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PDE5 inhibitors, including VIAGRA, and alpha-adrenergic blocking agents

Country/Region	Approval Status	Regulatory Body	Prescription Requirement	Additional Regulations
USA	Approved	FDA	Prescription Required	Controlled substance
EU	Approved	EMA	Prescription Required	Marketed under strict regulations
Canada	Approved	Health Canada	Prescription Required	Pharmacovigilance measures

are both vasodilators with blood pressure lowering effects.

More about sildenafil

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)]. 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 sildenafil oral jelly 100 mg Specific Populations (8.5, 8.6, 8.7) and Clinical Pharmacology (12.3)]. 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.

Comparing Sildenafil vs. Tadalafil Dosage

Consistent with its known effects on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.1, 12.2)], 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)]. 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)]. When vasodilators are used in combination, an additive effect on blood pressure may occur.

Side Effect	Frequency	Severity	Management	Notes
Headache	Common	Mild	Analgesics	Usually transient
Flushing	Common	Mild	Cooling measures	Temporary
Nasal Congestion	Common	Mild	Decongestants	Usually resolves
Dizziness	Less common	Moderate	Rest and hydration	Exercise caution

In some patients, concomitant use of these two drug classes can lower blood pressure significantly

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[see Drug Interactions (7.2) and Clinical Pharmacology (12.2)]

How should I take sildenafil?

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 sildenafil 10mg 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. 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.

Dosage for pulmonary arterial hypertension (PAH)

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 canadian sildenafil citrate 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. leading to symptomatic hypotension (e.g., dizziness, lightheadedness, fainting). Consideration should be given to the following:

• Sildenafil 50mg is a medication used to treat erectile dysfunction.
• It belongs to the class of phosphodiesterase type 5 inhibitors.
• Typical starting dose is 50mg taken about an hour before activity.
• Sildenafil works by increasing blood flow to the penis.
• It can help achieve and maintain an erection suitable for sex.
• The effects of sildenafil usually last around 4 to 6 hours.
• Avoid taking sildenafil with high-fat meals as it may delay absorption.
• Common side effects include headaches, flushing, and nasal congestion.
• Patients should not exceed one dose within a 24-hour period.
• It is important to consult a doctor before using sildenafil, especially if on other medications.
• Sildenafil may cause dizziness; avoid driving until effects are known.

Patients who demonstrate hemodynamic instability on alpha-blocker

Why Am I Prescribed Viagra 50mg or Sildenafil 50mg in That Dosage?

⚠️ Availability is not guaranteed at the time of purchase. Viagra is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, sildenafil works by increasing blood flow to the penis to help a man get and keep an erection. VIAGRA- sildenafil citrate tablet, film coated Pfizer Laboratories Div Pfizer Inc 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.

What should I do if I miss a dose of sildenafil?

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. 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)]. 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)]. therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.

• Sildenafil 50mg is available by prescription or over-the-counter in some regions.
• It is not a treatment for erectile dysfunction caused by psychological issues alone.
• Women and children should not use sildenafil unless prescribed by a doctor.
• Sildenafil interacts with nitrates, which can cause dangerous blood pressure drops.
• Alcohol consumption can reduce the effectiveness of sildenafil and increase side effects.
• Storage of sildenafil should be in a cool, dry place away from children.
• The medication is typically taken only once per day to avoid overdose.
• Some people may experience visual disturbances as a side effect.
• Sildenafil may be used with other erectile dysfunction medications under medical supervision.
• The onset of action is usually within 30 to 60 minutes after ingestion.
• Sildenafil 50mg is preferred for men who find higher doses cause adverse effects.

Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.

What to avoid

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. 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 (6.1, 6.2)]. Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors

When Can I Expect Viagra or Sildenafil to Take Effect?

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.

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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. 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. should be initiated at the lowest dose [see Dosage and Administration (2.3)].

Absorption and metabolism

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.