Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Inform patients to stop use of all PDE5 inhibitors, including LEVITRA, and seek medical attention in the event of sudden loss of vision in one or both eyes. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye.
Effect of Co-administration of Potent CYP3A4 Inhibitors
They can interact with other medicines you take, such as blood thinners and some alpha blockers, which are used to treat high blood pressure and prostate conditions. Even mixing them with grapefruit juice can worsen side effects. These are issues your doctor needs to talk to you about during an office visit before they prescribe the medicine. Sudden loss or decrease in hearing, buy xanax without prescrition sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including Levitra.
Vardenafil may lead to improved hemodynamics and quality of life in PAH patients based on preliminary results; however, larger, more rigorously designed studies are necessary to validate these observations. Levitra has been studied clinically in many randomized, double-blind, placebo-controlled trials in a variety of patient populations. In a landmark study appearing in the New England Journal of Medicine, Goldstein et al. (2002) showed that Levitra markedly improved erectile function regardless of the severity of ED. The study randomized 540 patients to Levitra or placebo, with the primary endpoint being the proportion of successful intercourse attempts.
If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including LEVITRA, and call a doctor right away. Physicians should advise patients to stop taking all PDE5 inhibitors, including LEVITRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including vardenafil. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see ADVERSE REACTIONS].
You may report side effects to FDA at FDA-1088 or at /medwatch. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
The results showed that 72% of patients receiving Levitra were able to have successful intercourse, whereas this was the case for only 25% in the placebo group (1). Dosage adjustment is necessary in patients with moderate hepatic impairment. Inform patients that in some patient’s concomitant use of PDE5 inhibitors, including LEVITRA, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). In humans, vardenafil alone in doses up to 20 mg does not prolong the bleeding time. There is no clinical evidence of any additive prolongation of the bleeding time when vardenafil is administered with aspirin. LEVITRA has not been administered to patients with bleeding disorders or significant active peptic ulceration.
Yes, Levitra and vardenafil contain the same active ingredient. The only difference is that vardenafil is the generic version, and Levitra is the brand-name product. Government agencies require that generic products contain the same dosage and mechanism of action.
Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore, PDE5 inhibitors, including LEVITRA, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. The common, adverse drug reactions (side effects) are the same as with other PDE5 inhibitors. When Levitra was taken as recommended in placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1).
The cGMP is primarily responsible for increasing and decreasing the size of the blood vessels carrying blood to and from the penis, respectively. Vardenafil prevents an enzyme called phosphodiesterase-5 (PDE-5) from destroying cGMP so that cGMP persists longer. The longer cGMP persists, the more prolonged the engorgement of the penis. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely.
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. 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. An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period. The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34).
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