Sildenafil Oral

6.1 Clinical Trials Experience
8.6 Patients with Hepatic Impairment
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
8.5 Geriatric Use
6.2 Postmarketing Experience
5.4 Visual Loss

[1] The evaluation of ED should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment. Sildenafil doses of 25-100 mg reduce the maximum supine systolic/diastolic blood pressure by an average of about 8.4/5.5 mm Hg within 1-2 hours after administration of the drug in healthy adults, returning to baseline values within 4-8 hours after a dose. Clinicians should consider whether patients with underlying cardiovascular disease could be affected adversely by the vasodilatory activity of selective PDE type 5 inhibitor therapy, especially in combination with sexual activity. Because there are no controlled clinical data establishing the safety and efficacy of sildenafil in the following subpopulations of patients with ED, the drug should be used with caution in those with a recent (within 6 months) myocardial infarction, stroke, or life-threatening arrhythmia; in those with resting hypotension (blood pressure less than 90/50 mm Hg) or hypertension (blood pressure exceeding 170/110 mm Hg); and in those with cardiac failure or coronary artery disease causing unstable angina. [1][31][101][127][144][154][155][159] The possibility of a hypotensive reaction in patients receiving a selective PDE type 5 inhibitor concomitantly with antihypertensive drug therapy should be considered.

Misconception	Reality	Explanation
Sildenafil cures erectile dysfunction	It does not cure, only treats symptoms	Helps achieve an erection, not a cure
Takes effect immediately	Usually takes 30-60 minutes	Depends on individual and food intake
Only for older men	Used by men of various ages	Suitable for adult men of different ages

Patients should avoid grapefruit or grapefruit juice while taking sildenafil tablets.
Consult your doctor if you experience persistent pain or vision changes.
Sildenafil tablets can be part of a broader treatment plan including lifestyle changes.

[28][67][159] In patients with severe renal impairment, concomitant use of sildenafil and antihypertensive agents should be undertaken with caution.

6.1 Clinical Trials Experience

Interactions that increase your risk for side effects

[28][31][67] The risk of an undesired hypotensive response is of particular concern in patients with congestive heart failure and a borderline low blood volume and low blood pressure status as well as in patients with left-ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis), those with severely impaired autonomic control of blood pressure, and in those who are receiving a complex, multidrug antihypertensive regimen. [1][67] Some experts state that monitoring of blood pressure during initiation of sildenafil therapy may be useful in identifying patients who may have an undesirable hypotensive response to the drug and is recommended for patients receiving a multidrug antihypertensive regimen and in those with congestive heart failure who have a borderline low blood volume because of concern about the potential consequences on blood pressure. [28][67][159] In patients with severe renal impairment, concomitant use of sildenafil and antihypertensive agents should be undertaken with caution. Nonarteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely during postmarketing experience in temporal association with use of all PDE type 5 inhibitors for the treatment of ED. [1][190][191][192][196][197] Most, but not all, of these patients had underlying anatomic or vascular risk factors for the development of NAION, including but not limited to low cup-to-disc ratio (''crowded" optic disc), age (older than 50 years), diabetes mellitus, hypertension, coronary artery disease, hyperlipidemia, and smoking. Nonarteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely during postmarketing experience in temporal association with use of all PDE type 5 inhibitors for the treatment of ED. [1][190][191][192][196][197] Most, but not all, of these patients had underlying anatomic or vascular risk factors for the development of NAION, including but not limited to low cup-to-disc ratio (''crowded" optic disc), age (older than 50 years), diabetes mellitus, hypertension, coronary artery disease, hyperlipidemia, and smoking. [1][191][192][196] Available data suggest that the annual incidence of NAION in the general population of men 50 years of age or older is 2.5-11.8 cases per 100,000.

Sildenafil tablets may cause dizziness; avoid sudden movements after taking.
Combining sildenafil with other medications for erectile dysfunction can increase risks.
Always inform your healthcare provider about all medications you are using before starting sildenafil.

