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Viagra

Viagra helps men with erectile dysfunction get and maintain an erection long enough for sexual intercourse. It usually starts to work within 30-60 minutes.

Viagra Overview

Viagra is a prescription medication used to treat erectile dysfunction (ED).

Viagra is in a class of medications called PDE inhibitors. It increases blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection.

This medication comes in tablet form and is taken one hour before sexual activity if treating for ED.

Common side effects include headache, facial flushing, and upset stomach.

Viagra Cautionary Labels

precautionsprecautions

Uses of Viagra

Viagra is a prescription medication used to treat erectile dysfunction (ED) in adult males.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Viagra helps men with erectile dysfunction get and maintain an erection long enough for sexual intercourse. It usually starts to work within 30-60 minutes.

 
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PDE5 Inhibitors

Viagra Overview

Viagra is a prescription medication used to treat erectile dysfunction (ED).

Viagra is in a class of medications called PDE inhibitors. It increases blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection.

This medication comes in tablet form and is taken one hour before sexual activity if treating for ED.

Common side effects include headache, facial flushing, and upset stomach.

 
 

Patient Ratings for Viagra

 

 

Viagra 25 MG Oral Tablet
pill-image Viagra 25 MG Oral Tablet
Color: BlueShape: DiamondSize: 9.00Score: 1Imprint: VGR25 Pfizer
 
 
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Viagra Cautionary Labels

precautionsprecautions
 

Uses of Viagra

Viagra is a prescription medication used to treat erectile dysfunction (ED) in adult males.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

 
 

Manufacturer

 

Generic

 

Viagra Drug Class

Viagra is part of the drug class:

 

Side Effects of Viagra

The most common side effects of Viagra are:

  • headache
  • flushing of the face
  • upset stomach

Less common side effects that may occur are temporary changes in color vision (such as trouble telling the difference between blue and green objects or having a blue color tinge to them), eyes being more sensitive to light, or blurred vision.

In rare instances, men taking PDE5 inhibitors reported a sudden decrease or loss of vision in one or both eyes. It is not possible to determine whether these events are related directly to these medicines, to other factors such as high blood pressure or diabetes, or to a combination of these. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including Viagra, and call a doctor right away.

In rare instances, men have reported an erection that lasts many hours. You should call a doctor immediately if you ever have an erection that lasts more than 4 hours. If not treated right away, permanent damage to your penis could occur.

Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including Viagra. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking Viagra and contact a doctor right away.

Heart attack, stroke, irregular heart beats, and death have been reported rarely in men taking Viagra. Most, but not all, of these men had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Viagra.

Viagra may cause other side effects besides those listed. If you want more information or develop any side effects or symptoms you are concerned about, talk to your doctor or pharmacist.

 
 

Viagra Interactions

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take any of the following:

  • medicines called alpha blockers. These include Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl) or Uroxatral (alfuzosin HCl). Alpha blockers are sometimes prescribed for prostate problems or high blood pressure. If Viagra is taken with certain alpha blockers, your blood pressure could suddenly drop and you could get dizzy or faint.
  • other medicines to treat high blood pressure (hypertension)
  • medications that block a protein in the body (CYPA4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone (Serzone)
  • medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (TegretolEquetroCarbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
  • other medicines or treatments for ED

Do not take Viagra if you take any medicines called “nitrates.” Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.

  • Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite.
  • Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates.

This is not a complete list of Viagra drug interactions. Ask your doctor or pharmacist for more information.

 

Viagra Precautions

  • Viagra is not for newborns, children, or women.
  • Do not let anyone else take your Viagra.
  • Viagra must be used only under a doctor's supervision.
  • There is potential risk of sexual activity in patients with cardiovascular risk factors. If you experience symptoms (chest pain, dizziness, nausea) upon initiation of sexual activity, it is advised to refrain from further sexual activity and discuss the episode with your doctor.
  • Viagra can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke.
  • Tell all of your healthcare providers that you take Viagra. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took Viagra.
  • Seek immediate medical attention if sudden loss of vision occurs, which could be a sign of non-arteritic ischemic optic neuropathy (NAION).
  • Seek immediate medical attention if sudden decrease or loss of hearing occurs.

