Zmax™
(azithromycin extended release) for oral suspension

Zmax (azithromycin extended release) for oral suspension contains the active ingredient azithromycin (as azithromycin dihydrate), an azalide, a subclass of macrolide antibiotics. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C₃₈H₇₂N₂O₁₂, and its molecular weight is 749.0. Azithromycin has the following structural formula:

Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C₃₈H₇₂N₂O₁₂•2H₂O and a molecular weight of 785.0.

Zmax is a single-dose, extended release formulation of microspheres for oral suspension containing azithromycin (as azithromycin dihydrate) and the following excipients: 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.

Each bottle contains azithromycin dihydrate equivalent to 2.0 g of azithromycin.  It is constituted with 60 mL of water and the entire spans are administered orally as a single dose. 

Zmax is an extended release microsphere formulation.  Based on data obtained from studies evaluating the pharmacokinetics (PK) of azithromycin in healthy adult subjects a higher peak serum concentration (C_max) and greater systemic exposure (AUC_0–24) of azithromycin are achieved on the day of dosing following a single 2.0 g dose of Zmax versus 1.5 g of azithromycin tablets administered over 3 days (500 mg/day) or 5 days (500 mg on day 1, 250 mg/day on days 2–5) [Table 1]. Consequently, due to these different PK profiles, Zmax is not interchangeable with azithromycin tablet 3-day and 5-day dosing regimens.

Drug interaction studies were performed with azithromycin capsules and tablets (doses ranged from 500 to 1200 mg) and drugs likely to be co-administered. The effects of co-administration of azithromycin on the pharmacokinetics of other drugs are shown in Table 3 and the effects of other drugs on the pharmacokinetics of azithromycin are shown in Table 4.

Co-administration of azithromycin capsules and tablets at therapeutic doses had a modest effect on the pharmacokinetics of the drugs uled in Table 3. Although the drug interaction studies were not conducted with Zmax, no potential drug interactions are expected since the total exposure to azithromycin is comparable for Zmax and the other azithromycin regimens. Therefore, no dosage adjustment of drugs uled in Table 3 is recommended when co-administered with Zmax. (See PRECAUTIONS - Drug Interactions.)

Co-administration of azithromycin tablets with efavirenz or fluconazole had a modest effect on the pharmacokinetics of azithromycin. Nelfinavir significantly increased the C_max and AUC of azithromycin. Similar results are expected with Zmax. Although no dosage adjustment of Zmax is recommended when administered with drugs uled in Table 4, close monitoring for known side effects of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted when co-administered with nelfinavir. (See PRECAUTIONS - Drug Interactions.)

Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms, thus interfering with microbial protein synthesis. Nucleic acid synthesis is not affected.

Azithromycin concentrates in fibroblasts, epithelial cells, macrophages, and circulating neutrophils and monocytes. In vitro incubation techniques have shown that the ratio of intracellular to extracellular concentration was >30 after one hour incubation. In vivo studies suggest that concentration in macrophages and circulating white blood cells may contribute to drug distribution to inflamed tissues.

Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Aerobic and facultative Gram-positive microorganisms
    Streptococcus pneumoniae

NOTE: Erythromycin- and penicillin-resistant Gram-positive isolates may demonstrate cross-resistance to azithromycin.

Aerobic and facultative Gram-negative microorganisms
    Haemophilus influenzae
    Moraxella catarrhalis

"Other" microorganisms
    Chlamydophila pneumoniae
    Mycoplasma pneumoniae

Beta-lactamase production should not affect azithromycin activity.

The following in vitro data are available, but their clinical significance is unknown.

At least 90% of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoints for azithromycin. However, the safety and effectiveness of azithromycin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled trials.

Aerobic and facultative Gram-positive microorganisms
    Staphylococcus aureus
    Streptococcus pyogenes
    Streptococcus agalactiae
    Streptococci (Groups C, F, G)
    Viridans group streptococci

Aerobic and facultative Gram-negative microorganisms
    Bordetella pertussis
    Legionella pneumophila

Anaerobic microorganisms
    Peptostreptococcus species
    Prevotella bivia

"Other" microorganisms
    Ureaplasma urealyticum

When available, the clinical microbiology laboratory should provide cumulative results of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial.

