| Levitra Information
What is
the appropriate dose of Levitra?
Currently, Levitra is available
in 2.5mg, 5mg, 10mg, and 20mg doses. The standard
dose is to take an initial dose of 10mg. This dose
is decreased for various medical conditions (liver
conditions, end stage renal disease, hypotension,
cardiovascular disease, taking other medications,
etc.) and increased up to 20mg if the standard dose
is not effective in healthy individuals. Men over
the age of 65 years will often take a lower dose.
Similar to any prescription medication, consult
with a physician prior to taking Levitra. The medication
is usually taken 25 - 60 minutes prior to sexual
activity. If you overdose on Levitra seek immediate
medical attention.
Similar
to Viagra can individuals buy a larger dose of Levitra
and then split the dose?
Yes, individuals can buy
the 20mg Levitra tablets and then split the dose
into the standard dose of 10mg. Many individuals
even split the 20mg tablets into fourths and just
take 5mg of Levitra. Individuals should not take
more than 20mg of Levitra at any time.
Is Levetra
also known as Vardenafil HCL?
Yes, Levitra is the brand
name and Vardenafil HCL is the generic name for
the medication.
Which company
manufactures Levitra?
Levitra is manufactured
by the Bayer corporation in Germany and will most
likely also be distributed and marketed by GlaxoSmithKline.
Is Levitra an effective
treatment option for erectile dysfunction following
prostate surgery?
Levitra is extremely effective
in treating erectile dysfunction (impotence) following
prostate cancer surgery. Some 71% of men who had
undergone prostate removal reported significant
improvements in erections with Levrita (20mg) versus
12 per cent in men taking placebo (sugar pill).
The study concluded that this was an important finding
for Levitra, as erectile dysfunction (impotence)
following prostate surgery is usually severe.
What is
the mechanism of action of Levitra?
Levitra
is a new class of medication to help men with erectile
dysfunction (impotence) Viagra was the first of
the so called "PDE-5 inhibitors" and Levitra is known in the same class
to significantly help individual overcome their
erectile dysfunction (impotence). Similar to Viagra,
Levitra increases the quantity of blood supplied
to the penis improving the erection. Levitra is
very selective in inhibiting the PDE-5 without
affecting other isoenzymes. This allows a smaller
dose of Levitra to have a more pronounced effect
as a larger dose of Viagra (the standard dose of
Levitra dose is 10mg while the standard dose of
Viagra dose is 50mg). Through this action,
smooth muscle in the penis remains relaxed for a
longer period. This allows for increased blood
flow into the cavernous tissue of the penis thereby
generating an erection. Levitra is unique
in that it increases a natural occurring process,
therefore, only through sexual stimulation will
an erection occur.
More specifically, Penile
erection is a haemodynamic process. During sexual
stimulation, nitric oxide is subsequently released.
The nitric acid activates an enzyme guanylate cyclase,
resulting in an increased level of cyclic guanosine
monophosphate (cGMP) in the corpus cavernosum of
the penis. This results in smooth muscle relaxation
in the penis, allowing increased inflow of blood
into the penis. The level of cGMP is regulated by
the rate of synthesis via guanylate cyclase and
by the rate of degradation via cGMP hydrolysing
phosphodiesterases (PDEs).
Levitra is a potent and selective inhibitor of the
cGMP specific phosphodiesterase type 5 (PDE5), the
most prominent PDE in the human corpus cavernosum.
Levitra enhances the effect of endogenous nitric
oxide in the corpus cavernosum by inhibiting PDE5.
When nitric oxide is released secondary to sexual
stimulation, inhibition of PDE5 by Levitra results
in increased corpus cavernosum levels of cGMP. Sexual
stimulation is required for Levitra to produce its
beneficial therapeutic effects.
Is there
a generic version of Levitra?
Levitra
is still under the patent of Bayer/GlaxoSmithKline which have the exclusive rights
to market Levitra. Some companies may advertise
a generic version of Levitra, however, this medication
is not approved or tested by the FDA or European
regulators so you cannot be sure of the purity and/or
quality of the medication.
Will I have
a spontaneous erection after I take Levitra?
