Alphagra Superb Tablets

Alphagra Superb Tablets
© Clearsky Pharmacy
Alphagra Superb 160 mg, a combination of Sildenafil Citrate
100 mg and Dapoxetine Hydrochloride 60 mg, is a new
medicine, manufactured by Alpha-Pharma Healthcare, India
used to treat men 18 years and above with erectile
dysfunction (ED) when at the same time treatment of
premature ejaculation is also necessary.

Alphagra Superb tablets are
manufactured by Alpha-Pharma
Healthcare, India.
(Website: www.alpha-pharma.com)

Sildenafil and Dapoxetine Tablets – Brand Names
Sildenafil Citrate and Dapoxetine
Hydrochloride combination tablets
are available as Alphagra Superb,
Super P-Force tablets and Super
Kamagra tablets.

Active Ingredients
The active ingredients contained in Alphagra
Superb tablets are Sildenafil Citrate and
Dapoxetine Hydrochloride. Each 160 mg
Alphagra Superb tablet contains 100 mg of
Sildenafil Citrate and 60 mg of Dapoxetine
Hydrochloride.

Chemical Structure
The structure of Sildenafil Citrate is given
below:

Chemical Structure
The structure of Dapoxetine HCl is given
below:

Alphagra Superb Tablets Dosage
➢This medicine is to be administered orally
whenever required.
➢Take One Alphagra Superb 160 mg tablet
one to three hours before any sexual activity
with at least one full glass of water.
➢Do not take more than one tablet in any 24
hour period. At least 24 hours must pass since
your last dose.
The dosage of Alphagra Superb tablets
(Sildenafil Citrate and Dapoxetine Hydrochloride)
is given below:

Uses of Alphagra Superb Tablets
Alphagra Superb 160 mg Oral tablets are used
for the treatment of male erectile dysfunction as
well as treatment of premature ejaculation
simultaneously in men aged 18 years and above.
Sildenafil Citrate, an oral medicine for erectile
dysfunction, is a selective inhibitor of cyclic
guanosine monophosphate (cGMP)-specific
phosphodiesterase type 5.
Dapoxetine Hydrochloride, is a selective
serotonin reuptake inhibitor (SSRI) which is used to
treat persistent or recurrent ejaculation with
minimal sexual stimulation before, on, or shortly
after penetration and before the patient wishes.

Storage Instructions
Alphagra Superb 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
Alphagra Superb 160 mg tablets (Sildenafil Dapoxetine
tablets) should not be administered to patients in case
sexual activity is NOT advisable for them due to their
cardiovascular status.
Patients must seek emergency treatment in case an
erection lasts for greater than 4 hours. Use Alphagra
Superb Oral tablets with caution in patients predisposed
to priapism.
Patients must stop Alphagra Superb tablets and seek
immediate medical treatment in case a sudden loss of
vision occurs in one or both eyes, which could be a sign of
non arteritic anterior ischemic optic neuropathy (NAION).
Patients must stop Alphagra Superb tablets and seek
immediate medical treatment in the event of sudden
decrease or loss of hearing.

Alphagra Superb Tablets Warnings
Caution is advised when Alphagra Superb is co-
administered along with alpha-blockers or anti-
hypertensives. Concomitant use may lead to hypotension.
Decreased blood pressure, syncope, and prolonged erection
can occur at higher Sildenafil exposures. In patients taking
strong CYP inhibitors, such as Ritonavir, Sildenafil exposure
is increased.
Dizziness, disturbance in attention, syncope, blurred vision
and somnolence have been observed in patients receiving
Dapoxetine, a constituent of Alphagra Superb oral tablets.
Patients must be advised not to use Alphagra Superb
tablets in combination with recreational drugs.
Recreational drugs with serotonergic activity such as
Ketamine, methylenedioxy-methamphetamine (MDMA) and
lysergic acid diethylamide (LSD) can lead to potentially
serious reactions if combined with Alphagra Superb tablets.

