Sildenafil teva 100 mg film coated tablets

The vardenafil results showed an increase in QTc (Fridericia) of 8 msec (90% CI: 6-9) and 10 msec (90% CI: 8-11) at 10 and 80 mg doses compared to placebo and an increase in QTci of 4 msec (90% CI: 3-6) and 6 msec (90% CI: 4-7) at 10 and 80 mg doses compared to placebo, at one hour post-dose. At t max , only the mean change in QTcF for vardenafil 80 mg was out of the study established limit (mean 10 msec, 90% CI: 8-11). When using the individual correction formulae, none of the values were out of the limit. In a separate post-marketing study of 44 healthy volunteers, single doses of 10 mg vardenafil or 50 mg sildenafil were co-administered concomitantly with 400 mg gatifloxacin, a drug with comparable QT effect.

Both vardenafil and sildenafil showed an increase of Fridericia QTc effect of 4 msec (vardenafil) and 5 msec (sildenafil) when compared to either drug alone.

The actual clinical impact of these QT changes is unknown. In clinical trials vardenafil was administered to over 17,000 men with erectile dysfunction (ED) aged 18 - 89 years, many of whom had multiple co-morbid conditions.

Over 2,500 patients have been treated with vardenafil for six months or longer. Of these, 900 patients have been treated for one year or longer. The following patient groups were represented: elderly (22%), patients with hypertension (35%), diabetes mellitus (29%), ischaemic heart disease and other cardiovascular diseases (7%), chronic pulmonary disease (5%), hyperlipidemia (22%), depression (5%), radical prostatectomy (9%). The following groups were not well represented in clinical trials: elderly (>75 years, 2.4%), and patients with certain cardiovascular conditions (see section 4.3).

No clinical trials in CNS diseases (except spinal cord injury), patients with severe renal or hepatic impairment, pelvic surgery (except nerve-sparing prostatectomy) or trauma or radiotherapy and hypoactive sexual desire or penile anatomic deformities have been performed.

Across the pivotal trials, treatment with vardenafil ( tablets) resulted in an improvement of erectile function compared to placebo. In the small number of patients who attempted intercourse up to four to five hours after dosing the success rate for penetration and maintenance of erection was consistently greater than placebo.

In fixed dose studies ( tablets) in a broad population of men with erectile dysfunction, 68% price of sildenafil 50 mg (5 mg), 76% (10 mg) and 80% (20 mg) of patients experienced successful penetrations (SEP 2) compared to 49% on placebo over a three month study period. The ability to maintain the erection (SEP 3) in this broad ED population was given as 53% (5 mg), 63% (10 mg) and 65% (20 mg) compared to 29% on placebo.

In pooled data from the major efficacy trials, the proportion of patients experiencing successful penetration on vardenafil were as follows: psychogenic erectile dysfunction (77-87%), mixed erectile dysfunction (69-83%), organic erectile dysfunction (64-75%), elderly (52-75%), ischaemic heart disease (70-73%), hyperlipidemia (62-73%), chronic pulmonary disease (74-78%), depression (59-69%), and patients concomitantly treated with antihypertensives (62-73%). In a clinical trial in patients with diabetes mellitus, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg.

The response rates for the ability to obtain and maintain an erection was 61% and 49% on 10 mg and 64% and 54% on 20 mg vardenafil compared to 36% and 23% on placebo for patients who completed three months treatment.

In a clinical trial in post-prostatectomy patients, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg.

The response rates for the ability to obtain and maintain an erection was 47% and 37% on 10 mg and 48% and 34% on 20 mg vardenafil compared to 22% and 10% on placebo for patients who completed three months treatment.

In a flexible-dose clinical trial in patients with Spinal Cord Injury, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo.

The number of patients who returned to a normal IIEF domain score ( >26) were 53% on vardenafil compared to 9% on placebo.