Do not take Viagra if you:

  • take any medicines called “nitrates”. See "Drug Interactions" section.
  • use recreational drugs called “poppers” like amyl nitrite and butyl nitrite
  • are allergic to Viagra or any of its ingredients. Symptoms of an allergic reaction may include:
    • rash
    • hives
    • swelling of the lips, tongue, or throat
    • difficulty breathing or swallowing
  • Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above.
  • Only your doctor can decide if Viagra is right for you. Viagra can cause mild, temporary lowering of your blood pressure. You will need to have a thorough medical exam to diagnose your erectile dysfunction and to find out if you can safely take Viagra alone or with your other medicines.

 

 

Viagra Food Interactions

Grapefruit and grapefruit juice may interact with Viagra and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

 

 

Inform MD

Be sure to tell your doctor if you:

  • have ever had any heart problems (e.g., angina, chest pain, heart failure, irregular heart beats, heart attack or narrowing of the aortic valve)
  • have ever had a stroke
  • have low or high blood pressure
  • have ever had severe vision loss
  • have a rare inherited eye disease called retinitis pigmentosa
  • have ever had any kidney problems
  • have ever had any liver problems
  • have ever had any blood problems, including sickle cell anemia or leukemia
  • are allergic to Viagra or any of the other ingredients of Viagra
  • have a deformed penis, Peyronie's disease, or ever had an erection that lasted more than 4 hours
  • have stomach ulcers or any types of bleeding problems
  • are taking any other medicines
  • have sickle cell disease; Viagra may cause serious complications if PAH is secondary to sickle cell disease
 

Viagra and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B.

Viagra is not indicated for use in newborns, children, or women.

 

Viagra and Lactation

It is not known if Viagra or its metabolites are excreted in human breast milk. Because many drugs pass into human milk, caution should be used when Viagra is administered to a nursing woman.

 

Viagra Usage

This medication comes in tablet form and is taken one hour before sexual activity if treating for ED.

 
 

Viagra Dosage

For the treatment of ED:

For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, Viagra may be taken anywhere from 4 hours to 0.5 hour before sexual activity. Your doctor may increase the dose to a maximum recommended dose of 100 mg or decreased it to 25 mg. Viagra is to be taken only once per day.

 

Viagra Overdose

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

 

Other Requirements

  • Keep Viagra out of the reach of children.
  • Keep Viagra in its original container.
  • Store at room temperature away from excessive heat or moisture.

 

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use VIAGRA safely and effectively. See full prescribing information for VIAGRA. 

    VIAGRA® (sildenafil citrate) tablets, for oral use 
    Initial U.S. Approval: 1998

    RECENT MAJOR CHANGES

    Warnings and Precautions, Effects on the Eye (5.3) 08/2017
     

    INDICATIONS AND USAGE

    VIAGRA is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)

    DOSAGE AND ADMINISTRATION

    • For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, VIAGRA may be taken anywhere from 30 minutes to 4 hours before sexual activity (2.1)
    • Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg (2.1)
    • Maximum recommended dosing frequency is once per day (2.1)
     
     
     
     
     

    DOSAGE FORMS AND STRENGTHS

    Tablets: 25 mg, 50 mg, 100 mg (3)

    CONTRAINDICATIONS

    • Administration of VIAGRA to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. VIAGRA was shown to potentiate the hypotensive effect of nitrates (4.17.112.2)
    • Known hypersensitivity to sildenafil or any component of tablet (4.2)
    • Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3)
     
     
     

    WARNINGS AND PRECAUTIONS

    • Patients should not use VIAGRA if sexual activity is inadvisable due to cardiovascular status (5.1)
    • Patients should seek emergency treatment if an erection lasts >4 hours. Use VIAGRA with caution in patients predisposed to priapism (5.2)
    • Patients should stop VIAGRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). VIAGRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION. (5.3)
    • Patients should stop VIAGRA and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.4)
    • Caution is advised when VIAGRA is co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension (5.5)
    • Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in VIAGRA dosage is recommended (2.45.6)
     