No, men still need some
form of sexual stimulation in order to achieve an
erection.
Does Levitra help
with erectile dysfunction related depression?
Yes, studies have shown
that Levitra is effective in treating the depressive
symptoms experienced by men with erectile dysfunction
(impotence). The studies showed men taking Levitra
reported improved erections and fewer depressive
symptoms than those men taking a placebo (sugar
pill).
How good
is Levitra as compared to Viagra in treating erectile
dysfunction (impotence)?
Many
men in clinical studies have reported that Levitra
lasts longer, produces an erection faster, has fewer
side effects, and helps more men achieve fuller
erections when compared to Viagra. More clinical
studies need to be completed to evaluate the two
medications. Levitra
is the new alternative to Viagra!
Should I
eat prior to taking Levitra?
Individuals can take Levitra
with or without food, however, preferably not following
a heavy or a meal high in fat content. In addition,
individuals should not take Levitra with grapefruit
juice, alcohol can worsen the erection process.
Why should
individuals not drink grapefruit juice while taking
Levitra?
Grapefruit juice being
a weak inhibitor of CYP3A4 gut wall metabolism,
may give rise to modest increases in plasma levels
of Levitra.
In addition
to the active ingredients, what else is in Levitra?
In addition to the active
ingredient, vardenafil HCl, each tablet contains
colloidal silicon dioxide, magnesium stearate, microcrystalline
cellulose,
titanium dioxide, crospovidone, hypromellose, polyethylene
glycol, yellow ferric oxide, and red ferric oxide.
What are
the most common side effects associated with the
use of Levitra?
The most common side effects
associated with the use of Levitra include the following:
headache, flushing, dyspepsia, nausea and rhinitis. Most
of the reported adverse reactions were mild and
stopped when the individual discontinued the medication.
Uncommon side effects
associated with taking Levitra (these may affect less than 1 in 100 people) included the
following:
- Sensitivity of the eye
to sunlight
- High or low blood pressure
- Fainting
- Stiffness in muscles
- Effects on vision
- Erectile disturbances
(such as spontaneous or painful erections)
Are there
any drug interactions associated with the use of
Levitra?
Studies in human liver
microsomes showed that Levitra is metabolized primarily
by cytochrome P450 (CYP) isoforms 3A4/5, and to
a lesser degree by CYP 2C9. Therefore, inhibitors
of these enzymes are expected to reduce Levitra
clearance.
Cytochrome P450 Inhibitors:
Cimetidine: (400 mg b.i.d.) had no effect
on vardenafil bioavailability (AUC) and maximum
concentration (Cmax) of vardenafil when co-administered
with 20 mg LEVITRA in healthy volunteers.
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.
Erythromycin: (500 mg t.i.d) produced a 4-fold
increase in vardenafil AUCand a 3-fold increase
in Cmax when co-administered with Levitra 5 mg in
healthy volunteers It is recommended not to exceed
a single 5 mg dose of Levitra in a 24-hour period
when used in combination with erythromycin.
HIV Protease Inhibitors:
Alpha-blockers:
When Levitra 10 or 20
mg was given to healthy volunteers either simultaneously
or 6 hours after a 10 mg dose of terazosin, significant
hypotension developed in a substantial number of
subjects. With simultaneous dosing of Levitra 10
mg and terazosin 10 mg, 6 of 8 subjects experienced
a standing systolic blood pressure of less than
85 mm Hg. With simultaneous dosing of Levitra 20
mg and terazosin 10 mg, 2 of 9 subjects experienced
a standing systolic blood pressure of less than
85 mm Hg. When Levitra dosing was separated from
terazosin 10 mg by 6 hours, 7 of 28 subjects who
received 20 mg of Levitra experienced a decrease
in standing systolic blood pressure below 85 mm
Hg. In a similar study with tamsulosin in healthy
volunteers, 1 of 24 subjects dosed with Levitra
20 mg and tamsulosin 0.4 mg separated by 6 hours
experienced a standing systolic blood pressure below
85 mm Hg. Two of 16 subjects dosed simultaneously
with Levitra 10 mg and tamsulosin 0.4 mg experienced
a standing systolic blood pressure below 85 mm Hg.
