Label: SILDENAFIL CITRATE- sildenafil tablet, film coated
In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [ see Warnings and Precautions (5.4) and Patient Counseling Information (17)].Ocular: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment.Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil citrate. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [ see Warnings and Precautions (5.3) and Patient Counseling Information (17)].Urogenital: prolonged erection, priapism [ see Warnings and Precautions (5.2) and Patient Counseling Information (17)], and hematuria.
Other uses for this medicine
Ocular: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment. Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil citrate. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [ see Warnings and Precautions (5.3) and Patient Counseling Information (17)]. Urogenital: prolonged erection, priapism [ see Warnings and Precautions (5.2) and Patient Counseling Information (17)], and hematuria. 7 DRUG INTERACTIONS 7.1 NitratesAdministration of sildenafil citrate with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated.
What can I do to make Viagra work faster?
Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil citrate was shown to potentiate the hypotensive effects of nitrates [ see Dosage and Administration (2.3), Contraindications (4.1), Clinical Pharmacology (12.2)].7.2 Alpha-blockersUse caution when co-administering alpha-blockers with sildenafil citrate because of potential additive blood pressure-lowering effects. When sildenafil citrate is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Dosage and Administration (2.3), Warnings and Precautions (5.5), Clinical Pharmacology (12.2)].7.3 AmlodipineWhen sildenafil citrate 100 mg was co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic [ see Warnings and Precautions (5.5), Clinical Pharmacology (12.2)].7.4 Ritonavir and other CYP3A4 inhibitorsCo-administration of ritonavir, a strong CYP3A4 inhibitor, greatly increased the systemic exposure of sildenafil (11-fold increase in AUC). It is therefore recommended not to exceed a maximum single dose of 25 mg of sildenafil citrate in a 48 hour period [ see Dosage and Administration (2.4), Warnings and Precautions (5.6), Clinical Pharmacology (12.3)].Co-administration of erythromycin, a moderate CYP3A4 inhibitor, resulted in a 160% and 182% increases in sildenafil C max and AUC, respectively. Co-administration of saquinavir, a strong CYP3A4 inhibitor, resulted in 140% and 210% increases in sildenafil C max and AUC, respectively. The following are discussed in more detail in other sections of the labeling: Cardiovascular [ see Warnings and Precautions (5.1)] Prolonged Erection and Priapism [ see Warnings and Precautions (5.2)] Effects on the Eye [ see Warnings and Precautions (5.3)] Hearing Loss [ see Warnings and Precautions (5.4)] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [ see Warnings and Precautions (5.5)] Adverse Reactions with the Concomitant Use of Ritonavir [ see Warnings and Precautions (5.6)] Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [ see Warnings and Precautions (5.7)] Effects on Bleeding [ see Warnings and Precautions (5.8)] Counseling Patients About Sexually Transmitted Diseases [ see Warnings and Precautions (5.9)] The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Kamagra | 100mg | 180 + 6 Pills | 436.79€ 415.99€ | |
| Viagra Generic | 25mg | 10 Pills | 25.19€ 23.99€ | |
| Kamagra Polo | 100mg | 272 + 12 Pills | 622.94€ 593.28€ | |
| Kamagra Oral Jelly | 100mg | 110 + 9 Sachets | 334.87€ 318.92€ | |
| Kamagra Polo | 100mg | 120 + 6 Pills | 327.15€ 311.57€ | |
| Viagra Generic | 50mg | 360 + 10 Pills | 225.33€ 214.60€ | |
| Kamagra Polo | 100mg | 32 Pills | 125.88€ 119.89€ | |
| Viagra Generic | 25mg | 30 + 4 Pills | 47.97€ 45.69€ | |
| Viagra Generic | 200mg | 20 Pills | 61.69€ 58.75€ | |
| Viagra Generic | 150mg | 180 + 10 Pills | 236.46€ 225.20€ | |
| Kamagra Soft Tabs | 100mg | 84 + 4 Pills | 233.05€ 221.95€ | |
| Viagra Generic | 150mg | 60 + 4 Pills | 111.25€ 105.95€ |
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 clinical practice.
