Zmax

Zmax®
(azithromycin extended release) Oral suspension

Read the Patient Information that comes with Zmax® carefully before you or your child take it. This leaflet does not take the place of talking with your doctor about you or your child's medical condition or treatment. Only your doctor can decide if Zmax is right for you or your child.

What is Zmax?

Zmax is an antibiotic that kills certain bacteria. Zmax is dosed differently from other antibiotics. You take just one dose, one time.

• Day 1: Take Zmax in one dose. Zmax starts working.
• Days 2 – 3: As with most antibiotics, you may not feel better right away.
• After Day 3: Zmax continues to work over time. If your symptoms are not better, call your doctor.

Zmax is used in adults and in children over the age of 6 months against bacteria to treat certain kinds of pneumonia (lung infections)

Zmax is used in adults against bacteria to treat sinus infections. Zmax only works against bacteria. It does not work against viruses, like the common cold or flu.

Zmax has not been studied in children under 6 months of age.

Who should not take Zmax?

• You or your child should not take Zmax if allergic to:
  • anything in Zmax. See the end of this leaflet for a complete list of ingredients in Zmax.
  • antibiotics like erythromycin or telithromycin (Ketek®).

Talk with your doctor or pharmacist if you have questions about your medicine allergies.

Before you start Zmax

Tell your doctor about all your or your child's medical problems including if you or your child:

• have liver problems.
• have kidney problems.
• have myasthenia gravis.
• are pregnant, or might be pregnant. It is not known if Zmax could harm your baby.
• are breast-feeding.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your doctor if you or your child are taking warfarin (Coumadin®, Jantoven)

Know the medicines you take. Keep a list of your medicines and show it to your doctor or pharmacist when you get a new prescription.

Do I need to prepare Zmax?

• If you get Zmax in liquid form, it is ready to take.
• If you get Zmax as dry powder, you must add water to the bottle
• before you take it. To prepare Zmax:

1. Open the bottle: To open the bottle, press down on the cap and twist.
2. Use a measuring cup to add 60 mL (1/4 cup) water to the Zmax bottle.
3. Tightly close the bottle and shake to mix it.

How do I take Zmax?

• Keep Zmax at room temperature between 59°F to 86°F (15° to 30°C).
• Shake the bottle well before using.
• Take Zmax or give it to your child within 12 hr after it has been prepared by the pharmacy or you add water to the powder.
• Take Zmax or give it to your child exactly how your doctor prescribes it. This will help to treat you or your child's infection and decrease the chance that Zmax or other antibiotics will not work to treat infections in the future.
• Adults: take all the medicine in the bottle.
• Children: give your child the amount of Zmax prescribed by your doctor and throw away the rest of the medicine.
• To be sure that you give your child the right dose of Zmax, use a dosing spoon, medicine syringe, or cup.
• Take Zmax on an empty stomach (at least 1 hr before eating or 2 hr after eating).
• You can take antacids with Zmax.
• If you or your child throws up (vomits) within one hr of taking Zmax, call your doctor right away to see if more medicine is needed. Do not give your child more Zmax unless your doctor tells you to.
• If your child takes too much Zmax, call your doctor right away or go to the nearest hospital emergency room.

How will I know Zmax is working?

Zmax needs time to work, so you or your child may not feel better right away. If you or your child's symptoms do not get better in a few days, call your doctor.

What are the possible side effects of Zmax?

Zmax may cause serious side effects. These happened in a small number of patients. Call your doctor right away or get emergency treatment if you or your child have any of the following:

• Serious allergic reaction or serious skin reaction: Get emergency help right away if you or your child has:
  • Skin rash (hives), sores in your mouth, or your skin blisters and peels
  • Trouble swallowing,
  • Swelling of your face, eyes, lips, tongue or throat
  • Wheezing or trouble breathing
  • New onset of fever and swollen lymph nodes

These symptoms could go away and then come back.

• Diarrhea: Call your doctor right away if you have diarrhea that does not go away, is severe, watery, or has blood in it. Diarrhea can occur as late as two or more months after you take an antibiotic such as Zmax.
• Abnormal heart rhythm. Tell your doctor right away if you or your child feel your heart beating in your chest or an abnormal heart beat, get dizzy or faint. This has been seen with other antibiotics like Zmax.

The most common side effects in adults are:

• Diarrhea/loose stools
• Nausea
• Stomach pain
• Headache
• Vomiting

The most common side effects in children are:

• Vomiting
• Diarrhea/loose stools
• Nausea
• Stomach pain

Tell your doctor if you have any side effects that bother your or your child, or that does not go away. These are not all of the possible side effects with Zmax. For a list of all reported side effects, ask your doctor or pharmacist.

General information about Zmax

Doctors sometimes prescribe medicines for conditions that are not in the patient leaflets. Do not use Zmax for anything other than what your doctor prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet is a summary of the most important information about Zmax. For more information, talk with your doctor. You can ask your doctor or pharmacist for information about Zmax that is written for healthcare professionals. For more information, go to our website at www.zmaxinfo.com or call 1-800-438-1985.

