Pexep Tablets (Generic Paroxetine Hydrochloride Tablets)

Pexep Tablets (Generic Paroxetine Hydrochloride Tablets)
© The Swiss Pharmacy

Pexep (Generic Paroxetine Hydrochloride Tablets) is used
in adults for the treatment of Major Depressive Disorder
(MDD), Obsessive Compulsive Disorder (OCD), Panic
Disorder (PD), Generalised Anxiety Disorder (GAD), Social
Anxiety Disorder (SAD), Post-Traumatic Stress Disorder
(PTSD) and Premenstrual Dysphoric Disorder (PMDD).
This medication may improve your mood, sleep, appetite,
and energy level and may help restore your interest in daily
living.

Pexep Tablets are manufactured by Intas
Pharmaceuticals Limited, India in the strength of 10 mg,
20 mg, 30 mg and 40 mg.

Chemical Structure

The active ingredient contained in Pexep tablets is Paroxetine
Hydrochloride.
Each film-coated Pexep tablet contains Paroxetine
Hydrochloride equivalent to 10 mg, 20 mg, 30 mg or 40 mg of
Paroxetine.

Uses of Pexep 10 mg, 20 mg, 30 mg and 40 mg Tablets:
Pexep (Generic Paroxetine Hydrochloride Tablets) is a type of
antidepressant known as an SSRI (selective serotonin reuptake inhibitor). It's
used to treat depression or Major Depressive Disorder (MDD) and also
sometimes for Obsessive Compulsive Disorder (OCD), panic attacks or Panic
Disorder (PD), Generalised Anxiety Disorder (GAD), Social Anxiety Disorder
(SAD), anxiety or Post-Traumatic Stress Disorder (PTSD) and a severe form
of premenstrual syndrome known as Premenstrual Dysphoric Disorder
(PMDD).
Pexep is thought to work by increasing the activity of the chemical called
serotonin in the brain.
Paroxetine helps many people recover from depression, and it has fewer
unwanted effects than older antidepressants. It works by helping to restore
the balance of a certain natural substance (serotonin) in the brain.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9589_Paroxetine-Tablets.html

Uses of Pexep 10 mg, 20 mg, 30 mg and 40 mg Tablets:
Pexep may improve your mood, sleep, appetite, and energy level
and may help restore your interest in daily living.
It may decrease fear, anxiety, unwanted thoughts, and the number of
panic attacks.
It may also reduce the urge to perform repeated tasks (compulsions
such as hand-washing, counting, and checking) that interfere with
daily living.
This medicine is not indicated for use in children or adolescents
aged less than 18 years.

Recommended Adult Dosage
Major Depressive Disorder: For most patients, the starting dose of
Pexep Tablets (Generic Paroxetine Hydrochloride Tablets) is 20 mg/day to
be administered as a single daily dose with or without food, usually in the
morning. Some patients not responding to a 20 mg dose may benefit from
dose increases, in 10 mg/day increments, up to a maximum of 50 mg/day.
Obsessive Compulsive Disorder: The recommended dose of Paroxetine
Hydrochloride tablets in the treatment of OCD is 40 mg daily administered as
a single daily dose with or without food, usually in the morning.
Patients should be started on 20 mg/day and the dose can be increased in
10 mg/day increments. Dose changes should occur at intervals of at least 1
week. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials.

Panic Disorder: The recommended starting dose of Paroxetine
Hydrochloride tablets (Pexep) in the treatment of panic disorder is 10
mg/day administered as a single daily dose with or without food, usually in
the morning. The target dose of Paroxetine tablets in the treatment of panic
disorder is 40 mg/day.
Dose changes should occur in 10 mg/day increments and at intervals of at
least 1 week. Patients were dosed in a range of 10 to 60 mg/day in the
clinical trials. The maximum dosage should not exceed 60 mg/day.
Social Anxiety Disorder: The recommended starting dose of Paroxetine
Hydrochloride tablets (Pexep) in the treatment of social anxiety disorder is
20 mg/day administered as a single daily dose with or without food, usually
in the morning. Available information does not suggest any additional
benefit for doses above 20 mg/day.

Generalized Anxiety Disorder: The recommended starting dose of Paroxetine
Hydrochloride tablets (Pexep) in the treatment of generalized anxiety
disorder is 20 mg/day administered as a single daily dose with or without
food, usually in the morning. There is no sufficient evidence to suggest a
greater benefit to doses higher than 20 mg/day.
Posttraumatic Stress Disorder: The recommended starting dose of Paroxetine
Hydrochloride tablets (Pexep) in the treatment of posttraumatic stress
disorder is 20 mg/day administered as a single daily dose with or without
food, usually in the morning.
There was no sufficient evidence in a fixed dose study, to suggest a greater
benefit for a dose of 40 mg/day compared to 20 mg/day.
Dose changes, if indicated, should occur in 10 mg/day increments and at
intervals of at least 1 week.

Premenstrual Dysphoric Disorder: The recommended starting dose of
Pexep (Generic Paroxetine Hydrochloride Tablets) in the treatment
of premenstrual dysphoric disorder is 12.5 mg/day administered as
a single daily dose with or without food, usually in the morning.
Pexep may be administered either daily throughout the menstrual
cycle or limited to the luteal phase of the menstrual cycle,
depending on physician assessment. The recommended initial dose
is 12.5 mg/day. During clinical trials, both 12.5 mg/day and 25
mg/day were shown to be effective. Dose changes should occur at
intervals of at least 1 week.