The response rates for the ability to obtain and maintain an erection were 76% and 59% on vardenafil compared to 41% and 22% on placebo for patients who completed three months treatment which were clinically and statistically significant (p th Floor, 40 Bank Street, Canary Wharf. 1 hour before sexual activity; may be increased to 20 mg sildenafil citrate at walgreens or reduced to 5 mg, depending on effectiveness and tolerance; not to exceed 1 dose/day. Orally disintegrating tablet (ODT): 10 mg PO placed on tongue.

1 hour before sexual activity; not to exceed 1 dose/day. 10-mg ODT not interchangeable with 10-mg film-coated tablet; ODT provides higher systemic exposure at same dose; if higher or lower doses are required, film-coated tablet should be prescribed. Ketoconazole 200 mg/day or itraconazole 200 mg/day: Vardenafil dosage not to exceed 5 mg/day Ketoconazole 400 mg/day or itraconazole 400 mg/day: Vardenafil dosage not to exceed 2.5 mg/day Indinavir, saquinavir, atazanavir, or clarithromycin: Vardenafil dosage not to exceed 2.5 mg/day Ritonavir (600 mg q12hr): Vardenafil dosage not to exceed 2.5 mg/72 hr. Erythromycin 500 mg q8hr: Vardenafil dosage not to exceed 5 mg/day. Stabilized on alpha-blocker therapy (eg, alfuzosin, terazosin, tamsulosin): 5 mg/day PO initially Stabilized on alpha-blocker therapy and taking moderate-to-strong CYP3A4 inhibitor: 2.5 mg/day PO initially.

Mild, moderate, severe impairment: Dosage adjustment not necessary Hemodialysis: Not recommended. Child-Pugh class A: Dosage adjustment not necessary Child-Pugh class B: Film-coated tablet, 5 mg PO.

1 hour before sexual activity; not to exceed 10 mg once daily; ODT not recommended Child-Pugh class C: Not recommended. Pulmonary Arterial Hypertension (Orphan) Orphan designation for treatment of pulmonary arterial hypertension. Respira Therapeutics, Inc; 5901 Indian School Road NE, suite 107; Albuquerque, New Mexico 87110.

AUC and Cmax increased by 39% and 21%, respectively, in elderly men (compared with men Enter a drug name and

vardenafil

Adding plans allows you to compare formulary status to other drugs in the same class. To view formulary information first create a list of plans.

Your list will be saved and can be edited at any time.

Adding plans allows you to: View the formulary and any restrictions for each plan. Manage and sildenafil citrate 100mg cvs price view all your plans together – even plans in different states.

Compare formulary status to other drugs in the same class. Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only.

Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. Vardenafil, a New Phosphodiesterase Type 5 Inhibitor, in the Treatment of Erectile Dysfunction in Men With Diabetes.

A multicenter double-blind placebo-controlled fixed-dose study. Young , MD 2, Jerome Fischer , MD 3, Keith Bangerter , PHD 4, Thomas Segerson , MD 4, Terry Taylor , MD 4 and The Vardenafil Diabetes Study Group 1 Boston University Medical Center, Boston, Massachusetts 2 South Coast Urological Medical Center, Laguna Hills, California 3 Diabetes and Glandular Disorders Clinic, San Antonio, Texas 4 Bayer Corporation, West Haven, Connecticut.

A multicenter double-blind placebo-controlled fixed-dose study. OBJECTIVE —This study evaluated the efficacy and safety of vardenafil treatment for erectile dysfunction (ED) in men with diabetes. RESEARCH DESIGN AND METHODS —In this prospective multicenter double-blind placebo-controlled fixed-dose parallel-group phase III trial, 452 patients with diabetes (type 1 or type 2) and ED were randomized to take 10 or 20 mg vardenafil or placebo as needed for 12 weeks.

Efficacy responses were assessed by International Index of Erectile Function domain scores, rates of vaginal penetration and successful intercourse, and a global assessment question (GAQ) about erection improvement during the previous 4 weeks.

