Drug Information for Zmax (Pfizer, Inc): PATIENT COUNSELING INFORMATION

  • See FDA-approved Patient Labeling (17.2)

  • 17.1 General Patient Counseling

    • Patients should be instructed to take Zmax on an empty stomach (at least 1 hour before or 2 hours following a meal).
    • To ensure accurate dosing for children, use of a dosing spoon, medicine syringe, or cup is recommended.
    • Patients should be told that Zmax needs time to work, so the patient may not feel better right away. If the patient's symptoms do not improve in a few days, the patient or their guardian should call their doctor.
    • Patients should be instructed to immediately contact a physician if any signs of an allergic reaction occur.
    • Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, 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 antibiotic. If this occurs, patients should contact their physician as soon as possible.
    • Patients who vomit within the first hour should contact their health care provider about further treatment.
    • Keep bottle tightly closed. Store at room temperature. Use within 12 hours of constitution. Shake bottle well before use. Adult patients should consume the entire contents of the bottle; pediatric patients should take the recommended dose and MUST discard any unused portion.
    • Patients should be advised that Zmax may be taken without regard to antacids containing magnesium hydroxide and/or aluminum hydroxide.

    Patients should be counseled that antibacterial drugs including Zmax should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). Not taking the complete prescribed dose 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 Zmax or other antibacterial drugs in the future.

  • 17.2 FDA-approved patient labeling

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

    How do I take Zmax?

    • Keep Zmax at room temperature between 59ºF to 86ºF (15º to 30ºC).
    • Shake the bottle well before using.
    • Take Zmax or give it to your child within 12 hours 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 hour before eating or 2 hours after eating).
    • You can take antacids with Zmax.
    • If you or your child throws up (vomits) within one hour 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 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:
      • Hives, skin rash, 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

    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 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

  • Drug Information Provided by National Library of Medicine (NLM).