WARNINGS AND PRECAUTIONS

SILDENAFIL ORAL FILM 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. Patients should stop SILDENAFIL ORAL FILM and seek prompt medical attention in the event of sudden decrease or loss of hearing. Caution is advised when SILDENAFIL ORAL FILM is co-administered with alpha-blockers or antihypertensives. 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 SILDENAFIL ORAL FILM dosage is recommended. Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash.

7. Conclusions

SILDENAFIL ORAL FILM 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. Patients should stop SILDENAFIL ORAL FILM and seek prompt medical attention in the event of sudden decrease or loss of hearing. Caution is advised when SILDENAFIL ORAL FILM is co-administered with alpha-blockers or antihypertensives. Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.

Revatio Injection

In patients taking strong CYP inhibitors such as ritonavir, sildenafil exposure is increased. Decrease in SILDENAFIL ORAL FILM dosage is recommended. Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash. To report SUSPECTED ADVERSE REACTIONS, contact YARAL Pharma Inc at 1-866-218-9009 or FDA at 1-800-FDA-1088 or SILDENAFIL ORAL FILM can potentiate the hypotensive effects of nitrates, alpha blockers, and antihypertensives. ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2) With concomitant use of alpha blockers, initiate SILDENAFIL ORAL FILM at 25 mg dose.

Dosage Forms and Strengths

Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48- hour period. Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg. ( 2.2, 7.4) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. SILDENAFIL ORAL FILM is sildenafil oral jelly 100 mg indicated for the treatment of erectile dysfunction. For most patients, the recommended dosage is 50 mg orally administered on the tongue, taken as needed, approximately 1 hour before sexual activity. To report SUSPECTED ADVERSE REACTIONS, contact YARAL Pharma Inc at 1-866-218-9009 or FDA at 1-800-FDA-1088 or SILDENAFIL ORAL FILM can potentiate the hypotensive effects of nitrates, alpha blockers, and antihypertensives. ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2) With concomitant use of alpha blockers, initiate SILDENAFIL ORAL FILM at 25 mg dose. Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48- hour period. Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg. ( 2.2, 7.4) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. SILDENAFIL ORAL FILM is sildenafil oral jelly 100 mg indicated for the treatment of erectile dysfunction. For most patients, the recommended dosage is 50 mg orally administered on the tongue, taken as needed, approximately 1 hour before sexual activity. Based on effectiveness and tolerability the dosage may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg, not to exceed once per day. For administration instructions, see Dosage and Administration (2.4). Concomitant use of nitrates in any form is contraindicated [see Contraindications (4.1), Drug Interactions (7.1) and Clinical Pharmacology (12.2)].

Initiate SILDENAFIL ORAL FILM at 25 mg orally in patients on concomitant therapy with an alpha-blocker.

Patients should be stable on alpha-blocker therapy prior to initiating SILDENAFIL ORAL FILM [seeWarningsand Precautions (5.5), Drug Interactions(7.2), and Clinical Pharmacology(12.2)]. The maximum recommended dose and dosing frequency is 25 mg orally taken once within a 48-hour period in ritonavir-treated patients. Concomitant administration of ritonavir increased the blood levels of sildenafil by 11-fold [seeWarnings andPrecautions (5.6), Drug Interactions (7.4), and Clinical Pharmacology (12.3)]. The recommended starting dosage is 25 mg orally, in patients taking strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin.

What causes Erectile Dysfunction?

Clinical data have shown that co-administration with saquinavir or erythromycin increased blood levels of sildenafil by about 3-fold [seeDrug Interactions (7.4) and Clinical Pharmacology (12.3)]. The recommended starting dosage is 25 mg orally in patients greater than 65 years of age [see Use in Specific Populations(8.5)]. The recommended starting dosage is 25 mg sildenafil for women orally, in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). The recommended starting dosage is 50 mg, in patients with mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 49 mL/min) renal impairment [see Use in Specific Populations(8.6) and Clinical Pharmacology (12.3)]. The recommended starting dosage is 25 mg orally in patients with any degree of hepatic impairment. In volunteers with mild and moderate degrees of hepatic impairment (Child-Pugh Class A and B), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (47% for Cmax and 85% for AUC), and the pharmacokinetics of sildenafil in patients with severe hepatic impairment (Child-Pugh Class C) have not been studied [see Use in Specific Populations (8.7)and Clinical Pharmacology (12.3)]. 25 mg sildenafil, opaque light blue, thin, flexible oral film imprinted with identification code S 25 50 mg sildenafil, opaque light blue, thin, flexible oral film imprinted with identification code S 50 75 mg sildenafil, opaque light blue, thin, flexible oral film imprinted with identification code S 75 100 mg sildenafil, opaque light blue, thin, flexible oral film imprinted with identification code S 100 Consistent with its known effects on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.1,12.2)] , SILDENAFIL ORAL FILM potentiates 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.

• Sildenafil film tablets are available by prescription only.
• They may interact with nitrates, causing dangerous blood pressure drops.
• Alcohol can impair the effectiveness of these tablets.

After patients have taken SILDENAFIL ORAL FILM it is unknown when nitrates, if necessary, can be safely administered.

Aronix 50mg Film-coated Sildenafil - 4 Tablets

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). 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 [seeDosage and Administration (2.2), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. SILDENAFIL ORAL FILM is contraindicated in patients with a known hypersensitivity to sildenafil or any SILDENAFIL ORAL FILM component. Hypersensitivity reactions, including rash and urticaria, have been reported [see Adverse Reactions (6.1)]. Therefore, treatments for erectile dysfunction, including SILDENAFIL ORAL FILM should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.

