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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 citrate 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) TID 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%). The study population consisted of 25%

men

years

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 to 50 meters were observed with all doses of sildenafil citrate.

These increases were significantly different from placebo, but the sildenafil citrate dose groups were not different from each other (see Figure 9), indicating no additional clinical benefit from doses higher than 20 mg TID.

The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at week 8 and week 12. 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.

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.

Additionally, walk distance and functional class status appeared to be stable in patients taking sildenafil citrate. Without a control group, these sildenafil without rx 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 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 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 (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). 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 price of sildenafil at costco clinical

worsening

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 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 3 (Sildenafil Citrate 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 generic viagra online reviews 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 citrate: 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%

67%

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 to 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 (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 three months.

The PAH patients included those buy sildenafil citrate 100mg online 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 to 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. Sildenafil tablets, 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: Bottles of 90: NDC 68001-176-05.

Recommended Storage for Sildenafil Tablets: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Drug Name : Sildenafil 20 MG (as sildenafil citrate) Oral Tablet Ingredient(s) :

croscarmellose

Read this Patient Information before you start taking sildenafil citrate 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 citrate, ask your doctor or pharmacist.

What is the most important information I should know about sildenafil citrate? Never take sildenafil citrate with any nitrate 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) Ask your doctor or pharmacist if you are not sure if you are taking a nitrate medicine.

Sildenafil citrate is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH).

With PAH, the blood pressure in your lungs is too high.

Your heart has to work hard to pump blood into your lungs.

Sildenafil citrate improves the ability to exercise and can slow down worsening changes in your physical condition. Sildenafil citrate is

not

Do not take sildenafil citrate if you: Take nitrate medicines. See “What is the most important information I should know about sildenafil citrate?” 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 citrate? 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

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 nonprescription medicines, vitamins, and herbal products. Sildenafil citrate 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 citrate.

Especially tell your doctor if you take Nitrate medicines. See “What is the most important information I should know about sildenafil citrate?” Ritonavir (Norvir®) or other medicines used to treat HIV infection Ketoconazole (Nizoral®) Itraconazole (Sporanox) High blood pressure medicine Know the medicines you take.

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

Take sildenafil citrate exactly as your doctor tells you.

Sildenafil citrate may be prescribed to you as Sildenafil tablets Take sildenafil tablets 3 times a day about 4 to 6 hours apart.

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

soon

Do not take more than one dose of sildenafil citrate at a time. Do not change your dose or stop taking sildenafil citrate on your own. If you take too much sildenafil citrate, call your doctor or go to the nearest hospital emergency room. What are the possible side effects of sildenafil citrate?

Low blood pressure may cause you to feel faint or dizzy.

Tell your doctor if you get more short of breath after you start sildenafil citrate. More shortness of breath than usual may be due to your underlying medical condition. Decreased eyesight or loss of sight in one or both eyes (NAION). If you notice a sudden decrease or loss of eyesight, talk to your doctor right away.

If you notice a sudden decrease or loss of hearing, talk to your doctor right away.

It is not possible to determine whether these events are related directly to this class of oral medicines, including sildenafil citrate, or to other diseases or medicines, to other factors, or to a combination of factors.

Heart attack, stroke, irregular

heartbeats

Tell your doctor right away if you have an erection that lasts more than 4 hours. The most common side effects with sildenafil citrate include: Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased, respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children. Tell your doctor if you have any side effect that bothers you or doesn’t go away. These are not all the possible side effects of sildenafil citrate. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Store sildenafil tablets at controlled room temperature, between 68°F to 77°F (20°C to 25°C).

Keep sildenafil citrate and all medicines away from children. Medicines are sometimes prescribed for purposes that are not in the patient leaflet. Do not use sildenafil citrate for a condition for which it was not prescribed.

Do not give sildenafil citrate to other people, even if they have the same symptoms you have.

This patient leaflet summarizes the most important information about sildenafil citrate.

If you would like more information about sildenafil citrate, talk with your doctor.

You can ask your doctor or pharmacist for information about sildenafil citrate that is written for health professionals.

For more information go to www.amneal.com or call 1-877-835-5472.

Inactive ingredients : croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

For current full prescribing information, please visit www.amneal.com This Patient Information has been approved by the U.S. Food and Drug Administration Manufactured by: Amneal Pharmaceuticals Co.

Ahmedabad, INDIA 382220 For BluePoint Laboratories Rev.

Levitra Vs Viagra: Finding The Best ED Treatment For You. Andy is a co-founder, the superintendent pharmacist and director at The Independent Pharmacy.

Each medication helps treat erectile dysfunction (ED) issues by increasing the blood flow to the penis and are proven to help men achieve harder, longer-lasting erections for sexual activity.

