5 WARNINGS AND PRECAUTIONS
Patients were randomized to receive placebo (n=70) or sildenafil tablet 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. The study population consisted of 25% men and 75% women with a mean age of 49 years (range: 18 to 81 years) and baseline 6-minute walk distance between 100 and 450 meters (mean 343). The primary efficacy endpoint was the change from baseline at Week 12 (at least 4 hours after the last dose) in the 6-minute walk distance. The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at Week 8 and Week 12. Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in SUPER-1: Mean (95% Confidence Interval) Figure 4 displays subgroup efficacy analyses in SUPER-1 for the change from baseline in 6-Minute Walk Distance at Week 12 including baseline walk distance, disease etiology, functional class, gender, age, and hemodynamic parameters. Placebo-Corrected Change From Baseline in 6-Minute Walk Distance (meters) at Week 12 by Study Subpopulation in SUPER-1: Mean (95% Confidence Interval) Key: PAH = pulmonary arterial hypertension; CTD = connective tissue disease; PH = pulmonary hypertension; PAP = pulmonary arterial pressure; PVRI = pulmonary vascular resistance index; TID = three times daily. SUPER-2 (NCT00159887) Long-term Treatment of PAH In a long-term follow-up of patients who were treated with sildenafil (n=277), K-M estimates of survival at 1, 2, and 3 years were 94%, 88% , and 79%, respectively. These uncontrolled observations do not allow comparison with a group not given sildenafil and cannot be used to determine the long term-effect of sildenafil on mortality.
- Sildenafil tablets LP 100 mg can cause visual disturbances in some users.
- Headaches are among the most common side effects reported.
- Avoid driving if you experience dizziness after taking the medication.
PACES-1 (NCT00159861) - Sildenafil citrate Co-administered with Epoprostenol A randomized, double-blind, placebo-controlled study (PACES-1) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol. Patients were randomized to placebo or sildenafil citrate (in a fixed titration starting from 20 mg to 40 mg and then 80 mg, three times a day) and all patients continued intravenous epoprostenol therapy. At baseline patients had PPH (80%) or PAH secondary to CTD (20%);WHO Functional Class I (1%), II (26%), III (67%), or IV (6%); and the mean age was 48 years, 80% were female, and 79% were Caucasian. There was a statistically significant greater increase from baseline in 6-minute walk distance at Week 16 (primary endpoint) for the sildenafil citrate group compared with the placebo group. The mean change from baseline at Week 16 (last observation carried forward) was 30 meters for the sildenafil tablet group compared with 4 meters for the placebo group giving an adjusted treatment difference of 26 meters (95% CI: 10.8, 41.2) (p = 0.0009). Patients on sildenafil citrate achieved a statistically significant reduction in mPAP compared to those on placebo. A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favor of sildenafil tablet (95% CI: -5.7, -2.1) (p = 0.00003). Time to clinical worsening of PAH was defined as the time from randomization to the first occurrence of a clinical worsening event (death, lung transplantation, initiation of bosentan therapy, or clinical deterioration requiring a change in epoprostenol therapy). Kaplan- Meier plot of time to clinical worsening is presented in Figure 5. Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in PACES-1 Improvements in WHO Functional Class for PAH were also demonstrated in patients on sildenafil tablet compared to placebo. More than twice as many sildenafil citrate-treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH. Study A1481243 (NCT00323297) – Sildenafil citrate Added to Bosentan Therapy – Lack of Effect on Exercise Capacity A randomized, double-blind, placebo-controlled study was conducted in 103 patients with PAH who were on bosentan therapy for a minimum of 3 months.
- Do not exceed one dose of sildenafil LP 100 mg per day.
- Common side effects include headache, flushing, and nasal congestion.
- Consult a doctor if you experience chest pain or vision changes.
The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 mg plus bosentan and bosentan alone. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil 20 mg tablets USP are white to off-white, round biconvex film coated tablets debossed with '85' on one side and plain on other side.Bottles of 30 NDC 82804-243-30Bottles of 90 NDC 82804-243-90Recommended Storage for Sildenafil Tablets USP: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
5.3 Worsening Pulmonary Vascular Occlusive Disease
Advise patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors. • Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil tablets. Such an event may be a sign of NAION. • Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets. These events may be accompanied by tinnitus and dizziness.
