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Clinical Studies on Sildenafil 50 mg Efficacy

Sildenafil > sildenafil 50 mg tab


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  • What other information should I know?

[247] A high rate of drug discontinuance generally has been observed among patients receiving combination therapy with sildenafil and riociguat; at least one death, possibly related to the combined use of these drugs, has been reported. Because of the risk of hypotension, concomitant use of sildenafil and riociguat is contraindicated.

  • Sildenafil 50 mg may cause flushing and nasal stuffiness.
  • Do not use if allergic to sildenafil or similar drugs.
  • Patients should discuss health history before use.
  • It may take longer to work in some individuals.
  • Do not use as a performance enhancer.
  • Avoid using other medications without doctor approval.
  • Keep a record of any side effects experienced.
  • Inform your doctor if you are pregnant or breastfeeding.

The safety and efficacy of sildenafil in combination with other treatments for ED have not been established, and therefore such combined therapy currently is not recommended by the manufacturer. [67] No pharmacokinetic interaction has been observed between warfarin, a CYP2C9 substrate, and sildenafil.

What do Sildenafil 50mg Tablets contain?

Sildenafil is a selective inhibitor of phosphodiesterases (PDEs), with the greatest selectivity for PDE type 5, the principal isoenzyme of PDE involved in the metabolism of cyclic guanosine monophosphate (cGMP) to GMP in the corpora cavernosa of the penis. [1][2][4][5][7][8][10][24][27][33][41][42][54][56][57][67][87][88][91][131] Sildenafil has no direct relaxant effect on isolated human corpora cavernosa of the penis, but enhances the effect of nitric oxide by inhibiting PDE type 5-mediated hydrolysis of cGMP. [1][2][4][5][7][8][10][33][41][42][127][131] During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpora cavernosa. [1][2][4][56][67][91][131] By selectively inhibiting PDE type 5, sildenafil causes accumulation of cGMP in various tissues. [1][2][4][5][31][33][34][41][42][56][57][67][91][131] Because sildenafil potentiates the accumulation of cGMP rather than stimulating its production, the drug is effective only when cGMP production in the penis is increased by sexual arousal. [34][91][131] Sildenafil at recommended doses has no effect on erectile function in the absence of sexual stimulation. [1][4][33][34][91][127][130][131][132] Sildenafil also exhibits some activity against other PDE isoenzymes. [1][4][5][31][44][57][67][87][88] In vitro, sildenafil is about 10 times more active against PDE type 5 than against PDE type 6, greater than 70-80 times more active against PDE type 5 than against PDE type 1, greater than 1000 times more active against PDE type 5 than against PDE types 2 and 4, and 4000 times more active against PDE type 5 than against PDE type 3. [1][4][27][31][45][52][55][57][67][87][88] The duration of erectile responsiveness (i.e., the time period in which adequate sexual stimulation can produce an erection) with oral sildenafil has been reported to be approximately 2 hours, with some penile responsiveness persisting for up to 4 hours after oral administration. [1] In the largest clinical study published to date, the onset and duration of action of oral sildenafil were not reported. [33][34] In most other placebo-controlled studies in which improvement in erection was determined by penile plethysmography, the erectile effect was determined at a fixed time of 60 minutes after an oral dose of the drug. Sildenafil is rapidly absorbed following oral administration; the mean absolute bioavailability is 41% (range, 25-63%). [1][4][56][67][91][116][249] Although studies indicate that more than 90% of an oral sildenafil dose is absorbed from the GI tract, the drug undergoes extensive metabolism in the GI mucosa during absorption and on first pass through the liver, with only about 40% of a dose reaching systemic circulation unchanged.

  • Sildenafil 50 mg tablets should be stored away from moisture.
  • Do not alter the dosage prescribed by your doctor.
  • Men with optic conditions should exercise caution.
  • Be aware of the risk of sudden hearing loss.
  • Use only as directed by healthcare providers.
  • Keep track of medication expiration dates.
  • The drug works best when taken on an empty stomach.
  • Always inform your doctor of any new symptoms.

[1][4][56][67][91][116][131][249] Pharmacokinetics of the drug (as determined by peak plasma concentrations or AUC) are dose proportional over the single-dose range of 1.25-200 mg.[1][4][56][91][116][131] Peak plasma concentrations of sildenafil and its active N-desmethyl metabolite are achieved within 30-120 (median: 60) minutes following oral administration in fasting adults. [1][4][91][127][130][249] Administration with a high-fat meal delays GI absorption, with a reduction in peak plasma concentrations of about 29% and a delay in time to peak plasma concentrations of about 60 minutes; the extent of absorption is not affected.

