FULL PRESCRIBING INFORMATION: CONTENTS*
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.
| Patient Group | Recommended Dose | Frequency of Use | Notes |
|---|---|---|---|
| First-time users | 20 mg | Once per day | Take 30-60 min before activity |
| Experienced users | May increase to 50 mg | As needed | Under medical supervision |
| Elderly patients | 20 mg or lower | As needed | Start with lowest dose |
| Patients on other medications | Consult doctor | Varies | Adjust dose accordingly |
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. 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.
What to avoid
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.
What should I do if I miss a dose of sildenafil?
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)].
Sildenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
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)]. Cardiovascular Considerations Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. 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].
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Kamagra Soft Tabs | 100mg | 60 + 4 Pills | 180.59€ 171.99€ | |
| Kamagra | 100mg | 32 Pills | 121.24€ 115.47€ | |
| Viagra Generic | 100mg | 180 + 8 Pills | 199.37€ 189.88€ | |
| Kamagra Soft Tabs | 100mg | 32 Pills | 120.11€ 114.39€ | |
| Kamagra Oral Jelly | 100mg | 90 + 8 Sachets | 303.56€ 289.10€ | |
| Kamagra Polo | 100mg | 60 + 4 Pills | 189.39€ 180.37€ | |
| Viagra Generic | 150mg | 10 Pills | 36.73€ 34.98€ | |
| Viagra Generic | 50mg | 360 + 10 Pills | 225.33€ 214.60€ | |
| Kamagra Soft Tabs | 100mg | 84 + 4 Pills | 233.05€ 221.95€ | |
| Kamagra Oral Jelly | 100mg | 30 + 5 Sachets | 136.20€ 129.71€ | |
| Kamagra | 100mg | 180 + 6 Pills | 436.79€ 415.99€ |
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)]. Cardiovascular Considerations Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. 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.
What Are Warnings and Precautions for Sildenafil?
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)]. Priapism 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 tablets.
5.4 Hearing Loss
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. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854.
7.3 Amlodipine
Manufactured by: Evaric Pharmaceuticals Inc. 155 COMMERCE DRIVE, HAUPPAUGE, sildenafil price ireland 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? Do not take sildenafil tablets if you take any other medicines called ''nitrates.'' Nitrates are used to treat chest pain (angina). 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. 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 erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets.
| Parameter | Description | Typical Value |
|---|---|---|
| Absorption Time | Time to reach peak plasma levels | 30-120 minutes |
| Half-life | Time for plasma concentration to reduce by half | 4 hours |
| Bioavailability | Percentage of dose that reaches circulation | 40% |
| Metabolism | Mainly processed in the liver | Cytochrome P450 enzymes |
| Excretion | Mainly via feces and urine | - |
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. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854. Manufactured by: Evaric Pharmaceuticals Inc. 155 COMMERCE DRIVE, HAUPPAUGE, sildenafil price ireland 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?
- 20mg sildenafil provides a balance between effectiveness and safety.
- It is not a cure for ED but helps achieve and maintain an erection.
- Using sildenafil without medical advice can be risky.
- The medication may cause nasal congestion or stomach upset.
- Always follow the dosage instructions provided by your healthcare provider.
Do not take sildenafil tablets if you take any other medicines called ''nitrates.'' Nitrates are used to treat chest pain (angina). 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. Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated). 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. See the end of this leaflet for a complete list of ingredients in sildenafil tablets. What should I tell my healthcare provider before taking 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 tablets may affect the way other medicines work, and other medicines may affect the way sildenafil tablet works causing side effects.
- The medication should be stored at room temperature between 15-30°C (59-86°F).
- Keep the tablets in their original container, tightly closed.
- Protect from light and moisture; avoid storing in bathrooms or near sinks.
- Do not use the medication if the packaging is torn or shows signs of tampering.
- Check the expiration date printed on the bottle or blister pack before use.
- Properly discard any medication that is outdated or no longer needed.
- Do not flush medications down the toilet or pour them into a drain.
- Consult a pharmacist or local waste disposal company for proper disposal methods.
- Many communities have drug take-back programs for safe disposal.
- Keeping old medication increases the risk of accidental ingestion or misuse.
- Safe storage and disposal protect children, pets, and the environment.
Especially tell your healthcare provider if you take any of the following: • medicines called nitrates (see 'What is the most important information I should know about sildenafil tablets?') • medicines called guanylate cyclase stimulators, such as riociguat (Adempas) • medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin).
What should I know about storage and disposal of this medication?
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. Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated). 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. See the end of this leaflet for a complete list of ingredients in sildenafil tablets. What should I tell my healthcare provider before taking sildenafil tablets?
12.3 Pharmacokinetics
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 tablets may affect the way other medicines work, and other medicines may affect the way sildenafil tablet works causing side effects. Especially tell your healthcare provider if you take any of the following: • medicines called nitrates (see 'What is the most important information I should know about sildenafil tablets?') • medicines called guanylate cyclase stimulators, such as riociguat (Adempas) • medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). In some patients, the use of sildenafil tablets with alpha-blockers can lead to a drop in blood pressure or to fainting. • medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz) • some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconozale (Sporanox) • some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin • other medicines that treat high blood pressure • other medicines or treatments for ED • sildenafil tablets contains sildenafil, which is the same medicine found in another drug called REVATIO.
Sildenafil Tablets for ED
Sildenafil tablets should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]). • Take sildenafil tablets exactly as your healthcare provider tells you to take it. • Your healthcare provider will tell you how much sildenafil tablets to take and when to take it. • Your healthcare provider may change your dose if needed. • Take sildenafil tablets about 1 hour before sexual activity. In some patients, the use of sildenafil tablets with alpha-blockers can lead to a drop in blood pressure or to fainting. • medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz) • some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconozale (Sporanox) • some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin • other medicines that treat high blood pressure • other medicines or treatments for ED • sildenafil tablets contains sildenafil, which is the same medicine found in another drug called REVATIO. Sildenafil tablets should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]). • Take sildenafil tablets exactly as your healthcare provider tells you to take it. • Your healthcare provider will tell you how much sildenafil tablets to take and when to take it. • Your healthcare provider may change your dose if needed. • Take sildenafil tablets about 1 hour before sexual activity.
13. Nonclinical Toxicology
• Sildenafil tablets can be taken with or without food. If you take sildenafil tablets after a high fat meal (such as a cheeseburger and french fries), sildenafil tablets may take a little longer to start working • Do nottake sildenafil tablets more than 1 time a day. • If you accidentally take too much sildenafil tablets, call your doctor or go to the nearest hospital emergency room right away. What are the possible side effects of sildenafil tablets? Sildenafil tablets can cause serious side effects .
8.6 Renal Impairment
Rarely reported side effects include: • an erection that will not go away (priapism). • Sildenafil tablets can be taken with or without food.
12.3 Pharmacokinetics
If you take sildenafil tablets after a high fat meal (such as a cheeseburger and french fries), sildenafil tablets may take a little longer to start working • Do nottake sildenafil tablets more than 1 time a day. • If you accidentally take too much sildenafil tablets, call your doctor or go to the nearest hospital emergency room right away. What are the possible side effects of sildenafil tablets? Sildenafil tablets can cause serious side effects . Rarely reported side effects include: • an erection that will not go away (priapism).