Sildenafil dosing question
Most patients were PAH treatment naïve (83%). For most patients the etiology of PAH was idiopathic (72%). The most common WHO Functional Class was Class III (58% of patients).
12.2 Pharmacodynamics
Treatment groups were well balanced with respect to baseline demographics of strata history of PAH treatment and etiology of PAH, as well as the WHO Functional Class categories. The primary objective of the study was to compare sildenafil 80 mg TID versus 5 mg TID for mortality, with success defined by ruling out twice the mortality at 80 mg. The key secondary efficacy endpoint was time to first event of clinical worsening, defined as a composite endpoint of all-cause mortality, hospitalization for worsening PAH or disease progression. An additional secondary endpoint was 6MWD at Months 6 and 12. Overall Survival At the time of a planned interim analysis (50% deaths) it was identified that the primary efficacy objective of this protocol was met and therefore the study was stopped. Based on the primary efficacy endpoint (mortality), the non-inferiority of sildenafil 80 mg TID arm versus 5 mg TID arm was met using a 2-sided significance level of 0.003 for the interim analysis. Primary comparison of the 80 mg TID group to the 5-mg TID group yielded the HR (99.7% CI) = 0.51 (0.22, 1.21); i.e., non-inferiority was established. Kaplan-Meier estimates of survival at 3 years were 66%, 79%, and 85% in the 5-, 20-, and 80mg TID dose groups, respectively Clinical Worsening Sildenafil 80 mg was also superior to 5 mg for time to first event of clinical worsening with HR (99.7% CI) = 0.44 (0.22, 0.89). At baseline, the median of 6MWD for the intent-to-treat (ITT) population was 332 to 352 m. At Month 6, the median change from baseline was highest for sildenafil 80 mg TID with 28 m compared to 18 m and 19 m for sildenafil 5 mg TID and sildenafil 20 mg TID groups, respectively. The same was seen at Month 12, the median change from baseline for sildenafil 80 mg TID group was 33 m compared to 17 m for sildenafil 5 mg TID and 31 m in sildenafil 20 mg TID groups. Overall, the safety data for sildenafil 20 mg TID and for the higher sildenafil 80 mg TID dose were consistent with the established safety profile of sildenafil in previous adult PAH studies [see Adverse Reactions (6.1)].
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 50mg | 60 + 4 Pills | 83.93€ 79.93€ | |
| Viagra Generic | 100mg | 60 + 4 Pills | 96.36€ 91.77€ | |
| Viagra Generic | 150mg | 180 + 10 Pills | 236.46€ 225.20€ | |
| Kamagra Oral Jelly | 100mg | 10 Sachets | 54.55€ 51.95€ | |
| Viagra Generic | 50mg | 120 + 6 Pills | 129.64€ 123.47€ | |
| Kamagra | 100mg | 120 + 6 Pills | 330.74€ 314.99€ | |
| Kamagra Polo | 100mg | 60 + 4 Pills | 189.39€ 180.37€ | |
| Viagra Generic | 50mg | 20 Pills | 40.52€ 38.59€ | |
| Kamagra Polo | 100mg | 120 + 6 Pills | 327.15€ 311.57€ | |
| Viagra Generic | 50mg | 90 + 6 Pills | 107.37€ 102.26€ | |
| Viagra Generic | 50mg | 30 + 4 Pills | 54.26€ 51.68€ | |
| Kamagra Polo | 100mg | 84 + 4 Pills | 244.49€ 232.85€ |
Sildenafil 20 mg tablets USP are white to off-white, round biconvex film coated tablets debossed with '85' on one side and plain on other side. Bottles of 30 Tablets NDC: 80425-0304-01 Bottles of 60 Tablets NDC: 80425-0304-02 Bottles of 90 Tablets NDC: 80425-0304-03 Bottles of 50 Tablets NDC: 80425-0304-04 Recommended Storage for Sildenafil Tablets USP: 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].
What Are Side Effects Associated with Using Sildenafil?
Most patients were PAH treatment naïve (83%). For most patients the etiology of PAH was idiopathic (72%). The most common WHO Functional Class was Class III (58% of patients). Treatment groups were well balanced with respect to baseline demographics of strata history of PAH treatment and etiology of PAH, as well as the WHO Functional Class categories. The primary objective of the study was to compare sildenafil 80 mg TID versus 5 mg TID for mortality, with success defined by ruling out twice the mortality at 80 mg.
Allergy warning
The key secondary efficacy endpoint was time to first event of clinical worsening, defined as a composite endpoint of all-cause mortality, hospitalization for worsening PAH or disease progression. An additional secondary endpoint was 6MWD at Months 6 and 12. Overall Survival At the time of a planned interim analysis (50% deaths) it was identified that the primary efficacy objective of this protocol was met and therefore the study was stopped. Based on the primary efficacy endpoint (mortality), the non-inferiority of sildenafil 80 mg TID arm versus 5 mg TID arm was met using a 2-sided significance level of 0.003 for the interim analysis. Primary comparison of the 80 mg TID group to the 5-mg TID group yielded the HR (99.7% CI) = 0.51 (0.22, 1.21); i.e., non-inferiority was established.
Sildenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Kaplan-Meier estimates of survival at 3 years were 66%, 79%, and 85% in the 5-, 20-, and 80mg TID dose groups, respectively Clinical Worsening Sildenafil 80 mg was also superior to 5 mg for time to first event of clinical worsening with HR (99.7% CI) = 0.44 (0.22, 0.89). At baseline, the median of 6MWD for the intent-to-treat (ITT) population was 332 to 352 m. At Month 6, the median change from baseline was highest for sildenafil 80 mg TID with 28 m compared to 18 m and 19 m for sildenafil 5 mg TID and sildenafil 20 mg TID groups, respectively. The same was seen at Month 12, the median change from baseline for sildenafil 80 mg TID group was 33 m compared to 17 m for sildenafil 5 mg TID and 31 m in sildenafil 20 mg TID groups. Overall, the safety data for sildenafil 20 mg TID and for the higher sildenafil 80 mg TID dose were consistent with the established safety profile of sildenafil in previous adult PAH studies [see Adverse Reactions (6.1)]. Advise the patient to read the FDA-approved patient labeling (Patient Information). • Inform patients of contraindication of sildenafil tablets with regular sildenafil 45 mg chewable tablets and/or intermittent use of organic nitrates. • Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors. • Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil tablets. • Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets.
Pregnancy & Lactation
Sildenafil 20 mg tablets USP are white to off-white, round biconvex film coated tablets debossed with '85' on one side and plain on other side. Bottles of 30 Tablets NDC: 80425-0304-01 Bottles of 60 Tablets NDC: 80425-0304-02 Bottles of 90 Tablets NDC: 80425-0304-03 Bottles of 50 Tablets NDC: 80425-0304-04 Recommended Storage for Sildenafil Tablets USP: 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]. Advise the patient to read the FDA-approved patient labeling (Patient Information). • Inform patients of contraindication of sildenafil tablets with regular sildenafil 45 mg chewable tablets and/or intermittent use of organic nitrates. • Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction.
Sildenafil Oral Film for ED
Advise patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors. • Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil tablets. • Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets. TORRENT PHARMA INC., Basking Ridge, NJ 07920. Sildenafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED).
2.1 Dosage Information
In combination with sexual stimulation, sildenafil works by increasing blood flow to the penis to help a man get and keep an erection. Sildenafil does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Practice "safe sex" such as sildenafil 50 mg tab using latex condoms. Consult your doctor or pharmacist for more details. Sildenafil is also available in other brands and strengths for treating high blood pressure in the lungs (pulmonary hypertension). TORRENT PHARMA INC., Basking Ridge, NJ 07920. Sildenafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, sildenafil works by increasing blood flow to the penis to help a man get and keep an erection. Sildenafil does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis).
What happens if I overdose?
Do not take sildenafil with any other product that contains sildenafil or other similar medications for erectile dysfunction-ED or pulmonary hypertension (such as tadalafil, vardenafil). Sildenafil is available under the following different brand names: Revatio, and Viagra. Dosage Considerations – Should be Given as Follows: 50 mg orally 1 hour before sexual activity may be increased to 100 mg or reduced to 25 mg, depending on effectiveness and tolerance Oral: 5 mg or 20 mg 3 times daily, administered 4-6 hours apart Intravenous (IV): 2.5-mg or 10-mg bolus 3 times daily if patient is temporarily unable to take orally Recommended oral/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on exercise capacity Hepatic impairment or severe renal impairment: Use initial dose of 25 mg Older than 65 years: 25 mg orally initially 1 hour before sexual activity Oral: 5 mg or 20 mg 3 times daily, administered 4-6 hours apart Intravenous (IV): 2.5-mg or 10-mg bolus 3 times daily if patient is temporarily unable to take orally Recommended oral/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on exercise capacity Clinical trials found no significant difference in response between elderly patients and younger adults; however, cautious dose selection should be considered in elderly because of greater frequency of decreased hepatic, renal, and cardiac function, as well as comorbid conditions and concomitant pharmacotherapy Compared with healthy younger volunteers, healthy elderly volunteers (65 years and older) had reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively Not to be prescribed to children (1-17 years) for pulmonary arterial hypertension (PAH); this recommendation against use is based on long-term clinical pediatric trial showing that children taking high doses had higher risk of death than children taking low doses and that low doses were not effective in improving exercise ability Side effects associated with use of Sildenafil, include the following: Postmarketing side effects of sildenafil reported include: Vaso-occlusive crisis (PAH secondary to sickle-cell anemia) This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects. If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.