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Sildenafil appears to be widely distributed in the body. [1][4][67][116][131] Sildenafil and its major circulating N-desmethyl metabolite are each approximately 96% bound to plasma proteins; protein binding reportedly is independent of plasma concentration. [1][67][91][116][131] Sildenafil is distributed to a limited extent in semen following oral administration, with less than 0.001% of a single dose appearing in semen 90 minutes after dosing in healthy individuals. [1][67] Such concentrations are unlikely to cause any effects in sexual partners exposed to the semen.

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The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty or merchantability and/or fitness for a particular purpose, with respect to such database and specifically disclaims all such warranties and representations. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the database if provided for informational purposes only. The entire monograph for a drug should be reviewed for a throrough understanding of the drug's actions, uses and side effects. [67] Plasma sildenafil concentrations appear to decline in a biphasic manner following oral administration, with a terminal elimination half-life sildenafil 100mg hexal of about 4 hours (range: 3-5 hours). [1][4][67][91][116][127][130][131] Sildenafil is metabolized principally via hepatic cytochrome P-450 (CYP) microsomal isoenzymes 3A4 (major route) and 2C9 (minor route).

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[247] A high rate of drug discontinuance generally has been observed among patients receiving combination therapy with sildenafil and riociguat; at least one death, possibly related to the combined use of these drugs, has been reported. Because of the risk of hypotension, concomitant use of sildenafil and riociguat is contraindicated. The safety and efficacy of sildenafil in combination with other treatments for ED have not been established, and therefore such combined therapy currently is not recommended by the manufacturer. [67] No pharmacokinetic interaction has been observed between warfarin, a CYP2C9 substrate, and sildenafil. Sildenafil is a selective inhibitor of phosphodiesterases (PDEs), with the greatest selectivity for PDE type 5, the principal isoenzyme of PDE involved in the metabolism of cyclic guanosine monophosphate (cGMP) to GMP in the corpora cavernosa of the penis.

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[1][2][4][5][7][8][10][24][27][33][41][42][54][56][57][67][87][88][91][131] Sildenafil has no direct relaxant effect on isolated human corpora cavernosa of the penis, but enhances the effect of nitric oxide by inhibiting PDE type 5-mediated hydrolysis of cGMP. [1][2][4][5][7][8][10][33][41][42][127][131] During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpora cavernosa. [1][2][4][56][67][91][131] By selectively inhibiting PDE type 5, sildenafil causes accumulation of cGMP in various tissues. [1][2][4][5][31][33][34][41][42][56][57][67][91][131] Because sildenafil potentiates the accumulation of cGMP rather than stimulating its production, the drug is effective only when cGMP production in the penis is increased by sexual arousal. [34][91][131] Sildenafil at recommended doses has no effect on erectile function in the absence of sexual stimulation.

What should I know about sildenafil before taking it?

[1][4][33][34][91][127][130][131][132] Sildenafil also exhibits some activity against other PDE isoenzymes. [1][4][5][31][44][57][67][87][88] In vitro, sildenafil is about 10 times more active against PDE type 5 than against PDE type 6, greater than 70-80 times more active against PDE type 5 than against PDE type 1, greater than 1000 times more active against PDE type 5 than against PDE types 2 and 4, and 4000 times more active against PDE type 5 than against PDE type 3. [1][4][27][31][45][52][55][57][67][87][88] The duration of erectile responsiveness (i.e., the time period in which adequate sexual stimulation can produce an erection) with oral sildenafil has been reported to be approximately 2 hours, with some penile responsiveness persisting for up to 4 hours after oral administration. [1] In the largest clinical study published to date, the onset and duration of action of oral sildenafil were not reported. [33][34] In most other placebo-controlled studies in which improvement in erection was determined by penile plethysmography, the erectile effect was determined at a fixed time of 60 minutes after an oral dose of the drug. [1][26][67][91][131] Plasma concentrations of the active N-desmethyl metabolite are approximately 40% of those observed with sildenafil, and the metabolite reportedly accounts for about 20% of sildenafil's pharmacologic activity.

  • Sildenafil 50 mg is part of PDE5 inhibitor class.
  • It may improve quality of life for men with ED.
  • Avoid taking it if you have a recent heart attack.
  • Be aware of potential priapism, a rare prolonged erection.
  • Use with caution if you have low blood pressure.
  • Review all medications with your healthcare provider.
  • The medication does not cause dependency.
  • Check product labels and consult pharmacists if unsure.