Combining alcohol with Alphagra Superb could increase
alcohol-related neurocognitive effects and could also
increase neurocardiogenic adverse events such as
syncope, thereby increasing the risk of accidental injury.
Hence patients must be advised to avoid drinking
alcohol while taking Alphagra Superb Oral tablets.
Possibly prodromal symptoms such as nausea,
dizziness/lightheadedness, and diaphoresis were seen
more frequently among patients treated with Dapoxetine
compared to placebo.
An orthostatic test should be carried out before
starting therapy with this medicine. In case of a history
of documented or suspected orthostatic reaction,
treatment with Alphagra Superb tablets (Sildenafil and
Dapoxetine tablets) MUST be avoided.

Alphagra Superb oral tablets should not
be administered to patients with a
history of mania/hypomania or bipolar
disorder and must be stopped
immediately in any patient who
develops ANY symptoms of such
disorders.
Therapy with Alphagra Superb tablets
must be discontinued in any patient who
develops seizures and avoided in
patients with unstable epilepsy.

Contraindications
Alphagra Superb oral tablets are contraindicated in
patients with a hypersensitivity to Sildenafil Citrate,
Dapoxetine Hydrochloride or any other ingredient
present in this medicine.
Administration of Alphagra Superb to patients
using nitric oxide donors, such as organic nitrates or
organic nitrites in any form is contraindicated.
Alphagra Superb tablets are also contraindicated in
patients with significant cardiac conditions as well as
in patients for whom sexual intercourse is NOT
advisable due to cardiovascular risk factors.
This medication is contraindicated in men with
severe hepatic impairment (decreased liver function).

Contraindications
Alphagra Superb oral tablets are contraindicated in patients
with Significant pathological cardiac conditions such as Heart
failure, Conduction abnormalities, Significant ischemic heart
disease, Significant valvular disease or a history of syncope.
Concomitant treatment with monoamine oxidase inhibitors
(MAOIs) or Thioridazine, or within 14 days of discontinuing
treatment with an MAOI or Thioridazine. Similarly, an MAOI
or Thioridazine should not be administered within 7 days
after Alphagra Superb 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 (Hypericum perforatum)] or within 14 days of
discontinuing treatment with these medicinal/herbal products.

Contraindications
Alphagra Superb (Sildenafil and Dapoxetine Tablets)
is contraindicated in patients with a history of mania
or severe depression.
Concomitant treatment of potent CYP3A4 inhibitors
such as ketoconazole, itraconazole, ritonavir,
saquinavir, telithromycin, nefazadone, nelfinavir,
atazanavir, etc. is contraindicated

Alphagra Superb Side Effects
➢The most common side effects caused
by Dapoxetine with an incidence rate of
5% or more are headache, dizziness,
nausea, dry mouth, diarrhoea, insomnia
and fatigue.
➢Most common side effects with an
incidence rate of 2% or more caused by
Sildenafil Citrate include headache,
flushing, dyspepsia, abnormal vision,
nasal congestion, back pain, myalgia,
nausea, dizziness and rash.

Alphagra Superb Tablets Overdose
The overdose effects due to Sildenafil Citrate
can cause prolonged erections, known as
priapism, nausea, chest pains and irregular
heartbeat.
In case priapism is not treated within 24
hours the penis may become permanently
damaged, leading to difficulties achieving an
erection in future.
Symptoms of overdose with Dapoxetine
Hydrochloride are somnolence,
gastrointestinal disturbances such as nausea
and vomiting, tachycardia, tremor, agitation
and dizziness.

Alphagra Superb Tablets Overdose
In cases of Alphagra Superb tablets
overdose, standard supportive measures
must 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.
Similarly renal dialysis is not expected to
accelerate clearance as Sildenafil is highly
bound to plasma proteins and it is not
eliminated in the urine.

Alphagra Superb Tablets During Pregnancy
Sildenafil Citrate has been classified by the
US FDA as Pregnancy Category B.
Dapoxetine Hydrochloride has been
classified by the US FDA as Pregnancy
Category C.
Alphagra Superb oral tablets (Sildenafil
Citrate and Dapoxetine tablets) is not
indicated for use by women.
There are no adequate and well-controlled
studies of Sildenafil Citrate as well as
Dapoxetine Hydrochloride in pregnant
women.

For more details on
Alphagra Superb tablets click here
Alphagra Superb 160 mg Tablets (Sildenafil
Dapoxetine Tablets) by Alpha-Pharma Healthcare
Limited, India.

Alphagra Superb Tablets

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