Viagra 100mg (Sildenafil) 4 Tablets

Sildenafil > sildenafil citrate 100mg tablets


However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity. The maximum recommended dosing frequency is once per day.Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.2.3 Dosage Adjustments in Specific SituationsSildenafil tablets was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [ see Contraindications (4.1), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].When sildenafil tablets are co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at 25 mg [ see Warnings and Precautions (5.5), Drug Interactions (7.2), and Clinical Pharmacology (12.2)].2.4 Dosage Adjustments Due to Drug InteractionsRitonavirThe recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [ see Warnings and Precautions (5.6), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].CYP3A4 InhibitorsConsider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin.

See also:

In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.Sildenafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia). However, there are no controlled clinical data on the safety or efficacy of sildenafil in patients with sickle cell or related anemias.5.3 Effects on the EyePhysicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil , and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 in males aged ≥ 50.

Sildenafil side effects

An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period. The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.20). Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed 50 mg sildenafil price to the occurrence of NAION in these studies. Neither the rare post-marketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [ see Adverse Reactions (6.2) ].Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [ see Drug Interactions (7.4)and Clinical Pharmacology (12.3)].2.5 Dosage Adjustments in Special PopulationsConsider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets in these patients resulted in higher plasma levels of sildenafil [ see Use in Specific Populations (8.5, 8.6, 8.7)and Clinical Pharmacology (12.3)]. For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. The maximum recommended dosing frequency is once per day.

Ingredient Quantity per Tablet Purpose Notes
Sildenafil Citrate 100 mg Active ingredient Main PDE5 inhibitor
Lactose Monohydrate 50 mg Binder, filler Assists disintegration
Magnesium Stearate 5 mg Lubricant Ensures tablet flow
Microcrystalline Cellulose 20 mg Filler mass Binds ingredients
Hypromellose 10 mg Coating agent Protects active ingredient

Sildenafil tablets was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [ see Contraindications (4.1), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets in these patients resulted in higher plasma levels of sildenafil [ see Use in Specific Populations (8.5, 8.6, 8.7)and Clinical Pharmacology (12.3)]. 3 DOSAGE FORMS AND STRENGTHS Sildenafil tablets, USP are supplied as pale blue to blue, caplet shaped film-coated tablets containing sildenafil citrate USP equivalent to 50 mg, or 100 mg of sildenafil. Tablets are debossed with 1A1 and 1A2 on one side and plain on the other to indicate the dosage strengths viz. 100 mg and 50 mg respectively.Sildenafil tablets 25 mg USP is supplied as Pale blue to blue, round film-coated tablets, debossed with “25” on one side and “SL” on other side. Sildenafil tablets, USP are supplied as pale blue to blue, caplet shaped film-coated tablets containing sildenafil citrate USP equivalent to 50 mg, or 100 mg of sildenafil. 4 CONTRAINDICATIONS 4.1 NitratesConsistent with its known effects on the nitric oxide/cGMP pathway [ see Clinical Pharmacology (12.1, 12.2) ], sildenafil tablets was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or sildenafil from canada intermittently is therefore contraindicated.After patients have taken sildenafil tablets, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [ see Dosage and Administration (2.3), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].4.2 Hypersensitivity ReactionsSildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO, or any component of the tablet.

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Hypersensitivity reactions have been reported, including rash and urticaria [ see Adverse Reactions (6.1)].

5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives

Sildenafil tablets, USP are supplied as pale blue to blue, caplet shaped film-coated tablets containing sildenafil citrate USP equivalent to 50 mg, or 100 mg of sildenafil. 4 CONTRAINDICATIONS 4.1 NitratesConsistent with its known effects on the nitric oxide/cGMP pathway [ see Clinical Pharmacology (12.1, 12.2) ], sildenafil tablets was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or sildenafil from canada intermittently is therefore contraindicated.After patients have taken sildenafil tablets, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [ see Dosage and Administration (2.3), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].4.2 Hypersensitivity ReactionsSildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO, or any component of the tablet. Hypersensitivity reactions have been reported, including rash and urticaria [ see Adverse Reactions (6.1)]. Consistent with its known effects pfizer sildenafil 50 on the nitric oxide/cGMP pathway [ see Clinical Pharmacology (12.1, 12.2) ], sildenafil tablets was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated.