What do Hycosan Extra Dry Eye Drops contain

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.

Professional resources

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. The following groups of patients were not included in clinical safety and efficacy trials for sildenafil, and therefore, until further information is available, SILDENAFIL ORAL FILM is not recommended for use in the following groups: 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. Patients with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure can be sensitive to the actions of vasodilators, including SILDENAFIL ORAL FILM. As with other PDE5 inhibitors, SILDENAFIL ORAL FILM has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers.

VIAGRA Connect 50mg - 12 Tablets

Based on effectiveness and tolerability the dosage may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg, not to exceed once per day. For administration instructions, see Dosage and Administration (2.4). Concomitant use of nitrates in any form is contraindicated [see Contraindications (4.1), Drug Interactions (7.1) and Clinical Pharmacology (12.2)]. Initiate SILDENAFIL ORAL FILM at 25 mg orally in patients on concomitant therapy with an alpha-blocker. Patients should be stable on alpha-blocker therapy prior to initiating SILDENAFIL ORAL FILM [seeWarningsand Precautions (5.5), Drug Interactions(7.2), and Clinical Pharmacology(12.2)].

Incidence not known

The maximum recommended dose and dosing frequency is 25 mg orally taken once within a 48-hour period in ritonavir-treated patients. Concomitant administration of ritonavir increased the blood levels of sildenafil by 11-fold [seeWarnings andPrecautions (5.6), Drug Interactions (7.4), and Clinical Pharmacology (12.3)]. The recommended starting dosage is 25 mg orally, in patients taking strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. Clinical data have shown that co-administration with saquinavir or erythromycin increased blood levels of sildenafil by about 3-fold [seeDrug Interactions (7.4) and Clinical Pharmacology (12.3)]. The recommended starting dosage is 25 mg orally in patients greater than 65 years of age [see Use in Specific Populations(8.5)].

Warnings for other groups

The recommended starting dosage is 25 mg sildenafil for women orally, in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). The recommended starting dosage is 50 mg, in patients with mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 49 mL/min) renal impairment [see Use in Specific Populations(8.6) and Clinical Pharmacology (12.3)]. The recommended starting dosage is 25 mg orally in patients with any degree of hepatic impairment. In volunteers with mild and moderate degrees of hepatic impairment (Child-Pugh Class A and B), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (47% for Cmax and 85% for AUC), and the pharmacokinetics of sildenafil in patients with severe hepatic impairment (Child-Pugh Class C) have not been studied [see Use in Specific Populations (8.7)and Clinical Pharmacology (12.3)]. 25 mg sildenafil, opaque light blue, thin, flexible oral film imprinted with identification code S 25 50 mg sildenafil, opaque light blue, thin, flexible oral film imprinted with identification code S 50 75 mg sildenafil, opaque light blue, thin, flexible oral film imprinted with identification code S 75 100 mg sildenafil, opaque light blue, thin, flexible oral film imprinted with identification code S 100 Consistent with its known effects on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.1,12.2)] , SILDENAFIL ORAL FILM potentiates 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. In healthy subjects aged 18 to 45 years, SILDENAFIL ORAL FILM 100 mg resulted in mean maximal decreases relative to placebo of 6 mmHg systolic and 3 mmHg diastolic. In healthy subjects aged 65 years and older, SILDENAFIL ORAL FILM 100 mg resulted in mean maximal decreases relative to placebo of 14 mmHg systolic and sildenafil citrate tablets 50mg 8 mmHg diastolic [see Clinical Pharmacology (12.2)]. Prior to prescribing SILDENAFIL ORAL FILM, carefully consider whether patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity. 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. 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)] .

• Possible interactions include medications for HIV, antibiotics, and blood pressure.
• Overdose symptoms include severe headaches and chest pain.
• Seek immediate medical attention if adverse reactions occur.

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.

8. Use In Specific Populations

After patients have taken SILDENAFIL ORAL FILM 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 [seeDosage and Administration (2.2), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. SILDENAFIL ORAL FILM is contraindicated in patients with a known hypersensitivity to sildenafil or any SILDENAFIL ORAL FILM component. Hypersensitivity reactions, including rash and urticaria, have been reported [see Adverse Reactions (6.1)]. Therefore, treatments for erectile dysfunction, including SILDENAFIL ORAL FILM should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

The following groups of patients were not included in clinical safety and efficacy trials for sildenafil, and therefore, until further information is available, SILDENAFIL ORAL FILM is not recommended for use in the following groups: 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. Patients with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure can be sensitive to the actions of vasodilators, including SILDENAFIL ORAL FILM. As with other PDE5 inhibitors, SILDENAFIL ORAL FILM has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers. In healthy subjects aged 18 to 45 years, SILDENAFIL ORAL FILM 100 mg resulted in mean maximal decreases relative to placebo of 6 mmHg systolic and 3 mmHg diastolic. In healthy subjects aged 65 years and older, SILDENAFIL ORAL FILM 100 mg resulted in mean maximal decreases relative to placebo of 14 mmHg systolic and sildenafil citrate tablets 50mg 8 mmHg diastolic [see Clinical Pharmacology (12.2)].

Sildenafil Oral Film Dosage and Administration

Prior to prescribing SILDENAFIL ORAL FILM, carefully consider whether patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity. 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. 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. 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)].

• These tablets provide a discreet alternative to traditional pills.
• They are designed to dissolve quickly in the mouth or be swallowed.
• Suitable for people who have difficulty swallowing capsules.

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).

• Sildenafil tablets should not be combined with certain medications like alpha-blockers.
• A healthcare provider will determine the appropriate dosage.
• Follow prescribed instructions precisely for safety.