Pfizer Other Medical Information — General gluten content of Pfizer prescription products

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Prescribing Information

Pfizer Other Medical Information — General gluten content of Pfizer prescription products


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Please note that Pfizer Inc lists active and most inactive ingredients in the package inserts or on the product containers. Inactive ingredients present in trace amounts (e.g., imprint ink) may not be listed. The accuracy of our statements is based upon the final product composition formula only and cannot guarantee that minute amounts of substances are not contained in raw materials obtained from various suppliers for our manufacturing process.

Gluten is a mixture of two proteins, gliadin and glutenin, that are present in wheat flour and to a lesser extent in barley, oats, and rye.¹

The Pfizer U.S. pharmaceutical products in Table 1 below do not list wheat, barley, oats, and/or rye as ingredients. Please note that Table 1 does not contain a complete listing of all Pfizer pharmaceutical products

Table 1. Pfizer U.S. Pharmaceutical Products That Do NOT list Wheat, Barley, Oats, and/or Rye as Ingredients

Accupril^® (quinapril HCl) Tablets²
Aldactone^® (spironolactone) Tablets²
Aldactazide^® (spironolactone/hydrochlorothiazide) Tablets²
Aricept^® (donepezil HCl) Tablets²
Aricept^® ODT (donepezil HCl, orally disintegrating) Tablets²
Aromasin^® (exemestane) Tablets²
Arthrotec^® (diclofenac sodium/misoprostol) Tablets²
Azulfidine^® (sulfasalazine) Tablets²
Azulfidine EN-tabs^® (sulfasalazine, delayed release) Tablets²
Cardura^®XL (doxazosin mesylate, extended release) Tablets²
Celebrex^® (celecoxib) Capsules²
Chantix^® (varenicline) Tablets²
Colestid^® (colestipol HCl) Tablets, Granules²
Cleocin^® (clindamycin hydrochloride) Capsules²
Cortef^® (hydrocortisone) Tablets²
Detrol^® (tolterodine) Tablets²
Detrol^®LA (tolterodine, extended release) Capsules²
Diflucan^® (fluconazole) Tablets, Oral Suspension²
Dilantin^® (phenytoin) Infatabs, Kapseals, Oral Suspension²
Dostinex^® (cabergoline) Tablets²
Estring^® (estradiol) Vaginal Ring²
Exubera^® (insulin human [rDNA origin]) Inhalation Powder²
Geodon^® (ziprasidone HCl) Capsules²
Glucotrol^® (glipizide) Tablets²
Glucotrol XL^® (glipizide, extended release) Tablets²
Glyset^® (miglitol) Tablets²
Inspra^® (eplerenone) Tablets²
Lipitor^® (atorvastatin calcium) Tablets²
Lomotil^® (diphenoxylate hydrochloride/atropine sulfate) Tablets, Liquid²
Lyrica^® (pregabalin) Capsules²
Medrol^® (methylprednisolone) Tablets²
Micronase^® (glyburide) Tablets²
Minizide^® (prazosin hydrochloride/polythiazide) Capsules²
Nardil^® (phenelzine sulfate) Tablets²
Neurontin^® (gabapentin) Capsules, Tablets, Oral Solution²
Norvasc^® (amlodipine besylate) Tablets²
Relpax^® (eletriptan hydrobromide) Tablets²
Revatio^™ (sildenafil citrate) Tablets²
Sutent^® (sunitinib malate) Capsules²
Vantin^® (cefpodoxime proxetil) Tablets, Oral Suspension²
Vfend^® (voriconazole) Tablets and Oral Suspension²
Viagra^® (sildenafil citrate) Tablets²
Vibramycin^® (doxycycline calcium) Oral Syrup²
Vibramycin^® (doxycycline hyclate) Capsules²
Vibramycin^® (doxycycline monohydrate) Oral Suspension²
Vibra-Tabs^® (doxycycline hyclate) Film Coated Tablets²
Zithromax^® (azithromycin) Tablets and Oral Suspension (all strengths)^2,>3
Zmax^® (azithromycin, extended release) Oral Suspension²
Zoloft^® (sertraline HCl) Tablets, Oral Concentrate²
Zyvox^® (linezolid) Tablets, Oral Suspension²

The Pfizer U.S. pharmaceutical products in Table 2 below contain gluten as an ingredient. Please note that Table 2 does not contain a complete listing of all Pfizer pharmaceutical products.

Table 2. Pfizer U.S. Pharmaceutical Products That Contain Gluten as an Ingredient

Halcion^® (triazolam) Tablets²
Xanax^® (alprazolam) Tablets²
Xanax XR^® (alprazolam, extended release) Tablets²

1. Sweetman SC. Martindale: The Complete Drug Reference. 33rd ed. London, UK: Pharmaceutical Press, 2002.
2. Data on file (35) - Pfizer Inc.
3. Data on file (38) - Pfizer Inc.
4. Data on file (36) - Pfizer Inc.

PRINTER-FRIENDLY

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)