12 CLINICAL PHARMACOLOGY

Over 550 patients were treated

for longer than one year.In

• Sildenafil tablets LP 100 mg should be used with caution in renal impairment.
• Adjust dosage as recommended by your healthcare provider.
• Do not share your medication with others; it is for personal use only.

placebo-controlled clinical studies, the discontinuation

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

There have been postmarketing reports of bleeding events in patients who have taken sildenafil tablets. In addition, the combination of heparin and sildenafil tablets had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans. The safety of sildenafil tablets is unknown in patients with bleeding disorders and patients with active peptic ulceration. The use of sildenafil tablets offers no protection against sexually transmitted diseases. 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 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 with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7)]• Effects on Bleeding [see Warnings and Precautions (5.8)]• Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions (5.9)]The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.6.1 Clinical 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 not reflect the rates observed in clinical practice.Sildenafil tablets were administered to over 3700 patients (aged 19–87 years) during pre-marketing clinical trials worldwide. rate due to adverse reactions for

sildenafil tablets (2.5%) was not

significantly different from placebo (2.3%).In

8.7 Patients with Renal Impairment

Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil tablets, 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. 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 tablets, for this uncommon condition.

Vybrique Oral Film

There are no controlled clinical data on the safety or efficacy of sildenafil tablets 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 tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. 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 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). fixed-dose studies, the incidence of

some adverse reactions increased with dose.

• The medication is usually well tolerated when used as directed.
• Avoid grapefruit juice, which can increase sildenafil levels in the blood.
• Limit physical activity if you experience dizziness or low blood pressure.