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Inform patients of contraindication of REVATIO with regular and/or intermittent use of organic nitrates.

• Sildenafil is useful in treating erectile dysfunction caused by various factors.
• It is recommended to avoid heavy meals close to medication time.
• Patients should be aware of potential side effects like dizziness.
• It is important to stay hydrated but avoid excessive fluid intake when taking sildenafil.
• Check with your doctor before discontinuing or changing dosage.
• Sildenafil may affect concomitant use of certain psychiatric medications.
• Adequate sexual stimulation is necessary for the medication to work effectively.
• Always adhere to your healthcare provider's instructions for best results.

Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction.

Topic	Focus Area	Potential Impact
New formulations	Fast-acting or long-lasting versions	Broader use scenarios
Combination therapies	Sildenafil with other drugs	Enhanced treatment efficacy
Genomic studies	Personalized medicine approaches	Improved safety and effectiveness
Improved delivery systems	Transdermal or injectable options	Increased convenience and adherence

Advise patients taking REVATIO not to take VIAGRA or other PDE-5 inhibitors.

Aspect	Description	Purpose	Formulation
Medication Name	Pfizer Sildenafil 50 mg	Erectile Dysfunction Treatment	Tablets, Oral
Manufacturer	Pfizer Inc.	Produces the medication	United States
Release Year	2012	When it was introduced to market	N/A
Active Ingredient	Sildenafil Citrate 50 mg	Main compound for efficacy	Yes
Approved Uses	Erectile dysfunction, Pulmonary hypertension	Medical indications	N/A

Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking REVATIO.

Aspect	Details	Implication
Average Cost per Dose	$10–$15	Affordable for most patients
Generic Availability	Available in many markets	Reduces cost
Insurance Coverage	Varies, often partial reimbursement	Can lower patient expense
Global Access	Limited in low-income countries	Affects availability worldwide

Such an event may be a sign of NAION.

Detection in biological fluids

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. REVATIO tablets are supplied as white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Recommended Storage for REVATIO Tablets: Store at controlled room temperature 20°C – 25°C (68°F – 77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) [see USP Controlled Room Temperature]. REVATIO injection is supplied as a clear, colorless, sterile, ready to use solution containing 10 mg sildenafil/12.5 mL presented in a single-use glass vial. Recommended Storage for REVATIO Injection: Store at controlled room temperature 20°C – 25°C (68°F – 77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) [see USP Controlled Room Temperature]. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking REVATIO.

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These events may be accompanied by tinnitus and dizziness.

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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. 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. Additionally, walk distance and functional class status appeared to be stable in patients taking REVATIO. Without a control group, these data must be interpreted cautiously.

Dosage questions

Study 2 (REVATIO 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 had to have a mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg and a pulmonary capillary wedge pressure (PCWP) less than or equal to 15 mmHg at rest via right heart catheterization within 21 days 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 349 meters). Patients were randomized to placebo or REVATIO (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 REVATIO group compared with the placebo group.

Before taking sildenafil,

The mean change from baseline at Week 16 (last observation carried forward) was 30 meters for the REVATIO 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 REVATIO 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 REVATIO (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). Table 4 displays the number of patients with clinical worsening events in Study 2. For current full prescribing information, please visit Read this Patient Information before you start taking REVATIO 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.

• Pfizer sildenafil 50mg has helped millions with erectile dysfunction worldwide.
• It can also improve exercise capacity in pulmonary hypertension patients.
• Generic sildenafil is often more affordable and equally effective.
• Patients should avoid grapefruit or grapefruit juice during treatment.
• Proper hydration may help reduce some side effects like headache.
• It is important to recognize contraindications to prevent health risks.
• Patient education about proper usage enhances treatment outcomes.
• The medication's patent status has impacted availability and pricing.

If you have any questions about REVATIO, ask your doctor or pharmacist.

More about sildenafil

Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity. There was no impairment of fertility in male or female rats given up to 60 mg sildenafil/kg/day, a dose producing a total systemic exposure (AUC) to unbound sildenafil and its major metabolite of 19- and 38- times for males and females, respectively, the human exposure at the RHD of 20 mg three times a day. Studies of Adults with Pulmonary Arterial Hypertension Study 1 (REVATIO monotherapy (20 mg, 40 mg, and 80 mg three times a day)) A randomized, double-blind, placebo-controlled study of REVATIO (Study 1) was conducted in 277 patients with PAH (defined as a mean pulmonary artery pressure of greater than or equal to 25 mmHg at rest with a pulmonary capillary wedge pressure less than 15 mmHg). Patients were predominantly World Health Organization (WHO) functional classes II–III. Allowed background therapy included a combination of anticoagulants, digoxin, calcium channel blockers, diuretics, and oxygen.

Highest Development Phases

The use of prostacyclin analogues, endothelin receptor antagonists, and arginine supplementation were not permitted. 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 REVATIO 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. They had either primary pulmonary hypertension (PPH) (63%), PAH associated with CTD (30%), or PAH following surgical repair of left-to-right congenital heart lesions (7%).

Rakshita Garg

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 REVATIO. These increases were significantly different from placebo, but the REVATIO 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. What is the most important information I should know about REVATIO?

Disease Explanation

Kaplan-Meier estimates and a stratified log-rank test demonstrated that placebo-treated patients were 3 times more likely to experience a clinical worsening event than REVATIO-treated patients and that REVATIO-treated patients experienced a significant delay in time to clinical worsening versus placebo-treated patients (p = 0.0074). Kaplan-Meier plot of time to clinical worsening is presented in Figure 11. Improvements in WHO functional class for PAH were also demonstrated in subjects on REVATIO compared to placebo. More than twice as many REVATIO-treated patients (36%) as placebo-treated patients (14%) canada sildenafil showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH. Study 3 (REVATIO 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.

Viagra Tablets

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 REVATIO: 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 IV (2%); the mean age was 44 years; and 67% were female. The majority of subjects were Asian (67%), and 28% were Caucasian.

Dosage for ED

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). Study 4 (REVATIO 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). Never take REVATIO with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level. Nitroglycerin in any form including tablets, patches, sprays, and ointments Street drugs called "poppers" (amyl nitrate or nitrite) Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.

About the Company

REVATIO powder for oral suspension is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil). Following reconstitution, the volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe (with 0.5 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided. See FDA-approved patient labeling (Patient Information).