[1] Results of an observational study in patients with recent, episodic PDE type 5 inhibitor use (typical of ED treatment) suggest an approximately two-fold increase in the risk of NAION, with a risk estimate of 2.15 within 5 half-lives of such use. [1] A risk estimate of 2.27 was reported in a similar study. Causality assessment is difficult because of the small number of events, the large number of patients receiving PDE type 5 inhibitors, the occurrence of optic neuropathy in a similar population of individuals who have not been exposed to PDE type 5 inhibitors, and plausible alternative causes (e.g., vascular risk factors, anatomic defects).

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Viagra Generic	50mg	90 + 6 Pills	107.37€ 102.26€
Kamagra Oral Jelly	100mg	90 + 8 Sachets	303.56€ 289.10€
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Kamagra Polo	100mg	32 Pills	125.88€ 119.89€
Viagra Generic	25mg	10 Pills	25.19€ 23.99€
Kamagra Oral Jelly	100mg	30 + 5 Sachets	136.20€ 129.71€
Viagra Generic	100mg	10 Pills	28.91€ 27.53€
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Kamagra Soft Tabs	100mg	180 + 8 Pills	425.45€ 405.19€
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Viagra Generic	25mg	120 + 6 Pills	125.56€ 119.58€

If sudden vision loss or decreased vision occurs in one or both eyes while a patient is receiving a PDE type 5 inhibitor, the patient should discontinue the drug and contact a clinician immediately. Clinicians should discuss the increased risk of NAION with patients who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE type 5 inhibitors. [1] Sildenafil should be used with caution for the treatment of ED in these patients and only when the anticipated benefits outweigh the risks. Although at greater risk for sildenafil citrates NAION compared to the general population, evidence is insufficient to support screening for "crowded" optic disc in prospective users of PDE type 5 inhibitors for the treatment of ED. Sildenafil should be used with caution in patients with retinitis pigmentosa, a retinal disorder that may be accompanied by a genetic disorder of retinal phosphodiesterases in some patients, since data establishing the safety and efficacy of the drug in these patients currently are lacking.

8.6 Patients with Hepatic Impairment

No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in rats and rabbits receiving up to 200 mg/kg daily of sildenafil during organogenesis. [1] These doses in rats and rabbits represent about 16 and 32 times, respectively, the maximum recommended human dose (MRHD) for the treatment of ED on a mg/m2 basis in a 50-kg patient. [1] No adverse effects were observed Iin a prenatal and postnatal development study in rats receiving 30 mg/kg daily for 36 days (equivalent to 2-times the MRHD on a mg/m2 basis in a 50-kg subject). [1] Limited data indicate that sildenafil and its active metabolite are present in human milk. [1] There is no information about the effects of sildenafil on the breastfed infant or on milk production.

What should I know about sildenafil before taking it?

Reproduction studies revealed no evidence of impaired fertility at sildenafil dosages up to 60 mg/kg daily (for 36 days in female rats and 102 days in male rats), a dosage representing more than 25 times the human male AUC. [1] No effect on sperm motility or morphology was noted after a single 100-mg oral sildenafil dose in healthy human adults. Sildenafil for ED (e.g., Viagra®) is not indicated for use in pediatric patients. [1] The manufacturer states that safety and efficacy of sildenafil in children have not been established. The AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45 and 57% higher, respectively, in healthy volunteers >=65 years of age compared to healthy volunteers 18-45 years of age. Sudden decrease or loss of hearing, with or without concomitant vestibular manifestations (e.g., tinnitus, dizziness), has been reported in temporal association with use of PDE type 5 inhibitors, including sildenafil.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Concomitant administration of ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC). [1] Data are limited; decreased blood pressure, syncope, and prolonged erection have been reported in some healthy volunteers exposed to high doses of sildenafil (200-800 mg). [1] Use sildenafil with caution in patients receiving ritonavir; reduced sildenafil dosage is recommended to decrease the chance of adverse reactions to sildenafil. Bleeding events have been reported in patients taking sildenafil for ED. [1] In patients with bleeding disorders or active peptic ulcers, sildenafil should be used with caution since safety of the drug has not been established.

What is sildenafil used for?