The administration of lower doses of Levitra
with alpha blockers has not been completely evaluated
to determine if they can be safely administered
together. Based on these data, Levitra should not
be used in patients on alpha-blocker therapy.
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.
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. 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.
Additional Drug Interactions:
No pharmacokinetic interactions
were observed between vardenafil and the following
drugs: Maalox, glyburide, warfarin, digoxin, and
ranitidine. In the warfarin study, vardenafil had
no effect on the prothrombin time or other pharmacodynamic
parameters.
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.
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. Nifedipine did not alter the plasma
levels of Levitra when taken in combination. In
these patients whose hypertension was controlled
with nifedipine, Levitra 20 mg produced mean additional
supine systolic/diastolic blood pressure reductions
of 6/5 mm Hg compared to placebo.
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
potentate 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).
Why should
Levitra not be used if an individual is taking Nitrates?
Individuals should be counseled that concomitant
use of Levitra with nitrates could cause blood pressure
to suddenly drop to an unsafe level, resulting in
dizziness, syncope, or even a stroke or heart attack.
Why should
Levitra not be used if an individual is taking Alpha-blockers?
Physicians should inform
their patients that concomitant use of Levitra with
alpha-blockers is contraindicated because co-administration
can produce hypotension.
Are there individuals that should not take
Levitra?
Yes, there are some patient
subgroups that have not been studied in clinical
trials. Therefore, the use of Levitra is not recommended
in the following patients until further studies
are completed: or until an individuals physician
has approved the use of the medication:
-
Unstable angina
-
Severe hepatic impairment
(Child-Pugh C)
-
End stage renal disease requiring
dialysis
-
Known hereditary degenerative
retinal disorders, including retinitis pigmentosa
-
Hypotension (resting systolic
blood pressure of <90 mm Hg)
-
Uncontrolled hypertension
(>170/110 mm Hg)
-
Recent history of stroke,
life-threatening arrhythmia, or myocardial infarction
(within the last 6 months); severe cardiac failure
-
If you have an allergy (if
you're hypersensitive) to vardenafil
or any of the other ingredients of Levitra.
-
If you are taking other medications
(consult with your physician)
-
Cardiovascular complications
(stroke, arrhythmia, heart attack, etc.)
-
Degenerative eye disease
i.e. retinitis pigmentosa
Additional
caution should be used in the following individuals:
- Individuals with a physical
condition affecting the shape of the penis (i.e.
angulation, Peyronie's disease and cavernosal
fibrosis, etc.).
- Individuals with an
illness that can cause priapism or sustained erections
(i.e. sickle cell disease, multiple myeloma
and leukemia, etc.).
- Individuals that have
stomach ulcers (i.e. gastric or peptic
ulcers).
- Individuals with
a bleeding disorder (i.e. haemophilia).
- Individuals that are
using any other treatments for erection difficulties
(i.e. Viagra, Cialis).
Will
Levitra improve the quality of my erection?
In
clinical trials, Levitra provided first time success
and reliable improvement in erection quality
for many men with erectile dysfunction (impotence).
In addition, Levitra consistently improved rates
of penetration and hardness, as well as, success
with intercourse a broad population of men with
erectile dysfunction.
Will
Levitra produce an erection for hours?
Levitra
only enhances a man's natural ability to achieve
an erection when you are sexually stimulated. Erections
should end following an orgasm or the end of stimulation.
In the rare case your erection should lasts for
more than 4 hours, please seek immediate medical
attention.
Can
I take Levitra if I have preexisting cardiovascular
complications?
No,
some individuals should not take Levitra with preexisting
medical conditions. Physicians should discuss with patients the potential
cardiac risk of sexual activity for patients with
preexisting cardiovascular risk factors.
Does
Levitra provide any protection against sexually
transmitted diseases?
No, the use
of Levitra offers no protection against sexually
transmitted diseases.
Should individuals drive a vehicle or operate
heavy machinery while taking Levitra?
Levitra may cause some people to feel dizzy or have
an alteration in there vision. These individuals
should not drive or operate heavy machinery while
taking Levitra.
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