13 NONCLINICAL TOXICOLOGY

Shipping Information
Proper Use
8.6 Renal Impairment
8.7 Patients with Renal Impairment
Warnings for Viagra
5.4 Visual Loss

This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil citrate. 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. 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.Cardiovascular and cerebrovascularSerious cardiovascular, cerebrovascular, and vascular 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.

Shipping Information

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 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.

Regional issues

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)]. 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.

Professional resources

Most, but not all, of these patients had preexisting cardiovascular risk factors.

Product	Dosage	Quantity + Bonus	Price
Kamagra Polo	100mg	180 + 8 Pills	446.52€ 425.26€
Kamagra Soft Tabs	100mg	60 + 4 Pills	180.59€ 171.99€
Viagra Generic	100mg	20 Pills	45.58€ 43.41€
Viagra Generic	200mg	20 Pills	61.69€ 58.75€
Viagra Generic	100mg	360 + 10 Pills	330.21€ 314.49€
Viagra Generic	200mg	360 + 10 Pills	481.98€ 459.03€
Kamagra	100mg	60 + 4 Pills	201.34€ 191.75€
Viagra Generic	50mg	360 + 10 Pills	225.33€ 214.60€
Viagra Generic	50mg	120 + 6 Pills	129.64€ 123.47€
Viagra Generic	25mg	90 + 6 Pills	105.03€ 100.03€
Viagra Generic	150mg	180 + 10 Pills	236.46€ 225.20€
Viagra Generic	100mg	10 Pills	28.91€ 27.53€
Kamagra Polo	100mg	32 Pills	125.88€ 119.89€

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 citrate without sexual activity. Others were reported to have occurred hours to days after the use of sildenafil citrate and sexual activity. 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.

Proper Use

Viagra strengths

Others were reported to have occurred hours to days after the use of sildenafil citrate and sexual activity. 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.Respiratory:epistaxisSpecial senses: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. 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.

Incidence not known

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 sildenafil pfizer 100g 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. 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. 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.Respiratory:epistaxisSpecial senses: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. 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 sildenafil pfizer 100g 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.

Sildenafil tablets 125 mg are manufactured by various brands.
Always verify the authenticity of medication sources.
Use only FDA-approved or certified pharmacies.
Cost can vary based on brand and location.
Generic versions are typically more affordable.
Beware of counterfeit sildenafil products.
Read customer reviews before purchasing online.
Consult your doctor about the best brand for you.

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. 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.

8.6 Renal Impairment

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. 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.

Warnings for other groups

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, 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. Reported events include those with a plausible relation to drug use; omitted are sildenafil citrate tablet 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.

Risk to travelers

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. 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. 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. 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, 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.

8.7 Patients with Renal Impairment

Dosage Forms and Strengths

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 sildenafil citrate tablet 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.

Step	Description	Notes
Consult a healthcare provider	Discuss suitability and health conditions	Important before use
Dose administration	Take with a glass of water, 30-60 min before activity	Avoid heavy or fatty meals
Frequency	Do not exceed once per day	Follow prescribed instructions
Food interactions	Fatty meals may delay absorption	Better taken on an empty stomach or light meal

This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.

Warnings for Viagra

The following adverse reactions have been identified during post approval use of sildenafil citrate.

Use Case	Description	Typical Dosage	Onset of Action	Duration
Erectile Dysfunction	Helps achieve and maintain erections during sex	125 mg	30-60 minutes	Up to 4-6 hours
Pulmonary Hypertension	Relieves high blood pressure in lung arteries	125 mg	15-30 minutes	4-6 hours
Off-Label Uses	Potential uses in other vascular conditions	Varies	Varies	Varies

Interaction	Effect	Management Tips
Nitrates	Severe hypotension, danger to life	Avoid combination
Alpha-blockers	Risk of hypotension	Use with caution, monitor blood pressure
CYP3A4 inhibitors	Increased sildenafil levels, risk of side effects	Dose adjustments may be needed
Other PDE-5 inhibitors	Increased risk of adverse effects	Use separate medications

5.4 Visual Loss

Sildenafil tablets 125 mg are often prescribed for pulmonary hypertension.
The dosage can vary depending on the condition.
It’s important to maintain open communication with your doctor.
Alcohol consumption can impair sildenafil’s effectiveness.
Avoid driving if you experience dizziness or vision problems.
Use sildenafil exactly as prescribed to avoid complications.
Do not share medication with others.
Regular medical check-ups are recommended during use.