This analysis was performed retrospectively and was not powered to detect any pre-specified difference in adverse reactions.
In the event of an erection that persists longer than 4 hours, instruct the patient to seek immediate medical assistance. Use SILDENAFIL ORAL FILM 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). Advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including SILDENAFIL ORAL FILM and seek medical attention in the event of a sudden loss of vision in one or both eyes. Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 in males aged 50 years and older. 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)] .
Consider whether patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Therefore, use PDE5 inhibitors, including SILDENAFIL ORAL FILM 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 SILDENAFIL ORAL FILM, for this uncommon condition. Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the sildenafil citrate clinical trials, and use in these patients is not recommended. Advise patients to stop taking PDE5 inhibitors, including SILDENAFIL ORAL FILM 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 sildenafil. 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)]. PDE5 inhibitors, including sildenafil, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects. 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)]leadingto symptomatic hypotension (e.g., dizziness, lightheadedness, fainting). Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. The following adverse reactions have been identified during post approval use of sildenafil.
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Cardiovascular andCerebrovascular: serious cardiovascular, cerebrovascular, and vascular events, including myocardial
Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful: Body as a Whole:face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury. Metabolic and Nutritional:thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia. Respiratory:asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased. Skin and Appendages:urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis. Analysis of the safety database from sildenafil controlled clinical trials showed no apparent difference in adverse reactions in patients taking sildenafil with and without antihypertensive medication. infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic
attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil.
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 Precautions5.6)] 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)] The most common adverse reactions reported in clinical trials (≥ 2%) of sildenafil are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. Sildenafil was administered to over 3700 patients (aged 19-87 years) during pre-marketing clinical trials worldwide. In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for sildenafil (2.5%) was not significantly different from placebo (2.3%). The type of adverse events in flexible-dose studies was similar to that for fixed dose studies. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 but generally were reported more frequently.
†Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge sildenafil 12 5 mg to vision, but also increased sensitivity to light, or blurred vision. When sildenafil was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took sildenafil at least once weekly, and the following adverse reactions were reported: †Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision. In these studies, only one patient discontinued due to abnormal vision. When SILDENAFIL ORAL FILM was taken as recommended (on an as-needed basis) in a flexible-dose, placebo-controlled clinical trial of twelve weeks duration, patients took SILDENAFIL ORAL FILM at least once weekly, not more than once per day, and the following adverse reactions were reported: In this study, none of the patients discontinued due to adverse reactions to SILDENAFIL ORAL FILM. The following events occurred in <2% of patients in controlled clinical trials of sildenafil; a causal relationship to sildenafil is uncertain. Others were reported to have occurred hours to days after the use of sildenafil and sexual activity. It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying
cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1) and Patient Counseling Information (17)].
In patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest dose [see Dosage andAdministration (2.2)] . In patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other antihypertensive drugs. SILDENAFIL ORAL FILM has systemic vasodilatory properties and may further lower blood pressure sildenafil citrate 200mg price in patients taking antihypertensive medications. When amlodipine, 5 mg or 10 mg, and sildenafil 100 mg were orally administered concomitantly to hypertensive patients, mean additional blood pressure reductions of 8 mmHg systolic and 7 mmHg diastolic were noted [see DrugInteractions (7.3) and Clinical Pharmacology (12.2) ].
Decreased blood pressure, syncope, and prolonged erection were reported in some healthy volunteers exposed to high doses of sildenafil (200-800 mg). To decrease the chance of adverse reactions in patients taking ritonavir, the maximum recommended dosage and dosing frequency of SILDENAFIL ORAL FILM is 25 mg once in a 48-hour period [seeDosage and Administration(2.2), Drug Interactions (7.4), and Clinical Pharmacology (12.3)]. The safety and efficacy of combinations of SILDENAFIL ORAL FILM with other PDE5 inhibitors, including pulmonary arterial hypertension (PAH) treatments containing sildenafil or other treatments for erectile dysfunction, have not been studied. There have been postmarketing reports of bleeding events in patients who have taken sildenafil. A causal relationship between sildenafil and these events has not been established.
In humans, sildenafil has no effect on bleeding time when taken alone or with aspirin. In addition, the combination of heparin and sildenafil had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans. The safety of sildenafil is unknown in patients with bleeding disorders and patients with active peptic ulceration. The use of SILDENAFIL ORAL FILM 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), should be considered. Hemic and Lymphatic: vaso-occlusive crisis: In a small, prematurely terminated study of sildenafil in patients with pulmonary arterial hypertension (PAH) secondary to
sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo.
| Point | Explanation |
|---|---|
| Take on an empty stomach | Food can delay onset |
| Avoid alcohol | May worsen side effects |
| Do not mix with Nitrates | Risk of severe hypotension |
| Seek medical help for priapism | Should last more than 4 hours |
The clinical relevance of this finding to men treated with sildenafil for ED is not known.