Zmax is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions uled below. Please see DOSAGE AND ADMINISTRATION for specific dosing recommendations.

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. (See CLINICAL STUDIES.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Zmax and other antibacterial drugs, Zmax 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.

Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to Zmax. Therapy with Zmax may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.

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

Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in patients on azithromycin therapy using other formulations. Although rare, fatalities have been reported. (SeeCONTRAINDICATIONS.) Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure. These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of azithromycin and subsequent exposure to antigen has not been determined.

If an allergic reaction occurs, appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.

Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis."

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

Because azithromycin is principally excreted via the liver, caution should be exercised when azithromycin is administered to patients with impaired hepatic function. Due to the limited data in subjects with GFR <10 mL/min, caution should be exercised when prescribing azithromycin in these patients. (See CLINICAL PHARMACOLOGY - Special Populations - Renal Insufficiency.)

Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with other macrolides. A similar effect with azithromycin cannot be completely ruled out in patients at increased risk for prolonged cardiac repolarization.

Prescribing Zmax in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Patients should be instructed to take Zmax on an empty stomach (at least 1 hour before or 2 hours following a meal).

Patients should be instructed to immediately contact a physician if any signs of an allergic reaction occur.

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. The entire spans of the bottle should be consumed.

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.

Co-administration of nelfinavir at steady-state with a single dose of azithromycin (2 × 600 mg tablets) results in increased azithromycin serum concentrations. Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known side effects of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. (See ADVERSE REACTIONS.)

Azithromycin did not affect the prothrombin time response to a single dose of warfarin. However, prudent medical practice dictates careful monitoring of prothrombin time in all patients treated with azithromycin and warfarin concomitantly. Concurrent use of macrolides and warfarin in clinical practice has been associated with increased anticoagulant effects.

Drug interaction studies were performed with azithromycin and other drugs likely to be co-administered. (See CLINICAL PHARMACOLOGY - Drug-Drug Interactions.) When used in therapeutic doses, azithromycin had a modest effect on the pharmacokinetics of atorvastatin, carbamazepine, cetirizine, didanosine, efavirenz, fluconazole, indinavir, midazolam, rifabutin, sildenafil, theophylline (intravenous and oral), triazolam, trimethoprim/sulfamethoxazole or zidovudine. Co-administration with efavirenz or fluconazole had a modest effect on the pharmacokinetics of azithromycin. No dosage adjustment of either drug is recommended when azithromycin is co-administered with any of the above agents.

Interactions with the drugs uled below have not been reported in clinical trials with azithromycin; however, no specific drug interaction studies have been performed to evaluate potential drug-drug interaction. Nonetheless, they have been observed with macrolide products. Until further data are developed regarding drug interactions when azithromycin and these drugs are used concomitantly, careful monitoring of patients is advised:

•  Digoxin–elevated digoxin concentrations.
•  Ergotamine or dihydroergotamine–acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia.
•  Cyclosporine, hexobarbital and phenytoin concentrations.

There are no reported laboratory test interactions.

Studies evaluating the use of repeated courses of Zmax have not been conducted.

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Azithromycin has shown no mutagenic potential in standard laboratory tests: mouse lymphoma assay, human lymphocyte clastogenic assay, and mouse bone marrow clastogenic assay. No evidence of impaired fertility due to azithromycin was found in rats given daily doses up to 10 mg/kg (approximately 0.05 times the single 2.0 g oral adult human dose on a mg/m² basis).

It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.

Data collected from the azithromycin capsule and tablet formulations indicate that a dosage adjustment does not appear to be necessary for older patients with normal renal function (for their age) and hepatic function receiving treatment with Zmax.

In clinical trials of Zmax, 16.6% of subjects were at least 65 years of age (214/1292) and 4.6% of subjects (59/1292) were at least 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Zmax 2.0 g oral suspension contains 148 mg of sodium.

In controlled Phase 3 clinical trials with Zmax, the majority of the reported treatment-related adverse reactions were gastrointestinal in nature and mild to moderate in severity.