RESULTS —After 12 weeks of treatment, a dose-dependent ( P = 0.02) improvement in erections was noted for the GAQ, with 57 and 72% of men taking 10 mg or 20 mg vardenafil, respectively, reporting improved erections, in contrast to 13% after taking placebo ( P 50% of diabetic men develop ED within 10 years of being diagnosed with diabetes (5). The prevalence of ED increases with age, from 9% in diabetic men ages 20–29 years to 95% in diabetic men >70 years (5), and increases with duration, poor control, and complications of diabetes (such as vascular and microvascular disease and neuropathies) (6). Diabetic men with ED tend to be less responsive to treatment perhaps because the pathogenesis of diabetes-associated ED is likely to be multifactorial (7,8).

Although treatment with phosphodiesterase type 5 (PDE5) inhibitors is less effective in the diabetic patient than in the nondiabetic ED patient, the convenience of an orally formulated PDE5 inhibitor has popularized treatment in a large number of men with diabetes and ED (9,10). Vardenafil, a new PDE5 inhibitor, is more selective for PDE5 and more biochemically potent than sildenafil in in vitro and in vivo studies when tested under the same conditions (11–13).

These properties suggest that vardenafil may be a highly efficacious oral treatment in the difficult-to-treat ED patients with diabetes.

The objective of this study was to assess the efficacy, tolerability, sildenafil teva 100 mg film coated tablets and safety of vardenafil in the treatment of ED in men with diabetes.

The study was a randomized double-blind fixed-dose parallel-group trial conducted at 47 centers in the U.S.

Baseline characteristics were assessed after a 4-week unmedicated phase during which time patients had to have attempted intercourse on at least 4 separate days and had to have been unsuccessful in at least half of these attempts. Lack of success was defined as failure to penetrate their partner or to maintain an erection to successful intercourse. Patients were then randomized to 10 or 20 mg vardenafil or placebo treatment arms for 12 weeks. Patients were instructed to take the study drug as needed, but no more than once a day and ?1 h before intercourse. No specific instructions were given with regard to food or alcohol use. Efficacy and safety data were collected at 4-week intervals.

After the active treatment phase, patients had the option of participating in a 12-week extension phase in which all patients received either 10 or 20 mg vardenafil. Safety sildenafil teva 100 mg film coated tablets and efficacy from the extension phase will be reported elsewhere.

Vardenafil hydrochloride (vardenafil) was supplied by Bayer AG.

Men over age 18 years who were in a stable heterosexual relationship, who had a clinical diagnosis of type 1 or type 2 diabetes, and who had experienced ED for longer than 6 months were included. Patients were excluded if their ED was the

result

According to the protocol, previous exposure to sildenafil was allowable. However, if patients had discontinued sildenafil because of significant side effects or because of dissatisfaction with its efficacy, they were excluded. Anti-androgens, anti-coagulant androgens, and trazodone hydrochloride were not allowed. The primary measures of efficacy were the erectile function (EF) domain of the validated International Index of Erectile Function (IIEF) questionnaire (14) and two diary questions concerning sexual encounter: “Were you able to insert your penis in your partner’s vagina?” and “Did your erection last long enough for you to have successful intercourse?” The secondary efficacy variable reported here is the global assessment question (GAQ), “Has the treatment you have been taking over the past 4 weeks improved your erections?” Safety. The safety population included all patients buy generic viagra tablets who took at least one dose of study medication and who had any postrandomization sildenafil teva

100

Patients who did not enter the extension study were followed for 7 days after the last dose to record any serious adverse events and for 30 days after the last dose to record any deaths. The intent-to-treat population, defined as individuals who took at least one dose of study medication and who had baseline and any post-baseline efficacy data, was used to calculate all the efficacy variables.

For EF domain scores, the last observation carried forward (LOCF) approach was used to account for missing values.

For both diary questions, the mean success rate of each individual patient over the entire treatment period was averaged across all patients and is reported as the mean success rate for each man.

For the GAQ, values were obtained from patients who completed 12 weeks of treatment; an LOCF value was also calculated. The primary efficacy variables were analyzed with ANCOVA, with baseline response as a covariate and with terms for center and treatment. The GAQ was analyzed using logistic regression with terms for center and treatment.

Download figure Open in new tab Download powerpoint.

