Label: SILDENAFIL CITRATE- sildenafil tablet, film coated

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 citrate improved their erections.

Country	Approval Status	Maximum Allowed Dose	Remarks
United States	Approved for ED and pulmonary hypertension	120 mg	Prescription-only, controlled use
European Union	Approved for ED, off-label for other uses	120 mg	Stringent prescribing regulations
Canada	Approved, similar to US	120 mg	Must be prescribed by healthcare provider
Australia	Approved with restrictions	120 mg	Medical supervision required
India	Available, OTC in some regions	120 mg	Use under medical guidance recommended

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 citrate 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 relationship satisfaction. One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). Diary data indicated that on sildenafil citrate, 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 citrate, 59% of attempts at sexual intercourse were successful compared to 13% on placebo. Across all trials, sildenafil citrate 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 citrate patients reported improvement in erections compared with 26% of placebo.

Pros and Cons of Cobra 120mg

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 citrate 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 citrate 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 relationship satisfaction. One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268).

Drug Interaction Studies

Diary data indicated that on sildenafil citrate, 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 citrate, 59% of attempts at sexual intercourse were successful compared to 13% on placebo. Across all trials, sildenafil citrate 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 citrate 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 citrate and 29% for placebo.

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Efficacy Results in Subpopulations in Controlled Clinical Studies A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. HOW SUPPLIED Sildenafil 50 mg tablets USP are blue, round biconvex, film coated tablets, debossed with '87'on one side and plain on other side.NDC: 70518-1641-00PACKAGING: 30 in 1 BOTTLE PLASTICRecommended Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].Repackaged and Distributed By:Remedy Repack, Inc.625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Sildenafil 50 mg tablets USP are blue, round biconvex, film coated tablets, debossed with '87'on one side and plain on other side. Recommended Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 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 citrate 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 citrate 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 citrate to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.

2.4 Dosage Adjustments Due to Drug Interactions

The safety and efficacy of sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors, including sildenafil tablets, 20 mg, have not been studied [ see Warnings and Precautions (5.7)].

Pharmacokinetics in Special Populations

Concomitant administration of sildenafil citrate and an alpha-blocker canadian sildenafil citrate may lead to symptomatic hypotension in some patients.

• The drug should be taken on an empty stomach for faster effect.
• Use of 120 mg may lead to priapism, a painful, prolonged erection.
• Sildenafil is also used to treat pulmonary arterial hypertension at lower doses.
• Do not exceed prescribed doses to avoid serious adverse reactions.
• Efficacy of sildenafil depends on individual health and possible drug interactions.
• Sildenafil can impair vision temporarily, including blue-tinted vision.

Therefore, when sildenafil citrate is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate 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.

Call to Action for Buyers, Importers, and Distributors

Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil citrate 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. HOW SUPPLIED Sildenafil 50 mg tablets USP are blue, round biconvex, film coated tablets, debossed with '87'on one side and plain on other side.NDC: 70518-1641-00PACKAGING: 30 in 1 BOTTLE PLASTICRecommended Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].Repackaged and Distributed By:Remedy Repack, Inc.625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Sildenafil 50 mg tablets USP are blue, round biconvex, film coated tablets, debossed with '87'on one side and plain on other side. Recommended Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

How should I store sildenafil?

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 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 citrate 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 citrate 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 citrate to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil citrate and an alpha-blocker canadian sildenafil citrate may lead to symptomatic hypotension in some patients. Therefore, when sildenafil citrate is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate 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 citrate, and seek medical attention in the event of a sudden loss of vision in one or both eyes. 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 citrate, 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 ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing 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.

• Overuse of sildenafil 120 mg may result in severe headache and nausea.
• Alcohol can reduce sildenafil effectiveness and worsen side effects.
• Always follow the doctor’s instructions for dosing and timing.
• Sildenafil should be stored away from moisture, heat, and light.
• Do not mix sildenafil with recreational drugs like 'poppers' or stimulants.
• Sudden vision loss is rare but requires immediate medical attention.

