50 Pill: white, four-sided, 11mm
Patients were predominantly World Health Organization (WHO) functional classes II-III.
| Storage Condition | Details | Notes |
|---|---|---|
| Temperature | Keep below 30°C (86°F) | Avoid excessive heat |
| Light | Keep away from direct sunlight | Protect from UV rays |
| Humidity | Store in dry place | Prevent moisture from degrading the tablet |
| Out of reach | Keep out of children's reach | Safety precaution |
Subjects who had failed to respond to bosentan were also excluded. Patients with left ventricular ejection fraction less than 45% or left ventricular shortening fraction less than 0.2 also were not studied.Patients were randomized to receive placebo (n=70) or sildenafil 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: 18-81 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.
| Precaution/Contraindication | Description | Notes |
|---|---|---|
| Nitrate use | Do not take with nitrates for chest pain | Risk of severe hypotension |
| Heart conditions | Consult a doctor if you have cardiovascular issues | Risk of adverse cardiovascular events |
| Liver or kidney impairment | Reduced dosing may be necessary | Altered drug metabolism |
| Drug interactions | Combine with caution; may interact with other meds | Always consult a healthcare provider |
Placebo-corrected mean increases in walk distance of 45-50 meters were observed with all doses of sildenafil. These increases were significantly different from placebo, but the sildenafil dose groups were not different from each other (see Figure 9), indicating no additional clinical benefit from doses higher than 20 mg three times a day. The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at week 8 and week 12.Figure 9. Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in Study 1: Mean (95% Confidence Interval)Figure 10 displays subgroup efficacy analyses in Study 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.Figure 10. Placebo-Corrected Change From Baseline in 6-Minute Walk Distance (meters) at Week 12 by study subpopulation in Study 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.Of the 277 treated patients, 259 entered a long-term, uncontrolled extension study. At the end of 1 year, 94% of these patients were still alive.
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Additionally, walk distance and functional class status appeared to be stable in patients taking sildenafil. Without a control group, these data must be interpreted cautiously.Study 2 (Sildenafil co-administered with epoprostenol)A randomized, double-blind, placebo controlled study (Study 2) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol. Patients were randomized to placebo or sildenafil (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 group compared with the placebo group. Table 4 displays the number of patients with clinical worsening events in Study 2. Kaplan-Meier plot of time to clinical worsening is presented in Figure 11.Figure 11.
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Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in Study 2Improvements in WHO functional class for PAH were also demonstrated in subjects on sildenafil compared to placebo. More than twice as many sildenafil-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 3 (Sildenafil monotherapy (1 mg, 5 mg, and 20 mg three times a day))A randomized, double-blind, parallel dose study (Study 3) was planned in 219 patients with PAH. This study was prematurely terminated with 129 subjects enrolled. Patients were required to have a mPAP greater than or equal to 25 mmHg and a PCWP less than or equal to 15 mmHg at rest via right heart catheterization within 12 weeks before randomization, and a baseline 6-minute walk test distance greater than or equal to 100 meters and less than or equal to 450 meters (mean 345 meters). Patients were randomized to 1 of 3 doses of sildenafil: 1 mg, 5 mg, and 20 mg, three times a day.At baseline patients had PPH (74%) or secondary PAH (26%); WHO functional class II (57%), III (41%), or pfizer sildenafil 50 IV (2%); the mean age was 44 years; and 67% were female. Additionally, walk distance and functional class status appeared to be stable in patients taking sildenafil.
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Without a control group, these data must be interpreted cautiously.Study 2 (Sildenafil co-administered with epoprostenol)A randomized, double-blind, placebo controlled study (Study 2) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol. Patients were randomized to placebo or sildenafil (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 group compared with the placebo group. Table 4 displays the number of patients with clinical worsening events in Study 2. Kaplan-Meier plot of time to clinical worsening is presented in Figure 11.Figure 11. Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in Study 2Improvements in WHO functional class for PAH were also demonstrated in subjects on sildenafil compared to placebo. More than twice as many sildenafil-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 3 (Sildenafil monotherapy (1 mg, 5 mg, and 20 mg three times a day))A randomized, double-blind, parallel dose study (Study 3) was planned in 219 patients with PAH. This study was prematurely terminated with 129 subjects enrolled. Patients were required to have a mPAP greater than or equal to 25 mmHg and a PCWP less than or equal to 15 mmHg at rest via right heart catheterization within 12 weeks before randomization, and a baseline 6-minute walk test distance greater than or equal to 100 meters and less than or equal to 450 meters (mean 345 meters).