[1][27][33][67][131] The possibility sildenafil 60mg that sildenafil could potentiate the effects of certain other drugs exhibiting antiplatelet activity should be considered. Safety and efficacy have not been established for use of sildenafil in combination with other PDE type 5 inhibitors or other treatments for ED; such combinations may further lower blood pressure and are not recommended. Patients should be advised that use of sildenafil provides no protection against sexually transmitted diseases and they should be counseled regarding protective measures to guard against such transmission. Sildenafil for ED (e.g., Viagra®) is not indicated for use in females. [1] There are no data with use in pregnant women to inform any drug-associated risks for adverse developmental outcomes. [1] It is unclear whether these otic effects are directly related to PDE type 5 inhibitors or attributed to other underlying risk factors for hearing loss, a combination of these factors, or to other factors.

8.5 Geriatric Use

Patients should discontinue sildenafil and seek medical attention immediately if sudden hearing loss or decreased hearing occurs. Prolonged erection (exceeding 4 hours) and priapism (painful erection exceeding 6 hours) have been reported infrequently during postmarketing surveillance with sildenafil. [1][31][127][131][139][146][147] Because of the risk of penile tissue damage and permanent loss of potency if priapism is not treated immediately, patients should be warned to seek immediate medical attention if an erection persists for longer than 4 hours. Sildenafil should be used with caution in patients with anatomic deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) and in patients who have conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia). Caution is advised when PDE type 5 inhibitors are co-administered with α-adrenergic blocking agents; blood pressure may be lowered significantly and in some patients, symptomatic hypotension (e.g., dizziness, lightheadedness, fainting) may occur. [1] Patients who demonstrate hemodynamic instability during therapy with an α-adrenergic blocking agent alone are at increased risk for symptomatic hypotension with concomitant use of a PDE type 5 inhibitor.

Use caution when driving or operating machinery after taking sildenafil tablets.
Avoid excessive alcohol consumption when using sildenafil tablets, as it can increase side effects.
Consult your doctor before taking sildenafil if you have heart issues or low blood pressure.

In patients who exhibit hemodynamic instability while receiving an α-adrenergic blocking agent, use caution. [1] Patients should be stable on an α-adrenergic blocking agent prior to initiation of sildenafil, and sildenafil should be administered at the lowest possible dose. [1] In patients receiving an optimal dose of sildenafil, initiate the α-adrenergic blocking agent at the lowest dose.

6.2 Postmarketing Experience

[1][191][192][196] Available data suggest that the annual incidence of NAION in the general population of men 50 years of age or older is 2.5-11.8 cases per 100,000. [1] Results of an observational study in patients with recent, episodic PDE type 5 inhibitor use (typical of ED treatment) suggest an approximately two-fold increase in the risk of NAION, with a risk estimate of 2.15 within 5 half-lives of such use. [1] A risk estimate of 2.27 was reported in a similar study. Causality assessment is difficult because of the small number of events, the large number of patients receiving PDE type 5 inhibitors, the occurrence of optic neuropathy in a similar population of individuals who have not been exposed to PDE type 5 inhibitors, and plausible alternative causes (e.g., vascular risk factors, anatomic defects). If sudden vision loss or decreased vision occurs in one or both eyes while a patient is receiving a PDE type 5 inhibitor, the patient should discontinue the drug and contact a clinician immediately.

