Vilitra (Generic Vardenafil Hydrochloride Tablets)

Vilitra (Generic Vardenafil Hydrochloride Tablets)
© The Swiss Pharmacy

Vilitra (Generic Vardenafil Hydrochloride Tablets) is used
for the treatment of erectile dysfunction in adult men, a
medical condition which implies the inability to attain or
maintain a penile erection long enough to satisfactorily
complete sexual activity.
After the penis is stroked, Vardenafil maintains an erection
by increasing blood flow. Without physical activity, such as
that occurring during sexual intercourse, Vardenafil will
not cause an erection.

Vilitra Tablets are manufactured by
Centurion Remedies Private Limited, India
in the strengths of 10 mg, 20 mg, 40 mg
and 60 mg.

Chemical Structure - Vardenafil Hydrochloride

The active ingredient contained in Vilitra
tablets is Vardenafil Hydrochloride.
Each Vilitra tablet contains Vardenafil
Hydrochloride equivalent to 10 mg, 20 mg, 40
mg or 60 mg of Vardenafil.

Uses of Vilitra 10 mg, 20 mg, 40 mg and 60 mg tablets:
Vardenafil Hydrochloride (Vilitra Tablets) is a phosphodiesterase 5
(PDE5) inhibitor indicated for the treatment of erectile dysfunction
(ED). It belongs to a group of medicines called phosphodiesterase 5
(PDE5) inhibitors.
After the penis is stroked, Vardenafil maintains an erection by
increasing blood flow. Without physical activity, such as that
occurring during sexual intercourse, Vardenafil will not cause an
erection.

Recommended Adult Dosage
For most patients, the starting dose of
Vilitra (Generic Vardenafil Hydrochloride Tablets) for
use as needed is 10mg as needed 25 minutes to 60 minutes
prior to sexual activity. Increase to 20mg or decrease to 5mg
based upon efficacy/tolerability.
Not to be taken more than once per day (i.e. 24 hours must
pass before you take your next dose)

Elderly (65 years old and more): Dose adjustments are not
required in elderly patients. However, an increase to a maximum 20
mg dose should be carefully considered depending on the individual
tolerability.
Hepatic impairment: A starting dose of 5 mg should be considered
in patients with mild and moderate hepatic impairment (Child-Pugh
A-B). Based on tolerability and efficacy, the dose may subsequently
be increased. The maximum dose recommended in patients with
moderate hepatic impairment (Child-Pugh B) is 10 mg.

Renal impairment: No dose adjustment is required in
patients with mild to moderate renal impairment. In
patients with severe renal impairment (creatinine
clearance less than 30 ml/min), a starting dose of 5 mg
should be considered. Based on tolerability and efficacy
the dose may be increased to 10 mg and 20 mg.

Contraindications
➔
Vilitra is contraindicated in patients with a known
hypersensitivity to Vardenafil Hydrochloride or any
component of the tablet.
➔
Administration of Vilitra with with nitrates and nitric
oxide donors is contraindicated.
➔
Vilitra is contraindicated in patients who have loss of
vision in one eye because of non-arteritic anterior
ischaemic optic neuropathy (NAION).

Storage Instructions
Vilitra (Generic Vardenafil Hydrochloride
Tablets) have to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F to 77°F)
with excursions permitted between 15° to 30°C
(59° to 86°F).
Keep this as well as all other medicines away
from children and pets.

Warnings
Cardiovascular Effects: Patients should not use Vilitra tablets in case
sex is inadvisable due to cardiovascular status.
Risk of Priapism: In the event that an erection lasts more than 4 hours,
the patient should seek immediate medical assistance.
Effects on the Eye: Patients should stop use of Vilitra, and seek medical
attention in the event of sudden loss of vision in one or both eyes,
which could be a sign of nonarteritic anterior ischemic optic neuropathy
(NAION). Vilitra should be used with caution, and only when the
anticipated benefits outweigh the risks, in patients with a history of
NAION. Patients with a “crowded” optic disc may also be at an
increased risk of NAION.

Warnings
Sudden Hearing Loss: Patients should stop Vilitra and seek
medical attention in the event of sudden decrease or loss in
hearing.
Alpha-Blockers: Caution is advised when PDE5 inhibitors are co
administered with alpha-blockers.
In some patients, concomitant use of these two drug classes can
lower blood pressure significantly leading to symptomatic
hypotension (for example, fainting).
QT Prolongation: Patients with congenital QT syndrome or taking
class IA or III antiarrhythmics should avoid using Vilitra tablets.

Possible Side Effects
Most common Vilitra (Generic Vardenafil tablets)
side effects with an incidence rate of greater than or
equal to 2% are headache, flushing, nasal congestion,
dyspepsia, sinusitis, flu syndrome, dizziness, increased
creatine kinase, nausea, back pain.

The following side effects occurred in less than 2% of the patients during
Vardenafil Hydrochloride tablets clinical trials:
Body as a whole: allergic edema and angioedema, feeling unwell, allergic
reactions, chest pain
Auditory: tinnitus, vertigo
Cardiovascular: palpitation, tachycardia, angina pectoris, myocardial
infarction, ventricular tachyarrhythmias, hypotension
Digestive: nausea, gastrointestinal and abdominal pain, dry mouth,
diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in
transaminases
Musculoskeletal: increase in creatine phosphokinase (CPK), increased
muscle tone and cramping, myalgia

Nervous: paresthesia and dysesthesia, somnolence, sleep disorder,
syncope, amnesia, seizure Respiratory: dyspnea, sinus congestion
Skin and appendages: erythema, rash
Ophthalmologic: visual disturbance, ocular hyperemia, visual
color distortions, eye pain and eye discomfort, photophobia,
increase in intraocular pressure, conjunctivitis
Urogenital: increase in erection, priapism

Vilitra Overdosage
The maximum dose of Vilitra (Generic Vardenafil
Hydrochloride Tablets) for which human data are available is a
single 120 mg dose administered to eight healthy male
volunteers. The majority of these subjects experienced
reversible back pain/myalgia and/or “abnormal vision.”
When Vardenafil was administered in higher doses and more
frequently than the recommended dose regimen (40 mg tablets
twice daily) cases of severe back pain have been reported. This
was not associated with any muscle or neurological toxicity.

Treatment of Vilitra Overdosage
In cases of Vilitra tablets overdose, standard
supportive measures should be taken as required.
Renal dialysis is not expected to accelerate clearance
since Vardenafil is highly bound to plasma proteins and
is not significantly eliminated in the urine.

Vilitra Tablets During Pregnancy
Vardenafil Hydrochloride (Vilitra Tablets) is classified by the US
FDA as Pregnancy Category B.
Vilitra tablets are not indicated for use in women.
No evidence of specific potential for teratogenicity, embryotoxicity
or fetotoxicity was observed in rats and rabbits that received
Vardenafil at up to 18 mg/kg/day during organogenesis.
This dose is approximately 100 fold (rat) and 29 fold (rabbit)
greater than the AUC values for unbound Vardenafil and its major
metabolite in humans given the maximum recommended human
dose (MRHD) of 20 mg.

Vilitra Tablets are manufactured by
Centurion Remedies Private Limited, India.
For More details Click Here

Vilitra (Generic Vardenafil Hydrochloride Tablets)

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