FDA approves sildenafil oral film for men with erectile dysfunction

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 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.

14. Clinical Studies

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)].

How Do Sildenafil Strips Work?

Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. The maximum recommended dosing frequency is once per day.

Step	Description	Equipment Needed	Quality Control Measures
Ingredient Mixing	Blend active and excipients uniformly	Mixers, blenders	Homogeneity testing
Casting	Pouring mixture into strip molds	Molding machines	Thickness and uniformity checks
Drying	Removing moisture to solidify strips	Drying ovens	Moisture content analysis
Cutting & Packaging	Cutting into individual strips and sealing	Cutting machines, sealers	Weight, appearance, and sterility tests

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).

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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.

7. Drug Interactions

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 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.

How do Sildenafil oral strips taste?

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. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result. 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. 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)].

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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.

Other Medical Problems

SILDENAFIL ORAL FILM is 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. The maximum recommended dosing frequency is once per day. 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). 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)]. The recommended starting dosage is 25 mg 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 sildenafil 100 mg tab 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)].

• Sildenafil oral strips are a fast-acting form of erectile dysfunction medication.
• They are administered orally, dissolving quickly on the tongue for rapid effect.
• Sildenafil strips are often flavored to improve the user experience.
• They contain the same active ingredient as traditional sildenafil tablets.
• These strips are designed for people seeking discreet medication options.
• Onset of action for sildenafil strips can be within 15-30 minutes.
• Proper storage of sildenafil strips involves keeping them in a cool, dry place.
• Dosage strength varies, typically available in 25mg, 50mg, and 100mg.
• Using sildenafil strips without medical consultation is not recommended.
• They may interact with other medications like nitrates or alpha-blockers.
• Sildenafil oral strips are approved for the treatment of erectile dysfunction.
• Users should follow prescribed dosages for safety and effectiveness.

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.

Benefits Of S-FILM Orally Disintegrating Strip

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 sildenafil 100 mg tab 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. 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)].

Faster Effect

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)]. There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. 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. 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. 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)]. There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. 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. 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.

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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)].

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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)]. The recommended starting dosage is 25 mg 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)]. As with other PDE5 inhibitors, SILDENAFIL ORAL FILM has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers.

Aspect	Strips	Tablets
Mode of Administration	Sublingual, dissolved in mouth	Oral, swallowed whole
Onset of Action	Faster (within 15 minutes)	Slightly slower (30-60 minutes)
Dosing Flexibility	Precise, customizable doses	Fixed dose per tablet
Convenience	Easy for those with swallowing difficulties	May require water
Storage	Compact, no need for water	Requires water for swallowing

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 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. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result. 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.

• Sildenafil strips are an alternative to traditional pill forms.
• The strips dissolve quickly, eliminating need for water to swallow.
• They are convenient for on-the-go use and discreet consumption.
• Possible side effects include headache, flushing, and dizziness.
• Sildenafil strips should be used approximately one hour before activity.
• Not suitable for individuals with certain health conditions; consult a doctor.
• They are typically used in men aged 18 and above.
• The medication works by increasing blood flow to the penis.
• Sildenafil strips can be part of a broader erectile dysfunction treatment plan.
• Side effects may vary depending on individual health status.
• Erectile response may improve with proper use and dosing.
• They are available through licensed pharmacies and online sources.

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.

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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. 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. An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 sildenafil citrates half-lives), compared to PDE5 inhibitor use in a prior time period. The results suggest an approximate 2-fold increase in the risk 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).

Incidence not known

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)] . Consider whether 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, use PDE5 inhibitors, including SILDENAFIL ORAL FILM with caution in these patients and only when the anticipated benefits outweigh the risks. 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. An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 sildenafil citrates half-lives), compared to PDE5 inhibitor use in a prior time period. The results suggest an approximate 2-fold increase in the risk 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).

Drug Interaction

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)] . Consider whether 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, use PDE5 inhibitors, including SILDENAFIL ORAL FILM with caution in these patients and only when the anticipated benefits outweigh the risks.

• Sildenafil oral strips provide a non-invasive way to treat ED.
• They avoid swallowing pills, which some patients find difficult.
• Strips are often manufactured with pleasant flavors to enhance appeal.
• The medication’s effect can be influenced by food intake.
• Alcohol consumption may reduce effectiveness or increase side effects.
• Sildenafil strips should be used as prescribed and not mixed with other ED drugs.
• These strips are designed for quick absorption in the oral mucosa.
• Overuse or misuse can lead to adverse health effects.
• Proper dosing helps minimize risks of prolonged erections or priapism.
• Sildenafil strips do not cure ED but help manage symptoms.
• They may be used in combination with psychological or lifestyle interventions.
• Always check expiration dates before using sildenafil strips.

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)]. Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers.