RECENT MAJOR CHANGES

For PAH: Sildenafil works by relaxing the muscles and opening up the blood vessels in your lungs.

• Sildenafil is sometimes used off-label for other health issues.
• Its interaction with blood thinners should be monitored.
• Men with retinitis pigmentosa should avoid sildenafil.
• Always inform healthcare providers about all treatments.
• Use sildenafil in conjunction with a healthy lifestyle.
• Avoid unnecessary medication to prevent side effects.
• Be aware of potential drug interactions with sildenafil.
• Proper storage maintains medication efficacy over time.

This decreases the blood pressure in your lungs.

• Always use the lowest effective dose of sildenafil.
• Follow your doctor’s instructions carefully.
• Do not alter the dosage without consulting your doctor.
• Keep track of your health conditions and medications.
• Use sildenafil responsibly to prevent dependency.
• Seek prompt medical attention for prolonged erections.
• Consider lifestyle changes to improve ED symptoms.
• Education about sildenafil can improve treatment outcomes.

Sildenafil slows down the progression of your illness.

• Sildenafil tablets 125 mg are manufactured by various brands.
• Always verify the authenticity of medication sources.
• Use only FDA-approved or certified pharmacies.
• Cost can vary based on brand and location.
• Generic versions are typically more affordable.
• Beware of counterfeit sildenafil products.
• Read customer reviews before purchasing online.
• Consult your doctor about the best brand for you.

It also makes you more able to exercise. Sildenafil can be used as early as 4 hours before sex and as late as 30 minutes before sex.

503A vs 503B

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

How should I store sildenafil?

These events may be accompanied by tinnitus and dizziness. All trademarks listed are the property of their respective owner. Sildenafil oral tablet is available as a brand-name drug and as a generic drug. Sildenafil comes in three forms: an oral tablet, an oral suspension (liquid), and an injection that’s only given by a doctor. Sildenafil sildenafil oral jelly 100mg oral tablet is used to treat erectile dysfunction (ED).

Allergy warning

It’s also used to treat pulmonary arterial hypertension (PAH). It comes in the form of a tablet and suspension (liquid). It also comes in an intravenous (IV) form, which is only given by a doctor. Sildenafil oral tablet is available as the brand-name drugs Viagra and Revatio. It’s also available as a generic drug. However, it is recommended to use this drug within an hour before sex.

Sildenafil should not be taken for ED more than once in a 24-hour period.

Overdose/Missed Dose

These drugs are often used to treat similar conditions. Sildenafil works in different ways, depending on the condition it’s being used to treat. For ED: Sildenafil works by increasing blood flow to the penis. This helps you get or maintain an erection. Sildenafil only works for ED if you’re sexually aroused. But if you have certain medical conditions or are taking other drugs, your doctor may recommend that you take this drug less often than once a day.

4.1 Nitrates

Patients were randomized to receive placebo (n = 70) or sildenafil citrate 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.

8.1 Pregnancy

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.

Study 2: Sildenafil citrate with Doxazosin

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 citrate 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 citrate (95% CI: -5.7, -2.1) (p = 0.00003). It is important to note that certain foods, particularly foods high in fat, can cause the drug to work more slowly than normal.

8.4 Pediatric Use

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. Table 4: Clinical Worsening Events in PACES-1 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 citrate 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.

Is 20 mg of sildenafil effective for ED?

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. HOW SUPPLIED Sildenafil Tablets USP, 20 mg are supplied as white to off-white, round shaped film-coated tablets with debossing ‘AN 351’ on one side and plain on the other side, containing sildenafil citrate, USP equivalent to the nominally indicated amount of sildenafil.They are available as follows:NDC: 70518-4596-00NDC: 70518-4596-01OUTER PACKAGING: 250 in 1 BOXINNER PACKAGING: 1 in 1 POUCHRecommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Repackaged and Distributed By:Remedy Repack, Inc.625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Sildenafil Tablets USP, 20 mg are supplied as white to off-white, round shaped film-coated tablets with debossing ‘AN 351’ on one side and plain on the other side, containing sildenafil citrate, USP equivalent to the nominally indicated amount of sildenafil. Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. 625 Kolter Dr.

Factors That Influence the Right Dosage for You

Suite #4 Indiana, PA 1-724-465-8762 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).Inform patients of contraindication of sildenafil citrate 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 citrate 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 citrate. 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 citrate. These events may be accompanied by tinnitus and dizziness.All trademarks listed are the property of their respective owner.Repackaged By / Distributed By: RemedyRepack Inc.625 Kolter Drive, Indiana, PA 15701(724) 465-8762 Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of contraindication of sildenafil citrate with regular and/or intermittent use of organic nitrates. Sildenafil oral tablet doesn’t cause drowsiness, but it can cause other side effects, including: flushing (reddening and warming of the face) an erection that lasts longer than normal If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

7.2 Alpha-blockers

Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug. Generic oral tablets are available for both conditions, but the brand-name drugs each treat only one of the conditions. Viagra: This drug is used to treat ED. With ED, you’re unable to get or maintain an erection.

Long-term use

Revatio: This drug is used to treat PAH. With PAH, the blood pressure in your lungs is too high. Your heart has to work very hard to pump blood into your lungs. Sildenafil belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors. A class of drugs is a group of medications that work in a similar way. Call your doctor right away if you have serious side effects.

• 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.

Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.