Sildenafil Citrate Tablets
Inform patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors. Use sildenafil tablets with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia).
7.2 Alpha-blockers
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.Cardiovascular EventsIn postmarketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without sexual activity. Others were reported to have occurred hours to days after use concurrent with sexual activity. It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient's underlying cardiovascular disease, or to a combination of these or other factors.Nervous systemSeizure, seizure recurrenceOphthalmologicNAION [see Warnings and Precautions (5.5)and Patient Counseling Information (17) ]. The following serious adverse events are discussed elsewhere in the labeling: Mortality with pediatric use [see Warnings and Precautions (5.1)and Use in Specific Populations (8.4)] Hypotension [see Warnings and Precautions (5.2)] Vision loss [see Warnings and Precautions (5.5)] Hearing loss [see Warnings and Precautions (5.6)] Priapism [see Warnings and Precautions (5.8)] Vaso-occlusive crisis [see Warnings and Precautions (5.9)] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Revatio Injection
Safety data of sildenafil tablets in adults were obtained from canada sildenafil the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 sildenafil tablets-treated patients with PAH, WHO Group I. The overall frequency of discontinuation in sildenafil tablets-treated patients on 20 mg three times a day was 3% and was the same for the placebo group. In Study 1, the adverse reactions that were reported by at least 3% of sildenafil tablets-treated patients (20 mg three times a day) and were more frequent in sildenafil tablets-treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were generally transient and mild to moderate in nature. At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.
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In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil tablets than by those randomized to placebo. ADVERSE REACTIONS The following serious adverse events are discussed elsewhere in the labeling:Mortality with pediatric use [see Warnings and Precautions (5.1)and Use in Specific Populations (8.4)]Hypotension [see Warnings and Precautions (5.2)]Vision loss [see Warnings and Precautions (5.5)]Hearing loss [see Warnings and Precautions (5.6)]Priapism [see Warnings and Precautions (5.8)]Vaso-occlusive crisis [see Warnings and Precautions (5.9)]6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Safety data of sildenafil tablets in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 sildenafil tablets-treated patients with PAH, WHO Group I. [see Clinical Studies (14)].The overall frequency of discontinuation in sildenafil tablets-treated patients on 20 mg three times a day was 3% and was the same for the placebo group.In Study 1, the adverse reactions that were reported by at least 3% of sildenafil tablets-treated patients (20 mg three times a day) and were more frequent in sildenafil tablets-treated patients than in placebo-treated patients are shown in Table 1.
| 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 |
Adverse reactions were generally transient and mild to moderate in nature.At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision.The incidence of retinal hemorrhage with sildenafil tablets 20 mg three times a day was 1.4% versus 0% placebo and for all sildenafil tablets doses studied was 1.9% versus 0% placebo. The incidence of eye hemorrhage at both 20 mg three times a day and at all doses studied was 1.4% for sildenafil tablets versus 1.4% for placebo.
5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives
How sildenafil is used
The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy.In a placebo-controlled fixed dose titration study (Study 2) of sildenafil tablets (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the sildenafil tablets + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)].6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction).
Prescription Required (Rx) to Buy?
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.Cardiovascular EventsIn postmarketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without sexual activity. Others were reported to have occurred hours to days after use concurrent with sexual activity. It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient's underlying cardiovascular disease, or to a combination of these or other factors.Nervous systemSeizure, seizure recurrenceOphthalmologicNAION [see Warnings and Precautions (5.5)and Patient Counseling Information (17) ]. The following serious adverse events are discussed elsewhere in the labeling: Mortality with pediatric use [see Warnings and Precautions (5.1)and Use in Specific Populations (8.4)] Hypotension [see Warnings and Precautions (5.2)] Vision loss [see Warnings and Precautions (5.5)] Hearing loss [see Warnings and Precautions (5.6)] Priapism [see Warnings and Precautions (5.8)] Vaso-occlusive crisis [see Warnings and Precautions (5.9)] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Safety data of sildenafil tablets in adults were obtained from canada sildenafil the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 sildenafil tablets-treated patients with PAH, WHO Group I. The overall frequency of discontinuation in sildenafil tablets-treated patients on 20 mg three times a day was 3% and was the same for the placebo group. In Study 1, the adverse reactions that were reported by at least 3% of sildenafil tablets-treated patients (20 mg three times a day) and were more frequent in sildenafil tablets-treated patients than in placebo-treated patients are shown in Table 1.
- Sildenafil 120 mg can cause flushing and nasal congestion as common side effects.
- It is important to follow medical advice to minimize health risks.
- The drug's effectiveness can be influenced by other health conditions like diabetes.
- Consuming grapefruit or grapefruit juice may affect sildenafil’s metabolism.
- Patients should seek emergency care if experiencing an erection lasting longer than 4 hours.
- Sildenafil’s effects typically last about 4-6 hours, depending on individual factors.
Adverse reactions were generally transient and mild to moderate in nature. At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances.
- Side effects from high doses may include dizziness, flushing, or stomach upset.
- The onset of action is typically within 30 to 60 minutes after intake.
- Patients should avoid heavy meals before taking sildenafil for quicker results.
- Overdose symptoms include chest pain, loss of vision, and fainting.
- Sildenafil is not a cure for erectile dysfunction but enhances blood flow temporarily.
- Medical review is crucial for safety when considering high-dose sildenafil.
Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision.
Route of administration
Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision. The incidence of retinal hemorrhage with sildenafil tablets 20 mg three times a day was 1.4% versus 0% placebo and for all sildenafil tablets doses studied was 1.9% versus 0% placebo. The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy. In a placebo-controlled fixed dose titration study (Study 2) of sildenafil tablets (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the sildenafil tablets + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)]. The following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction).
What should I do if I miss a dose of sildenafil?
In postmarketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug. It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient's underlying cardiovascular disease, or to a combination of these or other factors. NAION [see Warnings and Precautions (5.5)and Patient Counseling Information (17) ]. DRUG INTERACTIONS Concomitant use of sildenafil tablets with nitrates in any form is contraindicated [see Contraindications (4)].Ritonavir and other Potent CYP3A InhibitorsConcomitant use of sildenafil tablets with ritonavir and other potent CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3)].Other drugs that reduce blood pressureAlpha blockers.In drug-drug interaction studies, sildenafil (25 mg, 50 mg, or 100 mg) and the alpha-blocker doxazosin (4 mg or 8 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy. In these study populations, mean additional reductions of supine systolic and diastolic blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, respectively, were observed. The incidence of retinal hemorrhage with sildenafil tablets 20 mg three times a day was 1.4% versus 0% placebo and for all sildenafil tablets doses studied was 1.9% versus 0% placebo. The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy. In a placebo-controlled fixed dose titration study (Study 2) of sildenafil tablets (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the sildenafil tablets + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)].
- 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.
The following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). In postmarketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug. It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient's underlying cardiovascular disease, or to a combination of these or other factors. NAION [see Warnings and Precautions (5.5)and Patient Counseling Information (17) ]. DRUG INTERACTIONS Concomitant use of sildenafil tablets with nitrates in any form is contraindicated [see Contraindications (4)].Ritonavir and other Potent CYP3A InhibitorsConcomitant use of sildenafil tablets with ritonavir and other potent CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3)].Other drugs that reduce blood pressureAlpha blockers.In drug-drug interaction studies, sildenafil (25 mg, 50 mg, or 100 mg) and the alpha-blocker doxazosin (4 mg or 8 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
| Use Case | Description | Dosage Recommendations | Special Considerations |
|---|---|---|---|
| Erectile Dysfunction (ED) | To improve blood flow to the penis during arousal | 120 mg as prescribed | Not for use with nitrates |
| Pulmonary Arterial Hypertension | Off-label for vasodilation in lungs | Under doctor guidance | Monitor blood pressure |
| Off-label Use in Sexual Dysfunction | Sometimes used in other sexual dysfunctions | As prescribed | Limited evidence for other uses |
| Enhancement of Exercise Capacity | Occasionally used in sports medicine | Not approved | Risk of adverse effects |
In these study populations, mean additional reductions of supine systolic and diastolic blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, respectively, were observed. Mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were also observed. There were infrequent reports of patients who experienced symptomatic postural hypotension.
- Sildenafil citrate 120 mg is often used illicitly, which increases health risks.
- Long-term safety data for high doses are limited; risks are not fully understood.
- Use should be personalized based on medical history and current health status.
- Do not crush or chew sildenafil tablets; take them whole with water.
- Combining sildenafil with other vasodilators can lead to dangerous blood pressure drops.
- Always seek professional guidance before initiating or adjusting sildenafil dosage.
These reports included dizziness and light-headedness, but not syncope.Amlodipine.When sildenafil 100 mg oral was co-administered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic.Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil tablets [see Warnings and Precautions (5.2)].
Mechanism of action
Inform patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors. Use sildenafil tablets with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia). If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result. In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil tablets than by those randomized to placebo. ADVERSE REACTIONS The following serious adverse events are discussed elsewhere in the labeling:Mortality with pediatric use [see Warnings and Precautions (5.1)and Use in Specific Populations (8.4)]Hypotension [see Warnings and Precautions (5.2)]Vision loss [see Warnings and Precautions (5.5)]Hearing loss [see Warnings and Precautions (5.6)]Priapism [see Warnings and Precautions (5.8)]Vaso-occlusive crisis [see Warnings and Precautions (5.9)]6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Safety data of sildenafil tablets in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 sildenafil tablets-treated patients with PAH, WHO Group I.
Step-by-Step: How to Take Cobra 120
[see Clinical Studies (14)].The overall frequency of discontinuation in sildenafil tablets-treated patients on 20 mg three times a day was 3% and was the same for the placebo group.In Study 1, the adverse reactions that were reported by at least 3% of sildenafil tablets-treated patients (20 mg three times a day) and were more frequent in sildenafil tablets-treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were generally transient and mild to moderate in nature.At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision.The incidence of retinal hemorrhage with sildenafil tablets 20 mg three times a day was 1.4% versus 0% placebo and for all sildenafil tablets doses studied was 1.9% versus 0% placebo. The incidence of eye hemorrhage at both 20 mg three times a day and at all doses studied was 1.4% for sildenafil tablets versus 1.4% for placebo. The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy.In a placebo-controlled fixed dose titration study (Study 2) of sildenafil tablets (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the sildenafil tablets + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)].6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). Concomitant use of sildenafil tablets with nitrates in any form is contraindicated [see Contraindications (4)]. Concomitant use of sildenafil tablets with ritonavir and other potent CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3)].
Side Effects You Should Know About
Mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were also observed. There were infrequent reports of patients who experienced symptomatic postural hypotension. These reports included dizziness and light-headedness, but not syncope.Amlodipine.When sildenafil 100 mg oral was co-administered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic.Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil tablets [see Warnings and Precautions (5.2)]. Concomitant use of sildenafil tablets with nitrates in any form is contraindicated [see Contraindications (4)]. Concomitant use of sildenafil tablets with ritonavir and other potent CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3)].
Pulmonary Arterial Hypertension
Alpha blockers.In drug-drug interaction studies, sildenafil (25 mg, 50 mg, or 100 mg) and the alpha-blocker doxazosin (4 mg or 8 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy. Alpha blockers.In drug-drug interaction studies, sildenafil (25 mg, 50 mg, or 100 mg) and the alpha-blocker doxazosin (4 mg or 8 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.