Seek Immediate Medical Help If You Experience:

Sildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO, or any component of the tablet. 5 WARNINGS AND PRECAUTIONS 5.1 CardiovascularThere is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including sildenafil, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.Sildenafil has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg), [ see Clinical Pharmacology (12.2)]. While this normally would be expected to be of little consequence in most patients, prior to prescribing sildenafil, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including sildenafil - those with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure.There are no controlled clinical data on the safety or efficacy of sildenafil in the following groups; if prescribed, this should be done with caution.Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months;Patients with resting hypotension (BP <90/50 mmHg) or hypertension (BP >170/110 mmHg);Patients with cardiac failure or coronary artery disease causing unstable angina.5.2 Prolonged Erection and PriapismProlonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets. Consistent with its known effects pfizer sildenafil 50 on the nitric oxide/cGMP pathway [ see Clinical Pharmacology (12.1, 12.2) ], sildenafil tablets was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated. Sildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO, or any component of the tablet.

What special dietary instructions should I follow?

However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity. The maximum recommended dosing frequency is once per day.Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.2.3 Dosage Adjustments in Specific SituationsSildenafil tablets was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [ see Contraindications (4.1), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].When sildenafil tablets are co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at 25 mg [ see Warnings and Precautions (5.5), Drug Interactions (7.2), and Clinical Pharmacology (12.2)].2.4 Dosage Adjustments Due to Drug InteractionsRitonavirThe recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [ see Warnings and Precautions (5.6), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].CYP3A4 InhibitorsConsider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [ see Drug Interactions (7.4)and Clinical Pharmacology (12.3)].2.5 Dosage Adjustments in Special PopulationsConsider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets in these patients resulted in higher plasma levels of sildenafil [ see Use in Specific Populations (8.5, 8.6, 8.7)and Clinical Pharmacology (12.3)]. For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. The maximum recommended dosing frequency is once per day.

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Sildenafil tablets was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [ see Contraindications (4.1), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets in these patients resulted in higher plasma levels of sildenafil [ see Use in Specific Populations (8.5, 8.6, 8.7)and Clinical Pharmacology (12.3)]. 3 DOSAGE FORMS AND STRENGTHS Sildenafil tablets, USP are supplied as pale blue to blue, caplet shaped film-coated tablets containing sildenafil citrate USP equivalent to 50 mg, or 100 mg of sildenafil. Tablets are debossed with 1A1 and 1A2 on one side and plain on the other to indicate the dosage strengths viz. 100 mg and 50 mg respectively.Sildenafil tablets 25 mg USP is supplied as Pale blue to blue, round film-coated tablets, debossed with “25” on one side and “SL” on other side. 5 WARNINGS AND PRECAUTIONS 5.1 CardiovascularThere is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease.

8.5 Geriatric Use

Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore, PDE5 inhibitors, including sildenafil , should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including sildenafil, for this uncommon condition.There are no controlled clinical data on the safety or efficacy of sildenafil in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases); if prescribed, this should be done with caution.5.4 Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including sildenafil , and seek prompt medical attention in the event of sudden decrease or loss of hearing.

When to call your doctor

Therefore, treatments for erectile dysfunction, including sildenafil, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.Sildenafil has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg), [ see Clinical Pharmacology (12.2)].