Hierarchy Structure
Trademarks are the property of their respective owners. Torrent Pharma INC., Basking Ridge, NJ 07920. Proficient Rx LP., Thousand Oaks, CA 91320 If your selected quantity is intended to last longer than one month, please recheck the price using the 3-months supply option. In some cases, the estimated drug price may vary depending on the supply duration. You may find alternative ways to save with this medication.
Drug Interactions
Talk to your pharmacist about the potential option(s) noted below. View images of VIAGRA (Brand for SILDENAFIL CITRATE) and identify pills by imprint, color or shape. If you need to save money on your VIAGRA (Brand for SILDENAFIL CITRATE), compare our prices. Our prescription savings may even be lower than your insurance copay! Note: Multiple images may be displayed for medicines available in different strengths, sold under different brand names, or manufactured by different pharmaceutical companies. Sildenafil 20 mg tablets USP are white to off-white, round biconvex film coated tablets debossed with '85' on one side and plain on other side. Bottles of 30 NDC 82804-243-30 Bottles of 90 NDC 82804-243-90 Recommended Storage for Sildenafil Tablets USP: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
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17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).• Inform patients of contraindication of sildenafil tablets with regular and/or intermittent use of organic nitrates.• Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors.• Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil tablets. Such an event may be a sign of NAION.• Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets. These events may be accompanied by tinnitus and dizziness.Trademarks are the property of their respective owners.Dispense with Patient Information available at: by:Torrent Pharmaceuticals LTD., India.Manufactured for:Torrent Pharma INC., Basking Ridge, NJ 07920.Repackaged by:Proficient Rx LP., Thousand Oaks, CA 913208098157 Revised: November 2024 Advise the patient to read the FDA-approved patient labeling (Patient Information). • Inform patients of contraindication of sildenafil tablets with regular and/or intermittent use of organic nitrates. • Inform patients that sildenafil sildenafil 5mg for sale is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors. • Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil tablets. Such an event may be a sign of NAION. • Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets. These events may be accompanied by tinnitus and dizziness. Trademarks are the property of their respective owners. Torrent Pharma INC., Basking Ridge, NJ 07920. Proficient Rx LP., Thousand Oaks, CA 91320 If your selected quantity is intended to last longer than one month, please recheck the price using the 3-months supply option. In some cases, the estimated drug price may vary depending on the supply duration. You may find alternative ways to save with this medication. Talk to your pharmacist about the potential option(s) noted below. View images of VIAGRA (Brand for SILDENAFIL CITRATE) and identify pills by imprint, color or shape.
5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Anemia
If you need to save money on your VIAGRA (Brand for SILDENAFIL CITRATE), compare our prices. Our prescription savings may even be lower than your insurance copay! Note: Multiple images may be displayed for medicines available in different strengths, sold under different brand names, or manufactured by different pharmaceutical companies. Pacakaging (Quantity Per Box) 10 strips per box Function Helps in treating erectile dysfunction by increasing blood flow Take one tablet orally with water approximately 30-60 minutes before sexual activity. Do not exceed one tablet per day.
| Condition | Description | Off-label Use | Contraindications |
|---|---|---|---|
| Erectile Dysfunction | To improve erectile performance | Pulmonary Hypertension | Nitrates use, severe cardiovascular disease |
| Pulmonary Arterial Hypertension | As a vasodilator to reduce pulmonary pressure | - | Use with caution in certain populations |
| Raynaud's Phenomenon | To improve blood flow in extremities | - | Severe hypotension |
Helps in treating erectile dysfunction by increasing blood flow Store in a cool dry place below 30C away from direct sunlight and moisture. Grab Yours now-Silditop Sildenafil Citrate 100mg tablets, a top-ranking solution for men seeking support in combatting erectile dysfunction. This featured, new arrival brings together blue-ribbon quality and top-drawer efficacy in every tablet.
| Storage Parameter | Recommended Condition | Notes |
|---|---|---|
| Temperature | Keep below 25°C (77°F) | Avoid excessive heat or cold |
| Humidity | Store in a dry place | Protect from moisture |
| Light | Keep in original packaging | Prevent exposure to light |
| Shelf Life | 2-3 years from manufacturing date | Check expiration date before use |
Designed with precision, each dose works by improving blood flow to help achieve and maintain satisfying erections. With 10 strips per box and each strip containing 10 tablets, this product is ideal for adult men with erectile challenges.