Contraindications
➔
Pexep tablets are contraindicated in patients with a known
hypersensitivity to Paroxetine Hydrochloride or any component
of the tablet.
➔
The use of MAOIs intended to treat psychiatric disorders with
Pexep (Paroxetine Hydrochloride Tablets) or within 14 days of
stopping treatment with Paroxetine tablets is contraindicated
because of an increased risk of serotonin syndrome. The use of
Paroxetine tablets within 14 days of stopping an MAOI intended to
treat psychiatric disorders is also contraindicated.

Contraindications
➔
Starting Paroxetine tablets in a patient who is being treated with
MAOIs such as Linezolid or intravenous methylene blue is also
contraindicated because of an increased risk of serotonin
syndrome.
➔
Concomitant use in patients taking Pimozide or Thioridazine is
contraindicated.

Storage Instructions
Pexep Tablets (Generic Paroxetine 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
Increased risk of suicidal thoughts and behavior in pediatric and young adult
patients taking antidepressants. Closely monitor all antidepressant-treated
patients for clinical worsening and emergence of suicidal thoughts and
behaviors. Pexep is not approved for use in pediatric patients.
Serotonin Syndrome: Increased risk when co-administered with other
serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If
occurs, discontinue Pexep (Generic Paroxetine Hydrochloride Tablets) and
initiate supportive measures.
Embryofetal and Neonatal Toxicity: Can cause fetal and neonatal harm.
Increased risk of cardiovascular malformations for exposure during the first
trimester. Exposure in late pregnancy may lead to an increased risk for
persistent pulmonary hypertension (PPNH) of the newborn.

Warnings
Increased Risk of Bleeding: Concomitant use of aspirin,
nonsteroidal anti-inflammatory drugs, other antiplatelet drugs,
warfarin, and other anticoagulant drugs may increase risk.
Activation of Mania/Hypomania: Screen patients for bipolar
disorder.
Seizures: Use with caution in patients with seizure disorders.
Angle-Closure Glaucoma: Angle-closure glaucoma has occurred
in patients with untreated anatomically narrow angles treated
with antidepressants.

Possible Side Effects
Most common Paroxetine Hydrochloride (Pexep Tablets) side
effects with an incidence rate of greater than or equal to 5% and at
least twice placebo in placebo-controlled MDD, PD, SAD, and PMDD
clinical trials: abnormal ejaculation, abnormal vision, asthenia,
constipation, decreased appetite, diarrhea, dizziness, dry mouth,
female genital disorder, impotence, insomnia, libido decreased,
nausea, somnolence, sweating, tremor.

Possible Side Effects
The following less common side effects occurred during the clinical studies of
Paroxetine Hydrochloride (Pexep Tablets):
Cardiovascular System: Infrequent was postural hypotension.
Hemic and Lymphatic System: Rare was thrombocytopenia.
Metabolic and Nutritional Disorders: Infrequent were generalized edema and
hypercholesteremia.
Nervous System: Infrequent were convulsion, akathisia, and manic reaction.
Psychiatric: Infrequent were hallucinations.
Skin and Appendages: Frequent was rash; infrequent was urticaria; rare was
angioedema and erythema multiforme.
Urogenital System: Infrequent was urinary retention; rare was urinary incontinence.

Pexep Tablets Overdosage
Commonly reported adverse events associated with Paroxetine
Hydrochloride (Pexep tablets) overdosage include somnolence, coma,
nausea, tremor, tachycardia, confusion, vomiting, and dizziness. Other
notable signs and symptoms observed with overdoses involving
paroxetine (alone or with other substances) include mydriasis,
convulsions (including status epilepticus), ventricular dysrhythmias
(including torsades de pointes), hypertension, aggressive reactions,
syncope, hypotension, stupor, bradycardia, dystonia, rhabdomyolysis,
symptoms of hepatic dysfunction (including hepatic failure, hepatic
necrosis, jaundice, hepatitis, and hepatic steatosis), serotonin
syndrome, manic reactions, myoclonus, acute renal failure, and urinary
retention.

Treatment of Pexep Tablets Overdosage
No specific antidotes for Paroxetine Hydrochloride (Pexep Tablets) are known.
Treatment should consist of those general measures employed in the management of
overdosage with any drugs effective in the treatment of major depressive disorder.
Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and
vital signs. General supportive and symptomatic measures are also recommended.
Induction of emesis is not recommended.
Due to the large volume of distribution of this drug, forced diuresis, dialysis,
hemoperfusion, or exchange transfusion are unlikely to be of benefit.
A specific caution involves patients who are taking or have recently taken Paroxetine
who might ingest excessive quantities of a tricyclic antidepressant.
In such a case, accumulation of the parent tricyclic and/or an active metabolite may
increase the possibility of clinically significant sequelae and extend the time needed for
close medical observation. In managing overdosage, consider the possibility of multiple
drug involvement.

Pexep Tablets During Pregnancy
Paroxetine Hydrochloride (Pexep Tablets) has been classified by the
US FDA as Pregnancy Category D.
Epidemiological studies have shown that infants exposed to Paroxetine
Hydrochloride in the first trimester of pregnancy have an increased
risk of congenital malformations, particularly cardiovascular
malformations.
In case Paroxetine Hydrochloride (Pexep Tablets) is used during
pregnancy, or if the patient becomes pregnant while taking Paroxetine,
advise the patient of the potential hazard to the fetus.

Pexep Tablets (Generic Paroxetine Hydrochloride
Tablets) are manufactured by Intas Pharmaceuticals
Limited, India.

Pexep Tablets (Generic Paroxetine Hydrochloride Tablets)

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