Before taking sildenafil,
Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first. Sildenafil has serious interactions with at least 48 different drugs. Sildenafil has moderate interactions with at least 72 different drugs. This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.
How Sildenafil works
Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine. Do not take Revatio or Viagra if you are allergic to sildenafil or any ingredients contained in this drug. In case of overdose, get medical help or contact a Poison Control Center immediately Soluble guanylate cyclase (sGC) stimulators (e.g., riociguat); concomitant use can cause hypotension Co-administration with nitrates (either regularly and/or intermittently) and nitric oxide donors Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined Elicits vasodilatory properties, resulting in mild and transient decreases in blood pressure. See "What Are Side Effects Associated with Using Sildenafil?" Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi See "What Are Side Effects Associated with Using Sildenafil?” Elicits vasodilatory properties, resulting in mild and transient decreases in blood pressure Use with caution in patients with anatomic deformation of penis (e.g., angulation, cavernosal fibrosis, or Peyronie disease), conditions potentially predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), cardiovascular disease, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, concomitant use of CYP3A4 inhibitors Pulmonary vasodilators may significantly worsen cardiovascular status of patients with pulmonary veno-occlusive disease Patients taking alpha blocker should be stabilized before starting phosphodiesterase (PDE)-5 inhibitor, which should be initiated at lowest dose; if patient is already taking optimized dose of PDE-5 inhibitor, alpha blocker should be initiated at lowest dose to avoid hypotension Not to be taken with other PDE-5 inhibitors Sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness Viagra: Patients should stop sildenafil and seek medical care if a sudden loss of vision occurs in 1 or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION); use with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION; patients with a ”crowded” optic disc may also be at an increased risk of NAION Viagra: Potential for cardiac risk with sexual activity in patients with preexisting cardiovascular disease; therefore, treatment for erectile dysfunction generally should not be instituted in men for whom sexual activity is inadvisable because of their underlying cardiovascular status May cause dose-related impairment of color discrimination; use caution in patients with retinitis pigmentosa Evaluate underlying causes of erectile dysfunction or BPH before initiating therapy Revatio: In small, prematurely terminated study of patients with PAH secondary to sickle-cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil than by those randomized to placebo; effectiveness of sildenafil in PAH secondary to sickle-cell anemia has not been established; the clinical relevance to men treated for erectile dysfunction with sildenafil is not known Revatio: Not for use in children with PAH; increased mortality with increasing doses (hazard ratio 3.5) was observed in randomized, double-blind, placebo-controlled clinical trial of 234 children (1-17 years) with PAH who had mild-to-moderate symptoms at baseline Revatio: Epistaxis occurred in 13% of patients with PAH secondary to connective tissue disease (e.g., scleroderma); this effect was not seen in idiopathic PAH; incidence was also higher in those receiving concomitant PO vitamin K antagonist therapy (9%) than in those not receiving such therapy (2%) Sildenafil may be acceptable for use during pregnancy Either animal studies show no risk but human studies are not available, or animal studies showed minor risks and human studies were done and showed no risk It is unknown whether sildenafil is distributed into breast milk. Practice "safe sex" such as sildenafil 50 mg tab using latex condoms.
- Sildenafil works by relaxing blood vessels to increase blood flow.
- 20mg dosage is suitable for men with mild to moderate ED.
- It is available by prescription or over-the-counter in some regions.
- Avoid alcohol while taking sildenafil to prevent side effects.
- Do not exceed the prescribed dose to reduce health risks.
Consult your doctor or pharmacist for more details. Sildenafil is also available in other brands and strengths for treating high blood pressure in the lungs (pulmonary hypertension). Do not take sildenafil with any other product that contains sildenafil or other similar medications for erectile dysfunction-ED or pulmonary hypertension (such as tadalafil, vardenafil). Sildenafil is available under the following different brand names: Revatio, and Viagra.
- Myths and misconceptions about sildenafil are common and should be addressed.
- It is not a "party drug" or aphrodisiac; it requires sexual stimulation to work.
- It does not cause spontaneous erections without sexual arousal.
- More is not always better; higher doses increase side effect risk, not pleasure.
- It is not addictive, but psychological dependence on its use can develop.
- It does not permanently cure erectile dysfunction; effects are temporary.
- It is not safe to use just because it is widely available or discussed.
- Herbal "natural Viagra" products are not regulated and can be dangerous.
- It does not protect against sexually transmitted infections or prevent pregnancy.
- It is not approved or proven to enhance sexual performance in men without ED.
- Accurate information from a healthcare provider is essential.