     
     
     
     
     
     
     
     

    ADVERSE REACTIONS

    Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash (6.1)


    To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

     
     

    DRUG INTERACTIONS

    • VIAGRA can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives (4.15.57.17.27.312.2)
    • With concomitant use of alpha blockers, initiate VIAGRA at 25 mg dose (2.3)
    • CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase VIAGRA exposure (2.47.412.3)
      • Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period (2.45.6)
      • Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg (2.47.4)
     
     
     
     
     

    USE IN SPECIFIC POPULATIONS

    • Geriatric use: Consider a starting dose of 25 mg (2.58.5)
    • Severe renal impairment: Consider a starting dose of 25 mg (2.58.6)
    • Hepatic impairment: Consider a starting dose of 25 mg (2.58.7)
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     

    See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

    Revised: 12/2017

    CLOSE
  • FULL PRESCRIBING INFORMATION: CONTENTS*

    1 INDICATIONS AND USAGE

    2 DOSAGE AND ADMINISTRATION

    2.1 Dosage Information

    2.2 Use with Food

    2.3 Dosage Adjustments in Specific Situations

    2.4 Dosage Adjustments Due to Drug Interactions

    2.5 Dosage Adjustments in Special Populations

    3 DOSAGE FORMS AND STRENGTHS

    4 CONTRAINDICATIONS

    4.1 Nitrates

    4.2 Hypersensitivity Reactions

    4.3 Concomitant Guanylate Cyclase (GC) Stimulators

    5 WARNINGS AND PRECAUTIONS

    5.1 Cardiovascular

    5.2 Prolonged Erection and Priapism

    5.3 Effects on the Eye

    5.4 Hearing Loss

    5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives

    5.6 Adverse Reactions with the Concomitant Use of Ritonavir

    5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies

    5.8 Effects on Bleeding

    5.9 Counseling Patients About Sexually Transmitted Diseases

    6 ADVERSE REACTIONS

    6.1 Clinical Trials Experience

    6.2 Postmarketing Experience

    7 DRUG INTERACTIONS

    7.1 Nitrates

    7.2 Alpha-blockers

    7.3 Amlodipine

    7.4 Ritonavir and other CYP3A4 inhibitors

    7.5 Alcohol

    8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    8.2 Lactation

    8.4 Pediatric Use

    8.5 Geriatric Use

    8.6 Renal Impairment

    8.7 Hepatic Impairment

    10 OVERDOSAGE

    11 DESCRIPTION

    12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    12.2 Pharmacodynamics

    12.3 Pharmacokinetics

    13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    14 CLINICAL STUDIES

    16 HOW SUPPLIED/STORAGE AND HANDLING

    17 PATIENT COUNSELING INFORMATION

    *
    Sections or subsections omitted from the full prescribing information are not listed.
    CLOSE
  • 1 INDICATIONS AND USAGE

     

    VIAGRA is indicated for the treatment of erectile dysfunction.

    CLOSE
  • 2 DOSAGE AND ADMINISTRATION

     

     

    2.1 Dosage Information

    For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, VIAGRA may be taken anywhere from 30 minutes to 4 hours before sexual activity.

    The maximum recommended dosing frequency is once per day.

    Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.

     

    2.2 Use with Food

    VIAGRA may be taken with or without food.

     

    2.3 Dosage Adjustments in Specific Situations

    VIAGRA was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [see CONTRAINDICATIONS (4.1)DRUG INTERACTIONS (7.1), and CLINICAL PHARMACOLOGY (12.2)].

    When VIAGRA is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at 25 mg [see WARNINGS AND PRECAUTIONS (5.5)DRUG INTERACTIONS (7.2), and CLINICAL PHARMACOLOGY (12.2)].

     

    2.4 Dosage Adjustments Due to Drug Interactions

     

    Ritonavir

    The recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [see WARNINGS AND PRECAUTIONS (5.6)DRUG INTERACTIONS (7.4), and CLINICAL PHARMACOLOGY (12.3)].