5.4 Hearing Loss
Do not take sildenafil tablets 20 mg with VIAGRA or other PDE-5 inhibitors.Who should not take sildenafil tablets?Do not take sildenafil tablets if you:• take nitrate medicines. See “What is the most important information I should know about sildenafil tablets?”• take guanylate cyclase stimulator medicines. See “What is the most important information I should know about sildenafil tablets?”• are allergic to sildenafil or any other ingredient in sildenafil tablets. See “What are the ingredients in sildenafil tablets?” at the end of this leaflet.What should I tell my doctor before taking sildenafil tablets?Tell your doctor about all of your medical conditions, including if you• have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack• have a disease called pulmonary veno-occlusive disease (PVOD)• have high or low blood pressure or blood circulation problems• have an eye problem called retinitis pigmentosa• have or had loss of sight in one or both eyes• have any problem with the shape of your penis or Peyronie’s disease• have any blood cell problems such sickle cell anemia• have a stomach ulcer or any bleeding problems• are pregnant or planning to become pregnant. Patients were randomized to 1 of 3 doses of sildenafil: 1 mg, 5 mg, and 20 mg, three times a day.At baseline patients had PPH (74%) or secondary PAH (26%); WHO functional class II (57%), III (41%), or pfizer sildenafil 50 IV (2%); the mean age was 44 years; and 67% were female. The majority of subjects were Asian (67%), and 28% were Caucasian.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. Similar increases in walk distance (mean increase of 38-41 meters) were observed in the 5 and 20 mg dose groups. These increases were significantly better than those observed in the 1 mg dose group (Figure 12).Figure 12.
Other uses for this medicine
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information).Inform patients of contraindication of sildenafil tablets 20 mg 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 20 mg 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 20 mg. 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 20 mg. These events may be accompanied by tinnitus and dizziness.VIAGRA® is registered trademark of Pfizer Inc. All other trademarks herein are the property of their respective owners.Manufactured for:Macleods Pharma USA, Inc.Plainsboro, NJ 08536Manufactured by:Macleods Pharmaceutical Ltd.Baddi, Himachal Pradesh, IndiaRevised: February 2018PM01596108PATIENT INFORMATIONSildenafil (sil-DEN-a-fil) TabletsRead this Patient Information before you start taking sildenafil tablets and each time you get a refill.
Dosage for erectile dysfunction (ED)
This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about sildenafil tablets, ask your doctor or pharmacist.What is the most important information I should know about sildenafil tablets?Never take sildenafil tablets with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level. Nitrate medicines include:• Medicines that treat chest pain (angina)• Nitroglycerin in any form including tablets, patches, sprays, and ointments• Isosorbide mononitrate or dinitrate• Street drugs called “poppers” (amyl nitrate or nitrite)Guanylate cyclase stimulators include:• Riociguat (Adempas)Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). Your heart has to work hard to pump blood into your lungs.Sildenafil tablets improve the ability to exercise and can slow down worsening changes in your physical condition.• Sildenafil tablets are not for use in children• Adding sildenafil tablets to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise.Sildenafil tablets 20 mg contain the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence). Mean Change from Baseline in Six Minute Walk (meters) by Visit to Week 12 – ITT Population Sildenafil Protocol A1481244Study 4 (Sildenafil 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 three months. The PAH patients included those with primary PAH, and PAH associated with CTD. Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5-125 mg twice a day). The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD. 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 . Studies of Adults with Pulmonary Arterial Hypertension Study 1 (Sildenafil monotherapy (20 mg, 40 mg, and 80 mg three times a day)) Study 2 (Sildenafil co-administered with epoprostenol) Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in Study 2 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, USP are supplied as white to off-white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].
- The legality of purchasing sildenafil varies by country.
- Online pharmacies may offer sildenafil, but verify their legitimacy.
- White sildenafil tablets are designed for rapid dissolution in the mouth or swallowing.
- Be aware of potential allergic reactions, such as rash or swelling.
- Avoid taking sildenafil with large meals that contain high fat content.
- The effectiveness of sildenafil depends on individual health conditions.
- The American Urological Association provides guidelines on sildenafil use.
- Sildenafil can cause safety concerns in patients with low blood pressure.
- The drug works best when taken approximately one hour before intimacy.
- Use sildenafil solely as directed; misuse can lead to health risks.
- Regular check-ups can help monitor the impact of sildenafil on health.
Sildenafil tablets, USP are supplied as white to off-white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information).Inform patients of contraindication of sildenafil tablets 20 mg 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 20 mg 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 20 mg. 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 20 mg. These events may be accompanied by tinnitus and dizziness.VIAGRA® is registered trademark of Pfizer Inc. All other trademarks herein are the property of their respective owners.Manufactured for:Macleods Pharma USA, Inc.Plainsboro, NJ 08536Manufactured by:Macleods Pharmaceutical Ltd.Baddi, Himachal Pradesh, IndiaRevised: February 2018PM01596108PATIENT INFORMATIONSildenafil (sil-DEN-a-fil) TabletsRead this Patient Information before you start taking sildenafil tablets and each time you get a refill. This information does not take the place of talking with your doctor about your medical condition or treatment.
Side effects of Sildenafil (Revatio)
The majority of subjects were Asian (67%), and 28% were Caucasian.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. Similar increases in walk distance (mean increase of 38-41 meters) were observed in the 5 and 20 mg dose groups. These increases were significantly better than those observed in the 1 mg dose group (Figure 12).Figure 12. Mean Change from Baseline in Six Minute Walk (meters) by Visit to Week 12 – ITT Population Sildenafil Protocol A1481244Study 4 (Sildenafil 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 three months. The PAH patients included those with primary PAH, and PAH associated with CTD.
What are the most common side effects of sildenafil?
Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5-125 mg twice a day). The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD. 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 . Studies of Adults with Pulmonary Arterial Hypertension Study 1 (Sildenafil monotherapy (20 mg, 40 mg, and 80 mg three times a day)) Study 2 (Sildenafil co-administered with epoprostenol) Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in Study 2 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, USP are supplied as white to off-white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Sildenafil tablets, USP are supplied as white to off-white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. If you have any questions about sildenafil tablets, ask your doctor or pharmacist.What is the most important information I should know about sildenafil tablets?Never take sildenafil tablets with any nitrate or guanylate cyclase stimulator medicines.
| Form | Available Strengths | Description | Notes |
|---|---|---|---|
| Tablets | 25 mg, 50 mg, 100 mg | Standard oral tablets | Most common dosage |
| Sublingual Tabs | 25 mg | Dissolve under tongue | Rapid absorption |
| Liquid Suspension | 10 mg/5 mL | For easy dosing, especially in children | Requires precise measurement |
Your blood pressure could drop quickly to an unsafe level. Nitrate medicines include:• Medicines that treat chest pain (angina)• Nitroglycerin in any form including tablets, patches, sprays, and ointments• Isosorbide mononitrate or dinitrate• Street drugs called “poppers” (amyl nitrate or nitrite)Guanylate cyclase stimulators include:• Riociguat (Adempas)Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH).
6.2 Postmarketing Experience
Patients were predominantly World Health Organization (WHO) functional classes II-III. Subjects who had failed to respond to bosentan were also excluded. Patients with left ventricular ejection fraction less than 45% or left ventricular shortening fraction less than 0.2 also were not studied.Patients were randomized to receive placebo (n=70) or sildenafil 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: 18-81 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. Placebo-corrected mean increases in walk distance of 45-50 meters were observed with all doses of sildenafil.
