Precautions and Contraindications for Levitra 100mg
In these patients 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.
Information for Patients
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). 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. Blood cost of levitra per pill 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.
| Product | Dosage | Quantity + Bonus | Price | |
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| Levitra Professional | 20mg | 20 Pills | 101.00€ 96.19€ | |
| Levitra Original | 20mg | 34 + 2 Pills | 188.51€ 179.53€ | |
| Levitra Generic | 20mg | 90 + 8 Pills | 180.78€ 172.17€ | |
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| Levitra Original | 20mg | 14 + 2 Pills | 102.27€ 97.40€ | |
| Levitra Original | 20mg | 64 + 4 Pills | 298.45€ 284.24€ | |
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| Levitra Original | 20mg | 8 Pills | 65.05€ 61.95€ | |
| Levitra Generic | 10mg | 90 + 8 Pills | 150.58€ 143.41€ | |
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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). Figure 6: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 10 mg, vardenafil 20 mg or placebo with terazosin (10 mg) in healthy volunteers Figure 7: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 10 mg, vardenafil 20 mg or placebo with tamsulosin (0.4 mg) in healthy volunteers 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%. Upon administration of 10 mg of LEVITRA with 800 mg TID indinavir, the Cmax and AUC of indinavir were reduced by 40% and 30%, respectively. Alcohol: Alcohol (0.5 g/kg body weight: approximately 40 mL of absolute alcohol in a 70 kg person) and vardenafil plasma levels were not altered when dosed simultaneously. LEVITRA (20 mg) did not potentiate the hypotensive effects of alcohol during the 4-hour observation period in healthy volunteers when administered with alcohol (0.5 g/kg body weight). Aspirin: LEVITRA (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by aspirin (two 81 mg tablets).
Renal Insufficiency:
In these patients 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). 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.
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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. Blood cost of levitra per pill 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).
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Figure 6: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 10 mg, vardenafil 20 mg or placebo with terazosin (10 mg) in healthy volunteers Figure 7: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 10 mg, vardenafil 20 mg or placebo with tamsulosin (0.4 mg) in healthy volunteers 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%. Upon administration of 10 mg of LEVITRA with 800 mg TID indinavir, the Cmax and AUC of indinavir were reduced by 40% and 30%, respectively. Alcohol: Alcohol (0.5 g/kg body weight: approximately 40 mL of absolute alcohol in a 70 kg person) and vardenafil plasma levels were not altered when dosed simultaneously. LEVITRA (20 mg) did not potentiate the hypotensive effects of alcohol during the 4-hour observation period in healthy volunteers when administered with alcohol (0.5 g/kg body weight). Aspirin: LEVITRA (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by aspirin (two 81 mg tablets). Other interactions: LEVITRA had no effect on the pharmacodynamics of glyburide (glucose and insulin concentrations) and warfarin (prothrombin time or other pharmacodynamic parameters).
| Common Side Effects | Less Common Side Effects | Serious Side Effects |
|---|---|---|
| Headache | Dizziness | Vision loss |
| Flushing | Nasal congestion | Priapism (prolonged erection) |
| Indigestion | Muscle aches | Sudden hearing loss |
Vardenafil was not carcinogenic in rats brand levitra price and mice when administered daily for 24 months. In a corresponding 1-month rat toxicity study, this dose produced an AUC value for unbound vardenafil 200 fold greater than AUC in humans at the MRHD of 20 mg.
- Levitra 100 mg promises rapid onset for many men.
- It is designed to improve quality of life.
- Follow your doctor’s instructions strictly.
- The drug does not protect against STDs.
- Do not take more than the prescribed dose.
- Inform your healthcare provider about all existing conditions.
- Use with care if you have a history of strokes.
- Urgent medical attention is necessary for adverse reactions.
- The drug’s effects can be enhanced by proper arousal.
- It’s important to stay hydrated during use.
- Avoid high-fat meals before taking Levitra 100 mg.
- Discuss any concerns or side effects with your doctor.
There was no effect on sperm motility or morphology after single 20 mg oral doses of vardenafil in healthy volunteers. LEVITRA is not indicated for use in women, newborns, or children. It is not known if vardenafil is excreted in human breast milk. No evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis.
