Vardenafil odt
Vardenafil also may cause chest pain, low blood pressure, blurred vision and changes in color vision, abnormal ejaculation and priapism (painful erection lasting more than 6 hours) livertadota. Patients should seek immediate medical help if they experience an erection lasting more than 4 hours.
Vardenafil hydrochloride tablets should be used with caution by patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease) or by patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).
A study was conducted in which the blood pressure and heart rate response to 0.4 mg nitroglycerin (NTG) sublingually was evaluated in 18 healthy subjects following pretreatment with LEVITRA 20 mg at various times before NTG administration. LEVITRA 20 mg caused an additional time-related reduction in blood pressure and increase in heart rate in association with NTG administration. The blood pressure effects were observed when LEVITRA 20 mg was dosed 1 or 4 hours before NTG and the heart rate effects were observed when 20 mg was dosed 1, 4, or 8 hours before NTG. Additional blood pressure and heart rate changes were not detected when LEVITRA 20 mg was dosed 24 hours before NTG. (See Figure 2.)
Vardenafil odt
Patients should receive counseling on adverse effects. General adverse reactions have been reported with vardenafil ODT and mirror many adverse effects from PDE-5 inhibitors. The most common adverse reactions were headache, flushing, nasal congestion, dyspepsia, dizziness, and back pain. It is unknown if analgesia or antipyretic use prior to administering vardenafil ODT would reduce adverse effects.
Monitor Closely (1)metronidazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
Vardenafil is metabolized by hepatic cytochrome P450 3A4 (CYP3A4) and to a lesser extent CYP2C9. Inhibitors of CYP3A4 can reduce vardenafil clearance. Increased systemic exposure to vardenafil may result in an increase in vardenafil-induced adverse effects. In vivo studies report that several strong CYP3A4 inhibitors can significantly increase the AUC and Cmax of vardenafil when coadministered with vardenafil. Vardenafil dose adjustments are required when vardenafil is administered with such agents (see Dosage). The vardenafil orally disintegrating tablets provide increased exposure as compared to the regular tablets; therefore, do not use the orally disintegrating tablets with moderate or potent CYP3A4 inhibitors, such as erythromycin. Other potent CYP3A4 inhibitors such as conivaptan, mibefradil, imatinib, STI-571, other macrolides (i.e., clarithromycin, troleandomycin), would be expected to have effects on vardenafil clearance when coadministered. Other inhibitors of CYP3A4 may reduce the clearance of vardenafil, however, no interaction studies have been performed. Other CYP3A4 inhibitors may include amiodarone, diltiazem, fluoxetine, fluvoxamine, isoniazid, INH, nefazodone, nicardipine, verapamil, zafirlukast, and zileuton.
Contraindicated (1)vardenafil increases effects of nitroglycerin rectal by additive vasodilation. Contraindicated. Use of nitroglycerin within a few days of PDE5 inhibitors is contraindicated. PDE5 inhibitors have been shown to potentiate the hypotensive effects of organic nitrates.
Monitor Closely (1)deutetrabenazine and vardenafil both increase QTc interval. Use Caution/Monitor. At the maximum recommended dose, deutetrabenazine does not prolong QT interval to a clinically relevant extent. Certain circumstances may increase risk of torsade de pointes and/or sudden death in association with drugs that prolong the QTc interval (eg, bradycardia, hypokalemia or hypomagnesemia, coadministration with other drugs that prolong QTc interval, presence of congenital QT prolongation).
Monitor Closely (1)lopinavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
Vardenafil 20mg dosage
Discuss with patients the appropriate use of vardenafil and its anticipated benefits. It should be explained that sexual stimulation is required for an erection to occur after taking vardenafil. Vardenafil should be taken approximately 60 minutes before sexual activity. Patients should be counseled regarding the dosing of vardenafil especially regarding the maximum daily dose. Patients should be advised to contact their healthcare provider for dose modification if they are not satisfied with the quality of their sexual performance with vardenafil or in the case of an unwanted effect.
In vivo studies Nifedipine: Vardenafil 20 mg (film-coated tablets), when co-administered with slow-release nifedipine 30 mg or 60 mg once daily, did not affect the relative AUC or Cmax of nifedipine, a drug that is metabolized via CYP3A4. Nifedipine did not alter the plasma levels of vardenafil when taken in combination. Vardenafil orally disintegrating tablet, when co-administered with slow-release nifedipine 30 mg or 60 mg once daily in patients whose hypertension was controlled with nifedipine, produced mean additional supine systolic/diastolic blood pressure reductions of 3/4 mmHg (age group 65 to 69 years) and 5/5 mmHg (age group 70 to 80 years) compared to placebo.
Study 1 evaluated 355 mainly European (Belgium, France, Germany, Spain, South Africa, and Netherlands) patients (mean age 61.9; 67% White, 4% Black, 3% Asian, 26% Unknown). The mean baseline EF domain scores were 13 for both placebo and vardenafil orally disintegrating tablet groups. Study 2 evaluated 331 mainly North American (USA, Canada, Mexico, and Australia) patients (mean age 61.7; 69% White, 5% Black, 4% Asian, 22% Hispanic). The mean baseline EF domain scores were 12 for vardenafil orally disintegrating tablet and 13 for placebo.
Discuss with patients the appropriate use of vardenafil hydrochloride tablets and its anticipated benefits.It should be explained that sexual stimulation is required for an erection to occur after taking vardenafil hydrochloride tablets. Vardenafil hydrochloride tablets should be taken approximately 60 minutes before sexual activity. Patients should be counseled regarding the dosing of vardenafil hydrochloride tablets especially regarding the maximum daily dose. Patients should be advised to contact their healthcare provider for dose modification if they are not satisfied with the quality of their sexual performance with vardenafil hydrochloride tablets or in the case of an unwanted effect.
The maximum dose of vardenafil for which human data are available is a single 120 mg dose of the film–coated tablets administered to healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or «abnormal vision». Single doses up to 80 mg vardenafil and multiple doses up to 40 mg vardenafil administered once daily over 4 weeks were tolerated without producing serious adverse side effects.