10 OVERDOSAGE

See “What is the most important information

5.5 Hearing Loss

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. NDC 50268-717-15 (10 tablets per card, 5 cards per carton) 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]. 17 PATIENT COUNSELING INFORMATION See 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.

What should I do if I miss a dose of sildenafil?

These events may be accompanied by tinnitus and dizziness.All trademarks listed are the property of their respective owner.Manufactured by:AvKAREPulaski, TN 38478Mfg. See 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. I should know about sildenafil tablets?”Riociguat (Adempas).

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What Other Drugs Interact with Sildenafil?

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 sildenafil pricing 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.

What should I know about sildenafil before taking it?

PATIENT INFORMATION Sildenafil (sil-DEN-a-fil) Tablets, USPRead 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. 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 sildenafil 50 mg tab 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 ointmentsIsosorbide mononitrate or dinitrateStreet 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). should know about sildenafil tablets?”Ritonavir (Norvir ®) or

• Sildenafil 20 mg tablets are used primarily to treat erectile dysfunction.
• They work by increasing blood flow to the penis.
• Typically, the medication is taken 30-60 minutes before activity.
• The effects of sildenafil can last up to 4-6 hours.
• Do not take more than one tablet per day.

other medicines used to treat HIV infectionKetoconazole (Nizoral

Further information

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 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. 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.

Who should not take sildenafil?

Without a control group, these data must be interpreted cautiously. Study 2 (Sildenafil Citrate 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 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 sildenafil 12 5 mg (primary endpoint) for the sildenafil citrate group compared with the placebo group. ®)Itraconazole (Sporanox)High blood pressure medicineKnow the medicines you take.

• Sildenafil 20 mg can interact with nitrates used for chest pain.
• Store tablets at room temperature, away from moisture.
• Do not crush or split the tablets; swallow whole.
• It is not recommended for use by women or children.
• Known for its rapid onset, usually within 30 minutes.

Keep a list of your medicines and show it to your doctor and pharmacist when you get a

6.1 Clinical Trials Experience

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). 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 11.

Raynaud's phenomenon

Improvements in WHO functional class for PAH were also demonstrated in subjects 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 Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. 16 HOW SUPPLIED/STORAGE AND HANDLING 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 50268-717-15 (10 tablets per card, 5 cards per carton)Dispensed in Unit Dose package. For Institutional Use Only.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]. new medicine.How should I take sildenafil tablets?Take sildenafil tablets

Overdose/Missed Dose

With PAH, the blood pressure in your lungs is too high. Your heart has to work hard to pump blood into your lungs.Sildenafil tablets improves the ability to exercise and can slow down worsening changes in your physical condition.Sildenafil tablets are not for use in childrenAdding sildenafil tablets to another medication used to treat PAH, does not result in improvement in your ability to exercise.Sildenafil tablets contain the same medicine as VIAGRA ® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take sildenafil tablets 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.

Pregnancy Categories

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 youhave heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attackhave a disease called pulmonary veno-occlusive disease (PVOD)have high or low blood pressure or blood circulation problemshave an eye problem called retinitis pigmentosahave or had loss of sight in one or both eyeshave any problem with the shape of your penis or Peyronie’s diseasehave any blood cell problems such as sickle cell anemiahave a stomach ulcer or any bleeding problemsare pregnant or planning to become pregnant. It is not known if sildenafil tablets could harm your unborn baby.are breastfeeding. It is not known if sildenafil citrate passes into your breast milk or if it could harm your baby.Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. Sildenafil tablets and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take sildenafil tablets.Especially tell your doctor if you takeNitrate medicines. exactly as your doctor tells you.Sildenafil citrate may be prescribed to you asSildenafil tabletsTake sildenafil tablets 3 times

a day about 4 to 6 hours apart.Take sildenafil

• Sildenafil 20 mg tablets are manufactured by several pharmaceutical companies.
• Generic versions are usually less expensive than brand-name options.
• The drug works by inhibiting phosphodiesterase type 5 enzyme.
• Patients should report any unusual symptoms promptly.
• It is important to have a proper diagnosis before starting treatment.

tablets at the same times every day.If you miss a dose, take it as soon as you remember.