Tadalafil Dapoxetine Tablets to treat Erectile Dysfunction and Premature Ejaculation at the Same Time

© Clearsky Pharmacy
Tadalafil Dapoxetine Tablets to treat Erectile Dysfunction and
Premature Ejaculation at the Same Time

Tadalafil and Dapoxetine Combination medication is a
combination containing Tadalafil 20mg and Dapoxetine 60mg
in a single tablet.
Tadalafil Dapoxetine Tablets are used for the treatment of male
erectile dysfunction as well as treatment of premature ejaculation
in men at the same time.
Tadalafil is used to treat men who have erectile dysfunction (also
called sexual impotence).
Dapoxetine Hydrochloride is used to treat premature ejaculation
in adult men aged 18 to 64 years. Dapoxetine increases the time it
takes to ejaculate and can improve the control over the ejaculation.

Tadalafil Dapoxetine Tablets – Brand Names
Tadalafil Dapoxetine combination tablets
tablets are available as Tadali Superb
Tablets, Duraplus Tablets, Super Vidalista
Tablets, Super Tadalista Tablets, Super
Tadalis SX Tablets and Super Tadarise
Tablets.

Active Ingredients
The active ingredients contained in Tadalafil
Dapoxetine tablets are Tadalafil and Dapoxetine
Hydrochloride. Each Tadalafil Dapoxetine
combination tablet contains 20 mg of Tadalafil and
60 mg of Dapoxetine.

Chemical Structure
The structure of Tadalafil is given below:

Chemical Structure
The structure of Dapoxetine is given below:

Tadali Superb Tablets

Tadali Superb Tablets
Manufactured By: Alpha-Pharma Healthcare Private
Limited, India
Strengths Available: Strengths Available: 80 mg
( Tadalafil 20mg and Dapoxetine Hydrochloride 60mg)
More details on Tadali Superb Tablets

Super Vidalista Tablets

Super Vidalista Tablets
Manufactured By: Centurion Laboratories Private
Limited, India
More details on Super Vidalista Tablets

Super Tadalis SX Tablets

Super Tadalis SX Tablets
Manufactured By: Ajanta Pharma Limited, India
More details on Tadalis SX Tablets

Uses of Tadalafil and Dapoxetine Tablets
The medical effect produced by Tadalafil Dapoxetine tablets is due to it's two
components: Tadalafil and Dapoxetine Hydrochloride.
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor used for the treatment of
Erectile Dysfunction (ED).
Dapoxetine Hydrochloride is indicated for the treatment of premature ejaculation
(PE) in adult men aged 18 to 64 years. Dapoxetine Hydrochloride should only be
prescribed to patients who meet all the following criteria:
An intravaginal ejaculatory latency time (IELT) of less than two minutes; and
persistent or recurrent ejaculation with minimal sexual stimulation before, on, or
shortly after penetration and before the patient wishes; and marked personal
distress or interpersonal difficulty as a consequence of PE; and poor control over
ejaculation as well as a history of premature ejaculation in the majority of
intercourse attempts over the prior 6 months.

Recommended Adult Dosage
The dose of Tadalafil and Dapoxetine Combination
medication is orally one tablet once a day, with or
without meals.
The tablet has to be administered one to three hours
before sexual activity.
Do not take more than 1 tablet in any 24 hour period.
i.e. At least 24 hours should pass before you take the
next dose.

Contraindications
Tadalafil Dapoxetine tablets are contraindicated in patients with a known
hypersensitivity to Tadalafil, Dapoxetine Hydrochloride or any
component of the tablet.
Administration of this medicine to patients using any form of organic
nitrate is contraindicated. Tadalafil was shown to potentiate the
hypotensive effect of nitrates.
Administration of this medicine to patients with significant pathological
cardiac conditions is contraindicated.
A history of mania or severe depression.
Concomitant treatment with Thioridazine, or within 14 days of
discontinuing treatment with Thioridazine. Similarly, Thioridazine should
not be administered within 7 days after Tadalafil Dapoxetine tablets have
been discontinued.

Contraindications
Concomitant treatment with serotonin reuptake inhibitors [selective
serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine
reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs)] or
other medicinal/herbal products with serotonergic effects [e.g., L-
tryptophan, triptans, tramadol, linezolid, lithium, St. John's Wort
(Hypericum perforatum)] or within 14 days of discontinuing
treatment with these medicinal/herbal products.
Similarly, these medicinal/herbal products should not be
administered within 7 days after this medicine has been
discontinued.

Contraindications
Concomitant treatment of potent CYP3A4 inhibitors such as
Ketoconazole, Itraconazole, Ritonavir, Saquinavir,
Telithromycin, Nefazadone, Nelfinavir, Atazanavir, etc..
Moderate and severe hepatic impairment.
Do not use Tadalafil Dapoxetine tablets in patients who are
using a GC stimulator, such as Riociguat. Tadalafil may
potentiate the hypotensive effects of GC stimulators.

Storage Instructions
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.

Tadalafil Dapoxetine Tablets - Warnings
Patients should not use Tadalafil Dapoxetine tablets if sex is inadvisable
due to cardiovascular status.
Use of Tadalafil Dapoxetine tablets with alpha blockers,
antihypertensives or substantial amounts of alcohol (5 units or greater)
may lead to hypotension.
This medicine 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.
Caution is advised when Tadalafil Dapoxetine tablets are used as a
treatment for ED in men taking alpha blockers.
Tadalafil Dapoxetine tablets are not suitable and should not be used if
taking potent inhibitors of CYP3A4.

Patients should seek emergency treatment if an erection lasts for
more than 4 hours. Use Tadalafil Dapoxetine tablets with caution
in patients predisposed to priapism.
Patients should stop Tadalafil Dapoxetine tablets and seek medical
care if a sudden loss of vision occurs in one or both eyes, which
could be a sign of Non Arteritic Ischemic Optic Neuropathy
(NAION).
Discuss increased risk of NAION in patients with history of NAION.
Patients should stop Tadalafil Dapoxetine tablets and seek prompt
medical attention in the event of sudden decrease or loss of hearing.

Dapoxetine, a constituent of this medicine is only indicated in men
with Premature Ejaculation who meet all the criteria listed listed
earlier. Dapoxetine should not be prescribed to men who have not
been diagnosed with Premature Ejaculation. Safety has not been
established and there are no data on the ejaculation-delaying effects
in men without Premature Ejaculation.
Before treatment initiation, a careful medical examination including
history of orthostatic events should be performed by the physician. An
orthostatic test should be performed before initiating therapy (blood
pressure and pulse rate, supine and standing).
In case of a history of documented or suspected orthostatic reaction,
treatment with Tadalafil Dapoxetine tablets should be avoided.

Antidepressants, including SSRIs, increased 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. Short-term studies
did not show an increase in the risk of suicidality with antidepressants compared
to placebo in adults beyond age 24. In clinical trials with Dapoxetine, a constituent
of Tadalafil Dapoxetine tablets for the treatment of premature ejaculation, there
was no clear indication of treatment-emergent suicidality in evaluation of possibly
suicide-related adverse events.
Patients should avoid operating hazardous machinery, should syncope or its
prodromal symptoms such as dizziness or lightheadedness occur.
The risk of adverse cardiovascular outcomes from syncope (cardiac syncope and
syncope from other causes) is increased in patients with underlying structural
cardiovascular disease.

Patients should be advised not to use Tadalafil Dapoxetine tablets in
combination with recreational drugs.
Patients should be advised not to use Tadalafil Dapoxetine tablets in
combination with alcohol. Combining alcohol with dapoxetine may
increase alcohol-related neurocognitive effects and may also enhance
neurocardiogenic adverse events such as syncope, thereby increasing the
risk of accidental injury; therefore, patients should be advised to avoid
alcohol while taking Tadalafil Dapoxetine tablets .
Tadalafil Dapoxetine tablets should be prescribed with caution in patients
taking medicinal products with vasodilatation properties (such as alpha
adrenergic receptor antagonists and nitrates) due to possible reduced
orthostatic tolerance.

