11 DESCRIPTION

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)].

6. Adverse Reactions/Side Effects

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.

Dosage adjustments

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 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 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.

Natural Supplements That May Improve Erectile Function

Sildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil sildenafil uk price 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. 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.

• Patients with liver or kidney issues should consult a physician before use.
• Sildenafil 200 mg is a potent dose, usually used when lower doses are ineffective.
• Alcohol increases the risk of side effects like dizziness and fainting.
• The medication may cause a sudden decrease in blood pressure.
• Use sildenafil cautiously if taking antihypertensive medications.
• Always adhere to doctor’s advice for optimal safety.

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 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.

16. How is Sildenafil Tablets supplied

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.

Use In Specific Populations

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 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) sildenafil from canada ].Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors.

Other Interactions

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. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil . It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Adverse Reactions (6.1, 6.2)].5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensivesAlpha-blockersCaution is advised when PDE5 inhibitors are co-administered with alpha-blockers. Hypersensitivity reactions have been reported, including rash and urticaria [ see Adverse Reactions (6.1)]. Consistent 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 intermittently is therefore contraindicated.

• The effects of sildenafil 200 mg typically last for 4-6 hours.
• Do not take more than a prescribed dose to avoid overdose symptoms.
• Sildenafil's effectiveness varies based on individual health factors.
• It is available by prescription or from authorized pharmacies.
• The medication can cause priapism, a painful, persistent erection.
• Always follow dosing instructions to ensure safety and efficacy.

Sildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil sildenafil uk price tablets and REVATIO, or any component of the tablet.

4.3 Concomitant Guanylate Cyclase (GC) Stimulators

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. 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. 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 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) sildenafil from canada ].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. 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.

17. Patient Counseling Information

These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil . It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Adverse Reactions (6.1, 6.2)].5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensivesAlpha-blockersCaution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including sildenafil, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may occur. In some patients, concomitant use of these two drug classes can lower blood pressure significantly [ see Drug Interactions (7.2)and Clinical Pharmacology (12.2)] leading to symptomatic hypotension (e.g., dizziness, lightheadedness, fainting).Consideration should be given to the following:Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest dose [ see Dosage and Administration (2.3)].In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose.

How Hiforce 200mg Tablet Works in the Body

PDE5 inhibitors, including sildenafil, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may occur. In some patients, concomitant use of these two drug classes can lower blood pressure significantly [ see Drug Interactions (7.2)and Clinical Pharmacology (12.2)] leading to symptomatic hypotension (e.g., dizziness, lightheadedness, fainting).Consideration should be given to the following:Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest dose [ see Dosage and Administration (2.3)].In those patients already taking an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.Anti-hypertensivesSildenafil has systemic vasodilatory properties and may further lower blood pressure in patients taking anti-hypertensive medications.In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and sildenafil, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted [ see Drug Interactions (7.3) and Clinical Pharmacology (12.2)].5.6 Adverse Reactions with the Concomitant Use of RitonavirThe concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC).

What should I do if I miss a dose of sildenafil?

How is sildenafil supplied (dosage forms)?

Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.Anti-hypertensivesSildenafil has systemic vasodilatory properties and may further lower blood pressure in patients taking anti-hypertensive medications.In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and sildenafil, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted [ see Drug Interactions (7.3) and Clinical Pharmacology (12.2)].5.6 Adverse Reactions with the Concomitant Use of RitonavirThe concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC).