Add another 30 mL of water to the bottle.
| Use Case | Description | Typical Dosage | Onset of Action | Duration |
|---|---|---|---|---|
| Erectile Dysfunction | Helps achieve and maintain erections during sex | 125 mg | 30-60 minutes | Up to 4-6 hours |
| Pulmonary Hypertension | Relieves high blood pressure in lung arteries | 125 mg | 15-30 minutes | 4-6 hours |
| Off-Label Uses | Potential uses in other vascular conditions | Varies | Varies | Varies |
Remove cap and press the bottle adaptor into the neck of the bottle.
Clinical Pharmacology for Viagra
• Inform patients that sildenafil is also marketed as blue sildenafil 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. • Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets. Trademarks are the property of their respective owners.
Box 3.5.1
Package insert / product label Generic name: sildenafil citrate Dosage form: powder, for oral suspension Drug classes: Agents for pulmonary hypertension, Impotence medications Adults Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. Pediatric Patients (1 to 17 years old) Sildenafil for oral suspension is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise (1, 14) Adults: 20 mg orally three times a day. Dose may be increased based on symptoms and tolerability. Pediatric patients (2.2) ≤ 20 kg: 10 mg three times a day20 kg to 45 kg: 20 mg three times a day> 45 kg: 20 mg three times a day. ≤ 20 kg: 10 mg three times a day 20 kg to 45 kg: 20 mg three times a day > 45 kg: 20 mg three times a day.
5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease
Injection (Adults): 10 mg three times a day administered as an intravenous bolus injection. For oral suspension: 10 mg/mL (when reconstituted) (3) Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Pediatric Patients (1 to 17 Years Old) Sildenafil for oral suspension is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise [see Clinical Studies (14)]. Write the expiration date of the reconstituted oral suspension on the bottle label (the
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Kamagra | 100mg | 60 + 4 Pills | 201.34€ 191.75€ | |
| Viagra Generic | 50mg | 60 + 4 Pills | 83.93€ 79.93€ | |
| Viagra Generic | 200mg | 20 Pills | 61.69€ 58.75€ | |
| Kamagra | 100mg | 84 + 6 Pills | 264.44€ 251.85€ | |
| Viagra Generic | 150mg | 60 + 4 Pills | 111.25€ 105.95€ | |
| Viagra Generic | 100mg | 20 Pills | 45.58€ 43.41€ | |
| Viagra Generic | 100mg | 270 + 10 Pills | 270.47€ 257.59€ | |
| Kamagra | 100mg | 180 + 6 Pills | 436.79€ 415.99€ | |
| Viagra Generic | 150mg | 90 + 6 Pills | 147.18€ 140.17€ | |
| Viagra Generic | 25mg | 180 + 6 Pills | 154.93€ 147.55€ | |
| Viagra Generic | 25mg | 120 + 6 Pills | 125.56€ 119.58€ | |
| Viagra Generic | 50mg | 30 + 4 Pills | 54.26€ 51.68€ | |
| Viagra Generic | 150mg | 360 + 10 Pills | 423.48€ 403.31€ | |
| Kamagra Soft Tabs | 100mg | 12 Pills | 57.55€ 54.81€ | |
| Kamagra Oral Jelly | 100mg | 10 Sachets | 54.55€ 51.95€ | |
| Viagra Generic | 50mg | 270 + 8 Pills | 198.48€ 189.03€ |
expiration date of the reconstituted oral suspension is 60 days from the date of reconstitution).
Overdose/Missed Dose
Patients who had been in the placebo group in the short-term study were randomly reassigned to sildenafil treatment; patients weighing ≤20 kg entered the medium or high dose groups (1:2), while patients weighing >20 kg entered the low, medium, or high dose groups (1:1:1). Of the total 229 patients who received sildenafil, there were 55, 74, and 100 patients in the low, medium, and high dose groups, respectively. Across the short-term and long-term studies, the overall duration of treatment from start of double-blind for individual patients ranged from 3 to 3,129 days. By sildenafil treatment group, median duration of sildenafil treatment was 1,696 days (excluding the 5 patients who received placebo in double-blind and were not treated in the long-term extension study). Peak VO2 was assessed 1 year after the start of the placebo-controlled study.
2.1 Recommended Dosage in Adults
Of sildenafil-treated patients developmentally able to perform the CPET 59/114 patients (52%) had not shown any deterioration in PVO2 from start of sildenafil. Similarly, 191 of 229 patients (83%) who had received sildenafil had either maintained or improved their WHO Functional Class at 1 year assessment. Kaplan-Meier estimates of survival at 3 years in patients >20 kg in weight at baseline were 94%, 93%, and 85% in the low, medium, and high dose groups, respectively; for patients ≤20 kg in weight at baseline, the survival estimates were 94% and 93% for patients in the medium and high dose groups, respectively [see Use in Specific Populations (8.4) and Adverse Reactions (6.1)]. Study A1481324 (NCT02060487) - Study to Assess the Effects of Sildenafil citrate on Mortality in Adults with PAH A study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH was conducted following the observation of a higher risk of mortality in pediatric patients taking a high dose of Sildenafil citrate TID, based on body weight, compared to those taking a lower dose of Sildenafil citrate in the long-term extension of the pediatric clinical trial. The study was a randomized, double-blind, parallel-group study in 385 adults with PAH.
Starting Sildenafil: Recommended First-Time Dosage
Patients were randomly assigned 1:1:1 to one of three treatment groups (5, 20, and 80 mg TID). Most patients were PAH treatment naïve (83%). For most patients the etiology of PAH was idiopathic (72%). The most common WHO Functional Class was Class III (58% of patients). Treatment groups were well balanced with respect to baseline demographics of strata history of PAH treatment and etiology of PAH, as well as the WHO Functional Class categories. Do not mix with any other medication or additional flavoring agent.
| Country | Legal Status | Prescription Required | Notes |
|---|---|---|---|
| USA | Prescription required | Yes | Approved for ED, PH |
| UK | Prescription required | Yes | Prescription necessary |
| India | Over-the-counter in some states | Varies | Varies by region |
| Canada | Prescription required | Yes | Approved for ED and PH |
White to off-white granular powder containing 1.57 g of sildenafil citrate USP (equivalent to 1.12 g sildenafil) in a bottle intended for reconstitution.
- Recreational use of sildenafil without prescription is risky.
- The drug is not intended for daily use unless directed.
- Overuse can increase the risk of adverse effects.
- Always discuss health concerns with a healthcare professional.
- Managing stress and anxiety can improve ED symptoms.
- Patients should report persistent side effects promptly.
- Combining sildenafil with certain medications can be dangerous.
- Education on proper use enhances safety and effectiveness.
Following reconstitution with 90 mL of water, the volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil.
5.5 Hearing Loss
Based on the experience in adults, dose may be titrated to a maximum of 40 mg three times a day for pediatric patients > 45 kg, if required, based on symptoms and tolerability [see Clinical Studies (14)]. Note: Reconstitute the contents of the bottle with a total volume of 90 mL (60 mL followed by 30 mL). Tap the bottle to loosen the powder. Add 60 mL of water to the bottle. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. A 2 mL oral syringe (with 1 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided.
- Sildenafil tablets 125 mg are often prescribed for pulmonary hypertension.
- The dosage can vary depending on the condition.
- It’s important to maintain open communication with your doctor.
- Alcohol consumption can impair sildenafil’s effectiveness.
- Avoid driving if you experience dizziness or vision problems.
- Use sildenafil exactly as prescribed to avoid complications.
- Do not share medication with others.
- Regular medical check-ups are recommended during use.
Sildenafil for oral suspension is contraindicated in patients with: Concomitant use of organic nitrates in any
- Sildenafil tablets 125 mg are generally well-tolerated.