Overall, the most common treatment-related adverse reactions in adult subjects receiving a single 2.0 g dose of Zmax were diarrhea/loose stools (11.6%), nausea (3.9%), abdominal pain (2.7%), headache (1.3%), and vomiting (1.1%). The incidence of treatment-related gastrointestinal adverse reactions was 17.2% for Zmax and 9.7% for pooled comparators.

No other treatment-related adverse events occurred in subjects on Zmax with a frequency of ≥1%.

Treatment-related adverse reactions following Zmax treatment that occurred with a frequency of <1% included the following:

Cardiovascular: palpitations, chest pain
Gastrointestinal: constipation, dyspepsia, flatulence, gastritis, oral moniliasis, loose stools
Genitourinary: vaginitis
Nervous System: dizziness, vertigo
General: asthenia
Allergic: rash, pruritus, urticaria
Special Senses: taste perversion

In subjects with normal baseline values, the following clinically significant laboratory abnormalities (irrespective of drug relationship) were reported in Zmax clinical trials:

• -with an incidence of greater than or equal to 1%: reduced lymphocytes and increased eosinophils; reduced bicarbonate;
• -with an incidence of less than 1%: leukopenia, neutropenia, elevated bilirubin, AST, ALT, BUN, creatinine, alterations in potassium.

Where follow-up was provided, changes in laboratory tests appeared to be reversible.

Adverse events reported with azithromycin during the post-marketing period for which a causal relationship may not be established include:

Allergic: arthralgia, edema, urticaria and angioedema
Cardiovascular: palpitations and arrhythmias including ventricular tachycardia and hypotension
There have been rare reports of QT prolongation and torsades de pointes.
Gastrointestinal: anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea rarely resulting in dehydration, pseudomembranous colitis, pancreatitis, oral candidiasis and rare reports of tongue discoloration
General: asthenia, paresthesia, fatigue, malaise and anaphylaxis (rarely fatal)
Genitourinary: interstitial nephritis,acute renal failure, moniliasis and vaginitis
Hematopoietic: thrombocytopenia, mild neutropenia
Liver/Biliary: abnormal liver function including hepatitis and cholestatic jaundice, as well as rare cases of hepatic necrosis and hepatic failure, some of which have resulted in death
Nervous System: convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope
Psychiatric: aggressive reaction and anxiety
Skin/Appendages: pruritus, rash, photosensitivity, rarely serious skin reactions including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
Special Senses: hearing disturbances including hearing loss, deafness and/or tinnitus and rare reports of taste/smell perversion and/or loss

(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)

Zmax should be taken as a single 2.0 g dose. Zmax provides a full course of antibacterial therapy in a single oral dose. It is recommended that Zmax be taken on an empty stomach (at least 1 hour before or 2 hours following a meal).

In the Phase 3 program, no patient vomited within 5 minutes of dosing Zmax. In the event that a patient vomits within 5 minutes of administration, the health care provider should consider additional antibiotic treatment since there would be minimal absorption of azithromycin. Since insufficient data exist on absorption of azithromycin if a patient vomits between 5 and 60 minutes following administration, alternative therapy should be considered. Neither a second dose of Zmax nor alternative treatment is warranted if vomiting occurs ≥60 minutes following administration, in patients with normal gastric emptying.

Constitute with 60 mL of water and replace cap. Shake bottle well before dispensing.

Zmax is supplied in bottles (NDC 0069-4170-21) containing 2.0 g of azithromycin and should be constituted with 60 mL of water.

See DOSAGE AND ADMINISTRATION for constitution instructions.

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 hours.

(See INDICATIONS AND USAGE)

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 the first study, 247 subjects were treated with a single 2.0 g oral dose of Zmax and 252 subjects were treated with clarithromycin extended release, 1 g orally QD for 7 days. In the second study, 211 subjects were treated with a single 2.0 g oral dose of Zmax and 212 subjects were treated with levofloxacin, 500 mg orally QD 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:

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 2.0 g oral dose of Zmax and 268 subjects were treated with levofloxacin, 500 mg orally QD 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.