Recreational use
These increases were significantly different from placebo, but the sildenafil dose groups were not different from each other (see Figure 9), indicating no additional clinical benefit from doses higher than 20 mg three times a day. The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at week 8 and week 12.Figure 9. Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in Study 1: Mean (95% Confidence Interval)Figure 10 displays subgroup efficacy analyses in Study 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.Figure 10. Placebo-Corrected Change From Baseline in 6-Minute Walk Distance (meters) at Week 12 by study subpopulation in Study 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.Of the 277 treated patients, 259 entered a long-term, uncontrolled extension study. At the end of 1 year, 94% of these patients were still alive. Your heart has to work hard to pump blood into your lungs.Sildenafil tablets improve the ability to exercise and can slow down worsening changes in your physical condition.• Sildenafil tablets are not for use in children• Adding sildenafil tablets to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise.Sildenafil tablets 20 mg contain the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence).
- Sildenafil tablets are not intended for recreational use or performance enhancement.
- Always follow a healthcare provider’s instructions for safe use.
- Sildenafil’s effects last for a few hours, depending on individual factors.
- The medication is taken as needed, not as a daily supplement.
- Only use sildenafil under medical supervision if you have heart disease.
- Do not take sildenafil if you are allergic to sildenafil citrate.
- The drug helps improve quality of life for men with ED.
- Sildenafil may cause temporary visual disturbances, like a blue tint.
- Proper hydration can help minimize side effects.
- Certain genetic conditions may affect sildenafil's effectiveness.
- Regular medical reviews ensure safe long-term use of sildenafil.
Do not take sildenafil tablets 20 mg with VIAGRA or other PDE-5 inhibitors.Who should not take sildenafil tablets?Do not take sildenafil tablets if you:• take nitrate medicines. See “What is the most important information I should know about sildenafil tablets?”• take guanylate cyclase stimulator medicines.
- White sildenafil tablets may be counterfeit if lacking proper packaging.
- The expiry date on sildenafil tablets is important for safety.
- For improved absorption, take sildenafil with a light meal or on an empty stomach.
- Sildenafil should not be used more than once per day.
- Common side effects may include nasal congestion and muscle pain.
- Regular use without consulting a doctor can mask underlying health issues.
- Some users experience temporary vision disturbances after taking sildenafil.
- Sildenafil is approved by regulatory agencies like the FDA.
- Do not mix sildenafil with recreational drugs or alcohol.
- Always follow the prescribed dosage specified by your healthcare provider.
- Discontinue use and seek medical advice if adverse effects occur.
See “What is the most important information I should know about sildenafil tablets?”• are allergic to sildenafil or any other ingredient in sildenafil tablets.
- Sildenafil tablets are sometimes prescribed for conditions other than ED.
- The active ingredient aids in relaxing blood vessels in the body.
- White sildenafil tablets are often associated with certain pharmaceutical brands.
- Some countries have strict regulations on sildenafil distribution and sale.
- Sildenafil is typically not recommended for men with severe eyesight diseases.
- Adherence to prescribed guidelines optimizes treatment outcomes.
- The tablets are manufactured with quality control practices to ensure safety.
- Patients should avoid sudden changes in medication or dosage.
- Reactions to sildenafil can be immediate or delayed; monitor closely.
- Lifestyle factors like smoking can influence sildenafil’s effectiveness.
- Educate yourself on proper storage to maintain medication integrity.
See “What are the ingredients in sildenafil tablets?” at the end of this leaflet.What should I tell my doctor before taking sildenafil tablets?Tell your doctor about all of your medical conditions, including if you• have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack• have a disease called pulmonary veno-occlusive disease (PVOD)• have high or low blood pressure or blood circulation problems• have an eye problem called retinitis pigmentosa• have or had loss of sight in one or both eyes• have any problem with the shape of your penis or Peyronie’s disease• have any blood cell problems such sickle cell anemia• have a stomach ulcer or any bleeding problems• are pregnant or planning to become pregnant.