Patient Assistance Programs for Levitra
The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. LEVITRA has not been evaluated in patients with severe hepatic impairment (Child-Pugh C) (see CLINICAL PHARMACOLOGY, Metabolism and ExcretionWARNINGS and PRECAUTIONS).
- Levitra 20mg approval enhances options for erectile dysfunction treatment.
- It is usually considered safe when used correctly and under medical guidance.
- Users should consult their doctor if they experience sudden vision loss.
- The medication helps relax blood vessels in the penis for improved erection.
- Cost varies depending on pharmacy, generic availability, and insurance coverage.
Renal Impairment: For patients with mild (CLcr = 50-80 ml/min), moderate (CLcr = 30-50 ml/min), or severe (CLcr<30 ml/min) renal impairment, no dose adjustment is required.
- Levitra 20mg is manufactured by Bayer Pharmaceuticals.
- It is a generic alternative to other ED medications like Viagra.
- Efficacy can vary depending on individual health factors.
- Levitra can be used with or without food, but high-fat meals may delay effects.
- Regular medical checkups are recommended while using this medication.
LEVITRA has not been evaluated in patients on renal dialysis (see CLINICAL PHARMACOLOGY, Metabolism and Excretion and PRECAUTIONS).
- The medication should be used as part of a healthy lifestyle for managing ED.
- Addressing risk factors like smoking, obesity, and lack of exercise is important.
- A balanced diet and regular physical activity can improve cardiovascular health.
- Improved cardiovascular health can, in turn, improve erectile function.
- Reducing alcohol consumption can also have a positive impact.
- Levitra is a treatment for symptoms, not a cure for the underlying cause of ED.
Concomitant Medications: The dosage of LEVITRA may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin (see WARNINGS, PRECAUTIONS, Drug Interactions). For ritonavir, a single dose of 2.5 mg LEVITRA should not be exceeded in a 72-hour period.
Enlaces externos
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 and mice when administered daily for 24 months. In these studies systemic drug exposures (AUCs) for unbound (free) vardenafil and its major metabolite were approximately 400- and 170-fold for male and female rats, respectively, and 21- and 37-fold for male and female mice, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 20 mg. Vardenafil was not mutagenic as assessed in either the in vitro bacterial Ames assay or the forward mutation assay in Chinese hamster V79 cells. Vardenafil did not impair fertility in male and female rats administered doses up to 100 mg/kg/day for 28 days prior to mating in male, and for 14 days prior to mating and through day 7 of gestation in females.
Are you currently using Vardenafil (Levitra, Staxyn)?
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. 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.
J. Urol.
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. This dose is approximately 100 fold (rat) and 29 fold (rabbit) greater than the AUC values for unbound vardenafil and its major metabolite in humans given the MRHD of 20 mg. In the rat pre-and postnatal development study, the NOAEL (no observed adverse effect level) for maternal toxicity was 8 mg/kg/day. Retarded physical development of pups in the absence of maternal effects was observed following maternal exposure to 1 and 8 mg/kg possibly due to vasodilatation and/or secretion of the drug into milk. For indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, and clarithromycin, a single dose of 2.5 mg LEVITRA should 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.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Professional | 20mg | 60 + 2 Pills | 223.11€ 212.49€ | |
| Levitra Soft Tabs | 20mg | 90 + 6 Pills | 241.31€ 229.82€ | |
| Levitra Generic | 20mg | 10 Pills | 31.49€ 29.99€ | |
| Levitra Professional | 20mg | 90 + 2 Pills | 304.49€ 289.99€ | |
| Levitra Generic | 40mg | 10 Pills | 41.37€ 39.40€ | |
| Levitra Original | 20mg | 48 + 4 Pills | 235.14€ 223.94€ | |
| Levitra Professional | 20mg | 360 + 6 Pills | 914.63€ 871.08€ | |
| Levitra Original | 20mg | 4 Pills | 45.87€ 43.69€ | |
| Levitra Original | 20mg | 14 + 2 Pills | 102.27€ 97.40€ | |
| Levitra Generic | 40mg | 180 + 10 Pills | 405.06€ 385.77€ | |
| Levitra Generic | 60mg | 10 Pills | 47.42€ 45.16€ |
For alpha-blockers, caution is advised when PDE5 inhibitors, including LEVITRA, are used concomitantly with alpha-blockers because of the potential for an additive effect on blood pressure.