The bottom line
Time to clinical worsening of PAH was defined as the time from randomization to the first occurrence of a clinical worsening event (death, lung transplantation, initiation of bosentan therapy, or clinical deterioration requiring a change in epoprostenol therapy). Kaplan- Meier plot of time to clinical worsening is presented in Figure 5. Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in PACES-1 Improvements in WHO Functional Class for PAH were also demonstrated in patients on sildenafil tablet compared to placebo. More than twice as many sildenafil citrate-treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH. Study A1481243 (NCT00323297) – Sildenafil citrate Added to Bosentan Therapy – Lack of Effect on Exercise Capacity A randomized, double-blind, placebo-controlled study was conducted in 103 patients with PAH who were on bosentan therapy for a minimum of 3 months.
Patient resources
The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 mg plus bosentan and bosentan alone. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil 20 mg tablets USP are white to off-white, round biconvex film coated tablets debossed with '85' on one side and plain on other side.Bottles of 30 NDC 82804-243-30Bottles of 90 NDC 82804-243-90Recommended Storage for Sildenafil Tablets USP: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Sildenafil 20 mg tablets USP are white to off-white, round biconvex film coated tablets debossed with '85' on one side and plain on other side. Bottles of 30 NDC 82804-243-30 Bottles of 90 NDC 82804-243-90 Recommended Storage for Sildenafil Tablets USP: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).• Inform patients of contraindication of sildenafil tablets with regular and/or intermittent use of organic nitrates.• Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction.
How does sildenafil work (mechanism of action)?
Advise patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors.• Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil tablets. Such an event may be a sign of NAION.• Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets. These events may be accompanied by tinnitus and dizziness.Trademarks are the property of their respective owners.Dispense with Patient Information available at: by:Torrent Pharmaceuticals LTD., India.Manufactured for:Torrent Pharma INC., Basking Ridge, NJ 07920.Repackaged by:Proficient Rx LP., Thousand Oaks, CA 913208098157 Revised: November 2024 Advise the patient to read the FDA-approved patient labeling (Patient Information). • Inform patients of contraindication of sildenafil tablets with regular and/or intermittent use of organic nitrates. • Inform patients that sildenafil sildenafil 5mg for sale is also marketed as VIAGRA for erectile dysfunction. Store the tablets properly to maintain their effectiveness. Proudly exported from India, supplied by a trusted trader.Silditop Sildenafil Citrate 100mg: Directions & Type of UsageSilditop is specifically recommended for adult men experiencing erectile dysfunction, providing targeted relief through increased blood flow. The medication is intended for oral use with water, about 30-60 minutes prior to sexual activity. Do not exceed one tablet per day, as advised by dosage guidelines.
2.3 Dosage Adjustments in Specific Situations
Patients were randomized to receive placebo (n=70) or sildenafil tablet 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. The study population consisted of 25% men and 75% women with a mean age of 49 years (range: 18 to 81 years) and baseline 6-minute walk distance between 100 and 450 meters (mean 343). The primary efficacy endpoint was the change from baseline at Week 12 (at least 4 hours after the last dose) in the 6-minute walk distance. The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at Week 8 and Week 12. Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in SUPER-1: Mean (95% Confidence Interval) Figure 4 displays subgroup efficacy analyses in SUPER-1 for the change from baseline in 6-Minute Walk Distance at Week 12 including baseline walk distance, disease etiology, functional class, gender, age, and hemodynamic parameters.
Viagra Tablets
Placebo-Corrected Change From Baseline in 6-Minute Walk Distance (meters) at Week 12 by Study Subpopulation in SUPER-1: Mean (95% Confidence Interval) Key: PAH = pulmonary arterial hypertension; CTD = connective tissue disease; PH = pulmonary hypertension; PAP = pulmonary arterial pressure; PVRI = pulmonary vascular resistance index; TID = three times daily. SUPER-2 (NCT00159887) Long-term Treatment of PAH In a long-term follow-up of patients who were treated with sildenafil (n=277), K-M estimates of survival at 1, 2, and 3 years were 94%, 88% , and 79%, respectively. These uncontrolled observations do not allow comparison with a group not given sildenafil and cannot be used to determine the long term-effect of sildenafil on mortality. PACES-1 (NCT00159861) - Sildenafil citrate Co-administered with Epoprostenol A randomized, double-blind, placebo-controlled study (PACES-1) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol. Patients were randomized to placebo or sildenafil citrate (in a fixed titration starting from 20 mg to 40 mg and then 80 mg, three times a day) and all patients continued intravenous epoprostenol therapy.