| Form | Dose Range per Tablet | Typical Strengths | Administration Route | Manufacturer Examples |
|---|---|---|---|---|
| Oral Tablets | 25 mg - 100 mg | 25 mg, 50 mg, 100 mg | Oral (once or as needed) | Pfizer, Teva, Cipla |
| Chewable Tablets | 50 mg | 50 mg | Oral (chewed) | Generic brands |
| Sublingual Tablets | 50 mg | 50 mg | Sublingual | Experimental formulations |
Sildenafil citrate was administered to over 3,700 patients (aged 19 to 87 years) during pre-marketing clinical trials worldwide.
- Physical activity might improve erectile response when combined with medication.
- Maintain a healthy weight for better sexual function.
- Lifestyle changes can enhance sildenafil efficacy over time.
Over 550 patients were treated for longer than one year.
2.2 Use with Food
In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [ see Warnings and Precautions (5.4) and Patient Counseling Information (17)].Ocular: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment.Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil citrate. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [ see Warnings and Precautions (5.3) and Patient Counseling Information (17)].Urogenital: prolonged erection, priapism [ see Warnings and Precautions (5.2) and Patient Counseling Information (17)], and hematuria. The following are discussed in more detail in other sections of the labeling: Cardiovascular [ see Warnings and Precautions (5.1)] Prolonged Erection and Priapism [ see Warnings and Precautions (5.2)] Effects on the Eye [ see Warnings and Precautions (5.3)] Hearing Loss [ see Warnings and Precautions (5.4)] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [ see Warnings and Precautions (5.5)] Adverse Reactions with the Concomitant Use of Ritonavir [ see Warnings and Precautions (5.6)] Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [ see Warnings and Precautions (5.7)] Effects on Bleeding [ see Warnings and Precautions (5.8)] Counseling Patients About Sexually Transmitted Diseases [ see Warnings and Precautions (5.9)] The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.
What Is Viagra?
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 clinical practice. Sildenafil citrate was administered to over 3,700 patients (aged 19 to 87 years) during pre-marketing clinical trials worldwide. Over 550 patients were treated for longer than one year. In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for sildenafil citrate (2.5%) was not significantly different from placebo (2.3%). In fixed-dose studies, the incidence of some adverse reactions increased with dose. In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for sildenafil citrate (2.5%) was not significantly different from placebo (2.3%). In fixed-dose studies, the incidence of some adverse reactions increased with dose. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently. †Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision.
| Condition | Details | Notes |
|---|---|---|
| Temperature | Store below 25°C | Keep in a dry place |
| Light | Protect from light | Use opaque container |
| Humidity | Keep away from moisture | Avoid bathroom storage |
| Shelf Life | Usually 2-3 years | Check expiration date |
When sildenafil citrate was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, 200mg sildenafil citrate patients took sildenafil citrate at least once weekly, and the following adverse reactions were reported: †Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision.
Usual Pediatric Dose for Pulmonary Hypertension
Study 1: Sildenafil citrate with Doxazosin
In these studies, only one patient discontinued due to abnormal vision. The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil citrate is uncertain. Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful: Body as a Whole: face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury. Metabolic and Nutritional: thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia. Respiratory: asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased.
Liver Dose Adjustments
This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions. The following adverse reactions have been identified during post approval use of sildenafil citrate. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. Serious cardiovascular, cerebrovascular, and vascular sildenafil film tablet events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil citrate. It is not possible to determine whether these events are related directly to sildenafil citrate, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [ see Warnings and Precautions (5.1) and Patient Counseling Information (17)].
Can I take Viagra by snorting it?
Hemic and Lymphatic: vaso-occlusive crisis: In a small, prematurely terminated study of sildenafil tablets, 20 mg (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with sildenafil tablets, 25 mg, 50 mg and 100 mg for ED is not known. Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia. Hearing: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil citrate. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [ see Warnings and Precautions (5.4) and Patient Counseling Information (17)]. Skin and Appendages: urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis. Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking sildenafil citrate with and without anti-hypertensive medication. This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.