Phospholipidosis (intracellular phospholipid accumulation) has been observed in some tissues of mice, rats, and dogs given multiple doses of azithromycin. It has been demonstrated in numerous organ systems (e.g., eye, dorsal root ganglia, liver, gallbladder, kidney, spleen, and/or pancreas) in dogs treated with azithromycin at doses which, expressed on the basis of mg/m², are approximately one-sixth the recommended adult dose, and in rats treated at doses approximately one-fourth the recommended adult dose. This effect has been shown to be reversible after cessation of azithromycin treatment. Based on the pharmacokinetic data, phospholipidosis has been seen in the rat (50 mg/kg/day dose) at the observed maximal plasma concentration of 1.3 µg/mL (1.6 times the observed C_max of 0.821 µg/mL at the adult dose of 2.0 g.) Similarly, it has been shown in the dog (10 mg/kg/day dose) at the observed maximal serum concentration of 1.0 µg/mL (1.2 times the observed C_max of 0.821 µg/mL at the adult dose of 2.0 g. The significance of the finding for animals and for humans is unknown.

• National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically - Sixth Edition. Approved Standard NCCLS Document M7-A6 [ISBN 1-56238-486-4]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2003.
• National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests - Eighth Edition. Approved Standard NCCLS Document M2-A8 (ISBN 1-56238-485-6). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2003.
• National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Susceptibility Testing - Fourteenth Informational Supplement. NCCLS Document M100-S14 [ISBN1-56238-516-X]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

Zmax™
(azithromycin extended release)
for oral suspension

(ZEE-macks)

Read this patient information leaflet carefully before taking Zmax™. It does not replace talking with your doctor. Only your doctor can decide if Zmax is right for you. If you have any questions, ask your doctor or pharmacist.

What is Zmax?

Zmax is an antibiotic that kills 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.¹
• Days 2 – 3: As with most antibiotics, you may not feel better right away.
• After day 3: Zmax continues to work over time.^{1, 2} If your symptoms have not improved, call your doctor.

Zmax works in adults against bacteria to treat:

• Sinus infections
• Certain kinds of pneumonia (lung infections)

Zmax only works against bacteria. It does not work against viruses, like cold or flu.

You should not take Zmax if…

• You are allergic to antibiotics like erythromycin or telithromycin (Ketek^®).
• You are allergic to anything in Zmax. See a ul of ingredients at the end of this leaflet. Talk with your doctor or pharmacist if you have questions about your medicine allergies.

Before you start Zmax…

Tell your doctor about all your medical problems. Be sure to tell your doctor if you:

• Are pregnant, or might be pregnant. It is not known if Zmax could harm your baby.
• Are breast-feeding. Do not take if breast-feeding. Zmax may pass through breast milk into your baby.
• Have liver problems.
• Have kidney problems.

Tell your doctor about any medications you may be taking, including vitamins, herbal products, and over-the-counter drugs. Tell your doctor if you are taking:

• Warfarin (Coumadin^®), digoxin, or cyclosporine
• Drugs for migraine headache, seizures, or AIDS (HIV)

Know all the medicines you take. Keep a ul of them to show your doctor or pharmacist.

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 pouch and take out the bottle with the dry powder.
  • 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 (59 – 86°F or 15 – 30°C).
• Shake the bottle well before using.
• Use it within 12 hours after water was added.
• Take all the medicine in the bottle.
• It is recommended that you take Zmax on an empty stomach (at least 1 hour before eating or 2 hours after eating).
• You can take antacids with Zmax.

How will I know Zmax is working?

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

What are possible side effects?

Zmax may cause serious side effects. These happened in a small number of patients.

• Allergic reactions: Get emergency help right away if you:
  • have hives, trouble swallowing, or your face or throat swells
  • have 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.

The most common side effects in adults are:

• Diarrhea/loose stools
• Nausea
• Stomach pain

Other side effects are:

• Headache
• Vomiting

Patients who vomit within the first hour should contact their doctor.

There are other, less common side effects. For a ul of all reported side effects, ask your doctor or pharmacist.

General advice about Zmax

Doctors can 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. If this happens, call your doctor or local poison control center, or go to the emergency room. This leaflet is a summary of the most important information about Zmax. For more information, talk with your doctor or pharmacist, or visit our website at www.zmaxinfo.com.

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.

References:

• Pfizer Inc. Final Study Report A0661112.
• Pfizer Inc. Final Study Report A066087.

Rx only

LAB-0343-2.0
Rev April 2006