Patient Information
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 healthcare provider about you or your child's medical condition or treatment. Only your healthcare provider 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 healthcare provider.

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 healthcare provider or pharmacist if you have questions about your medicine allergies.

Before you start Zmax

Tell your healthcare provider 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.

Contact your healthcare provider immediately if you are giving Zmax 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.

Zmax and other medicines may affect each other causing side effects. Zmax may affect the way other medicines work, and other medicines may affect how Zmax 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 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 healthcare provider 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 healthcare provider 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 healthcare provider right away to see if more medicine is needed. Do not give your child more Zmax unless your healthcare provider tells you to.
• If your child takes too much Zmax, call your healthcare provider 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 healthcare provider.

What are the possible side effects of Zmax?

Zmax may cause serious side effects. These happened in a small number of patients. Call your healthcare provider 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 healthcare provider 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.
• Serious heart rhythm changes that can be life-threatening, including heart stopping (cardiac arrest), QT prolongation, torsades de pointes, feeling that your heart is pounding or racing (palpitations), chest discomfort, or irregular heartbeat: Tell your healthcare provider right away if you or your child feel a fast or irregular heartbeat, get dizzy or faint. This has been seen with other antibiotics like Zmax.
  Zmax 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)

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 healthcare provider 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 healthcare provider or pharmacist.

General information about Zmax

Healthcare providers sometimes prescribe medicines for conditions that are not in the patient leaflets. Do not use Zmax for anything other than what your healthcare provider 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 healthcare provider. You can ask your healthcare provider 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.

LAB-0606-7.0
Revised November 2021