Download figure Open in new tab Download powerpoint. Download figure Open in new tab Download powerpoint.

Relationship between response to treatment and baseline plasma HbA 1c levels.

There was no correlation between individual success rate of erections with a duration sufficient to complete intercourse from diary question sexual encounter profile 3 (SEP3) and baseline plasma levels of HbA 1c . Demographic and baseline characteristics (safety population) Incidence of treatment-emergent adverse events occurring in ?5% of any treatment group. Helene Dassule, John Firrell, Andre Guay, and Ken Snow for their contributions to the manuscript.

Results were presented at the American Diabetes Association 61st Scientific Sessions, 22–26 June

2001

Address correspondence and reprint requests to Irwin Goldstein, MD, Boston University Medical Center, Department of Urology, 720 Harrison Ave., Suite P-606, Boston, MA 02118. Received for publication 11 June 2002 and accepted in revised form 13 November 2002. has received honoraria for serving on the Western Section Advisory Panel. serves on advisory panels for Bayer, Abbott, Wyeth-Ayerst, Pharmacia, MacroChem, NexMed, Urometrics, Pfizer, and Lilly; has received honoraria for speaking engagements from Bayer, Pfizer, and Mentor; is a paid consultant for Bayer, MacroChem, Urometrics, Mentor, and Wyeth-Ayerst; and has received funds for clinical studies from Bayer, Pfizer, NexMed, and Vivus.

is a study site investigator and a speaker for Bayer, and is an investigator for Pfizer and Lilly-Icos.

A table elsewhere in this issue shows conventional and Systeme International (SI) units and conversion factors for many substances. Vardenafil Hydrochloride (Levitra®) Classification: Phosphodiesterase Inhibitor. About: Vardenafil Hydrochloride (Levitra®) Vardenafil 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.

Vardenafil is taken by mouth up to once a day, at least 60 minutes before sexual activity, and works for up to 4 hours. 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 vardenafil 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.

Do 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 vardenafil.

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

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 directed by your healthcare provider or pharmacist).

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. Vardenafil is available through most retail pharmacies. 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 vardenafil.

Talk to your care team if you have concerns about these side effects. Do not take a higher dose of vardenafil than your provider orders for you. Headache, facial flushing, stuffy or runny nose, and upset stomach can occur.

Less frequent side effects include blurry vision, a bluish hue to the field of vision, difficulty telling the difference between the colors blue and green, a sensitivity to light, or a sudden loss of vision or hearing.

If you experience any of the following while using vardenafil, seek immediate medical attention: An erection lasting more than 4 hours.

Chest, arm or neck pain, or nausea during sexual activity. Remember, vardenafil does not protect against sexually transmitted diseases, nor does it prevent pregnancy. Effective birth control is recommended during cancer treatment. Even if you are not producing sperm, you could still be fertile and conceive.

Vardenafil (Levitra) is an oral therapy for the treatment of erectile dysfunction.

It is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Penile

erection

Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum.

The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection. The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs).

The most abundant PDE in the human corpus cavernosum is the cGMPspecific phosphodiesterase type 5 (PDE5); therefore, the inhibition of PDE5 enhances erectile function by increasing the amount of cGMP.

BAY 389456 BAY-389456 BAY38-9456 DE 19750085 1997 WO 99/24433 1999. Associated Conditions Erectile Dysfunction Contraindications & Blackbox Warnings.

Learn about our commercial Contraindications & Blackbox Warnings data.

Vardenafil is used to treat male erectile dysfunction (impotence) and pulmonary arterial hypertension (PAH). Part of the physiological process of erection involves the release of nitric oxide (NO) in the corpus cavernosum.

This then activates the enzyme guanylate cyclase which results in increased levels of cyclic guanosine monophosphate (cGMP), leading to smooth muscle relaxation in the corpus cavernosum, resulting in increased inflow of blood and an erection.

Vardenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) which is responsible for degradation of cGMP in the corpus cavernosum. This means that, with vardenafil on board, normal sexual stimulation leads to increased levels of cGMP in the corpus cavernosum which leads to better erections.