- Seek medical attention if you experience vision changes.
- They are typically used on an as-needed basis.
- Avoid heavy meals before taking sildenafil to improve absorption.
- Sildenafil is not a cure for erectile dysfunction.
- Pregnant women should avoid sildenafil use.
- It is important to stay hydrated while using the medication.
- Follow specific instructions provided by your healthcare provider.
form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.1)].
MeSH terms
The recommended dosage of sildenafil for oral suspension is 20 mg three times a day. The recommended dose is 10 mg administered as an intravenous bolus injection three times a day. The dose of sildenafil injection does not need to be adjusted for body weight. A 10 mg dose of sildenafil injection is predicted to provide pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose. The recommended dosage in patients ≤ 20 kg is 10 mg three times a day. Known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension.
Publication types
The primary objective of the study was to compare sildenafil 80 mg TID versus 5 mg TID for mortality, with success defined by ruling out twice the mortality at 80 mg. The key secondary efficacy endpoint was time to first event of clinical worsening, defined as a composite endpoint of all-cause mortality, hospitalization for worsening PAH or disease progression. An additional secondary endpoint was 6MWD at Months 6 and 12. Overall Survival At the time of a planned interim analysis (50% deaths) it was identified that the primary efficacy objective of this protocol was met and therefore the study was stopped. Based on the primary efficacy endpoint (mortality), the non-inferiority of sildenafil 80 mg TID arm versus 5 mg TID arm was met using a 2-sided significance level of 0.003 for the interim analysis.
8.4 Pediatric Use
Primary comparison of the 80 mg TID group to the 5-mg TID group yielded the HR (99.7% CI) = 0.51 (0.22, 1.21); i.e., non-inferiority was established. Kaplan-Meier estimates of survival at 3 years were 66%, 79%, and 85% in the 5-, 20-, and 80mg TID dose groups, respectively Clinical Worsening Sildenafil 80 mg was also superior to 5 mg for time to first event of clinical worsening with HR (99.7% CI) = 0.44 (0.22, 0.89). At baseline, the median of 6MWD for the intent-to-treat (ITT) population was 332 to 352 m. At Month 6, the median change from baseline was highest for sildenafil 80 mg TID with 28 m compared to 18 m and 19 m for sildenafil 5 mg TID and sildenafil 20 mg TID groups, respectively. The same was seen at Month 12, the median change from baseline for sildenafil 80 mg TID group was 33 m compared to 17 m for sildenafil 5 mg TID and 31 m in sildenafil 20 mg TID groups.
Erectile dysfunction
Overall, the safety data for sildenafil 20 mg TID and for the higher sildenafil 80 mg TID dose were consistent with the established safety profile of sildenafil in previous adult PAH studies [see Adverse Reactions (6.1)]. 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 Tablets NDC: 80425-0304-01 Bottles of 60 Tablets NDC: 80425-0304-02 Bottles of 90 Tablets NDC: 80425-0304-03 Bottles of 50 Tablets NDC: 80425-0304-04 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]. 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. Sildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure.
| Step | Description | Notes |
|---|---|---|
| Consult a healthcare provider | Discuss suitability and health conditions | Important before use |
| Dose administration | Take with a glass of water, 30-60 min before activity | Avoid heavy or fatty meals |
| Frequency | Do not exceed once per day | Follow prescribed instructions |
| Food interactions | Fatty meals may delay absorption | Better taken on an empty stomach or light meal |
Before prescribing sildenafil, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients
- Sildenafil tablets 125 mg can be part of a broader ED treatment plan.
- Psychological counseling may enhance effectiveness.
- Combining therapies can improve outcomes.
- Lifestyle modifications include weight management and exercise.
- Quitting smoking can improve erectile health.
- Vasodilator drugs should be avoided when using sildenafil.
- Maintain a balanced diet alongside medication.
- Support groups can offer additional assistance.
on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction).