If you are taking medicines called alphablockers for
the treatment of high blood pressure or prostate
problems, your blood pressure could suddenly drop. You
could get dizzy or faint. These treatments include
pills, medicines that are injected or inserted into
the penis, implants or vacuum pumps. If you do not get
the results you expect, talk with your doctor. You and
your doctor can determine the dose that works best for
you. You will not get an erection just by taking the
pill. These effects are usually mild to moderate and
usually don't last longer than a few hours. Some of
these side effects are more likely to occur with
higher doses. It is not possible to determine whether
these events are related directly to these medicines,
to other factors such as high blood pressure or
diabetes, or to a combination of these. In rare
instances, men have reported an erection that lasts
many hours.
Before you start any treatment
for erectile dysfunction, ask your doctor if your
heart is healthy enough to handle the extra strain of
having sex. If you have chest pains, dizziness or
nausea during sex, stop having sex and immediately
tell your doctor you have had this problem. After sex
is over, the erection goes away. You could get dizzy,
faint, or even have a heart attack or stroke. If you
are not sure if any of your medicines contain
nitrates, or if you do not understand what nitrates
are, ask your doctor or pharmacist. It is a treatment
for
viagra tablets sildenafil dysfunction. Your
doctor should determine if your heart is healthy
enough to handle the extra strain of having sex. Be
sure to tell your doctor if you: have ever had any
heart problems (e. Tell your doctor about any
medicines you are taking. Do not start or stop taking
any medicines before checking with your doctor or
pharmacist.
There were no episodes of
syncope reported in this study. Sildenafil at steady
state (80 mg t. In the rat preand postnatal
development study, the no observed adverse effect dose
was 30 mg/kg/day given for 36 days. There are no
adequate and wellcontrolled studies of sildenafil in
pregnant women. Over 550 patients were treated for
longer than one year. The adverse events were
generally transient and viagra tablets sildenafil to
moderate in nature. In fixeddose studies, the
incidence of some adverse events increased with dose.
The nature of the adverse events in flexibledose
studies, which more closely reflect the recommended
dosage regimen, was similar to that for fixeddose
studies. In these studies, only one patient
discontinued due to abnormal vision. At doses above
the recommended dose range, adverse events were
similar to those detailed above but generally were
reported more frequently.
The time course of
effect was examined in one study, showing an effect
for up to 4 hours but the response was diminished
compared to 2 hours. The decrease in sitting blood
pressure was most notable approximately 12 hours after
dosing, and was not different than placebo at 8 hours.
A total dose of 40 mg sildenafil was administered by
four intravenous infusions. Even though this total
dosage produced plasma sildenafil concentrations which
were approximately 2 to 5 times higher than the mean
maximum plasma concentrations following a single oral
dose of 100 mg in healthy male volunteers, the
hemodynamic response to exercise was preserved in
these patients. The primary endpoint was time to
limiting angina in the evaluable cohort. The mean
times (adjusted for baseline) to onset of limiting
angina were 423. The studies that established benefit
demonstrated improvements in success rates for sexual
intercourse compared with placebo. The patient
addressed both questions at the final visit for the
last 4 weeks of the study. The possible categorical
responses to these questions were (0) no attempted
intercourse, (1) never or almost never, (2) a few
times, (3) sometimes, (4) most times, and (5) almost
always or always. Sexual function data were also
recorded by patients in a daily diary.
Sildenafil at recommended doses has no effect in the
absence of sexual stimulation. Its pharmacokinetics
are doseproportional over the recommended dose range.
Both sildenafil and the metabolite have terminal half
lives of about 4 hours. Maximum observed plasma
concentrations are reached within 30 to 120 minutes
(median 60 minutes) of oral dosing in the fasted
state. Protein binding is independent of total drug
concentrations. Based upon measurements of sildenafil
in semen of healthy volunteers 90
viagra tablets
sildenafil after dosing, less than 0. Plasma
concentrations of this metabolite are approximately
40% of those seen for sildenafil, so that the
metabolite accounts for about 20% of sildenafil's
pharmacologic effects. After either oral or
intravenous administration, sildenafil is excreted as
metabolites predominantly in the feces (approximately
80% of administered oral dose) and to a lesser extent
in the urine (approximately 13% of the administered
oral dose). Similar values for pharmacokinetic
parameters were seen in normal volunteers and in the
patient population, using a population pharmacokinetic
approach. Therefore, age 65, hepatic impairment and
severe renal impairment are associated with increased
plasma levels of sildenafil.
In addition,
patients were asked a global efficacy question and an
optional partner questionnaire was administered.
Results with all doses have been pooled, but scores
showed greater improvement at the 50 and 100 mg doses
than at 25 mg. The pattern of responses was similar
for the other principal question, the ability to
achieve an erection sufficient for intercourse. The
titration studies, in which most patients received 100
mg, showed similar results. At the same time,
ontreatment function was better in treated patients
who were less impaired at baseline. Onethird to
onehalf of the subjects in these studies reported
successful intercourse at least once during a 4week,
treatmentfree runin period. In many of the studies, of
both fixed dose and titration designs, daily diaries
were kept by patients. One randomized, doubleblind,
flexibledose, placebocontrolled study included only
patients with erectile dysfunction attributed to
complications of diabetes mellitus (n=268). One
randomized, doubleblind, placebocontrolled, crossover,
flexibledose (up to 100 mg) study of patients with
erectile dysfunction resulting from spinal cord injury
(n=178) was conducted. A review of population
subgroups demonstrated efficacy regardless of baseline
severity, etiology, race and age.
Digestive:
vomiting, glossitis, colitis, dysphagia, gastritis,
gastroenteritis, esophagitis, stomatitis, dry mouth,
liver function tests abnormal, rectal hemorrhage,
gingivitis. Musculoskeletal: arthritis, arthrosis,
myalgia, tendon rupture, tenosynovitis, bone pain,
myasthenia, synovitis. Nervous: ataxia, hypertonia,
neuralgia, neuropathy, paresthesia, tremor, vertigo,
depression, insomnia, somnolence, abnormal dreams,
reflexes decreased, hypesthesia. Respiratory: asthma,
dyspnea, laryngitis, pharyngitis, sinusitis,
bronchitis, sputum increased, cough increased.
Urogenital: cystitis, nocturia, urinary frequency,
breast enlargement, urinary incontinence, abnormal
ejaculation, genital edema and anorgasmia. Most, but
not all, of these patients had preexisting
cardiovascular risk factors. In some of the cases,
medical conditions and other factors were reported
that may have also played a role in the otologic
adverse events. In many cases, medical followup
information was limited. In cases of overdose,
standard supportive measures should be adopted as
required. Renal dialysis is not expected to accelerate
clearance as sildenafil is highly bound to plasma
proteins and it is not eliminated in the urine.
No severe adverse events potentially related to blood
pressure effects were reported in this group. There
were no reports of syncope among these patients. For
these four subjects, the placebosubtracted mean
maximum decreases from baseline in supine and standing
systolic blood pressures were 14. The mean subject age
in this study was 63. This patient had been taking
minoxidil, a potent vasodilator, during the study.
There were no severe adverse events potentially
related to blood pressure and no episodes of syncope
reported in this study. If a subject did not
successfully complete this first dosing period, he was
discontinued from the study. Treatment with doxazosin
continued for at least 7 days after dose period 1. The
mean subject age in this study was 66. Twentyfive
subjects were screened.
This is called an
erection. After the man is done having sex, this extra
blood flows out of the penis back into the body. The
erection goes away. You should call a doctor
immediately if you ever have a prolonged erection that
lasts more than 4 hours. Some conditions and medicines
interfere with this natural erection process. The
penis cannot fill with enough blood. The man cannot
have an erection. This is called erectile dysfunction
if it becomes a frequent problem. During sex, your
heart works harder. Therefore sexual activity may not
be advisable for people who have heart problems.
Based on effectiveness and toleration, the dose may be
increased to a maximum recommended dose of 100 mg or
decreased to 25 mg. The maximum recommended dosing
frequency is once per day. Since higher plasma levels
may increase both the efficacy and incidence of
adverse viagra tablets sildenafil, a starting dose of
25 mg should be considered in these patients. It is
not meant to take the place of your doctor's
instructions. This medicine can help many men when it
is used as prescribed by their doctors. It is intended
for use only by men who have a condition called
erectile dysfunction. This includes nitroglycerin. It
can help many men who have erectile dysfunction get
and keep an erection when they become sexually excited
(stimulated). You will not get an erection just by
taking this medicine. The penis then expands and
hardens.
Therefore, the use of such
combinations is not recommended. In vitro studies with
human platelets indicate that sildenafil potentiates
the antiaggregatory effect of sodium nitroprusside (a
nitric oxide donor). Physicians should discuss with
patients the potential cardiac risk of sexual activity
in patients with preexisting cardiovascular risk
factors. Patients who experience symptoms (e. If
priapism is not treated immediately, penile tissue
damage and permanent loss of potency may result.
Therefore, inhibitors of these isoenzymes may reduce
sildenafil clearance and inducers of these isoenzymes
may increase sildenafil clearance. Although the
interaction between other protease inhibitors and
sildenafil has not been studied, their concomitant use
is expected to increase sildenafil levels. In a study
of healthy male volunteers, coadministration of
sildenafil at steady state (80 mg t. These effects on
the metabolite are not expected to be of clinical
consequence. The mean subject age was 66.
This analysis was performed retrospectively, and was
not powered to detect any prespecified difference in
adverse reactions. In the following patients: age 65,
hepatic impairment (e. Although plasma levels of
sildenafil at 24 hours post dose are much lower than
at peak concentration, it is unknown whether nitrates
can be safely coadministered at this time point. In
the event of an erection that persists longer than 4
hours, the patient should seek immediate medical
assistance. If priapism is not treated immediately,
penile tissue damage and permanent loss of potency
could result. Data from subjects exposed to high
systemic levels of sildenafil are limited. Visual
disturbances occurred more commonly at higher levels
of sildenafil exposure. Decreased blood pressure,
syncope, and prolonged erection were reported in some
healthy volunteers exposed to high doses of sildenafil
(200800 mg). When vasodilators are used in
combination, an additive effect on blood pressure may
be anticipated. Viagra has systemic vasodilatory
properties and may augment the viagra tablets
sildenafil pressure lowering effect of other
antihypertensive medications.
You should
call a doctor immediately if you ever have an erection
that lasts more than 4 hours. Most, but not all, of
these men had heart problems before taking this
medicine. If you want more information or develop any
side effects or symptoms you are concerned about, call
your doctor. Only your doctor can decide if it is
right for you. This sheet is only a summary.
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