Table Of Contents
- Levitra Price Comparison Table
- Levitra Information
- Levitra Ingredients and Composition
- How Does Levitra Work?
- How To Take Levitra and Levitra Dosage and Administration
- If you suspect a Levitra Overdose
- Levitra Side Effects
- Levitra Precautions and Contraindications
- Levitra Drug Interactions
- Levitra Experiences and Results
- Levitra Clinical Trials and Studies
- Levitra and Women
- Storing Levitra
- Additional Notes
- Articles and information related to Levitra
- Articles and information related to Levitra
- Credits for Levitra Information
Brand names: Levitra
Levitra Price Comparison Table
| Product | Qty | Medical Fees & Shipping | Price/ Qty | Price | Click to Order |
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| Product | Qty | Medical Fees & Shipping | Price/ Qty | Price | Click to Order |
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| Product | Qty | Medical Fees & Shipping | Price/ Qty | Price | Click to Order |
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Levitra Information
Levitra is a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED(Erectile Dysfunction)) in men.
Levitra is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP(cyclic Guanosine Monophosphate))-specific phosphodiesterase type 5 (PDE5(Phosphodiesterase type 5)).
Levitra Ingredients and Composition
Vardenafil HCl, the active ingredient in Levitra, is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5- methyl-4-oxo-7-propylimidazo [5,1-f] [1,2,4] triazin-2-yl)-4- ethoxyphenyl]sulfonyl]-4-ethyl-monohydrochloride.
Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Levitra is formulated as orange, round, film-coated tablets with "BAYER" cross debossed on one side and "2.5", "5", "10", and "20" on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively.
In addition to the active ingredient, vardenafil HCl, each tablet contains:
- microcrystalline cellulose
- crospovidone
- colloidal silicon dioxide
- magnesium stearate
- hypromellose
- polyethylene glycol
- titanium dioxide-
- yellow ferric oxide
- and red ferric oxide
How Does Levitra Work?
Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP(cyclic Guanosine Monophosphate)) in the smooth muscle cells of the corpus cavernosum. The cGMP(cyclic Guanosine Monophosphate) in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection. The tissue concentration of cGMP(cyclic Guanosine Monophosphate) is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDE(Phosphodiesterase)s). The most abundant PDE(Phosphodiesterase) in the human corpus cavernosum is the cGMP(cyclic Guanosine Monophosphate)-specific phosphodiesterase type 5 (PDE5(Phosphodiesterase type 5)); therefore, the inhibition of PDE5(Phosphodiesterase type 5) enhances erectile function by increasing the amount of cGMP(cyclic Guanosine Monophosphate). Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5(Phosphodiesterase type 5) has no effect in the absence of sexual stimulation.
In Summary
When a man is sexually stimulated, his body's normal physical response is to increase blood flow to his penis. This results in an erection. Levira helps increase blood flow to the penis and may help men with erective dysfunction get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.
How To Take Levitra and Levitra Dosage and Administration
For most patients, the recommended starting dose of Levitra is 10 mg, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Levitra can be taken with or without food. Sexual stimulation is required for response to treatment.
Concomitant Medications (taking other medications with Levitra): The dosage of Levitra may require adjustment in patients receiving certain CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, and erythromycin). For ritonavir, a single dose of 2.5 mg Levitra should not be exceeded in a 72-hour period. For indinavir, ketoconazole 400 mg daily, and itraconazole 400 mg daily, a single dose of 2.5 mg Levitrashould not be exceeded in a 24-hour period. For ketoconazole 200 mg daily, itraconazole 200 mg daily, and erythromycin, a single dose of 5 mg Levitra should not be exceeded in a 24-hour period.
If you suspect a Levitra Overdose
The maximum dose of Levitra for which human data are available is a single 120 mg dose administered to eight healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or abnormal vision.
In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance because vardenafil is highly bound to plasma proteins and is not significantly eliminated in the urine.
Levitra Side Effects
Approximately 1 in 10 men taking Levitra experience some sort of mild or moderate side effects. These side effects are usually very mild and do not last long. The presence of side effects may increase when the dosage taken is too much for your body, or if you consume excess alcohol with Levitra in your system.
