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Drug Notebook

FDA Alerts

Special Alerts:

[Posted 10/18/2007] FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors sildenafil (Viagra), tadalafil (Levitra), vardenafil (Cialis) for the treatment of erectile dysfunction, and sildenafil (Revatio) for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for sildenafil (Viagra), tadalafil, and vardenafil were revised. FDA is working with the manufacturer to revise the labeling for sildenafil (Revatio). For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#PDE5, http://www.fda.gov/cder/consumerinfo/viagra/default.htm, http://www.fda.gov/cder/foi/label/2007/020895s027lbl.pdf, http://www.fda.gov/cder/drug/infopage/cialis/default.htm, http://www.fda.gov/cder/foi/label/2007/021368s012lbl.pdf, http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm and http://www.fda.gov/cder/foi/label/2007/021400s010lbl.pdf.

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sildenafil
(sil DEN a fil)

What is this medicine?
SILDENAFIL (sil DEN a fil) is used to treat erection problems in men.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Revatio 20MG Tablets PFIZER U.S.30/$497.36 or 90/$1361.52
Viagra 100MG Tablets PFIZER U.S.10/$147.99 or 30/$429.97
Viagra 25MG Tablets PFIZER U.S.10/$149.99 or 30/$429.97
Viagra 50MG Tablets PFIZER U.S.10/$149.99 or 30/$425.99

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What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • changes in hearing
  • changes in vision, blurred vision, trouble telling blue from green color
  • chest pain
  • fast, irregular heartbeat
  • men: prolonged or painful erection (lasting more than 4 hours)
  • seizures

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • diarrhea
  • flushing
  • headache
  • indigestion
  • stuffy or runny nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How should I use this medicine?
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. The dose is usually taken 1 hour before sexual activity. You should not take the dose more than once per day. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not used in children for this condition.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

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What if I miss a dose?
This does not apply. Do not take double or extra doses.

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What may interact with this medicine?
Do not take this medicine with any of the following medications:

  • cisapride
  • methscopolamine nitrate
  • nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
  • nitroprusside
  • other sildenafil products (Revatio)

This medicine may also interact with the following medications:

  • certain drugs for high blood pressure
  • certain drugs for the treatment of HIV infection or AIDS
  • certain drugs used for fungal or yeast infections, like fluconazole, itraconazole, ketoconazole, and voriconazole
  • cimetidine
  • erythromycin
  • rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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Who should NOT use this medication?

  • Known hypersensitivity to sildenafil or any ingredient in the formulation.
  • Concomitant use of organic nitrates or nitrites. (See Specific Drugs under Interactions.)
  • Should not be used for treatment of erectile dysfunction in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.

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What should I watch for while using this medicine?
If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible.

Call your health care provider right away if you have any change in vision.

Contact you doctor or health care professional right away if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking this medicine, you should refrain from further activity and call your doctor or health care professional as soon as possible.

Using this medicine does not protect you or your partner against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.

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What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:

  • eye or vision problems, including a rare inherited eye disease called retinitis pigmentosa
  • heart disease, angina, high or low blood pressure, a history of heart attack, or other heart problems
  • kidney disease
  • liver disease
  • stroke
  • an unusual or allergic reaction to sildenafil, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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