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The Effect of Sildenafil and Tadalafil on Skeletal Muscle and Perceptual Fatigue. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S.

Study Details Tabular View Study Results Disclaimer How to Read a Study Record.

Condition or disease Intervention/treatment Phase Fatigue Drug: Sildenafil Drug: tadalafil Drug: Placebo Not Applicable. Subjects were assigned to one of 4 arms: Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.

To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

For general information, Learn About Clinical Studies. Layout table for eligibility information Ages Eligible for Study: 50 Years to 60 Years (Adult) Sexes Eligible for Study: All Accepts Healthy

Volunteers

Age 50-60 years of age Ability to sign consent form (score>23 on the 30-item Mini

Mental

months

Pregnancy Significant heart, liver, kidney, blood or respiratory disease.

Diabetes mellitus or other untreated endocrine disease. Recent (within 6 months) treatment with anabolic steroids, or

corticosteroids

Cardiac abnormalities such as cardiac shunt or previously diagnosed pulmonary hypertension.

Systolic blood pressure 150, diastolic blood pressure .

This range is smaller than the acceptable range stated in the prescribing information for sildenafil/tadalafil (90/50 and. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider.

WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery.

The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Sildenafil is a Phosphodiesterase 5 Inhibitor that is FDA approved for the treatment of pulmonary arterial hypertension. Common adverse reactions include erythema,flushing, indigestion, headache, insomnia, visual disturbance, epistaxis, nasal congestion and rhinitis. FDA-Labeled Indications and Dosage (Adult) Pulmonary arterial hypertension (WHO Group I) Indication Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening.

The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Limitation of Use Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. Dosing information Recommended dosage: 20 mg PO tid. Administer sildenafil tablet doses 4 to 6 hours apart. In the clinical trial no greater efficacy was achieved with the use of higher doses.

Treatment with doses higher than 20 mg TID is not recommended.

Off-Label Use and Dosage (Adult) Guideline-Supported Use. There is limited information regarding Off-Label –Guideline-Supported Use of Sildenafil in adult patients.

Dosing information 50 mg/day [1]

Sexual

Dosing information 50 mg/day [2] Drug-induced impotence. Dosing information 25 mg/day or 50 mg/day [3] Drug withdrawal, Nitric oxide.

Dosing information 50 mg/day [4] Female sexual arousal disorder. Dosing information 25-100 mg/day [5] ‘’‘ 10-100 mg/day [6] In vitro fertilization. Dosing information 25 mg vaginal suppository intravaginally 4 times a day [7] Premature Ejaction. Dosing information 50 mg/day [8] , [9] , [10] 50- 100 mg/day [11] Secondary Raynaud's phenomenon.

Dosing information sildenafil 50 mg twice a day to 200 mg once a day [12] Pediatric Indications and Dosage. FDA-Labeled Indications and Dosage (Pediatric) FDA Package Insert for Sildenafil contains no information regarding FDA-labeled indications and dosage information for children.

Off-Label Use and Dosage (Pediatric) Guideline-Supported Use. There is limited information regarding Off-Label Guideline-Supported Use of Sildenafil in pediatric patients. Dosing information Not applicable [13] Contraindications.

Sildenafil tablets are contraindicated in patients with : Concomitant walgreens sell viagra use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension.

Known hypersensitivity to sildenafil or any component of the tablet.

Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. In a long-term trial in pediatric patients with PAH, an increase in mortality with increasing sildenafil citrate dose was observed. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH.

Use of viagra coupon walgreens sildenafil citrate, particularly chronic use, is not recommended in children.

Sildenafil citrate has vasodilatory properties, resulting in mild and transient decreases in blood pressure.

Before prescribing sildenafil citrate, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or

with

Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate.

Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of sildenafil citrate to patients with veno-occlusive disease, administration of sildenafil citrate to such patients is not recommended. Should signs of pulmonary edema occur when sildenafil citrate is administered, consider the possibility of associated PVOD.

The incidence of epistaxis was 13% in patients taking sildenafil citrate with PAH secondary to CTD. This effect was not seen in idiopathic PAH (sildenafil citrate 3%, placebo 2%) patients. The incidence of epistaxis was also higher in sildenafil citrate-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist). The safety of sildenafil citrate is unknown in patients with bleeding disorders or active peptic ulceration.

When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking.

Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 males aged ? 50 per year in the general population.

An observational study evaluated whether recent, episodic use of PDE5 inhibitors (as a class), typical of erectile dysfunction treatment, was associated with acute onset of NAION. The results suggest an approximately 2-fold increase in the risk of NAION within 5 half-lives of PDE5 inhibitor use.

It is not possible to determine whether these events are related directly to the use of PDE-5 inhibitors, to the

patient’s

Physicians should also discuss the increased risk of NAION with patients who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE-5 inhibitors.

There are no controlled clinical data on the safety or efficacy of sildenafil citrate in patients with retinitis pigmentosa, a minority whom have genetic disorders of retinal phosphodiesterases. Prescribe

sildenafil

Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil citrate.

In some of the cases, medical conditions and other factors were reported that may have played a role. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, to the patient’s underlying risk viagra coupon walgreens factors for hearing loss, a combination of these factors, or to other factors.

Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil citrate.

Sildenafil is also marketed as Sildenafil citrate®. The safety and efficacy of combinations of sildenafil citrate with Sildenafil citrate or

other

Use sildenafil citrate with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia).

In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result. Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Anemia.

In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil citrate than by those randomized to placebo. The effectiveness and safety of sildenafil citrate in the treatment of PAH secondary to sickle cell anemia has not been established.

Because clinical trials are conducted under

widely

Safety data of sildenafil citrate in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 sildenafil citrate-treated patients with PAH, WHO Group I Diagnostic Classification.

The overall frequency of discontinuation in sildenafil citrate-treated patients 20 mg TID was 3% and was the same for the placebo group. In Study 1, the adverse reactions that were reported by at least 3% of sildenafil citrate-treated patients (20 mg TID) and were more frequent in sildenafil citrate-treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were generally transient and mild to moderate in nature.

At doses higher than the recommended 20 mg TID, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision.

The incidence of retinal hemorrhage with sildenafil citrate 20 mg TID was 1.4% versus 0% placebo and for all sildenafil citrate doses studied was 1.9% versus 0% placebo. The incidence of eye hemorrhage at both 20 mg TID and at all doses studied was 1.4% for sildenafil citrate versus 1.4% for placebo.