Levitra side effects include:
Body as a whole:
- anaphylactic reaction (including laryngeal edema)
- asthenia
- face edema, pain
Auditory:
- tinnitus
Cardiovascular:
- angina pectoris
- chest pain
- hypertension
- hypotension
- myocardial ischemia
- myocardial infarction (heart attack)
- palpitation
- postural hypotension
- syncope
- tachycardia
Digestive:
- abdominal pain
- abnormal liver function tests
- diarrhea
- dry mouth
- dysphagia
- esophagitis
- gastritis
- gastroesophageal reflux
- GGTP increased
- vomiting
Musculoskeletal:
- arthralgia
- back pain
- myalgia
- neck pain
Nervous:
- hypertonia
- hypesthesia
- insomnia
- paresthesia
- somnolence
- vertigo
Respiratory:
- dyspnea
- epistaxis
- pharyngitis
Skin and Appendages:
- photosensitivity reaction
- pruritus
- rash
- sweating
Ophthalmologic:
- abnormal vision
- blurred vision
- chromatopsia
- changes in color vision
- conjunctivitis (increased redness of the eye)
- dim vision
- eye pain
- glaucoma
- photophobia
- watery eyes
Urogenital:
- abnormal ejaculation
- priapism (including prolonged or painful erections)
Levitra Precautions and Contraindications
Levitra is only for men with ED(Erectile Dysfunction). Levitra is not for women or children.
Levitra must be used only under a doctor's care.
Do not take Levitra if you:
- take any medicines called "nitrates". Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.
- Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or parches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called "poppers" also contain nitrates, such as amyl nitrate and butyl nitrate. Do not use Levitra if you are using these drugs. Ask your doctor or pharmacist if you are not sure if any of your medicines are nitrates,
- take medicines called "alpha blockers." Alpha blockers are sometimes prescribed for prostate problems or high blood pressure. If Levitra is taken with alpha blockers, your blood pressure could suddenly drop to an unsafe level. You could get dizzy and faint.
- you have been told by your healthcare provider to not have sexual activity because of health problems. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.
- are allergic to Levitra or any of its ingredients. The active ingredient in Levitra is vardenafil. See the end of this leaflet for a complete list of ingredients.
Before taking Levitra, tell your doctor about all your medical problems, including if you:
- have heart problems such as angina, hem failure, irregular heartbeats, or have
- had a heart attack. Ask your doctor if it is safe for you to have sexual activity.
- have low blood pressure or have high blood pressure that is not controlled
- have had a stroke,
- or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome)
- have liver problems
- have kidney problems and require dialysis
- have retinitis pigmentosa, a rare genetic (runs in families) eye disease
- have stomach ulcers
- have a bleeding problem
- have a deformed penis shape or Peyronie's disease
- have had an erection that lasted more than 4 hours
- have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
Levitra Drug Interactions
Nitrates
Administration of Levitra with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated. Consistent with the effects of PDE5(Phosphodiesterase type 5) inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5(Phosphodiesterase type 5) inhibitors may potentiate the hypotensive effects of nitrates. A suitable time interval following Levitra dosing for the safe administration of nitrates or nitric oxide donors has not been determined.
Alpha Blockers
Because the co-administration of alpha-blockers and Levitra can produce hypotension, Levitra is contraindicated in patients taking alpha-blockers. These include Hytrin (terazosin), Flomax (tamsulosin), Cardura (doxazosin), Minipress (prazosin) or Uroxatral (alfuzosin).
Levitra Experiences and Results
In vitro studies have shown that vardenafil is a selective inhibitor of PDE5(Phosphodiesterase type 5). The inhibitory effect of vardenafil is more selective on PDE5(Phosphodiesterase type 5) than for other known phosphodiesterases (>15-fold relative to PDE6(Phosphodiesterase type 6), >130-fold relative to PDE1(Phosphodiesterase type 1), >300-fold relative to PDE11(Phosphodiesterase type 11), and >1,000-fold relative to PDE2(Phosphodiesterase type 2), 3, 4, 7, 8, 9, and 10).
Levitra Clinical Trials and Studies
Levitra was evaluated in four major double-blind, randomized, placebo-controlled, fixed-dose, parallel design, multi-center trials that enrolled 2431 men aged 20-83 (mean age 57 years; 78% White, 7% Black, 2% Asian, 3% Hispanic and 10% Other/Unknown). The doses of Levitra in these studies were 5 mg, 10 mg, and 20 mg. Two of these trials were conducted in the general ED(Erectile Dysfunction) population and two in special ED(Erectile Dysfunction) populations (one in patients with diabetes mellitus and one in post-prostatectomy patients). Levitra was dosed without regard to meals on an as needed basis in men with erectile dysfunction (ED(Erectile Dysfunction)), many of whom had multiple other medical conditions. The primary endpoints were assessed at 3 months.
Primary efficacy assessment in all four major trials was by means of the Erectile Function (EF(Erectile Function)) Domain score of the validated International Index of Erectile Function (IIEF) Questionnaire and two questions from the Sexual Encounter Profile (SEP(Sexual Encounter Profile)) dealing with the ability to achieve vaginal penetration (SEP(Sexual Encounter Profile)2), and the ability to maintain an erection long enough for successful intercourse (SEP(Sexual Encounter Profile)3).
