Levitra 20mg Patient Information Leaflet
There were 3 cases of dizziness observed
| Condition | Risk/Consideration | Alternative Recommendation |
|---|---|---|
| Nitrate use | Severe hypotension | Do not take Levitra with nitrates |
| Severe hepatic impairment | Increased drug levels | Consult doctor for adjusted dose |
| Retinitis Pigmentosa | Potential for vision disturbance | Use under medical supervision |
| Hypotension (<90/50 mmHg) | Risk of worsening symptoms | Monitor blood pressure |
| Heart failure (unstable) | Increased cardiovascular risk | Medical evaluation beforehand |
with concomitant administration of terazosin and vardenafil.
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- Consult your doctor before starting this medication.
- Do not crush or chew the tablet; swallow whole.
- It is not intended for use by women or children.
- Possible side effects include dizziness and nasal congestion.
- Some men may experience vision changes.
- Levitra 20 mg may cause a slow or prolonged erection.
- Notify your doctor if you experience sudden vision loss.
- Do not take Levitra with large amounts of grapefruit.
- Use caution if you have a history of priapism.
- It does not protect against sexually transmitted diseases.
- Missing a dose does not require double dosing.
Seven subjects experienced dizziness mainly occurring
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Consequently, it is recommended not to exceed a single 2.5 mg LEVITRA dose in a 72-hour period when used in combination with ritonavir (see WARNINGS and DOSAGE AND ADMINISTRATION). Other CYP3A4 inhibitors: Although specific interactions have not been studied, other CYP3A4 inhibitors, including grapefruit juice would likely increase vardenafil exposure. Other Drug Interactions: No pharmacokinetic interactions were observed between vardenafil and the following drugs: glyburide, warfarin, digoxin, Maalox, and ranitidine. In the warfarin study, vardenafil had no effect on the prothrombin time or other pharmacodynamic parameters. Weak inhibitory effects toward other isoforms (CYP2C8, 2C9, 2C19, 2D6, 3A4) were found, but Ki values were in excess of plasma concentrations achieved following dosing.
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The most potent inhibitory activity was observed for vardenafil metabolite M1, which had a Ki of 1.4 µM toward CYP3A4, which is about 20 times higher than the M1 Cmax values after an 80 mg LEVITRA dose. Nitrates: The blood pressure lowering effects of sublingual nitrates (0.4 mg) taken 1 and 4 hours after vardenafil and increases in heart rate when taken at 1, 4 and 8 hours were potentiated by a 20 mg dose of LEVITRA in healthy middle-aged subjects. These effects were not observed when LEVITRA 20 mg was taken 24 hours before the NTG. Potentiation of the hypotensive effects of nitrates for patients with ischemic heart disease has not been evaluated, and concomitant use of LEVITRA and nitrates is contraindicated (see CLINICAL PHARMACOLOGY, Pharmacodynamics,Effects on Blood Pressure and Heart Rate when LEVITRA is Combined with Nitrates;CONTRAINDICATIONS). Nifedipine: Vardenafil 20 mg, when co-administered with slow-release nifedipine 30 mg or 60 mg once daily, did not affect the relative bioavailability (AUC) or maximum concentration (Cmax) of nifedipine, a drug that is metabolized via CYP3A4. with simultaneous Tmax administration of tamsulosin.
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Figure 6: Mean change from baseline in standing systolic blood pressure (mmHg) over
- Levitra 20 mg can be part of a sexual health treatment plan.
- Do not exceed the prescribed dose to avoid adverse effects.
- The tablet should be taken with water, not with food or alcohol.
- Inform your doctor about all medications being taken.
- Levitra is not a cure for erectile dysfunction but helps manage symptoms.
- Side effects are usually mild but report any severe reactions.
- Avoid driving or operating machinery if dizziness occurs.
- Use the medication only when needed, not regularly without consultation.
- The effectiveness of Levitra 20 mg may vary among individuals.
- Patients should abstain from heavy drinking while using it.
- Use caution in older adults who may be more sensitive.
- Keep out of reach of children and pets.