     

    CYP3A4 Inhibitors

    Consider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [see DRUG INTERACTIONS (7.4) and CLINICAL PHARMACOLOGY (12.3)].

     

    2.5 Dosage Adjustments in Special Populations

    Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of VIAGRA in these patients resulted in higher plasma levels of sildenafil [see USE IN SPECIFIC POPULATIONS (8.58.68.7) and CLINICAL PHARMACOLOGY (12.3)].

    CLOSE
  • 3 DOSAGE FORMS AND STRENGTHS

     

    VIAGRA is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to 25 mg, 50 mg, or 100 mg of sildenafil. Tablets are debossed with PFIZER on one side and VGR25, VGR50 or VGR100 on the other to indicate the dosage strengths.

    CLOSE
  • 4 CONTRAINDICATIONS

     

     

    4.1 Nitrates

    Consistent with its known effects on the nitric oxide/cGMP pathway [see CLINICAL PHARMACOLOGY (12.112.2)], VIAGRA was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated.

    After patients have taken VIAGRA, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [see DOSAGE AND ADMINISTRATION (2.3)DRUG INTERACTIONS (7.1), and CLINICAL PHARMACOLOGY (12.2)].

     

    4.2 Hypersensitivity Reactions

    VIAGRA is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in VIAGRA and REVATIO, or any component of the tablet. Hypersensitivity reactions have been reported, including rash and urticaria [see ADVERSE REACTIONS (6.1)].

     

    4.3 Concomitant Guanylate Cyclase (GC) Stimulators

    Do not use VIAGRA in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including VIAGRA, may potentiate the hypotensive effects of GC stimulators.

    CLOSE
  • 5 WARNINGS AND PRECAUTIONS

     

     

    5.1 Cardiovascular

    There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including VIAGRA, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.

    VIAGRA has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg), [see CLINICAL PHARMACOLOGY (12.2)]. While this normally would be expected to be of little consequence in most patients, prior to prescribing VIAGRA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.

    Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including VIAGRA – those with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure.

    There are no controlled clinical data on the safety or efficacy of VIAGRA in the following groups; if prescribed, this should be done with caution.

    • Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months;
    • Patients with resting hypotension (BP <90/50 mmHg) or hypertension (BP >170/110 mmHg);
    • Patients with cardiac failure or coronary artery disease causing unstable angina.

     

    5.2 Prolonged Erection and Priapism

    Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of VIAGRA. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

    VIAGRA should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia). However, there are no controlled clinical data on the safety or efficacy of VIAGRA in patients with sickle cell or related anemias.

     

    5.3 Effects on the Eye

    Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including VIAGRA, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Based on published literature, the annual incidence of NAION is 2.5–11.8 cases per 100,000 in males aged ≥ 50. An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period. The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.20). Other risk factors for NAION, such as the presence of "crowded" optic disc, may have contributed to the occurrence of NAION in these studies.

    Neither the rare post-marketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [see ADVERSE REACTIONS (6.2)].

    Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore, PDE5 inhibitors, including VIAGRA, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with "crowded" optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including VIAGRA, for this uncommon condition.

    There are no controlled clinical data on the safety or efficacy of VIAGRA in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases); if prescribed, this should be done with caution.

     

    5.4 Hearing Loss

    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. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to 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 [see ADVERSE REACTIONS (6.16.2)].

     

    5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives

     

    Alpha-blockers

    Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including VIAGRA, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may occur. In some patients, concomitant use of these two drug classes can lower blood pressure significantly [see DRUG INTERACTIONS (7.2) and CLINICAL PHARMACOLOGY (12.2)] leading to symptomatic hypotension (e.g., dizziness, lightheadedness, fainting).

    Consideration should be given to the following:

    • Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.
    • In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest dose [see DOSAGE AND ADMINISTRATION (2.3)].
    • In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.
    • Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.

     

    Anti-hypertensives

    VIAGRA has systemic vasodilatory properties and may further lower blood pressure in p

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