What is in Zmax?

Active ingredient: azithromycin dihydrate

Inactive ingredients: glyceryl behenate, poloxamer 407, sucrose, sodium phosphate tribasic anhydrous, magnesium hydroxide, hydroxypropyl cellulose, xanthan gum, colloidal silicon dioxide, titanium dioxide, artificial cherry flavor, and artificial banana flavor

Brand names are registered trademarks of their respective owners. Coumadin® is a registered trademark of Bristol-Myers Squibb, Inc. Ketek® is a registered trademark of Aventis Pharmaceuticals Inc.

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

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

Your pharmacist can provide more information about azithromycin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 16.02. Revision date: 9/13/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

• It is used to treat or prevent bacterial infections.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take on an empty stomach. Take 1 hour before or 2 hours after meals.
• Shake well before use.
• Use within 12 hours of making.
• If you throw up within 1 hour of taking Zmax, call your doctor to find out what to do.

What do I do if I miss a dose?

• Only 1 dose of this medicine is needed. If you miss your dose, take it as soon as you think about it.

• Store at room temperature. Do not refrigerate or freeze.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Acute Bacterial Sinusitis in Adults and Community-Acquired Pneumonia

Zmax (azithromycin) is a macrolide antibacterial drug indicated for the treatment with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. [See Clinical Studies (14)]

Acute bacterial sinusitis in adults due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.

Community-acquired pneumonia in adults and pediatric patients six months of age or older due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae, in patients appropriate for oral therapy. Pediatric use in this indication is based on extrapolation of adult efficacy. [See Use in Specific Populations (8.4)]

Limitations of Use

Zmax is not recommended for use 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 Zmax (azithromycin) and other antibacterial drugs, Zmax (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.

Hypersensitivity Reactions

Zmax is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin or any macrolide or ketolide drug.

Cholestatic Jaundice/Hepatic Dysfunction

Zmax is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.

Acute Bacterial Maxillary Sinusitis

Adult subjects with a diagnosis of acute bacterial maxillary sinusitis were evaluated in a randomized, double-blind, multicenter study; a maxillary sinus tap was performed on all subjects at baseline. Clinical evaluations were conducted for all subjects at the TOC visit, 7 to 14 days post-treatment. Two hundred seventy (270) subjects were treated with a single 2 g oral dose of Zmax and 268 subjects were treated with levofloxacin, 500 mg orally once daily for 10 days. A subject was considered a cure if signs and symptoms related to the acute infection had resolved, or if clinical improvement was such that no additional antibiotics were deemed necessary. The clinical response for the primary population, Clinical Per Protocol Subjects, is presented below.

Clinical response by pathogen in the Bacteriologic Per Protocol population is presented below.

Community-Acquired Pneumonia

Adult subjects with a diagnosis of mild-to-moderate community-acquired pneumonia were evaluated in two, randomized, double-blind, multicenter studies. In both studies, clinical and microbiologic evaluations were conducted for all subjects at the Test of Cure (TOC) visit, 7 to 14 days post-treatment. In Trial 1, 247 subjects were treated with a single 2 g oral dose of Zmax and 252 subjects were treated with clarithromycin extended-release, 1 g orally once daily for 7 days. In Trial 2, 211 subjects were treated with a single 2.0 g oral dose of Zmax and 212 subjects were treated with levofloxacin, 500 mg orally once daily for 7 days. A patient was considered a cure if signs and symptoms related to the acute infection had resolved, or if clinical improvement was such that no additional antibiotics were deemed necessary; in addition, the chest x-ray performed at the TOC visit was to be either improved or stable. The clinical response at TOC for the primary population, Clinical Per Protocol Subjects, is presented in the table below.

Clinical response by pathogen in the Bacteriologic Per Protocol population, across both studies, is presented below:

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Tenth Edition. CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Sixth Informational Supplement. CLSI document M100-S26, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2016.
3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
4. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Dilution and Disk Susceptibility Testing for Infrequently Isolated or Fastidious Bacteria: Approved GuidelinesThird Edition. CLSI document M45-A3, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2016.

NDC 0069-4170-34 for combined adult and pediatric use is supplied in bottles containing 2 g of azithromycin and should be constituted with 60 mL of water.

Storage

Before constitution, store dry powder at or below 30°C (86°F).

After constitution, store suspension at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Do not refrigerate or freeze.

Constituted suspension should be consumed within 12 hr. For adult patients, the entire bottle should be consumed. For pediatric patients, any suspension remaining after dosing MUST be discarded.

single use 2g bottle
NDC 0069-4170-34

Rx only

Zmax®
(azithromycin
extended release)
for oral suspension

2 g

Cherry-Banana Flavored

FOR ORAL USE ONLY