (azithromycin) or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibacterials which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials 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.

Licensed from Pliva

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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LAB-0023-21.0

patient information

ZITHROMAX® (Zith-roe-maks)
(azithromycin)
Tablets

ZITHROMAX®
(azithromycin)
Oral Suspension

Read this Patient Information leaflet before you start taking ZITHROMAX and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is ZITHROMAX?

ZITHROMAX is a macrolide antibiotic prescription medicine used in adults 18 years or older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:

  • acute worsening of chronic bronchitis
  • acute sinus infection
  • community-acquired pneumonia
  • infected throat or tonsils
  • skin infections
  • infections of the urethra or cervix
  • genital ulcers in men

ZITHROMAX is also used in children to treat:

  • ear infections
  • community-acquired pneumonia
  • infected throat or tonsils

Azithromycin should not be taken by people who cannot tolerate oral medications because they are very ill or have certain other risk factors including:

  • have cystic fibrosis
  • have hospital acquired infections
  • have known or suspected bacteria in the blood
  • need to be in the hospital
  • are elderly
  • have any medical problems that can lower the ability of the immune system to fight infections

ZITHROMAX is not for viral infections such as the common cold.

It is not known if ZITHROMAX is safe and effective for genital ulcers in women.

It is not known if ZITHROMAX is safe and effective for children with ear infections, sinus infections, and community-acquired pneumonia under 6 months of age.

It is not known if ZITHROMAX is safe and effective for infected throat or tonsils in children under 2 years of age.

Who should not take ZITHROMAX?

Do not take ZITHROMAX if you:

  • have had a severe allergic reaction to certain antibiotics known as macrolides or ketolides including azithromycin and erythromycin.
  • have a history of cholestatic jaundice or hepatic dysfunction that happened with the use of azithromycin.

What should I tell my healthcare provider before taking ZITHROMAX?

Before you take ZITHROMAX, tell your healthcare provider if you:

  • have pneumonia
  • have cystic fibrosis
  • have known or suspected bacteremia (bacterial infection in the blood)
  • have liver or kidney problems
  • have an irregular heartbeat, especially a problem called "QT prolongation"
  • have a problem that causes muscle weakness (myasthenia gravis)
  • have any other medical problems
  • are pregnant or plan to become pregnant. It is not known if ZITHROMAX will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. ZITHROMAX has been reported to pass into breast milk. Talk to your healthcare provider about the best way to feed your baby while you take ZITHROMAX.

Contact your healthcare provider immediately if you are giving ZITHROMAX to a young child (less than 6 weeks of age) and he or she vomits or becomes irritable when fed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

ZITHROMAX and other medicines may affect each other causing side effects. ZITHROMAX may affect the way other medicines work, and other medicines may affect how ZITHROMAX works.

Especially tell your healthcare provider if you take:

  • nelfinavir
  • a blood thinner (warfarin)
  • digoxin
  • colchicine
  • phenytoin
  • an antacid that contains aluminum or magnesium

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take ZITHROMAX?

  • Take ZITHROMAX exactly as your healthcare provider tells you to take it.
  • ZITHROMAX can be taken with or without food.
  • If you take ZITHROMAX Oral Suspension, shake the bottle well just before you take it.
  • Do not skip any doses of ZITHROMAX or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless you have a serious allergic reaction or your healthcare provider tells you to stop taking ZITHROMAX. "See What are the possible side effects of ZITHROMAX?" If you skip doses, or do not complete the total course of ZITHROMAX your treatment may not work as well and your infection may be harder to treat. Taking all of your ZITHROMAX doses will help lower the chance that the bacteria will become resistant to ZITHROMAX.
  • If the bacteria becomes resistant to ZITHROMAX, ZITHROMAX and other antibiotic medicines may not work for you in the future.
  • If you take too much ZITHROMAX, call your healthcare provider or get medical help right away.

What are the possible side effects of ZITHROMAX?

ZITHROMAX can cause serious side effects, including:

  • Serious allergic reactions. Allergic reactions can happen in people taking azithromcyin the active ingredient in ZITHROMAX, even after only 1 dose. Stop taking ZITHROMAX and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction:

    Stop taking ZITHROMAX at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to ZITHROMAX.

  • Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take ZITHROMAX. Call your healthcare provider right away if you have unexplained symptoms such as:
    • nausea or vomiting
    • stomach pain
    • fever
    • weakness
    • abdominal pain or tenderness
    • itching
    • unusual tiredness
    • loss of appetite
    • change in the color of your bowel movements
    • dark colored urine
    • yellowing of your skin or of the whites of your eyes

    Stop taking ZITHROMAX and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to ZITHROMAX (a liver problem).

  • Serious heart rhythm changes (QT prolongation and torsades de pointes).
    Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel faint and dizzy. ZITHROMAX may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this happening are higher in people:
    • who are elderly
    • with a family history of prolonged QT interval
    • with low blood potassium
    • who take certain medicines to control heart rhythm (antiarrhythmics)
  • Worsening of myasthenia gravis (a problem that causes muscle weakness). Certain antibiotics like ZITHROMAX may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
  • Diarrhea. Tell your healthcare provider right away if you have watery diarrhea, diarrhea that does not go away, or bloody stools. You may experience cramping and a fever. This could happen after you have finished your ZITHROMAX.
    The most common side effects of ZITHROMAX include:

These are not all the possible side effects of ZITHROMAX. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZITHROMAX?

  • Store ZITHROMAX Tablets at 59°F to 86°F (15°C to 30°C).
  • Store ZITHROMAX Oral Suspension at 41°F to 86°F (5°C to 30°C).
  • Keep ZITHROMAX Oral Suspension in a tightly closed container.
  • Safely throw away any medicine that is out of date or no longer needed.

Keep ZITHROMAX and all medicines out of the reach of children.

General information about the safe and effective use of ZITHROMAX.

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use ZITHROMAX for a condition for which it was not prescribed.

Do not give ZITHROMAX to other people, even if they have the same symptoms you have.

It may harm them.

This Patient Information leaflet summarizes the most important information about ZITHROMAX. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ZITHROMAX that is written for health professionals.

For more information, go to www.zithromax.com or call 1-800-438-1986.

What are the ingredients in ZITHROMAX Tablets and Oral Suspension?

ZITHROMAX Tablets and Oral Suspension

Active ingredient: azithromycin dehydrate

ZITHROMAX Tablets:

Inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide, triacetin, and D&C Red #30 aluminum lake.

ZITHROMAX Oral Suspension:

Inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla, and banana flavors.

This Patient Information has been approved by the U.S. Food and Drug Administration.

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LAB-0372-6.0
Revised April 2019

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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