6 hour interval following simultaneous or
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When tamsulosin and vardenafil 5 mg were separated by 6 hours, two patients had a standing SBP <85 mmHg and one patient had a decrease in SBP of >30 mmHg. There were no severe adverse events related to hypotension reported during the study. Blood pressure effects (standing SBP) in normotensive men on stable dose tamsulosin 0.4 mg following simultaneous administration of vardenafil 5 mg or placebo, or following administration of vardenafil 5 mg or placebo separated by 6 hours are shown in Figure 3. Blood pressure effects (standing SBP) in normotensive men on stable dose terazosin (5 or 10 mg) following simultaneous administration of vardenafil 5 mg or placebo, or following administration of vardenafil 5 mg or placebo separated by 6 hours, are shown in Figure 4. Figure 3: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 5 mg or placebo with stable dose tamsulosin 0.4 mg in normotensive BPH patients (Study 1) Figure 4: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 5 mg or placebo with stable dose terazosin (5 or 10 mg) in normotensive BPH patients (Study 1) Study 2: This study was designed to evaluate the effect of 10 mg vardenafil (stage 1) and 20 mg vardenafil (stage 2) compared to placebo, when administered to a single cohort of BPH patients (n=23) on stable therapy with tamsulosin 0.4 mg or 0.8 mg daily for at least four weeks.
Some side effects can be serious. If you experience any of the following symptoms , call your doctor immediately:
The design was a randomized, double blind, two-period cheapest levitra generic cross-over study. Vardenafil or placebo was given simultaneously with tamsulosin. One patient experienced a decrease from baseline in standing SBP of >30 mmHg following vardenafil 10 mg. There were no other instances of outlier blood pressure values (standing SBP <85 mmHg or decrease from baseline in standing SBP of >30 mmHg). Three patients reported dizziness following vardenafil 20 mg. 6 hr separation administration of vardenafil 10
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Nifedipine did not alter the plasma levels of LEVITRA when taken in combination. In these patients best price on levitra whose hypertension was controlled with nifedipine, LEVITRA 20 mg produced mean additional supine systolic/diastolic blood pressure reductions of 6/5 mmHg compared to placebo. Blood pressure effects in patients on stable alpha-blocker treatment: Two clinical pharmacology studies were conducted in patients with benign prostatic hyperplasia (BPH) on stable-dose alpha-blocker treatment for at least four weeks. Study 1: This study was designed to evaluate the effect of 5 mg vardenafil compared to placebo when administered to BPH patients on chronic alpha-blocker therapy in two separate cohorts: tamsulosin 0.4 mg daily (cohort 1, n=21) and terazosin 5 or 10 mg daily (cohort 2, n=21). The design was a randomized, double blind, cross-over study with four treatments: vardenafil 5 mg or placebo administered simultaneously with the alpha-blocker and vardenafil 5 mg or placebo administered 6 hours after the alpha-blocker.
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Blood pressure and pulse were evaluated over the 6-hour interval after vardenafil dosing. One patient after simultaneous treatment with 5 mg vardenafil and 10 mg terazosin exhibited symptomatic hypotension with standing blood pressure of 80/60 mmHg occurring one hour after administration and subsequent mild dizziness and moderate lightheadedness lasting for 6 hours. For vardenafil and placebo, five and two patients, respectively, experienced a decrease in standing systolic blood pressure (SBP) of >30 mmHg following simultaneous administration of terazosin. Hypotension was not observed when vardenafil 5 mg and terazosin were administered 6 hours apart. Following simultaneous administration of vardenafil 5 mg and tamsulosin, two patients had a standing SBP of <85 mmHg; two and one patient (vardenafil and placebo, respectively) had a decrease in standing SBP of >30 mmHg. mg, vardenafil 20 mg or placebo with terazosin (10 mg) in healthy volunteers
- Levitra 20 mg is used when other doses or forms have been ineffective.
- It can help improve confidence and sexual satisfaction.
- The effectiveness of Levitra depends on correct administration timing.
- Do not take it with fatty meals as absorption may be delayed.
- Always follow your doctor's instructions for use and dosage.
- The medication should not be used by individuals with certain health conditions without consultation.
- Avoid combining Levitra with recreational drugs.
- Stop using immediately if adverse effects occur.
- Keep track of any new or worsened side effects.
- Use only the prescribed dosage; do not increase it on your own.
- Levitra 20 mg should be used responsibly to ensure safety.
- Consult your healthcare professional for questions or concerns.