Country/Region Approval Status Regulatory Body Remarks
United States Approved by FDA FDA Prescription-only medication
European Union Approved under EMA EMA Prescription only
Canada Approved by Health Canada Health Canada Prescription medication
Australia Approved by TGA TGA Prescription required

While this normally would be expected to be of little consequence in most patients, prior to prescribing sildenafil, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including sildenafil - those with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure.There are no controlled clinical data on the safety or efficacy of sildenafil in the following groups; if prescribed, this should be done with caution.Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months;Patients with resting hypotension (BP <90/50 mmHg) or hypertension (BP >170/110 mmHg);Patients with cardiac failure or coronary artery disease causing unstable angina.5.2 Prolonged Erection and PriapismProlonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets.

  • Sildenafil citrate 100mg tablets are intended for male sexual health issues.
  • Never take more than the prescribed dose to prevent adverse effects.
  • If an erection lasts longer than 4 hours, seek immediate medical help.
  • Consult with a healthcare provider if you experience chest pain after use.
  • Sildenafil can affect blood pressure; monitor symptoms closely.
  • The medication is not suitable for women or children.
  • Use sildenafil only under supervision if you are taking alpha-blockers.
  • It may take some time for the medication to work, depending on individual factors.
  • Do not combine sildenafil with other ED medications unless advised.
  • Discontinue use and consult a healthcare professional if side effects occur.
  • Adequate hydration can help reduce some side effects like headaches.
  • Follow all instructions carefully to maximize treatment benefits.

In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance.

Reaction Percentage of Reports Severity Recommended Action
Priapism Rare Severe Immediate medical attention
Sudden vision loss Very rare Severe Seek emergency healthcare
Skin rash Uncommon Mild Discontinue and consult doctor
Digestive upset Common Mild Symptomatic treatment
Mood changes Occasionally Mild Report to healthcare provider

If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.Sildenafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia). However, there are no controlled clinical data on the safety or efficacy of sildenafil in patients with sickle cell or related anemias.5.3 Effects on the EyePhysicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil , and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 in males aged ≥ 50. An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period.

8.7 Hepatic Impairment

Revatio Injection

The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.20). Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed 50 mg sildenafil price to the occurrence of NAION in these studies.

  • Sildenafil citrate 100mg tablets can be part of erectile dysfunction treatment plans.
  • The medication should be taken approximately 30 minutes to 1 hour before sexual activity.
  • Sildenafil does not increase sexual desire but facilitates erection during arousal.
  • Patients with heart conditions should seek medical advice before use.
  • The medication can cause low blood pressure in some users.
  • S sildenafil is not intended for recreational use.
  • Do not use sildenafil if you are taking medications for high blood pressure without consulting a doctor.
  • The effects depend on individual health and other medications taken concurrently.
  • Sildenafil is contraindicated in patients taking certain alpha-blockers.
  • Regular follow-up with a healthcare provider is recommended during treatment.
  • Alcohol consumption may reduce the effectiveness of sildenafil.
  • Read all warnings and instructions provided with the medication.

Neither the rare post-marketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [ see Adverse Reactions (6.2) ].Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence.

  • Sildenafil citrate 100mg tablets are used to treat erectile dysfunction in men.
  • The usual recommended dose is 100mg taken about an hour before activity.
  • Sildenafil works by increasing blood flow to the penis during arousal.
  • This medication should not be used with nitrate drugs due to risk of dangerous interactions.
  • Common side effects include headache, flushing, upset stomach, and nasal congestion.
  • Do not take sildenafil more than once in a 24-hour period.
  • Sildenafil can cause hypotension, especially when combined with certain medications.
  • It is available by prescription and should be used under medical supervision.
  • Patients with heart problems should consult their doctor before use.
  • Sildenafil should be stored at room temperature, away from moisture and heat.
  • Alcohol can increase the risk of side effects when taking sildenafil.
  • Sildenafil may cause vision changes such as blue tinge or increased sensitivity to light.

Therefore, PDE5 inhibitors, including sildenafil , should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including sildenafil, for this uncommon condition.There are no controlled clinical data on the safety or efficacy of sildenafil in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases); if prescribed, this should be done with caution.5.4 Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including sildenafil , and seek prompt medical attention in the event of sudden decrease or loss of hearing.