[1][67][131] The N-demethylated metabolite, the major circulating metabolite, has a phosphodiesterase selectivity profile similar to that of sildenafil and an in vitro potency for PDE type 5 of approximately 50% of the parent drug. [1][116][131] Sildenafil is eliminated mainly in the feces as metabolites following oral administration. [1][67][91][116][131] In healthy adults and those with ED, approximately 80% of an oral dose is excreted as metabolites in feces and 13% is excreted in urine. Importance of instructing patients to read the manufacturer's patient information before starting sildenafil therapy and each time their prescription is refilled. [1]Instruct patients to avoid contraindicated medications such as regular and/or intermittent use of organic nitrates, organic nitrites (e.g., ''poppers''), and riociguat. [1]Inform patients that sildenafil is marketed for erectile dysfunction (Viagra) and pulmonary arterial hypertension (Revatio®).

Attribute Description Notes
Active Ingredient Sildenafil citrate 50 mg per tablet
Mechanism of Action PDE5 enzyme inhibition to promote vasodilation Enhances blood flow for erectile function
Onset of Action 30-60 minutes Varies with food intake
Duration of Effect Up to 4-6 hours Effect duration can vary
Metabolism Primarily processed in the liver through CYP3A4 and CYP2C9 enzymes Potential drug interactions
Contraindications Use with nitrates or contraindicated in severe cardiovascular conditions Precautions required

[1] Advise patients taking Viagra® not to take Revatio® or other PDE type 5 inhibitors. [1]Advise patients of the potential for sildenafil to augment the blood pressure lowering effect of α-adrenergic blocking agents (e.g., doxazosin) and anti-hypertensive medications (e.g., amlodipine) and concomitant administration may lead to symptomatic hypotension in some patients. [1]Inform patients taking sildenafil for erectile dysfunction and with potential for cardiac risk of sexual activity (e.g., patients with preexisting cardiovascular risk factors) to refrain from further activity and seek medical attention immediately if they experience symptoms (e.g., chest pain, dizziness, nausea) upon initiation of sexual activity. [1]Advise patients to seek immediate sildenafil citrate tablets 150 mg medical attention for a sudden loss of vision in one or both eyes while taking sildenafil. [1] Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision. [1]Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil. [1] These events may be accompanied by tinnitus and dizziness. [1]Advise patients to seek prompt medical attention for an erection that lasts more than 4 hours.

  • Sildenafil 50 mg is on the list of ED treatment options.
  • It has been FDA-approved for safety and efficacy.
  • Avoid high-fat foods immediately before taking.
  • Alcohol can diminish the drug's effect.
  • Patients should seek medical advice for persistent side effects.
  • The medication should never be used recreationally.
  • Disclose all health conditions before starting treatment.
  • Adhere strictly to prescribed dosage and instructions.

[1] If it is not treated right away, priapism can permanently damage the penis. [1]Inform patients taking sildenafil for erectile dysfunction that the drug offers no protection against sexually transmitted diseases and patients should use necessary protective measures to guard against such diseases, including the human immunodeficiency virus (HIV). [1]Instruct the patient to seek medical attention immediately if they take too much sildenafil. [1]Inform patients of the risk of symptomatic low blood pressure (e.g., dizziness, lightheadedness, fainting). [1] Monitor blood pressure when administering sildenafil in combination with blood pressure lowering drugs (e.g., α-adrenergic blocking agents). [1]Advise patients to take sildenafil with or without food 1 hour or, if needed, 30 minutes to 4 hours before sexual activity. [1] Inform patients that taking sildenafil with a high-fat meal may cause delayed onset. [1]Advise patient to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

Use Case Description Typical Dosage Notes
Erectile Dysfunction Improve erectile response during sexual activity 50 mg as needed Taken 30-60 min before activity
Pulmonary Arterial Hypertension Off-label use to reduce blood pressure in lungs Under medical supervision Brand: Revatio
Off-label uses Possible off-label benefits in other circulatory disorders Under research Not generally approved

[1]Inform patients of other important precautionary information. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

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Sildenafil is rapidly absorbed following oral administration; the mean absolute bioavailability is 41% (range, 25-63%). [1][4][56][67][91][116][249] Although studies indicate that more than 90% of an oral sildenafil dose is absorbed from the GI tract, the drug undergoes extensive metabolism in the GI mucosa during absorption and on first pass through the liver, with only about 40% of a dose reaching systemic circulation unchanged. [1][4][56][67][91][116][131][249] Pharmacokinetics of the drug (as determined by peak plasma concentrations or AUC) are dose proportional over the single-dose range of 1.25-200 mg.[1][4][56][91][116][131] Peak plasma concentrations of sildenafil and its active N-desmethyl metabolite are achieved within 30-120 (median: 60) minutes following oral administration in fasting adults. [1][4][91][127][130][249] Administration with a high-fat meal delays GI absorption, with a reduction in peak plasma concentrations of about 29% and a delay in time to peak plasma concentrations of about 60 minutes; the extent of absorption is not affected. Sildenafil appears to be widely distributed in the body.