This medicine is not suitable in patients taking moderate CYP3A4 inhibitors and
in patients taking potent CYP2D6 inhibitors since the Dapoxetine dose is restricted
to 30 mg.
Tadalafil Dapoxetine tablets 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, Tadalafil Dapoxetine
tablets should be discontinued in any patient who develops seizures and avoided
in patients with unstable epilepsy. Patients with controlled epilepsy should be
carefully monitored.
Tadalafil Dapoxetine tablets should not be used in individuals below 18 years of
age.

Tadalafil Dapoxetine tablets are not indicated for psychiatric disorders and
should not be used in men with these disorders, such as schizophrenia, or
in those suffering with co-morbid depression, as worsening of symptoms
associated with depression cannot be excluded.
There have been reports of bleeding abnormalities with SSRIs. Caution is
advised in patients taking this medicine, particularly in concomitant use
with medicinal products known to affect platelet function or
anticoagulants, as well as in patients with a history of bleeding or
coagulation disorders.
Tadalafil Dapoxetine tablets are not recommended for use in patients with
severe renal impairment and caution is advised in patients with mild or
moderate renal impairment.

Patients with rare hereditary problems of galactose intolerance,
the Lapp lactase deficiency or glucose-galactose malabsorption
should not take this Tadalafil Dapoxetine tablets.
The use of Dapoxetine, a constituent of Tadalafil Dapoxetine
tablets has been associated with ocular effects such as
mydriasis and eye pain. Dapoxetine should be used with
caution in patients with raised intraocular pressure or those at
risk of angle closure glaucoma.

Withdrawal Effects
Abrupt discontinuation of chronically administered SSRIs used to treat
chronic depressive disorders has been reported to result in the following
symptoms: dysphoric mood, irritability, agitation, dizziness, sensory
disturbances (e.g., paresthesias such as electric shock sensations), anxiety,
confusion, headache, lethargy, emotional lability, insomnia and
hypomania.

Possible Side Effects
Most common side effects Tadalafil Dapoxetine Combination
tablets are increased thirst and a light-headedness
following sudden movements - this is natural, as blood
moves into the genital areas.
The common side effects include headache, dyspepsia, back
pain, myalgia, nasal congestion, flushing, nausea, dizziness,
diarrhoea, insomnia,fatigue and pain in limb.

Tadalafil Dapoxetine Tablets Overdose
Single doses up to 500 mg of Tadalafil have been given
to healthy subjects, and multiple daily doses up to 100
mg have been given to patients. Adverse events were
similar to those seen at lower doses.
In cases of overdose, standard supportive measures
should be adopted as required. Hemodialysis contributes
negligibly to Tadalafil elimination.

Tadalafil Dapoxetine Tablets Overdose
No case of Dapoxetine overdose has been reported.
There were no unexpected adverse events in a clinical pharmacology
study of Dapoxetine with daily doses up to 240 mg (two 120 mg doses
given 3 hours apart). In general, symptoms of overdose with SSRIs
include serotonin-mediated adverse reactions such as somnolence,
gastrointestinal disturbances such as nausea and vomiting, tachycardia,
tremor, agitation and dizziness.
In cases of overdose, standard supportive measures should be adopted
as required. 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.
No specific antidotes for Dapoxetine are known.

Tadalafil Dapoxetine Tablets During Pregnancy
This is a combination medication containing Tadalafil and
Dapoxetine Hydrochloride. Tadalafil has been classified by the US
FDA as Pregnancy Category B. Dapoxetine Hydrochloride has
been classified by the US FDA as Pregnancy Category C. Tadalafil
Dapoxetine tablets are not indicated for use by women.
There is no evidence to suggest that Dapoxetine Hydrochloride
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.

Tadalafil Dapoxetine Tablets to treat Erectile Dysfunction and Premature Ejaculation at the Same Time

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Tadalafil Dapoxetine Tablets to treat Erectile Dysfunction and Premature Ejaculation at the Same Time

Similar to Tadalafil Dapoxetine Tablets to treat Erectile Dysfunction and Premature Ejaculation at the Same Time (20)

More from Clearsky Pharmacy

More from Clearsky Pharmacy (20)

Recently uploaded

Recently uploaded (20)

Tadalafil Dapoxetine Tablets to treat Erectile Dysfunction and Premature Ejaculation at the Same Time