Figure 7: Mean change from baseline in standing systolic blood pressure (mmHg) over
| Dose | Timing | Food Interaction | Notes |
|---|---|---|---|
| 20 mg tablet | 1 hour before activity | Can be taken with or without food | Max once per day |
| Take with water | Avoid high-fat meals | Slows absorption | Do not exceed prescribed dose |
| Onset of Effect | 30-60 minutes | Take 15-30 minutes in advance | |
| Missed Dose | Not applicable | Take as needed before activity | |
| Duration of Effect | Up to 4-5 hours | Effects vary by individual |
6 hour interval following simultaneous or
Vardenafil (Generic Levitra®) FAQs
Erythromycin (500 mg t.i.d.) produced a 4-fold increase in vardenafil AUC and a 3-fold increase in Cmax when co-administered with LEVITRA 5 mg in healthy volunteers (see DOSAGE AND ADMINISTRATION). It is recommended not to exceed a single 5 mg dose of LEVITRA in a 24-hour period when used in combination with erythromycin. Ketoconazole (200 mg once daily) produced a 10-fold increase in vardenafil AUC and a 4-fold increase in Cmax when co-administered with LEVITRA (5 mg) in healthy volunteers. A 5-mg LEVITRA dose should not be exceeded when used in combination with 200 mg once daily ketoconazole. Since higher doses of ketoconazole (400 mg daily) may result in higher increases in Cmax and AUC, a single 2.5 mg dose of LEVITRA should not be exceeded in a 24-hour period when used in combination with ketoconazole 400 mg daily (see WARNINGS and DOSAGE AND ADMINISTRATION).
When to Seek Medical Attention
Indinavir (800 mg t.i.d.) co-administered with LEVITRA 10 mg resulted in a 16-fold increase in vardenafil AUC, a 7-fold increase in vardenafil Cmax and a 2-fold increase in vardenafil half-life. It is recommended not to exceed a single 2.5 mg LEVITRA dose in a 24-hour period when used in combination with indinavir (see WARNINGS and DOSAGE AND ADMINISTRATION). Ritonavir (600 mg b.i.d.) co-administered with LEVITRA 5 mg resulted in a 49-fold increase in vardenafil AUC and a 13-fold increase in vardenafil Cmax. The interaction is a consequence of blocking hepatic metabolism of vardenafil by ritonavir, a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9. Ritonavir significantly prolonged the half-life of vardenafil to 26 hours. 6 hr separation administration of vardenafil 10
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Symptoms of hypotension were a cause for withdrawal in 2 subjects receiving terazosin and in 4 subjects receiving tamsulosin. Instances of outlier blood pressure values (defined as standing SBP <85 mmHg and/or a decrease from baseline of standing SBP >30 mmHg) were observed in 9/24 subjects receiving tamsulosin and 19/29 receiving terazosin. The incidence of subjects with standing SBP <85 mmHg given vardenafil and terazosin to achieve simultaneous Tmax led to early termination of that arm of the study. In most (7/8) of these subjects, instances of standing SBP <85 mmHg were not associated with symptoms. Among subjects treated with terazosin, outlier values were observed more frequently when vardenafil and terazosin were given to achieve simultaneous Tmax than when dosing was administered to separate Tmax by 6 hours. mg, vardenafil 20 mg or placebo with tamsulosin (0.4 mg) in healthy volunteers
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Blood pressure effects (standing SBP) in normotensive men on stable dose tamsulosin 0.4 mg following simultaneous administration of vardenafil 20 mg or placebo, or following administration of vardenafil 20 mg or placebo separated by 6 hours are shown in Figure 5. Figure 5: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous administration of vardenafil 10 mg (Stage 1), vardenafil 20 mg (Stage 2), or placebo with stable dose tamsulosin 0.4 mg in normotensive BPH patients (Study 2) Concomitant treatment with vardenafil and alpha-blockers should be initiated only if the patient is stable on his alpha-blocker therapy. In those patients who are stable on alpha-blocker therapy, LEVITRA should be initiated at the lowest recommended starting dose (see DOSAGE and ADMINISTRATION). Blood pressure effects in normotensive men after forced titration with alpha-blockers: Two randomized, double blind, placebo-controlled clinical pharmacology studies with healthy normotensive volunteers (age range, 45-74 years) were performed after forced titration of the alpha-blocker terazosin to 10 mg daily over 14 days (n=29), and after initiation of tamsulosin 0.4 mg daily for five days (n=24). There were no severe adverse events related to hypotension in either study. Ritonavir and indinavir: Upon concomitant administration of 5 mg of LEVITRA with 600 mg BID ritonavir, the Cmax and AUC of ritonavir were reduced by approximately 20%.
- Levitra 20 mg is a phosphodiesterase inhibitor used for ED.
- The tablet can be taken with or without food for convenience.
- It is important to have an erection sufficient for sexual activity.
- Do not take Levitra if you are on nitrate medications.
- Alcohol can impair the effectiveness and increase side effects.
- Overuse can increase the risk of serious side effects.
- Follow your doctor's guidelines for safe use and dosage.
- Patients should report any persistent or painful erections.
- Levitra 20 mg may cause flushing, headache, or upset stomach.
- Avoid using with grapefruit or grapefruit juice.
- Tell your doctor if you experience sudden vision loss.
- Store medication out of children's reach and at room temperature.
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