Side Effect Profile and Tolerability
Other interactions: LEVITRA had no effect on the pharmacodynamics of glyburide (glucose and insulin concentrations) and warfarin (prothrombin time or other pharmacodynamic parameters). Vardenafil was not carcinogenic in rats brand levitra price and mice when administered daily for 24 months. In a corresponding 1-month rat toxicity study, this dose produced an AUC value for unbound vardenafil 200 fold greater than AUC in humans at the MRHD of 20 mg. There was no effect on sperm motility or morphology after single 20 mg oral doses of vardenafil in healthy volunteers. LEVITRA is not indicated for use in women, newborns, or children.
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It is not known if vardenafil is excreted in human breast milk. No evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis. There are no adequate and well-controlled trials of vardenafil in pregnant women. Elderly males age 65 years and older have higher vardenafil plasma concentrations than younger males (18 – 45 years), mean Cmax and AUC were 34% and 52% higher, respectively (see CLINICAL PHARMACOLOGY,Pharmacokinetics in Special Populations, and DOSAGE AND ADMINISTRATION). ADVERSE REACTIONS LEVITRA was administered to over 4430 men (mean age 56, levitra canadian drugs range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide.
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Over 2200 patients were treated for 6 months or longer, and 880 patients were treated for at least 1 year.In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for LEVITRA compared to 1.1% for placebo.When LEVITRA was taken as recommended in placebo-controlled clinical trials, the following adverse events were reported (see Table 5).Back pain was reported in 2.0% of patients treated with LEVITRA and 1.7% of patients on placebo.Placebo-controlled trials suggested a dose effect in the incidence of some adverse events (headache, flushing, dyspepsia, nausea, rhinitis) over the 5 mg, 10 mg, and 20 mg doses of LEVITRA. The following section identifies additional, less frequent events (<2%) reported during the clinical development of LEVITRA. Excluded from this list are those events that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug.BODY AS A WHOLE: anaphylactic reaction (including laryngeal edema),asthenia, face edema, painAUDITORY: sudden decrease or loss of hearing, tinnitusCARDIOVASCULAR: angina pectoris, chest pain, hypertension,hypotension, myocardial ischemia, myocardial infarction, palpitation,postural hypotension, syncope, tachycardiaDIGESTIVE: abdominal pain, abnormal liver function tests, diarrhea, drymouth, dysphagia, esophagitis, gastritis, gastroesophageal reflux, GGTPincreased, vomitingMUSCULOSKELETAL: arthralgia, back pain, myalgia, neck painNERVOUS: hypertonia, hypesthesia, insomnia, paresthesia, somnolence,vertigoRESPIRATORY: dyspnea, epistaxis, pharyngitisSKIN AND APPENDAGES: photosensitivity reaction, pruritus, rash,sweatingOPHTHALMOLOGIC: abnormal vision, blurred vision, chromatopsia,changes in color vision, conjunctivitis (increased redness of the eye), dimvision, eye pain, glaucoma, photophobia, watery eyesUROGENITAL: abnormal ejaculation, priapism (including prolonged orpainful erections) LEVITRA was administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. Over 2200 patients were treated for 6 months or longer, and 880 patients were treated for at least 1 year. In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for LEVITRA compared to 1.1% for placebo. There are no adequate and well-controlled trials of vardenafil in pregnant women.
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When LEVITRA was taken as recommended in placebo-controlled clinical trials, the following adverse events were reported (see Table 5). Back pain was reported in 2.0% of patients treated with LEVITRA and 1.7% of patients on placebo. Placebo-controlled trials suggested a dose effect in the incidence of some adverse events (headache, flushing, dyspepsia, nausea, rhinitis) over the 5 mg, 10 mg, and 20 mg doses of LEVITRA. Excluded from this list are those events that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug. BODY AS A WHOLE: anaphylactic reaction (including laryngeal edema), AUDITORY: sudden decrease or loss of hearing, tinnitus DIGESTIVE: abdominal pain, abnormal liver function tests, diarrhea, dry MUSCULOSKELETAL: arthralgia, back pain, myalgia, neck pain SKIN AND APPENDAGES: photosensitivity reaction, pruritus, rash, UROGENITAL: abnormal ejaculation, priapism (including prolonged or POST-MARKETING EXPERIENCE OphthalmologicNon-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including LEVITRA.