Cessation and Adverse Effects of Treatment

Clinicians should discuss the increased risk of NAION with patients who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE type 5 inhibitors. [1] Sildenafil should be used with caution for the treatment of ED in these patients and only when the anticipated benefits outweigh the risks. Although at greater risk for sildenafil citrates NAION compared to the general population, evidence is insufficient to support screening for "crowded" optic disc in prospective users of PDE type 5 inhibitors for the treatment of ED. Sildenafil should be used with caution in patients with retinitis pigmentosa, a retinal disorder that may be accompanied by a genetic disorder of retinal phosphodiesterases in some patients, since data establishing the safety and efficacy of the drug in these patients currently are lacking. Sudden decrease or loss of hearing, with or without concomitant vestibular manifestations (e.g., tinnitus, dizziness), has been reported in temporal association with use of PDE type 5 inhibitors, including sildenafil. Concomitant administration of ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC). [1] Data are limited; decreased blood pressure, syncope, and prolonged erection have been reported in some healthy volunteers exposed to high doses of sildenafil (200-800 mg). [1] Use sildenafil with caution in patients receiving ritonavir; reduced sildenafil dosage is recommended to decrease the chance of adverse reactions to sildenafil. Bleeding events have been reported in patients taking sildenafil for ED. [1] In patients with bleeding disorders or active peptic ulcers, sildenafil should be used with caution since safety of the drug has not been established. [1][27][33][67][131] The possibility sildenafil 60mg that sildenafil could potentiate the effects of certain other drugs exhibiting antiplatelet activity should be considered. Safety and efficacy have not been established for use of sildenafil in combination with other PDE type 5 inhibitors or other treatments for ED; such combinations may further lower blood pressure and are not recommended. Patients should be advised that use of sildenafil provides no protection against sexually transmitted diseases and they should be counseled regarding protective measures to guard against such transmission. Sildenafil for ED (e.g., Viagra®) is not indicated for use in females. [1] There are no data with use in pregnant women to inform any drug-associated risks for adverse developmental outcomes. No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in rats and rabbits receiving up to 200 mg/kg daily of sildenafil during organogenesis. [1] These doses in rats and rabbits represent about 16 and 32 times, respectively, the maximum recommended human dose (MRHD) for the treatment of ED on a mg/m2 basis in a 50-kg patient. [1] No adverse effects were observed Iin a prenatal and postnatal development study in rats receiving 30 mg/kg daily for 36 days (equivalent to 2-times the MRHD on a mg/m2 basis in a 50-kg subject). [1] Limited data indicate that sildenafil and its active metabolite are present in human milk.

Side Effect	Severity	Frequency	Recommendations
Headache	Mild	Common	Take analgesics
Flushing	Mild	Common	Cool environment
Nasal Congestion	Mild	Sometimes	Use decongestants
Dizziness	Mild	Less common	Avoid sudden movements

[1] There is no information about the effects of sildenafil on the breastfed infant or on milk production. Reproduction studies revealed no evidence of impaired fertility at sildenafil dosages up to 60 mg/kg daily (for 36 days in female rats and 102 days in male rats), a dosage representing more than 25 times the human male AUC.

Potential side effects of sildenafil tablets include headache, flushing, and nasal congestion.
Serious side effects are rare but can include vision changes or prolonged erections.
Seek medical attention if you experience chest pain or an erection lasting over 4 hours.

[1] No effect on sperm motility or morphology was noted after a single 100-mg oral sildenafil dose in healthy human adults. Sildenafil for ED (e.g., Viagra®) is not indicated for use in pediatric patients. [1] The manufacturer states that safety and efficacy of sildenafil in children have not been established. The AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45 and 57% higher, respectively, in healthy volunteers >=65 years of age compared to healthy volunteers 18-45 years of age.

5.4 Visual Loss

[1] It is unclear whether these otic effects are directly related to PDE type 5 inhibitors or attributed to other underlying risk factors for hearing loss, a combination of these factors, or to other factors. Patients should discontinue sildenafil and seek medical attention immediately if sudden hearing loss or decreased hearing occurs. Prolonged erection (exceeding 4 hours) and priapism (painful erection exceeding 6 hours) have been reported infrequently during postmarketing surveillance with sildenafil. [1][31][127][131][139][146][147] Because of the risk of penile tissue damage and permanent loss of potency if priapism is not treated immediately, patients should be warned to seek immediate medical attention if an erection persists for longer than 4 hours. Sildenafil should be used with caution in patients with anatomic deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) and in patients who have conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).

#7 Vardenafil(Levitra)

Caution is advised when PDE type 5 inhibitors are co-administered with α-adrenergic blocking agents; blood pressure may be lowered significantly and in some patients, symptomatic hypotension (e.g., dizziness, lightheadedness, fainting) may occur. [1] Patients who demonstrate hemodynamic instability during therapy with an α-adrenergic blocking agent alone are at increased risk for symptomatic hypotension with concomitant use of a PDE type 5 inhibitor. In patients who exhibit hemodynamic instability while receiving an α-adrenergic blocking agent, use caution. [1] Patients should be stable on an α-adrenergic blocking agent prior to initiation of sildenafil, and sildenafil should be administered at the lowest possible dose. [1] In patients receiving an optimal dose of sildenafil, initiate the α-adrenergic blocking agent at the lowest dose.