Serious Side Effects
At baseline patients had PPH (80%) or PAH secondary to CTD (20%);WHO Functional Class I (1%), II (26%), III (67%), or IV (6%); and the mean age was 48 years, 80% were female, and 79% were Caucasian. There was a statistically significant greater increase from baseline in 6-minute walk distance at Week 16 (primary endpoint) for the sildenafil citrate group compared with the placebo group. The mean change from baseline at Week 16 (last observation carried forward) was 30 meters for the sildenafil tablet group compared with 4 meters for the placebo group giving an adjusted treatment difference of 26 meters (95% CI: 10.8, 41.2) (p = 0.0009). Patients on sildenafil citrate achieved a statistically significant reduction in mPAP compared to those on placebo. A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favor of sildenafil tablet (95% CI: -5.7, -2.1) (p = 0.00003). This usage protocol ensures optimal safety and maximizes effectiveness, supporting men to regain confidence and enhanced intimacy.
7.2 Alpha-blockers
Sample policies are available for reliable clients, ensuring transparency and trust across the entire domestic and international market landscape. Silditop Sildenafil Citrate 100mg: Directions & Type of Usage Silditop is specifically recommended for adult men experiencing erectile dysfunction, providing targeted relief through increased blood flow. Follow all instructions precisely to achieve the best results from this top-drawer pharmaceutical solution.Export Markets, Certifications & Logistics for Silditop Sildenafil CitrateSilditop Sildenafil Citrate 100mg tablets are widely supplied in domestic and international markets, reflecting strong logistics and goods transport infrastructure. Featured in top export destinations, this allopathic medicine is distributed by a leading exporter, supplier, and trader from India.
5.2 Worsening Pulmonary Vascular Occlusive Disease
Pacakaging (Quantity Per Box) 10 strips per box Function Helps in treating erectile dysfunction by increasing blood flow Take one tablet orally with water approximately 30-60 minutes before sexual activity. Do not exceed one tablet per day. Helps in treating erectile dysfunction by increasing blood flow Store in a cool dry place below 30C away from direct sunlight and moisture. Grab Yours now-Silditop Sildenafil Citrate 100mg tablets, a top-ranking solution for men seeking support in combatting erectile dysfunction. This featured, new arrival brings together blue-ribbon quality and top-drawer efficacy in every tablet.
Cite this article
Designed with precision, each dose works by improving blood flow to help achieve and maintain satisfying erections. With 10 strips per box and each strip containing 10 tablets, this product is ideal for adult men with erectile challenges. Store the tablets properly to maintain their effectiveness. Proudly exported from India, supplied by a trusted trader.Silditop Sildenafil Citrate 100mg: Directions & Type of UsageSilditop is specifically recommended for adult men experiencing erectile dysfunction, providing targeted relief through increased blood flow. The medication is intended for oral use with water, about 30-60 minutes prior to sexual activity.
Are you currently using Sildenafil (Viagra, Revatio)?
Do not exceed one tablet per day, as advised by dosage guidelines. This usage protocol ensures optimal safety and maximizes effectiveness, supporting men to regain confidence and enhanced intimacy. Follow all instructions precisely to achieve the best results from this top-drawer pharmaceutical solution.Export Markets, Certifications & Logistics for Silditop Sildenafil CitrateSilditop Sildenafil Citrate 100mg tablets are widely supplied in domestic and international markets, reflecting strong logistics and goods transport infrastructure. Featured in top export destinations, this allopathic medicine is distributed by a leading exporter, supplier, and trader from India. Certified for quality and safe handling, the product meets stringent industry standards. Certified for quality and safe handling, the product meets stringent industry standards. Sample policies are available for reliable clients, ensuring transparency and trust across the entire domestic and international market landscape. Silditop Sildenafil Citrate 100mg: Directions & Type of Usage Silditop is specifically recommended for adult men experiencing erectile dysfunction, providing targeted relief through increased blood flow.
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