In the titration studies (n=644) (with most patients eventually receiving 100 mg), results were similar. Percentage of Patients Reporting an Improvement in Erections. The patients in studies had varying degrees of ED.

8.6 Renal Impairment

One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 4-week, treatment-free run-in period. In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients.

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In these studies, involving about 1600 patients, analyses of patient diaries showed no effect of sildenafil tablets on rates of attempted intercourse (about 2 per week), but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged 1.3 on 50-100 mg of sildenafil tablets vs 0.4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on sildenafil tablets vs about 20% on placebo.

• 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.

During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label studies, few patients withdrew from active treatment for any reason, including lack of effectiveness. At the end of the long-term study, 88% of patients reported that sildenafil tablets improved their erections. Men with untreated ED had relatively low baseline scores for all aspects of sexual function measured (again using a 5-point scale) in the IIEF.

How should I take sildenafil?

Sildenafil tablets improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications oral sildenafil of diabetes mellitus (n=268). Diary data indicated that on sildenafil tablets, 48% of intercourse attempts were successful versus 12% on placebo.

Drug Class or Name	Effect on Sildenafil	Possible Outcome
Nitrates	Potentiate vasodilation	Risk of severe hypotension
Alpha-blockers	Enhanced blood pressure lowering	Caution advised, dose adjustments needed
CYP3A4 inhibitors (e.g., Ketoconazole)	Decrease sildenafil metabolism	Increased risk of side effects
Blood pressure medications	Additive effects	Monitor blood pressure closely

One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. Diary data indicated that on sildenafil tablets, 59% of attempts at sexual intercourse were successful compared to 13% on placebo. Across all trials, sildenafil tablets improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo. Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil tablets patients reported improvement in erections compared with 26% of placebo. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil tablets and 29% for placebo. Efficacy Results in Subpopulations in Controlled Clinical Studies A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, USP are supplied as white, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows:Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Sildenafil tablets, USP are supplied as white, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows: Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information)NitratesPhysicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see Contraindications (4.1)].Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [see Contraindications (4.3)].Concomitant Use with Drugs Which Lower Blood PressurePhysicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.

What happens if I miss a dose?

In the titration studies (n=644) (with most patients eventually receiving 100 mg), results were similar. Percentage of Patients Reporting an Improvement in Erections. The patients in studies had varying degrees of ED. One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 4-week, treatment-free run-in period. In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients.

Missed Dose

In these studies, involving about 1600 patients, analyses of patient diaries showed no effect of sildenafil tablets on rates of attempted intercourse (about 2 per week), but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged 1.3 on 50-100 mg of sildenafil tablets vs 0.4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on sildenafil tablets vs about 20% on placebo. During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label studies, few patients withdrew from active treatment for any reason, including lack of effectiveness. At the end of the long-term study, 88% of patients reported that sildenafil tablets improved their erections. Men with untreated ED had relatively low baseline scores for all aspects of sexual function measured (again using a 5-point scale) in the IIEF. Sildenafil tablets improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications oral sildenafil of diabetes mellitus (n=268).

What is sildenafil used for?

Diary data indicated that on sildenafil tablets, 48% of intercourse attempts were successful versus 12% on placebo. One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. Diary data indicated that on sildenafil tablets, 59% of attempts at sexual intercourse were successful compared to 13% on placebo. Across all trials, sildenafil tablets improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo. Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil tablets patients reported improvement in erections compared with 26% of placebo. Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil tablets are co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablet treatment and sildenafil tablets should be initiated at the lowest dose [see Warnings and Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)].Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior sildenafil citrate tablets 150 mg ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil tablets, for this uncommon condition [see Warnings and Precautions (5.3) and Adverse Reactions (6.2)].Sudden Hearing LossPhysicians 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 Warnings and Precautions (5.4) and Adverse Reactions (6.2)].PriapismPhysicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets.

7.3 Amlodipine

Viagra Tablets

Revatio for Oral Suspension

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension sildenafil 50g (PAH) treatments containing sildenafil. Sildenafil is also marketed as REVATIO for the treatment of PAH.

• Sildenafil LP 100 mg may interact with nitrate medications.
• Do not use sildenafil tablets LP 100 mg if allergic to sildenafil.
• Report any severe side effects such as prolonged erection immediately.