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 citrate, 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 citrate, 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 citrate. 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, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors including sildenafil tablets, 20 mg or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Sildenafil is also marketed as sildenafil tablets, 20 mg for the treatment of PAH. The safety and efficacy of sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors, including sildenafil tablets, 20 mg, have not been studied [ see Warnings and Precautions (5.7)].Sexually Transmitted DiseaseThe use of sildenafil citrate 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)].Dispense with Patient Information available at: December 2024Repackaged By / Distributed By: RemedyRepack Inc.625 Kolter Drive, Indiana, PA 15701(724) 465-8762 Advise the patient to read the FDA-approved patient labeling (Patient Information). Physicians should discuss with patients the contraindication of sildenafil citrate with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [ see Contraindications (4.1)]. Physicians should discuss with patients the contraindication of sildenafil citrate with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3)]. Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for sildenafil citrate to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Therefore, when sildenafil citrate is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Warnings and Precautions (5.5)]. Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors.

Sildenafil Citrate Tablets 120mg (NEOGRA) Technical Specification:

Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing 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 citrate, 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 citrate, 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 citrate. 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, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors including sildenafil tablets, 20 mg or other pulmonary arterial hypertension (PAH) treatments containing sildenafil.

Erectile dysfunction

Sildenafil is also marketed as sildenafil tablets, 20 mg for the treatment of PAH. The safety and efficacy of sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors, including sildenafil tablets, 20 mg, have not been studied [ see Warnings and Precautions (5.7)].Sexually Transmitted DiseaseThe use of sildenafil citrate 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)].Dispense with Patient Information available at: December 2024Repackaged By / Distributed By: RemedyRepack Inc.625 Kolter Drive, Indiana, PA 15701(724) 465-8762 Advise the patient to read the FDA-approved patient labeling (Patient Information). Physicians should discuss with patients the contraindication of sildenafil citrate with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [ see Contraindications (4.1)]. Physicians should discuss with patients the contraindication of sildenafil citrate with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3)]. 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)]. Physicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil citrate, and seek medical attention in the event of a sudden loss of vision in one or both eyes.

• Regular use of 120 mg sildenafil is not recommended without medical supervision.
• Potential interactions include blood pressure medications and certain antibiotics.
• Always check for contraindications before using sildenafil at high doses.
• The safety profile of large doses has not been well studied in women.
• Avoid driving or operating machinery until you know how sildenafil affects you.
• Keep track of side effects to report to your healthcare provider promptly.

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 citrate, for this uncommon condition [ see Warnings and Precautions (5.3)and Adverse Reactions (6.2)]. 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)]. Physicians 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 citrate.

Other Comments

Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for sildenafil citrate to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Therefore, when sildenafil citrate is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Warnings and Precautions (5.5)]. Physicians 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)]. Physicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil citrate, and seek medical attention in the event of a sudden loss of vision in one or both eyes.

Revatio Injection

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 citrate, for this uncommon condition [ see Warnings and Precautions (5.3)and Adverse Reactions (6.2)]. 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)]. Physicians 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 citrate. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions (5.2)]. Physicians should inform patients not to take sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors including sildenafil tablets, 20 mg or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions (5.2)].

Common Side Effects	Frequency	Serious Side Effects	Warning Signs	Management Tips
Headache	Common	Sudden vision loss	Vision changes, eye pain	Seek medical attention immediately
Flushing	Common	Priapism (painful erection)	Erections lasting >4 hours	Seek emergency care
Nasal Congestion	Common	Hypotension	Dizziness, fainting	Sit or lie down, hydrate
Indigestion (Dyspepsia)	Occasional	Hearing loss	Sudden deafness or ringing	Discontinue use and consult doctor
Muscle Pain	Less common	Severe allergic reactions	Rash, difficulty breathing	Discontinue and seek help

Physicians should inform patients not to take sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors including sildenafil tablets, 20 mg or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. The safety and efficacy of sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors, including sildenafil tablets, 20 mg, have not been studied [ see Warnings and Precautions (5.7)].