The main difference between Levitra and Viagra is the active ingredient that the two medications contain. Viagra’s active ingredient is Sildenafil, and Levitra’s is Vardenafil. Here’s what you need to know about the difference between

Sildenafil

Sildenafil (Viagra) helps men: Achieve an erection within 30-60 minutes Provides an erection for up to 4 hours. As you can see, there is very little to choose between Levitra and Viagra in terms of effectiveness.

Levitra, on average, works a little buy sildenafil citrate 100mg online quicker and provides an erection that lasts a little longer.

It’s also important to note that both only work when you are sexually aroused, meaning you need to engage in foreplay to experience the best results.

To learn more about Vardenafil, read our dedicated guide for a comprehensive overview page: What is Levitra?. One of the main differences between Levitra and Viagra is the effectiveness of the two medications when ingested with food. Food delays the absorption of all medication in the system.

If you eat a large or fatty meal before taking Viagra, the effects are likely to be significantly reduced.

Levitra, on the other hand, is typically less affected by food. The one main exception is grapefruit, which has been proven to significantly reduce the effect of the medication. An alternative to both Levitra and Viagra is Cialis, which does not contain either Vardenafil or Sildenafil. Instead, it contains a different active ingredient called Tadalafil. By increasing blood flow to the penis, it works in a similar way to both Levitra and Viagra.

However, Cialis helps men: Achieve an erection within 30 minutes Maintain an erection for up to 36 hours. The main difference is that Cialis stays in your buy sildenafil citrate 100mg online system for much longer than both Levitra and Viagra, therefore helping men to achieve an erection for longer. Levitra dosages and Cialis dosages available are very similar: 5mg, 5mg, 10mg, and 20mg. Viagra, by comparison, is available in larger three doses: 25mg, 50mg, and 100mg.

To see what actual users thought about Cialis as a treatment for ED read our Cialis reviews. As the name suggests, Cialis Daily is designed to be taken

every

The medication is for men who like to have spontaneous sex more than three times a week. When taking Cialis Daily, you don’t need to take a pill 30 minutes or an hour before sex. Instead, you keep your body topped up with the medication on a permanent basis, meaning you should be able to achieve an erection whenever you want to engage in sexual activity and without the need to

plan

About: Sildenafil (Viagra®) Sildenafil is a medication that is taken before sexual activity and allows men with erectile dysfunction (ED) to achieve and maintain an erection. ED or impotence is a condition in which a man is unable to achieve or maintain an erection long enough for sexual intercourse. This can be a result of medical conditions such as high blood pressure, diabetes, prostate problems, and heart disease, or a side effect of the medications typically taken for these conditions.

Personal lifestyle factors such as stress, alcohol and/or tobacco use can also play a contributing role. During surgery or radiation to the pelvic area (including prostate, bladder, and rectal procedures), damage can occur to the nerves that supply the penis. This can result in either temporary or permanent impotence.

Some surgeons perform "nerve-sparing" surgeries in an attempt to preserve erectile function.

Even in these cases, however, the nerves will suffer some injury, and it can take 18-24 months or longer for erectile function to return. These men should be treated aggressively with oral or injectable medications for ED in order to speed recovery of the nerves and to prevent muscle wasting in the penis.

It should be taken around 60 minutes before sex, but can be taken as much as four hours or as few as 30 minutes before sex. Your doctor will determine the dose that is best for you. Some men require dose adjustments to find the dose that works best for them.

Men who take sildenafil will not have an erection without sexual stimulation.

This drug is not an aphrodisiac and does not affect libido or desire. Having multiple intercourse sessions with one dose has not been studied.

You should not adjust your dose without talking to your provider first. Men who take nitrates, such as nitroglycerin, Nitro-Bid, Isordil, or Deponit should not take sildenafil.

Men who take Cardura, Flomax, or Hytrin for urinary symptoms should not take sildenafil.

This medication can affect how other medications work.

Be sure your provider and pharmacist know all the medication (prescription and over-the-counter) and supplements you take.

Store your medication in the original, labeled container at room temperature and in a dry location (unless

otherwise

This medication should not be stored in a pillbox since it should only be taken prior to sexual activity. Ask your care team where to return any unused medication for disposal.

Do not flush down the toilet or throw in the trash. This medication may be covered under your prescription drug plan.

Patient assistance may be available to qualifying individuals without prescription drug coverage through the pharmaceutical company that makes the medication.

Your care team can help you find these resources, if they are available. There are a few side effects experienced with sildenafil.

Talk to your doctor, nurse or pharmacist if you have concerns about these side effects.