- The onset of action is usually within 30 minutes.
- Peak effect occurs around 1 hour after ingestion.
- The duration of action can last up to 4-6 hours.
The following adverse reactions have been identified during post approval use of sildenafil citrate. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors.
| Common Side Effect | Frequency | Severity | Notes |
|---|---|---|---|
| Headache | Very common | Mild to moderate | Usually transient |
| Flushing | Common | Mild | Often resolves quickly |
| Dyspepsia / Indigestion | Common | Mild | Can be managed with antacids |
| Visual Disturbances | Less common | Mild | Changes in color perception |
| Priapism | Rare | Serious | Medical emergency, requires immediate attention |
Serious cardiovascular, cerebrovascular, and vascular sildenafil film tablet events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil citrate. It is not possible to determine whether these events are related directly to sildenafil citrate, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [ see Warnings and Precautions (5.1) and Patient Counseling Information (17)]. Hemic and Lymphatic: vaso-occlusive crisis: In a small, prematurely terminated study of sildenafil tablets, 20 mg (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with sildenafil tablets, 25 mg, 50 mg and 100 mg for ED is not known. Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia. Hearing: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil citrate.
- Sildenafil is generally safe when used as prescribed.
- Always follow your healthcare provider’s dosage instructions.
- Do not double doses if a dose is missed.
It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [ see Warnings and Precautions (5.4) and Patient Counseling Information (17)]. Ocular: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment.
5.5 Hearing Loss
At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently. †Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision. When sildenafil citrate was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, 200mg sildenafil citrate patients took sildenafil citrate at least once weekly, and the following adverse reactions were reported: †Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision. In these studies, only one patient discontinued due to abnormal vision. The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil citrate is uncertain.
Does Viagra help with premature ejaculation?
Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful: Body as a Whole: face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury. Metabolic and Nutritional: thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia. Respiratory: asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased. Skin and Appendages: urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis. Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking sildenafil citrate with and without anti-hypertensive medication. Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil citrate. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [ see Warnings and Precautions (5.3) and Patient Counseling Information (17)].
- Typical sildenafil dose ranges from 25 to 100 mg.
- It should be taken 30-60 minutes before activity.
- Do not exceed one dose within 24 hours.
Urogenital: prolonged erection, priapism [ see Warnings and Precautions (5.2) and Patient Counseling Information (17)], and hematuria.
4.3 Concomitant Guanylate Cyclase (GC) Stimulators
7 DRUG INTERACTIONS 7.1 NitratesAdministration of sildenafil citrate with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil citrate was shown to potentiate the hypotensive effects of nitrates [ see Dosage and Administration (2.3), Contraindications (4.1), Clinical Pharmacology (12.2)].7.2 Alpha-blockersUse caution when co-administering alpha-blockers with sildenafil citrate because of potential additive blood pressure-lowering effects. When sildenafil citrate is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Dosage and Administration (2.3), Warnings and Precautions (5.5), Clinical Pharmacology (12.2)].7.3 AmlodipineWhen sildenafil citrate 100 mg was co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic [ see Warnings and Precautions (5.5), Clinical Pharmacology (12.2)].7.4 Ritonavir and other CYP3A4 inhibitorsCo-administration of ritonavir, a strong CYP3A4 inhibitor, greatly increased the systemic exposure of sildenafil (11-fold increase in AUC).
7.1 Nitrates
Azole Antifungals
It is therefore recommended not to exceed a maximum single dose of 25 mg of sildenafil citrate in a 48 hour period [ see Dosage and Administration (2.4), Warnings and Precautions (5.6), Clinical Pharmacology (12.3)].Co-administration of erythromycin, a moderate CYP3A4 inhibitor, resulted in a 160% and 182% increases in sildenafil C max and AUC, respectively. Co-administration of saquinavir, a strong CYP3A4 inhibitor, resulted in 140% and 210% increases in sildenafil C max and AUC, respectively.
English 
German