ZMAX® (azithromycin extended release) for oral suspension Description

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Prescribing Information

ZMAX^® (azithromycin extended release) for oral suspension
Description


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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 bacteria.

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 contents are administered orally as a single dose.

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Zmax Safety Information

Important Safety Information

Zmax is indicated for mild to moderate Acute Bacterial Sinusitis in adults due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae, and is also indicated for community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in adults and pediatrics aged 6 months and over deemed appropriate for oral therapy.

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

In the 27 mg/mL currently approved oral suspension (n=61), the most common side effects of Zmax are vomiting (3.3%), diarrhea (1.6%), abdominal pain (1.6%), rash (1.6%), dermatitis (1.6%), fungal rash (1.6%), and constipation (1.6%).

In clinical trials using the 60 mg/mL premarketing oral concentration (n=846), the most common side effects of Zmax are vomiting (11.9%), diarrhea (8%), loose stools (5.6%), abdominal pain (3%), rash (2.8%), nausea (1.7%), and anorexia (1.2%).

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued, and appropriate management and treatment of C. difficile should be instituted as clinically indicated.

Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.

Please see full prescribing information.

Zmax^® (azithromycin extended release)