There were highly statistically significant improvements on the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on sildenafil tablets compared to placebo. On a global improvement question, 57% of sildenafil tablets patients reported improved erections versus 10% on placebo. 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. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of sildenafil tablets. On a global improvement question, 83% of patients reported improved erections on sildenafil tablets versus 12% on placebo. 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. sildenafil tablets was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and anti-hypertensives/diuretics. They are available as follows: Bottles of 30 tablets NDC 31722-965-30 Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'E' on one side and '114 'on the other side. They are available as follows: Bottles of 30 tablets NDC 31722-966-30 Bottles of 100 tablets NDC 31722-966-01 Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'E' on one side and '115' on the other side. They are available as follows: Bottles of 30 tablets NDC 31722-967-30 Bottles of 100 tablets NDC 31722-967-01 Recommended Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Advise the patient to read the FDA-approved patient labeling (Patient Information) Nitrates Physicians 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)].
8.2 Lactation
There were highly statistically significant improvements on the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on sildenafil tablets compared to placebo. On a global improvement question, 57% of sildenafil tablets patients reported improved erections versus 10% on placebo. 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. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of sildenafil tablets.
2.3 Dosage Adjustments in Specific Situations
On a global improvement question, 83% of patients reported improved erections on sildenafil tablets versus 12% on placebo. 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.
Key takeaways
Efficacy Results in Subpopulations in Controlled Clinical Studies A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. sildenafil tablets was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and anti-hypertensives/diuretics. They are available as follows: Bottles of 30 tablets NDC 31722-965-30 Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'E' on one side and '114 'on the other side. They are available as follows: Bottles of 30 tablets NDC 31722-966-30 Bottles of 100 tablets NDC 31722-966-01 Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'E' on one side and '115' on the other side. They are available as follows: Bottles of 30 tablets NDC 31722-967-30 Bottles of 100 tablets NDC 31722-967-01 Recommended Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Guanylate Cyclase (GC) Stimulators Physicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [see Contraindications (4.3)].
- Sildenafil 200 mg is a powerful treatment requiring careful medical evaluation.
- It is not a cure but helps manage symptoms of erectile dysfunction.
- Patients should keep track of medication reactions and report to their doctor.
- Do not mix sildenafil with alcohol, cigarettes, or recreational drugs.
- Avoid heavy or fatty meals close to the time of intake.
- Always use medication as directed to prevent health complications.
Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients.
- Sildenafil 200 mg's safety profile depends on individual health conditions.
- It is important to inform your doctor of all medications being taken.
- Use sildenafil only when needed for sexual activity.
- Avoid engaging in activities that require alertness until effects are known.
- The drug is often part of a broader erectile dysfunction treatment strategy.
- Safe storage is essential to prevent accidental ingestion by children or others.
Therefore, when sildenafil tablets are co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at the lowest dose [see Warnings and Precautions (5.5)]. Cardiovascular Considerations 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)]. Sudden Loss of Vision Physicians 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. 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 Loss Physicians 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)].
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 200mg | 120 + 8 Pills | 204.80€ 195.05€ | |
| Viagra Generic | 150mg | 270 + 10 Pills | 326.61€ 311.06€ | |
| Kamagra Soft Tabs | 100mg | 20 Pills | 79.79€ 75.99€ | |
| Viagra Generic | 100mg | 120 + 6 Pills | 149.50€ 142.38€ | |
| Kamagra Oral Jelly | 100mg | 63 + 7 Sachets | 224.18€ 213.50€ | |
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| Kamagra Polo | 100mg | 32 Pills | 125.88€ 119.89€ | |
| Viagra Generic | 200mg | 60 + 4 Pills | 125.19€ 119.23€ | |
| Viagra Generic | 150mg | 10 Pills | 36.73€ 34.98€ | |
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| Kamagra Soft Tabs | 100mg | 180 + 8 Pills | 425.45€ 405.19€ |
Priapism Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful buy pills sildenafil 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 Inhibitors Physicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [see Warnings and Precautions(5.7)].
Addressing the Psychological Factors
Advise the patient to read the FDA-approved patient labeling (Patient Information) Nitrates Physicians 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) Stimulators Physicians 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 Pressure Physicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. 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 tablets treatment and sildenafil tablets should be initiated at the lowest dose [see Warnings and Precautions (5.5)].
2.5 Dosage Adjustments in Special Populations
Cardiovascular Considerations 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)]. Sudden Loss of Vision Physicians 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. 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 Loss Physicians 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.
Lifestyle changes
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)]. Priapism Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful buy pills sildenafil 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 Inhibitors Physicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. 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 Disease The 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 for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854. Manufactured by: Evaric Pharmaceuticals Inc. 155 COMMERCE DRIVE, HAUPPAUGE, New York (NY) 11788, United States (USA). Sildenafil Tablets, USP (sil den' a fil) What is the most important information I should know about sildenafil tablets?
| Parameter | Description | Typical Values | Notes |
|---|---|---|---|
| Absorption | Time to peak plasma concentration (Tmax) | 30-120 minutes | Taken on an empty stomach for faster absorption |
| Bioavailability | Percentage absorbed into bloodstream | 40% | Affected by food intake |
| Half-life | Duration for plasma concentration to reduce by half | 4 hours | Determines dosing frequency |
| Metabolism | Liver enzyme involved | CYP3A4 | Also metabolized by CYP2C9 |
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 chronicthromboembolic 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.
1. Indications and Usage for Sildenafil Tablets
Sexually Transmitted Disease The 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 for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854. Manufactured by: Evaric Pharmaceuticals Inc.
12.3 Pharmacokinetics
155 COMMERCE DRIVE, HAUPPAUGE, New York (NY) 11788, United States (USA). Sildenafil Tablets, USP (sil den' a fil) 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.
What should I know about sildenafil before taking it?
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 chronicthromboembolic 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. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex. Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.
Overdose/Missed Dose
Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS. Sildenafil tablet is a prescription medicine used to treat erectile dysfunction (ED). 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.
2.1 Dosage Information
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. Before you take sildenafil tablets, tell your healthcare provider if you: • have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure • have had heart surgery within the last 6 months • have pulmonary hypertension • have had a stroke • have low blood pressure, or high blood pressure that is not controlled • have a deformed penis shape • have had an erection that lasted for more than 4 hours • have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia • have retinitis pigmentosa, a rare genetic (runs in families) eye disease • have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) • have bleeding problems • have or have had stomach ulcers • have liver problems • have kidney problems or are having kidney dialysis • have any other medical conditions Tell your healthcare provider about all the medicines you take*,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sildenafil tablet is a prescription medicine used to treat erectile dysfunction (ED). 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. 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. Before you take sildenafil tablets, tell your healthcare provider if you: • have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure • have had heart surgery within the last 6 months • have pulmonary hypertension • have had a stroke • have low blood pressure, or high blood pressure that is not controlled • have a deformed penis shape • have had an erection that lasted for more than 4 hours • have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia • have retinitis pigmentosa, a rare genetic (runs in families) eye disease • have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) • have bleeding problems • have or have had stomach ulcers • have liver problems • have kidney problems or are having kidney dialysis • have any other medical conditions Tell your healthcare provider about all the medicines you take*,including prescription and over-the-counter medicines, vitamins, and herbal supplements.