Dosage Considerations – Should be Given as Follows: 50 mg orally 1 hour before sexual activity may be increased to 100 mg or reduced to 25 mg, depending on effectiveness and tolerance Oral: 5 mg or 20 mg 3 times daily, administered 4-6 hours apart Intravenous (IV): 2.5-mg or 10-mg bolus 3 times daily if patient is temporarily unable to take orally Recommended oral/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on exercise capacity Hepatic impairment or severe renal impairment: Use initial dose of 25 mg Older than 65 years: 25 mg orally initially 1 hour before sexual activity Oral: 5 mg or 20 mg 3 times daily, administered 4-6 hours apart Intravenous (IV): 2.5-mg or 10-mg bolus 3 times daily if patient is temporarily unable to take orally Recommended oral/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on exercise capacity Clinical trials found no significant difference in response between elderly patients and younger adults; however, cautious dose selection should be considered in elderly because of greater frequency of decreased hepatic, renal, and cardiac function, as well as comorbid conditions and concomitant pharmacotherapy Compared with healthy younger volunteers, healthy elderly volunteers (65 years and older) had reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively Not to be prescribed to children (1-17 years) for pulmonary arterial hypertension (PAH); this recommendation against use is based on long-term clinical pediatric trial showing that children taking high doses had higher risk of death than children taking low doses and that low doses were not effective in improving exercise ability Side effects associated with use of Sildenafil, include the following: Postmarketing side effects of sildenafil reported include: Vaso-occlusive crisis (PAH secondary to sickle-cell anemia) This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects. If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.
| 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 | - |
Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.
| Aspect | Details | Notes |
|---|---|---|
| Active Ingredient | Sildenafil citrate | Used for erectile dysfunction |
| Dosage Strength | 20 mg per tablet | Common dosage for initial treatments |
| Recommended Use | Oral administration | Taken with water before sexual activity |
| Availability | Over-the-counter in some countries | Prescription required in others |
| Onset of Action | Typically 30-60 minutes | Varies by individual |
Sildenafil has serious interactions with at least 48 different drugs. Sildenafil has moderate interactions with at least 72 different drugs. This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine. Do not take Revatio or Viagra if you are allergic to sildenafil or any ingredients contained in this drug. In case of overdose, get medical help or contact a Poison Control Center immediately Soluble guanylate cyclase (sGC) stimulators (e.g., riociguat); concomitant use can cause hypotension Co-administration with nitrates (either regularly and/or intermittently) and nitric oxide donors Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined Elicits vasodilatory properties, resulting in mild and transient decreases in blood pressure. See "What Are Side Effects Associated with Using Sildenafil?" Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi See "What Are Side Effects Associated with Using Sildenafil?” Elicits vasodilatory properties, resulting in mild and transient decreases in blood pressure Use with caution in patients with anatomic deformation of penis (e.g., angulation, cavernosal fibrosis, or Peyronie disease), conditions potentially predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), cardiovascular disease, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, concomitant use of CYP3A4 inhibitors Pulmonary vasodilators may significantly worsen cardiovascular status of patients with pulmonary veno-occlusive disease Patients taking alpha blocker should be stabilized before starting phosphodiesterase (PDE)-5 inhibitor, which should be initiated at lowest dose; if patient is already taking optimized dose of PDE-5 inhibitor, alpha blocker should be initiated at lowest dose to avoid hypotension Not to be taken with other PDE-5 inhibitors Sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness Viagra: Patients should stop sildenafil and seek medical care if a sudden loss of vision occurs in 1 or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION); use with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION; patients with a ”crowded” optic disc may also be at an increased risk of NAION Viagra: Potential for cardiac risk with sexual activity in patients with preexisting cardiovascular disease; therefore, treatment for erectile dysfunction generally should not be instituted in men for whom sexual activity is inadvisable because of their underlying cardiovascular status May cause dose-related impairment of color discrimination; use caution in patients with retinitis pigmentosa Evaluate underlying causes of erectile dysfunction or BPH before initiating therapy Revatio: In small, prematurely terminated study of patients with PAH secondary to sickle-cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil than by those randomized to placebo; effectiveness of sildenafil in PAH secondary to sickle-cell anemia has not been established; the clinical relevance to men treated for erectile dysfunction with sildenafil is not known Revatio: Not for use in children with PAH; increased mortality with increasing doses (hazard ratio 3.5) was observed in randomized, double-blind, placebo-controlled clinical trial of 234 children (1-17 years) with PAH who had mild-to-moderate symptoms at baseline Revatio: Epistaxis occurred in 13% of patients with PAH secondary to connective tissue disease (e.g., scleroderma); this effect was not seen in idiopathic PAH; incidence was also higher in those receiving concomitant PO vitamin K antagonist therapy (9%) than in those not receiving such therapy (2%) Sildenafil may be acceptable for use during pregnancy Either animal studies show no risk but human studies are not available, or animal studies showed minor risks and human studies were done and showed no risk It is unknown whether sildenafil is distributed into breast milk.