In all four fixed-dose efficacy trials, Levitra showed clinically meaningful and statistically significant improvement in the EF(Erectile Function) Domain, SEP(Sexual Encounter Profile)2, and SEP(Sexual Encounter Profile)3 scores compared to placebo. The mean baseline EF(Erectile Function) Domain score in these trials was 11.8 (scores range from 0-30 where lower scores represent more severe disease). Levitra (5 mg, 10 mg, and 20 mg) was effective in all age categories (<45, 45 to <65, and >65 years) and was also effective regardless of race (White, Black, Other).
Trials in a General Erectile Dysfunction Population: In the major North American fixed dose trial, 762 patients (mean age 57, range 20-83 years, 79% White, 13% Black, 4% Hispanic, 2% Asian and 2% Other) were evaluated. The mean baseline EF(Erectile Function) Domain scores were 13, 13, 13, 14 for the Levitra 5 mg, 10 mg, 20 mg and placebo groups, respectively. There was significant improvement (p<0.0001) at three months with Levitra (EF(Erectile Function) Domain scores of 18, 21, 21, for the 5 mg , 10 mg and 20 mg dose groups, respectively) compared to the placebo group (EF(Erectile Function) Domain score of 15). The European trial (total N=803) confirmed these results. The improvement in mean score was maintained at all doses at six months in the North American trial.
In the North American trial, Levitra significantly improved the rates of achieving an erection sufficient for penetration (SEP(Sexual Encounter Profile)2) at doses of 5 mg, 10 mg, and 20 mg compared to placebo (65%, 75%, and 80%, respectively, compared to a 52% response in the placebo at 3 months; p< 0.0001). The European trial confirmed these results.
Levitra demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP(Sexual Encounter Profile)3) (51% on 5 mg, 64% on 10 mg, and 65% on 20 mg, respectively, compared to 32% on placebo, p< 0.0001) at 3 months in the North American trial. The European trial showed comparable efficacy. This improvement in mean score was maintained at all doses at 6 months in the North American trial.
Trial in Patients with ED(Erectile Dysfunction) and Diabetes Mellitus
Levitrademonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg Levitra double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33-81; 80% White, 9% Black, 8% Hispanic, and 3% Other).
Significant improvements in the EF(Erectile Function) Domain were shown in this study (EF(Erectile Function) Domain scores of 17 on 10 mg Levitra and 19 on 20 mg Levitra compared to 13 on placebo; p< 0.0001).
Levitra significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP(Sexual Encounter Profile)2) (61% on 10 mg and 64% on 20 mg Levitra compared to 36% on placebo; p< 0.0001).
Levitra demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP(Sexual Encounter Profile)3) (49% on 10 mg, 54% on 20 mg Levitra compared to 23% on placebo; p< 0.0001).
Trial in Patients with ED(Erectile Dysfunction) after Radical Prostatectomy
Levitra demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg Levitra) double-blind, placebo-controlled trial in post-prostatectomy patients (n=427, mean age 60, range 44-77 years; 93% White, 5% Black, 2% Other).
Significant improvements in the EF(Erectile Function) Domain were shown in this study (EF(Erectile Function) Domain scores of 15 on 10 mg Levitra and 15 on 20 mg Levitra compared to 9 on placebo; p< 0.0001).
Levitra significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP(Sexual Encounter Profile)2) (47% on 10 mg and 48% on 20 mg Levitra compared to 22% on placebo; p <0.0001).
Levitra demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP(Sexual Encounter Profile)3) (37% on 10 mg, 34% on 20 mg Levitra compared to 10% on placebo; p< 0.0001).
Levitra and Women
Levitra is not indicated for use in women, newborns, or children. Vardenafil was secreted into the milk of lactating rats at concentrations approximately 10-fold greater than found in the plasma. Following a single oral dose of 3 mg/kg, 3.3% of the administered dose was excreted into the milk within 24 hours. It is not known if vardenafil is excreted in human breast milk.
Storing Levitra
Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Additional Notes
Levitra does not:
- cure ED(Erectile Dysfunction)
- increase a man's sexual desire
- protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your doctor about ways to guard against sexually transmitted diseases.
- serve as a male form of birth control
Articles and information related to Levitra
- Impotence
- Edema
Articles and information related to Levitra
Credits for Levitra Information
Levitra information on this page is copyright by Drug Information at Pharma-Help.com, reprinted with Permission. All Rights Reserved. Other pages with reprint permission include Levitra.