Pulmonary hypertension

[1][4][67][116][131] Sildenafil and its major circulating N-desmethyl metabolite are each approximately 96% bound to plasma proteins; protein binding reportedly is independent of plasma concentration. [1][67][91][116][131] Sildenafil is distributed to a limited extent in semen following oral administration, with less than 0.001% of a single dose appearing in semen 90 minutes after dosing in healthy individuals. [1][67] Such concentrations are unlikely to cause any effects in sexual partners exposed to the semen. [67] Plasma sildenafil concentrations appear to decline in a biphasic manner following oral administration, with a terminal elimination half-life sildenafil 100mg hexal of about 4 hours (range: 3-5 hours). [1][4][67][91][116][127][130][131] Sildenafil is metabolized principally via hepatic cytochrome P-450 (CYP) microsomal isoenzymes 3A4 (major route) and 2C9 (minor route).

When and How to Take Sildenafil for Best Results

[1][26][67][91][131] Plasma concentrations of the active N-desmethyl metabolite are approximately 40% of those observed with sildenafil, and the metabolite reportedly accounts for about 20% of sildenafil's pharmacologic activity. [1][67][131] The N-demethylated metabolite, the major circulating metabolite, has a phosphodiesterase selectivity profile similar to that of sildenafil and an in vitro potency for PDE type 5 of approximately 50% of the parent drug. [1][116][131] Sildenafil is eliminated mainly in the feces as metabolites following oral administration. [1][67][91][116][131] In healthy adults and those with ED, approximately 80% of an oral dose is excreted as metabolites in feces and 13% is excreted in urine. Importance of instructing patients to read the manufacturer's patient information before starting sildenafil therapy and each time their prescription is refilled. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. \* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name © Copyright, 1959-2026, Selected Revisions April 10, 2024. American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

What causes Diarrhoea?

[1]Advise patients to take sildenafil with or without food 1 hour or, if needed, 30 minutes to 4 hours before sexual activity. [1] Inform patients that taking sildenafil with a high-fat meal may cause delayed onset. [1]Advise patient to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses. [1]Inform patients of other important precautionary information. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Azole Antifungals

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. \* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name © Copyright, 1959-2026, Selected Revisions April 10, 2024. American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. The American Society of Health-System Pharmacists, Inc. represents that the database provided hereunder as formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. represents that the database provided hereunder as formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc.

What other information should I know?

[1]Instruct patients to avoid contraindicated medications such as regular and/or intermittent use of organic nitrates, organic nitrites (e.g., ''poppers''), and riociguat. [1]Inform patients that sildenafil is marketed for erectile dysfunction (Viagra) and pulmonary arterial hypertension (Revatio®). [1] Advise patients taking Viagra® not to take Revatio® or other PDE type 5 inhibitors. [1]Advise patients of the potential for sildenafil to augment the blood pressure lowering effect of α-adrenergic blocking agents (e.g., doxazosin) and anti-hypertensive medications (e.g., amlodipine) and concomitant administration may lead to symptomatic hypotension in some patients. [1]Inform patients taking sildenafil for erectile dysfunction and with potential for cardiac risk of sexual activity (e.g., patients with preexisting cardiovascular risk factors) to refrain from further activity and seek medical attention immediately if they experience symptoms (e.g., chest pain, dizziness, nausea) upon initiation of sexual activity.

Drug Interactions

[1]Advise patients to seek immediate sildenafil citrate tablets 150 mg medical attention for a sudden loss of vision in one or both eyes while taking sildenafil. [1] Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision. [1]Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil. [1] These events may be accompanied by tinnitus and dizziness. [1]Advise patients to seek prompt medical attention for an erection that lasts more than 4 hours.

What are the serious side effects of sildenafil?

[1] If it is not treated right away, priapism can permanently damage the penis. [1]Inform patients taking sildenafil for erectile dysfunction that the drug offers no protection against sexually transmitted diseases and patients should use necessary protective measures to guard against such diseases, including the human immunodeficiency virus (HIV). [1]Instruct the patient to seek medical attention immediately if they take too much sildenafil. [1]Inform patients of the risk of symptomatic low blood pressure (e.g., dizziness, lightheadedness, fainting). [1] Monitor blood pressure when administering sildenafil in combination with blood pressure lowering drugs (e.g., α-adrenergic blocking agents). makes no representations or warranties, express or implied, including, but not limited to, any implied warranty or merchantability and/or fitness for a particular purpose, with respect to such database and specifically disclaims all such warranties and representations. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the database if provided for informational purposes only. The entire monograph for a drug should be reviewed for a throrough understanding of the drug's actions, uses and side effects.

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