The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [see Warnings and Precautions (5.7)].Sexually Transmitted DiseaseThe use of sildenafil tablets 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 [see Warnings and Precautions (5.9)].Manufactured by:Appco Pharma LLCPiscataway, NJ 08854.Distributed by: Cipla USA, Inc.10 Independence Boulevard, Suite 300Warren, NJ 07059Repackaged by: Proficient Rx LPThousand Oaks, CA 91320Rev.

5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies

Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [see Warnings and Precautions (5.9)].Manufactured by:Appco Pharma LLCPiscataway, NJ 08854.Distributed by: Cipla USA, Inc.10 Independence Boulevard, Suite 300Warren, NJ 07059Repackaged by: Proficient Rx LPThousand Oaks, CA 91320Rev. 05/2020Patient InformationSildenafil tablets(sil den' a fil si' trate)What is the most important information I should know about sildenafil tablets?Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take sildenafil tablets if you take any other medicines called “nitrates”. Nitrates are used to treat chest pain (angina). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.Do not take sildenafil tablets if you take medicines called guanylate cyclase stimulators which include:• Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.Tell all your healthcare providers that you take sildenafil tablets.

Corresponding author

If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took sildenafil tablets.Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.Sildenafil tablets do not protect you or your partner from getting sexually transmitted diseases, including HIV - the virus that causes AIDS.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine. Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).Sildenafil tablets are not for use in women or children.It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age.Who should not take sildenafil tablets?Do not take sildenafil tablets if you:• take medicines called nitrates (such as nitroglycerin)• use street drugs called “poppers” such as amyl nitrate or amyl nitrite, and butyl nitrate• take any medicines called guanylate cyclase stimulators such as riociguat (Adempas)• are allergic to sildenafil, as contained in sildenafil tablets and REVATIO, or any of the ingredients in sildenafil tablets.

Revatio Injection

05/2020Patient InformationSildenafil tablets(sil den' a fil si' trate)What is the most important information I should know about sildenafil tablets?Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take sildenafil tablets if you take any other medicines called “nitrates”. Nitrates are used to treat chest pain (angina). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.Do not take sildenafil tablets if you take medicines called guanylate cyclase stimulators which include:• Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.Tell all your healthcare providers that you take sildenafil tablets. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took sildenafil tablets.Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.Sildenafil tablets do not protect you or your partner from getting sexually transmitted diseases, including HIV - the virus that causes AIDS.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine.

Author information

Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil tablets and 29% for placebo. Efficacy Results in Subpopulations in Controlled Clinical Studies A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, USP are supplied as white, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows:Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Sildenafil tablets, USP are supplied as white, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows: Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information)NitratesPhysicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see Contraindications (4.1)].Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [see Contraindications (4.3)].Concomitant Use with Drugs Which Lower Blood PressurePhysicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.

What are the primary indications for this medication?

Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil tablets are co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablet treatment and sildenafil tablets should be initiated at the lowest dose [see Warnings and Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)].Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior sildenafil citrate tablets 150 mg ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye.

Other Interactions

Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil tablets, for this uncommon condition [see Warnings and Precautions (5.3) and Adverse Reactions (6.2)].Sudden Hearing LossPhysicians 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 Warnings and Precautions (5.4) and Adverse Reactions (6.2)].PriapismPhysicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension sildenafil 50g (PAH) treatments containing sildenafil. Sildenafil is also marketed as REVATIO for the treatment of PAH. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [see Warnings and Precautions (5.7)].Sexually Transmitted DiseaseThe use of sildenafil tablets offers no protection against sexually transmitted diseases. Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).Sildenafil tablets are not for use in women or children.It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age.Who should not take sildenafil tablets?Do not take sildenafil tablets if you:• take medicines called nitrates (such as nitroglycerin)• use street drugs called “poppers” such as amyl nitrate or amyl nitrite, and butyl nitrate• take any medicines called guanylate cyclase stimulators such as riociguat (Adempas)• are allergic to sildenafil, as contained in sildenafil tablets and REVATIO, or any of the ingredients in sildenafil tablets.

Side Effect	Frequency	Severity	Notes
Headache	Common	Mild to moderate	Usually resolves within hours
Flushing	Common	Mild	Often transient
Nasal Congestion	Common	Mild	Temporary
Dizziness	Less common	Mild	Do not operate machinery
Visual Disturbances	Rare	Mild	Includes blue-tinted vision