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Erectile Dysfunction Treatment and Causes Better Sex Naturally Indian Herbal Remedies: Viritenz Vs Viagra Magnum XXL BasakojЕі takas. The Effect of Sildenafil and Tadalafil on Skeletal Muscle and Perceptual Fatigue. The safety and scientific validity of this study is viagra online 200mg 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

three

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. Severe depression (>5 on the 15-item Geriatric Depression Scale, GDS). 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

Off-Label Use and Dosage (Adult) Guideline-Supported Use. There is limited

information

Dosing information 50 mg/day [1] Sexual dysfunction. 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

FDA-Labeled Indications and Dosage (Pediatric) FDA Package Insert for Sildenafil contains no information regarding FDA-labeled viagra online 200mg 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 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 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 resting hypotension [BP less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). Monitor

blood

pressure

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

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 underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors.

Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking PDE-5 inhibitors, including sildenafil citrate.

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 citrate with caution in these patients. 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 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 PDE-5 inhibitors have not been studied.

Inform patients taking sildenafil citrate not to take Sildenafil citrate or other PDE5 inhibitors.

Use sildenafil citrate with

caution

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 varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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

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

The following adverse reactions have been identified during post approval use of * Sildenafil (marketed for both PAH and erectile dysfunction).

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or

establish

In postmarketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug. Most, but not all, of these patients had preexisting cardiovascular risk factors.

Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the

use

It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, or to a combination of these or other factors.

Concomitant use of sildenafil citrate with nitrates in any form is contraindicated.

Concomitant use of sildenafil citrate with ritonavir and other potent CYP3A inhibitors is not recommended.

In drug-drug interaction studies, sildenafil (25 mg, 50 mg, or 100 mg) and the alpha-blocker doxazosin (4 mg or 8 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.

In these study populations, mean additional reductions of supine systolic and diastolic blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, respectively, were observed. Mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were also observed.

There were infrequent reports of patients who experienced symptomatic postural hypotension. These reports included dizziness and light-headedness, but not syncope.

When sildenafil 100 mg oral was co-administered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic. Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate. There are no adequate and well-controlled studies of sildenafil in pregnant women. No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m2 basis, 32- and 68-times, respectively, the recommended human dose (RHD) of 20 mg three times a day. In a rat pre- and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the RHD on a mg/m2 basis).

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sildenafil in women who are pregnant. The safety and efficacy of sildenafil citrate during labor and delivery has not been studied.

It is not known if sildenafil or its metabolites are excreted in human breast milk.

Because many drugs are excreted in human milk, caution should be exercised when sildenafil

citrate

In a randomized, double-blind,

multi-center

citrate

The primary objective of the study was to assess the effect of sildenafil citrate on exercise capacity as measured by cardiopulmonary exercise testing in pediatric patients developmentally able to perform the test (n = 115).

Administration of sildenafil citrate did not result in a statistically significant improvement in exercise capacity in those patients. No patients died during the 16-week controlled study. After completing the 16-week controlled study, a patient originally randomized to sildenafil citrate remained on his/her dose of sildenafil citrate or, if originally randomized to placebo, was randomized to low-, medium-, or high-dose sildenafil citrate.

After all patients completed 16 weeks of follow-up in the controlled study, the blind was broken and doses were adjusted as clinically indicated. Patients treated with sildenafil were followed for a median of 4.6 years (range 2 days to 8.6 years).

Mortality during the long-term study, by originally assigned dose, is shown in Figure 6: During the study, there were 42 reported deaths with 37 of these deaths reported prior to a decision to titrate subjects to a lower dosage because of a finding of increased mortality with increasing sildenafil citrate doses.

For the survival analysis which included 37 deaths, the hazard ratio for high dose compared to low dose was 3.9, p=0.007.

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

Clinical studies of sildenafil citrate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

There is no FDA guidance on the use of Sildenafil with respect to specific gender populations. There is no FDA guidance on the use of Sildenafil with respect to specific racial populations. No dose adjustment is required (including severe impairment CLcr Hepatic Impairment.

No dose adjustment for mild to moderate impairment is required. There is no FDA guidance on the use of Sildenafil in women of reproductive potentials and males.

There is no FDA guidance one the use of Sildenafil in patients who are immunocompromised.

FDA Package Insert for Sildenafil contains no information regarding drug monitoring. There is limited information about the IV Compatibility. In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but cheap non prescription viagra rates and severities were increased.

In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine. Sildenafil is an inhibitor of cGMP specific phosphodiesterase type-5 (PDE-5) in the smooth muscle of the pulmonary vasculature, where PDE-5 is responsible for degradation of cGMP. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. In patients with PAH, this can lead to vasodilation of the pulmonary vascular bed and, to a lesser degree, vasodilatation in the systemic circulation.