3 DOSAGE FORMS AND STRENGTHS
In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive
| User Rating (out of 5) | Reported Benefits | Common Complaints | Additional Comments |
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| 4.2 | Effective in enhancing erection | Mild headaches | Usually well-tolerated, quick onset |
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crises requiring hospitalization were more commonly reported by patients who received sildenafil citrate than by those randomized to placebo.
| Country | Approval Status | Prescription Requirement | Notes |
|---|---|---|---|
| USA | FDA approved for ED | Yes | Prescription mandatory |
| UK | MHRA approved for ED | Yes | Dispensed by licensed pharmacies |
| India | Approved for ED | Yes | Available in pharmaceutical stores |
| Canada | Approved for ED | Yes | Prescription required |
6 ADVERSE REACTIONS The following serious adverse events are
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Known hypersensitivity to sildenafil or any component of the tablet. 5 WARNINGS AND PRECAUTIONS 5.1 HypotensionSildenafil citrate has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil tablets, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, tablet sildenafil 50 mg severe left ventricular outflow obstruction, or autonomic dysfunction). Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate.5.2 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of sildenafil citrate to patients with veno-occlusive disease, administration of sildenafil citrate to such patients is not recommended.
Common Side Effects:
Should signs of pulmonary edema occur when sildenafil citrate is administered, consider the possibility of associated PVOD.5.3 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil citrate with PAH secondary to CTD. This effect was not seen in idiopathic PAH (sildenafil 3%, placebo 2%) patients. The incidence of epistaxis was also higher in sildenafil-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist).The safety of sildenafil citrate is unknown in patients with bleeding disorders or active peptic ulceration.5.4 Visual LossWhen used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”).Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking sildenafil citrate.There are no controlled clinical data on the safety or efficacy of sildenafil citrate in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of sildenafil citrate in patients with retinitis pigmentosa is not recommended.5.5 Hearing LossCases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil citrate. discussed elsewhere in the labeling:Hypotension [see Warnings and Precautions (5.1)]Vision
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Loss [see Warnings and Precautions (5.4)]Hearing Loss [see Warnings and
Brand names
Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil citrate. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil tablets. Inform patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result. Precautions (5.5)]Priapism [see Warnings and Precautions (5.7)]Vaso-occlusive Crisis in Patients
- Sildenafil citrate 150 mg should not be used by individuals under 18 years old.
- Pregnant or breastfeeding women should consult a doctor before exposure.
- The drug is intended solely for male erectile dysfunction.
with Pulmonary Hypertension Secondary to Sickle Cell Disease [see
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2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage in AdultsOral DosageThe recommended dosage of sildenafil tablets are 20 mg three times a day. Dose may be titrated to a maximum of 80 mg three times a day, if required, based on symptoms and tolerability [see Clinical Studies (14)].Although dose-response improvement in exercise ability was not observed in short-term studies in adults with PAH, the delay in clinical worsening with long-term use of sildenafil in Study A1481324 supports dosing up to a maximum of 80 mg three times a day [see Clinical Studies (14)].Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. The recommended dosage of sildenafil tablets are 20 mg three times a day. Dose may be titrated to a maximum of 80 mg three times a day, if required, based on symptoms and tolerability [see Clinical Studies (14)]. Although dose-response improvement in exercise ability was not observed in short-term studies in adults with PAH, the delay in clinical worsening with long-term use of sildenafil in Study A1481324 supports dosing up to a maximum of 80 mg three times a day [see Clinical Studies (14)].
Key Features
4 CONTRAINDICATIONS Sildenafil citrate is contraindicated in patients with:Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions ( 5.1)] .Concomitant use of riociguat, a guanylate cyclase stimulator. Phosphodiesterase-5 (PDE5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.Known hypersensitivity to sildenafil or any component of the tablet. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. Sildenafil citrate is contraindicated in patients with: Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions ( 5.1)] . Phosphodiesterase-5 (PDE5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. Warnings and Precautions (5.8) ]6.1 Clinical Trials ExperienceBecause clinical trials
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In some of the cases, medical conditions and other factors were reported that may have played a role. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors.Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil tablets.5.6 Combination with Other PDE-5 InhibitorsSildenafil is also marketed as VIAGRA®. The safety and efficacy of combinations of sildenafil tablets with VIAGRA or other PDE-5 inhibitors have not been studied. Inform patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors.5.7 PriapismUse sildenafil citrate with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia).
Warnings &Precautions:
In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell DiseaseIn a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil citrate than by those randomized to placebo. The effectiveness and safety of sildenafil citrate in the treatment of PH secondary to sickle cell disease has not been established. Sildenafil citrate has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate. are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly
Warnings And Contradictions
Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Should signs of pulmonary edema occur when sildenafil citrate is administered, consider the possibility of associated PVOD. The incidence of epistaxis was 13% in patients taking sildenafil citrate with PAH secondary to CTD. The incidence of epistaxis was also higher in sildenafil-treated patients with a concomitant oral vitamin K antagonist lovegra sildenafil (9% versus 2% in those not treated with concomitant vitamin K antagonist). The safety of sildenafil citrate is unknown in patients with bleeding disorders or active peptic ulceration.
Q: What is the Red Viagra Pill used for?
When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”). Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking sildenafil citrate. There are no controlled clinical data on the safety or efficacy of sildenafil citrate in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of sildenafil citrate in patients with retinitis pigmentosa is not recommended. compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.In
- Sildenafil citrate metabolism can be affected by liver or kidney impairment.
- Dosage adjustments might be needed in such cases.
- Always report any pre-existing health conditions to your doctor.
a 12-week, placebo-controlled clinical study and an open-label extension study
| Drug Class | Interaction Effect | Clinical Significance | Recommendations |
|---|---|---|---|
| Nitrates | Severe hypotension | High | Avoid combining with sildenafil |
| CYP3A4 inhibitors | Increased plasma levels | Moderate to high | Reduce dose or adjust frequency |
| Alpha-blockers | Potential for hypotension | Moderate | Use with caution, monitor BP |
| Antifungal agents | Altered sildenafil metabolism | Variable | Consult healthcare provider |
(SUPER-1) in 277 sildenafil citrate-treated adults with PAH (WHO Group
- Sildenafil citrate can improve confidence and sexual satisfaction when used correctly.
- Should be integrated with healthy lifestyle choices for best outcomes.
- Not a permanent cure for erectile dysfunction but a temporary aid.
I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil citrate-treated patients in any dosing group, and were more frequent in sildenafil citrate-treated patients than in placebo-treated patients are shown in Table 1.
- Sildenafil citrate may interact with other medications like alpha-blockers or protease inhibitors.
- Inform your healthcare provider of all medications before using sildenafil.
- Overdose can cause serious side effects such as vision changes or chest pain.