3 DOSAGE FORMS AND STRENGTHS

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling:Cardiovascular [ see Warnings and Precautions (5.1)]Prolonged Erection and

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While this normally would be expected to be of little consequence in most patients, prior to prescribing sildenafil citrate, 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 sildenafil citrate – 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 sildenafil citrate 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 sildenafil tablets.

How sildenafil is used

If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result. Sildenafil citrate 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, sildenafil citrate chewable tablets multiple myeloma, or leukemia). However, there are no controlled clinical data on the safety or efficacy of sildenafil citrate in patients with sickle cell or related anemias. Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil citrate, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies. Priapism [ see Warnings and Precautions (5.2)]Effects on the Eye [ see Warnings and Precautions (5.3)]Hearing Loss [ see Warnings and Precautions (5.4)]Hypotension when

Co-administered with Alpha-blockers or Anti-hypertensives [ see Warnings and Precautions (5.5)]Adverse Reactions

with the Concomitant Use of Ritonavir [ see Warnings and Precautions (5.6)]Combination

• Sildenafil citrate tablets are a popular choice for ED treatment worldwide.
• Take the medication on an empty stomach for faster absorption when possible.
• Be aware of signs of overdose, such as dizziness and prolonged erection.
• Do not use sildenafil with other PDE5 inhibitors or similar drugs.
• Any sudden or severe side effects should prompt immediate medical review.
• Consult your healthcare provider before starting sildenafil if on other treatments.
• Store tablets in a secure, dry, and temperature-controlled environment.
• This medication may not be suitable for all men, depending on health status.

with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [ see Warnings

What special precautions should I follow?

Such combinations may further lower blood pressure. Therefore, the use of such combinations is not recommended.5.8 Effects on BleedingThere have been postmarketing reports of bleeding events in patients who have taken sildenafil citrate. A causal relationship between sildenafil citrate and these events has not been established. In humans, sildenafil citrate has no effect on bleeding time when taken alone or with aspirin. However, in vitro studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor).

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In addition, the combination of heparin and sildenafil citrate had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.The safety of sildenafil citrate is unknown in patients with bleeding disorders and patients with active peptic ulceration.5.9 Counseling Patients About Sexually Transmitted DiseasesThe use of sildenafil citrate offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered. There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment. Sildenafil citrate 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)]. and Precautions (5.7)]Effects on Bleeding [ see Warnings and Precautions (5.8)]Counseling Patients

• Sildenafil citrate 50mg may cause priapism, a prolonged erection needing medical attention.
• Use with caution in men taking blood pressure medications.
• Check for contraindications: heart disease, stroke history, or liver issues.
• Avoid taking sildenafil with fatty meals to improve absorption time.
• The drug's effectiveness can be reduced if taken with certain drugs.
• Patients should inform their doctor of all medications they are taking.
• The medication does not protect against sexually transmitted infections.
• Follow the prescribed dosage schedule strictly to avoid adverse reactions.

About Sexually Transmitted Diseases [ see Warnings and Precautions (5.9)]The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia,

What should I know about storage and disposal of this medication?

Therefore, the use of such combinations is not recommended. There have been postmarketing reports of bleeding events in patients who have taken sildenafil citrate. In addition, the combination of heparin and sildenafil citrate had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans. The safety of sildenafil citrate is unknown in patients with bleeding disorders and patients with active peptic ulceration. The use of sildenafil citrate offers no protection against sexually transmitted diseases. abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.6.1 Clinical

What causes Erectile Dysfunction?

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.

How it works

Safety of combined use of PDE5 inhibitors and alpha-blockers may sildenafil 130mg be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs. Sildenafil citrate has systemic vasodilatory properties and may further lower blood pressure in patients taking anti-hypertensive medications. In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and sildenafil citrate, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted [ see Drug Interactions (7.3)and Clinical Pharmacology (12.2)]. To decrease the chance of adverse reactions in patients taking ritonavir, a decrease in sildenafil dosage is recommended [ see Dosage and Administration (2.4), Drug Interactions (7.4), and Clinical Pharmacology (12.3)]. The safety and efficacy of combinations of sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 Inhibitors, including sildenafil tablets, 20 mg or other pulmonary arterial hypertension (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied. Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction

rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may

• Sildenafil citrate 50mg tablets are available by prescription only.
• The medication helps men achieve and maintain an erection.
• Do not take sildenafil if you are allergic to it.
• Alcohol may increase the risk of side effects when combined.
• Notify your doctor if you experience vision changes or hearing loss.
• Avoid heavy meals or alcohol before taking the medication.
• Usage may be inappropriate for men with certain health conditions.
• Keep out of reach of children and pets.

not reflect the rates observed in clinical practice.Sildenafil citrate was administered to over 3,700 patients (aged 19 to 87 years) during pre-marketing clinical trials worldwide.

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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 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 sildenafil citrate, for this uncommon condition. There are no controlled clinical data on the safety or efficacy of sildenafil citrate 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 sildenafil citrate, and seek prompt medical attention in the event of sudden decrease or loss of hearing.

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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. PDE5 inhibitors, including sildenafil citrate, 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). Over 550 patients were treated for longer than one year.In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for sildenafil citrate (2.5%) was not significantly different from placebo (2.3%).In fixed-dose studies, the incidence of some adverse reactions increased with dose.

The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed-dose studies.

• Sildenafil 50mg tablets are sometimes used for pulmonary hypertension.
• The onset of action is typically within 30 minutes, lasting up to 4 hours.
• Do not crush or break the tablets; take them whole with water.
• Regular use is not recommended without medical advice.
• Be aware of potential side effects like dizziness or nasal congestion.
• Combining sildenafil with other ED medications can be dangerous.
• Patients should follow dosing instructions provided by their healthcare provider.
• Report any persistent or severe side effects to a healthcare professional.