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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
Zyrtec® (cetirizine HCl) Tablets4
Zyrtec® (cetirizine HCl) Chewable Tablets4
Zyrtec® (cetirizine HCl) Oral Syrup2
Zyrtec-D 12 Hour® (cetirizine HCl/pseudoephedrine HCl, extended release) Tablets2
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.


LIPITOR Safety Information
 

LIPITOR (atorvastatin calcium) Indication Statement

LIPITOR is indicated as an adjunct to diet to reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adult patients with multiple risk factors but without clinically evident coronary heart disease (CHD); to reduce the risk of MI and stroke in patients with type 2 diabetes and without clinically evident CHD, but with multiple risk factors; to reduce the risk of nonfatal MI, fatal and nonfatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adult patients with clinically evident CHD.

LIPITOR, as an adjunct to diet, is also indicated to reduce elevated total-C, LDL-C, apo B, and TG levels; and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.

Important Safety Information

LIPITOR is contraindicated in patients with active liver disease or unexplained persistent elevations of hepatic transaminases; in women who are or may become pregnant or who are nursing; in patients with hypersensitivity to any component of this medication.

Rare cases of rhabdomyolysis have been reported with LIPITOR and other statins. Tell patients to promptly report muscle pain, tenderness, or weakness. Predisposing factors include advanced age (≥65), uncontrolled hypothyroidism, and renal impairment. Patients with a history of renal impairment merit closer monitoring. In cases of myopathy or rhabdomyolysis, therapy should be temporarily withheld or discontinued.

The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (eg, clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis. Lower doses of LIPITOR should be considered. Physicians should carefully monitor patients for signs or symptoms of myopathy early during therapy and when titrating the dose of either drug.

It is recommended that liver function tests be performed prior to and 12 weeks following both the initiation of therapy and any elevation of dose, and periodically thereafter. If ALT or AST values >3 x ULN persist, dose reduction or withdrawal is recommended.

In a post hoc analysis of the SPARCL study in patients without CHD who had a stroke or TIA within the preceding 6 months, a higher incidence of hemorrhagic stroke was seen in the LIPITOR 80-mg group compared with placebo (2.3% vs 1.4%). Some baseline characteristics, including hemorrhagic and lacunar stroke on study entry, were associated with a higher incidence of hemorrhagic stroke in the atorvastatin group.

The most commonly reported adverse reactions with LIPITOR in placebo-controlled trials were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection.

 

Please see full prescribing information.

LIPITOR® (atorvastatin calcium) tablets

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