| 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 Levtra 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. |