Key Participants Requirements
LEVITRA can be taken with or without food. Sexual stimulation is required for a response to treatment. Geriatrics: A starting dose of 5 mg LEVITRA should be considered in patients ≥65 years of age (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations and PRECAUTIONS). Hepatic Impairment: For patients with mild hepatic impairment (Child-Pugh A), no dose adjustment of LEVITRA is required. Vardenafil clearance is reduced in patients with moderate hepatic impairment (Child-Pugh B), and a starting dose of 5 mg LEVITRA is recommended. In some patients, concomitant use of these two drug classes can lower blood pressure significantly (see PRECAUTIONS,Alpha-blockers and Drug Interactions) leading to symptomatic hypotension (e.g., fainting).
Further information
The number of living pups born to rats exposed pre- and postnatally was reduced at 60 mg/kg/day. Based on the results of the pre- and postnatal study, the developmental NOAEL is less than 1 mg/kg/day. Based on plasma exposures in the rat developmental toxicity study, 1 mg/kg/day in the pregnant rat is estimated to produce total AUC values for unbound vardenafil and its major metabolite comparable to the human AUC at the MRHD of 20 mg. 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).
Related treatment guides
Phase 3 clinical trials included more than 834 elderly patients, and no differences in safety or effectiveness of LEVITRA 5, 10, or 20 mg were noted when these elderly patients were compared to younger patients. However, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg LEVITRA should be considered in patients ≥65 years of age. LEVITRA was administered to over 4430 men (mean age 56, range vardenafil levitra 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.
Am. J. Med.
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. Concomitant treatment should be initiated only if the patient is stable on his alpha blocker therapy.
| Aspect | Details | Notes |
|---|---|---|
| Storage Temperature | Between 15°C and 30°C | Keep away from heat and moisture |
| Keep Out of Reach of Children | Yes | To prevent accidental ingestion |
| Storage Conditions | Store in original packaging, away from direct sunlight | Maintain stability and potency |
| Expiry Date | Usually 3 years from manufacturing date | Do not use expired medication |
| Handling Precautions | Avoid crushing or splitting tablets | Follow prescribed instructions |
In those patients who are stable on alpha-blocker therapy, LEVITRA should be initiated at a dose of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors - see Drug Interactions).
- Levitra 20mg is part of a class known as phosphodiesterase inhibitors.
- The medication’s effectiveness is influenced by overall health and lifestyle.
- Patients should report any persistent side effects to their doctor.
- Use Levitra only as directed; misuse can lead to serious health issues.
- Combining Levitra with recreational drugs like poppers can be dangerous.
LEVITRA (vardenafil HCl) is formulated as orange, film-coated round tablets with debossed “BAYER” cross on one side and “10” and “20” on the other side equivalent to 10 mg and 20 mg of vardenafil, respectively.
Side Effects
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. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient’s underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors (see PRECAUTIONS, Information for Patients). Visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity, have also been reported rarely in post-marketing experience. It is not possible to determine whether these events are related directly to the use of LEVITRA. Seizure, seizure recurrence and transient global amnesia have been reported post-marketing in temporal association with LEVITRA.
The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction
Cases of sudden decrease or loss of hearing have been reported post-marketing in temporal association with the use of PDE5 inhibitors, including LEVITRA. In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. 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 LEVITRA, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors (see PRECAUTIONS, Information for Patients). The maximum dose of LEVITRA for which human data are available is a single 120 mg dose administered to eight healthy male volunteers.
Does vardenafil interact with foods or drinks?
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. 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 levitra generic quality once per day. Vardenafil HCl (Levitra) 10mg tablets are supplied in bottles of 2, 4, 6, 12 and 18 tablets per bottle.Vardenafil HCl (Levitra) 20mg tablets are supplied in bottles of 2, 3, 4, 6, 12 and 18 tablets per bottle.
| Aspect | Description | Notes |
|---|---|---|
| Active Ingredient | Vardenafil | PDE-5 inhibitor |
| Dosage Forms | Tablets, sublingual | 20mg is standard for adult use |
| Manufacturer | Bayer Pharmaceuticals | Globally recognized brand |
| Approved Uses | Erectile Dysfunction | Prescribed by healthcare providers |
| Common Side Effects | Headache, flushing, nasal congestion | Usually mild and temporary |
| Onset of Action | Approximately 25-60 minutes | Varies by individual |
| Duration of Effect | Up to 4-5 hours | Depends on individual metabolism |
