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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.


VIAGRA Safety Information
 

VIAGRA® (sildenafil citrate) Indication

VIAGRA is indicated for the treatment of erectile dysfunction (ED).

Important Safety Information

The use of VIAGRA and organic nitrates in any form, at any time, is contraindicated.

Before treating ED, physicians should consider the impact of resuming sexual activity and the mild and transient vasodilatory effects of VIAGRA on blood pressure. Physicians should carefully consider whether patients with underlying cardiovascular disease or other more unusual conditions could be adversely affected by vasodilatory effects, especially in combination with sexual activity.

As there have been infrequent reports of prolonged erections lasting more than 4 hours or priapism with all ED treatments in this drug class, patients should be advised to seek immediate medical attention should these occur. Erections lasting longer than 6 hours can result in penile tissue damage and long-term loss of potency.

Use a starting dose of 25 mg for a patient who may have increased plasma levels (age >65, hepatic impairment, severe renal impairment, and concomitant use of potent CYP450 3A4 inhibitors). Patients taking ritonavir should not exceed 25 mg in a 48-hour period.

Patients with the following characteristics (recent serious cardiovascular events, hypotension or uncontrolled hypertension, or retinitis pigmentosa) did not participate in pre-approval clinical trials. In these patients, physicians should prescribe VIAGRA with caution.

Non-arteritic anterior ischemic optic neuropathy (NAION) has been reported rarely post-marketing in temporal association with the use of PDE5 inhibitors, including VIAGRA. It is not possible to determine if these events are related to PDE5 inhibitors or to other factors. Physicians should advise patients to stop use of PDE5 inhibitors, including VIAGRA, and seek medical attention in the event of sudden loss of vision.

Sudden decrease or loss of hearing has been reported in temporal association with the intake of PDE5 inhibitors, including VIAGRA. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors. Physicians should advise patients to stop taking PDE5 inhibitors, including VIAGRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing.

In a controlled interaction study of VIAGRA and amlodipine, the mean additional reduction in supine blood pressure was 8 mm Hg systolic and 7 mm Hg diastolic.

Physicians should advise patients of the potential for PDE5 inhibitors, including VIAGRA, to augment the blood pressure lowering effect of alpha blockers and anti-hypertensive medications. In some patients concomitant administration of a PDE5 inhibitor and alpha blocker may lead to symptomatic hypotension. Patients should be stable on alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at the lowest dose (25 mg).

Use of VIAGRA offers no protection against sexually transmitted diseases, including the human immunodeficiency virus (HIV); therefore, physicians should consider counseling their patients about protective measures.

The most common side effects of VIAGRA were headache (16%), flushing (10%), and dyspepsia (7%). Adverse events, including visual effects (3%), were generally transient and mild to moderate.

 

Please see full prescribing information.

VIAGRA® (sildenafil citrate) tablets

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