Super Vidalista (Tadalafil Dapoxetine Tablets)

Super Vidalista (Tadalafil Dapoxetine Tablets)
© The Swiss Pharmacy

Super Vidalista (Tadalafil Dapoxetine Tablets) is a combination medication
consisting of Tadalafil 20 mg and Dapoxetine Hydrochloride 60 mg. It is a
convenient solution for patients that require treatment for Erectile
Dysfunction (ED) as well as Premature Ejaculation (PE) at the same time.
Tadalafil is used to treat erectile dysfunction, a condition in wherein a
man cannot get, or keep, a hard erect penis suitable for sexual activity.
Dapoxetine Hydrochloride is a treatment for premature ejaculation (PE)
in men 18 to 64 years old who have ejaculate within 2 minutes following
penetration and before the man wishes to as well as marked personal
distress and interpersonal difficulty as a result of premature ejaculation
and poor control over ejaculation.

Super Vidalista Tablets are
manufactured by Centurion
Laboratories Private Limited,
India.

Tadalafil - Chemical Structure

Dapoxetine - Chemical Structure

The active ingredients contained in
tablets are Tadalafil and Dapoxetine
Hydrochloride.
Each Super Vidalista tablet contains 20
mg of Tadalafil and 60 mg of Dapoxetine
Hydrochloride.

Uses of Super Vidalista 80 mg tablets:
Super Vidalista is made up of two active ingredients (the substances that
produce the desired medical effects) Tadalafil and Dapoxetine Hydrochloride.
Dapoxetine Hydrochloride is a treatment for men 18 to 64 years old with
frequent premature ejaculation (PE), which troubles the man and affects the
relationship with his sexual partner. PE is a common sexual disorder in
which ejaculation happens with minimal sexual stimulation before, on, or
shortly after penetration, and before the man wishes it.
Tadalafil ia a phosphodiesterase 5 (PDE5) inhibitor used for the treatment of
erectile dysfunction in adult males. In order for Tadalafil to be effective for
the treatment of erectile dysfunction, sexual stimulation is required.

Recommended Adult Dosage
The dose of Super Vidalista (Tadalafil Dapoxetine Tablets) is
one 80 mg tablet taken approximately one to three hours
before sexual activity with at least one full glass of water.
Tablets must be swallowed whole.
Do not take more than 1 tablet in any 24 hour period. At least
24 hours must pass since your last dose.

Contraindications
➔Super Vidalista is contraindicated in patients with a known hypersensitivity to
Tadalafil, Dapoxetine Hydrochloride or any component of the tablet.
➔Patients with significant pathological cardiac conditions, conduction
abnormalities, significant ischemic heart disease or significant valvular disease.
➔Administration of Super Vidalista to patients using any form of organic nitrate
is contraindicated. Tadalafil (Super Vidalista) has been shown to potentiate the
hypotensive effect of nitrates.
➔Administration of this medicine along with guanylate cyclase (GC) stimulators,
such as Riociguat is contraindicated.

Contraindications
➔Super Vidalista is contraindicated for concomitant treatment with monoamine oxidase
inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI.
Similarly, an MAOI should not be administered within 7 days after Super Vidalista has
been discontinued.
➔Concomitant treatment with Thioridazine, or within 14 days of discontinuing
treatment with Thioridazine. Similarly, Thioridazine should not be administered within 7
days after Super Vidalista has been discontinued
➔Concomitant treatment with serotonin reuptake inhibitors or other medicinal/herbal
products with serotonergic effects [e.g., L-tryptophan, Triptans, Tramadol, Linezolid,
Lithium, St. John's Wort ] or within 14 days of discontinuing treatment with these
medicinal/herbal products is contraindicated.

Contraindications
➔Super Vidalista is contraindicated for simultaneous treatment
with potent CYP3A4 inhibitors such as Ketoconazole,
Itraconazole, Ritonavir, Saquinavir, Telithromycin, Nefazodone,
Nelfinavir, Atazanavir, etc.
➔Super Vidalista is contraindicated in patients with moderate
and severe hepatic impairment.

Storage Instructions
Super Vidalista (Tadalafil Dapoxetine
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
Patients should not use Super Vidalista if sex is inadvisable due to
cardiovascular status.
Use of Super Vidalista with alpha-blockers, antihypertensives or substantial
amounts of alcohol (5 units or greater) could lead to hypotension.
Patients should not use Super Vidalista if sex is inadvisable due to
cardiovascular status.
Use of Super Vidalista with alpha-blockers, antihypertensives or substantial
amounts of alcohol (5 units or greater) may lead to hypotension
Super Vidalista is not recommended in combination with alpha-blockers for
the treatment of BPH because efficacy of the combination has not been
adequately studied and because of the risk of blood pressure lowering.

Warnings
Caution is advised when Super Vidalista is used as a treatment for ED in men taking
alpha-blockers.
Patients should seek emergency treatment if an erection lasts for greater than 4
hours. Use Super Vidalista with caution in patients predisposed to priapism.
Patients should stop Super Vidalista and seek medical care if a sudden loss of vision
occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic
optic neuropathy (NAION).
Super Vidalista 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 Patients should stop Super
Vidalista and seek prompt medical attention in the event of sudden decrease or loss
of hearing.

Warnings
Super Vidalista is only indicated in men with PE along with ED.
Patients must be advised not to use Tadalafil and Dapoxetine tablets in combination
with recreational drugs. Recreational drugs with serotonergic activity like ketamine,
methylenedioxy- methamphetamine (MDMA) and lysergic acid diethylamide (LSD)
may lead to potentially serious reactions if combined with Super Vidalista tablets.
These adverse reactions include, but are not limited to, arrhythmia, hyperthermia,
and serotonin syndrome.
Combining alcohol with Super Vidalista may increase alcohol-related neurocognitive
effects and may also enhance neurocardiogenic adverse events such as syncope,
thereby increasing the risk of accidental injury. Hence patients must be advised to
avoid alcohol while taking Super Vidalista.

Warnings
The number and percentage of patients with syncope (characterized as loss of
consciousness) was greater in Dapoxetine-treated subjects than in those who were
treated with placebo during clinical trials. Possibly prodromal symptoms such as
nausea, dizziness/light-headedness, and diaphoresis were reported more frequently
among patients treated with Dapoxetine , a constituent of this medicine compared to
placebo.
The risk of adverse cardiovascular outcomes from syncope (cardiac syncope and
syncope from other causes) is increased in patients with underlying structural
cardiovascular disease.
An orthostatic test should be performed before initiating therapy. In case of a history of
documented or suspected orthostatic reaction, treatment with Super Vidalista should be
avoided.

Warnings
Caution is advised in all patients concomitantly treated with moderate CYP3A4 inhibitors. Unless
the patient is known to be a CYP2D6 extensive metaboliser, caution is advised when used
concomitantly with moderate CYP3A4 inhibitors.
Caution is advised in patients taking potent CYP2D6 inhibitors or in patients known to be of
CYP2D6 poor metaboliser genotype, as this may increase exposure levels, which may result in a
higher incidence and severity of dose dependent adverse events.
SSRIs like Dapoxetine, a constituent of this medication have been shown to increase the risk
compared to placebo of suicidal thinking and suicidality in short-term studies in children and
adolescents with Major Depressive Disorder and other psychiatric disorders.
Super Vidalista should not be used in patients with a history of mania/hypomania or bipolar
disorder and should be discontinued in any patient who develops symptoms of these disorders.
Due to the potential of SSRIs to lower the seizure threshold,Super Vidalista should be discontinued
in any patient who develops seizures and avoided in patients with unstable epilepsy. Patients with
controlled epilepsy should be carefully monitored.

Warnings
Super Vidalista should not be used in individuals below 18 years of age or
patients with Co-morbid depression and psychiatric disorders.
Men with underlying signs and symptoms of depression should be evaluated
prior to treatment with Super Vidalista to rule out undiagnosed depressive
disorders. Concomitant treatment of Dapoxetine with antidepressants, including
SSRIs and SNRIs, is contraindicated.
There have been reports of bleeding abnormalities with SSRIs. Caution is advised
in patients taking Super Vidalista, particularly in concomitant use with medicinal
products known to affect platelet function, as well as in patients with a history of
bleeding or coagulation disorders.
Super Vidalista is not recommended for use in patients with renal impairment.

Possible Side Effects
The most common side effects of Super Vidalista (Tadalafil
Dapoxetine Tablets) are headache, dyspepsia, back pain,
myalgia, nasal congestion, flushing, pain in limb, dizziness,
nausea, diarrhoea, insomnia, somnolence, fatigue,
abdominal pain and anxiety.

Overdosage
Super Vidalista overdose symptoms are a combination of the overdose
symptoms of Tadalafil and Dapoxetine Hydrochloride and can include chest
pain, nausea, irregular heartbeat, feeling light-headed or fainting, somnolence,
gastrointestinal disturbances such as nausea and vomiting, tachycardia,
tremor, agitation and dizziness.
In cases of overdose, standard supportive measures should be taken as
necessary. Due to high protein binding and large volume of distribution of
Dapoxetine Hydrochloride, forced diuresis, dialysis, hemoperfusion and
exchange transfusion are unlikely to be of benefit. Hemodialysis contributes
negligibly to Tadalafil elimination. No specific antidotes for Super Vidalista
(Tadalafil Dapoxetine Tablets) are presently known.

Super Vidalista During Pregnancy
Super Vidalista is a combination medication containing Tadalafil and
Dapoxetine Hydrochloride. Tadalafil has been classified by the US FDA as
Pregnancy Category B. Dapoxetine HCl has been classified by the US FDA
as Pregnancy Category C. Super Vidalista is not indicated for use by
women.
There is no evidence to suggest that Dapoxetine exposure has an effect
on a partner's pregnancy based on limited observational data obtained
from the clinical trial database. There are no adequate and well-
controlled studies of Tadalafil or Dapoxetine conducted in pregnant
women.

Super Vidalista Tablets are manufactured by
Centurion Laboratories Private Limited, India.
For More details Click Here

Super Vidalista (Tadalafil Dapoxetine Tablets)

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