Pharmacokinetics in Special Populations
Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of 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. Elderly males age 65 years and older have higher vardenafil plasma concentrations than younger males (18 – 45 years), mean Cmax and AUC were 34% and 52% higher, respectively (see CLINICAL PHARMACOLOGY,Pharmacokinetics in Special Populations, and DOSAGE AND ADMINISTRATION). ADVERSE REACTIONS LEVITRA was administered to over 4430 men (mean age 56, levitra canadian drugs range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide.
| Contraindications | Precautions | Interactions |
|---|---|---|
| Nitrate use | Liver impairment | Alcohol consumption |
| Heart condition | Recent stroke or heart attack | Certain antibiotics (e.g., clarithromycin) |
| Allergy to PDE5 inhibitors | Low blood pressure | Use with other ED meds |
Over 2200 patients were treated for 6 months or longer, and 880 patients were treated for at least 1 year.In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for LEVITRA compared to 1.1% for placebo.When LEVITRA was taken as recommended in placebo-controlled clinical trials, the following adverse events were reported (see Table 5).Back pain was reported in 2.0% of patients treated with LEVITRA and 1.7% of patients on placebo.Placebo-controlled trials suggested a dose effect in the incidence of some adverse events (headache, flushing, dyspepsia, nausea, rhinitis) over the 5 mg, 10 mg, and 20 mg doses of LEVITRA.
- Levitra 100 mg is most effective when taken on an empty stomach.
- It is recommended to avoid alcohol consumption during treatment.
- Consistent use can help improve sexual performance.
- Use only as prescribed by your healthcare provider.
- It is not intended for daily use unless instructed.
- The medication can cause an erection lasting over 4 hours.
- If this occurs, seek emergency medical help immediately.
- Levitra 100 mg is a treatment option for many men.
- Be aware of the proper storage conditions.
- Discuss any concerns or questions with your doctor.
- The medication is part of a holistic approach to ED.
- Never share your medication with others.
The following section identifies additional, less frequent events (<2%) reported during the clinical development of LEVITRA. Excluded from this list are those events that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug.BODY AS A WHOLE: anaphylactic reaction (including laryngeal edema),asthenia, face edema, painAUDITORY: sudden decrease or loss of hearing, tinnitusCARDIOVASCULAR: angina pectoris, chest pain, hypertension,hypotension, myocardial ischemia, myocardial infarction, palpitation,postural hypotension, syncope, tachycardiaDIGESTIVE: abdominal pain, abnormal liver function tests, diarrhea, drymouth, dysphagia, esophagitis, gastritis, gastroesophageal reflux, GGTPincreased, vomitingMUSCULOSKELETAL: arthralgia, back pain, myalgia, neck painNERVOUS: hypertonia, hypesthesia, insomnia, paresthesia, somnolence,vertigoRESPIRATORY: dyspnea, epistaxis, pharyngitisSKIN AND APPENDAGES: photosensitivity reaction, pruritus, rash,sweatingOPHTHALMOLOGIC: abnormal vision, blurred vision, chromatopsia,changes in color vision, conjunctivitis (increased redness of the eye), dimvision, eye pain, glaucoma, photophobia, watery eyesUROGENITAL: abnormal ejaculation, priapism (including prolonged orpainful erections) LEVITRA was administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. Over 2200 patients were treated for 6 months or longer, and 880 patients were treated for at least 1 year. In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for LEVITRA compared to 1.1% for placebo. When LEVITRA was taken as recommended in placebo-controlled clinical trials, the following adverse events were reported (see Table 5). Back pain was reported in 2.0% of patients treated with LEVITRA and 1.7% of patients on placebo. Placebo-controlled trials suggested a dose effect in the incidence of some adverse events (headache, flushing, dyspepsia, nausea, rhinitis) over the 5 mg, 10 mg, and 20 mg doses of LEVITRA. Excluded from this list are those events that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug. BODY AS A WHOLE: anaphylactic reaction (including laryngeal edema), AUDITORY: sudden decrease or loss of hearing, tinnitus DIGESTIVE: abdominal pain, abnormal liver function tests, diarrhea, dry MUSCULOSKELETAL: arthralgia, back pain, myalgia, neck pain SKIN AND APPENDAGES: photosensitivity reaction, pruritus, rash, UROGENITAL: abnormal ejaculation, priapism (including prolonged or POST-MARKETING EXPERIENCE OphthalmologicNon-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including LEVITRA. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of 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.