Venlor XR Capsules (Generic Venlafaxine Hydrochloride XR Capsules)

Venlor XR Capsules (Generic Venlafaxine Hydrochloride XR Capsules)
© The Swiss Pharmacy

Venlor XR (Generic Venlafaxine Hydrochloride XR
Capsules) is used for the treatment of major depressive
disorder (MDD), moderate to severe Generalised Anxiety
Disorder (GAD) and prevention of depressive episodes,
Social Anxiety Disorder (SAD) and Panic Disorder (PD). It
increases the amount of serotonin and norepinephrine in
the brain, hormones that help regulate mood. It belongs to a
group of medications called SNRIs.

Venlor XR Capsules are manufactured by Cipla Limited,
India in the strengths of 37.5 mg, 75 mg and 150 mg.

Chemical Structure

The active pharmaceutical
ingredient contained in Venlor XR
Capsules is Venlafaxine
Hydrochloride. Each extended-
release Venlor XR Capsule
contains Venlafaxine
Hydrochloride equivalent to 37.5
mg, 75 mg, or 150 mg Venlafaxine.
Venlor XR belongs to a class of
medications for depression and
anxiety, called Serotonin-
Noradrenaline Reuptake Inhibitors
(SNRIs).

Uses of Venlor XR 37.5 mg, 75 mg and 150 mg Capsules:
Venlor XR (Venlafaxine Hydrochloride XR Capsules) is used to treat
depression. It is also used to treat general anxiety disorder, social
anxiety disorder, and panic disorder. Venlafaxine belongs to a group
of medicines known as serotonin and norepinephrine reuptake
inhibitors (SNRI). These medicines are thought to work by increasing
the activity of a chemical called serotonin in the brain.
Venlor XR Capsules are indicated for the treatment of Major
Depressive Disorder (MDD) as defined in the DSM-5, including
depression accompanied by anxiety. Following an initial response,
Venlor XR Capsules are indicated for the prevention of relapses of
the initial episode of depression or recurrence of new episodes.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9548_Venlafaxine-HCl-Capsules.html

Uses of Venlor XR 37.5 mg, 75 mg and 150 mg Capsules:
Venlor XR Capsules are indicated for the treatment of Generalized
Anxiety Disorder (GAD) as defined in the DSM-5. Anxiety or tension
associated with the stress of everyday life usually does not require
treatment with an anxiolytic.
Venlor XR Capsules are indicated for the treatment of Social Anxiety
Disorder (SAD), also known as social phobia, as defined in the DSM-5.
Venlor XR Capsules are indicated for the treatment of Panic Disorder,
with or without agoraphobia, as defined in the DSM-5.

Recommended Adult Dosage
Venlor XR Capsules (Generic Venlafaxine XR Capsules)
should be administered in a single dose with food either in the
morning or in the evening at approximately the same time
each day. Each capsule should be swallowed whole with fluid:
Major Depressive Disorder: For most patients, the
recommended starting dose for Generic Venlafaxine XR is 75
mg/day, administered in a single dose.
Generalized Anxiety Disorder: For most patients, the
recommended starting dose for Generic Venlafaxine XR is 75

Recommended Adult Dosage
Venlor XR Capsules (Generic Venlafaxine XR Capsules)
should be administered in a single dose with food either in the
morning or in the evening at approximately the same time
each day. Each capsule should be swallowed whole with fluid:
Panic Disorder: The recommended initial dose of Venlor XR
(Generic Venlafaxine XR Capsules) is a single dose of 37.5
mg/day for 7 days.
Social Anxiety Disorder (Social Phobia): The recommended
dose of Venlor XR (Generic Venlafaxine XR Capsules) is 75

Contraindications
➔
Venlor XR Capsules are contraindicated in patients with a
hypersensitivity to Venlafaxine Hydrochloride or other components
present in this medication.
➔
It is also contraindicated in patients aged below 18 years, patients
with very high risk of a serious cardiac ventricular arrhythmia,
uncontrolled hypertension.
➔
Concomitant treatment with irreversible monoamine oxidase
inhibitors (MAOIs) is contraindicated due to the risk of serotonin
syndrome with symptoms such as agitation, tremor and
hyperthermia.

Contraindications
➔
Venlor XR Capsules must be discontinued for at least 7 days
before starting treatment with an irreversible MAOI.
➔
Venlor XR Capsules (Generic Venlafaxine HCL) must not be
initiated for at least 14 days after discontinuation of treatment with
an irreversible MAOI.

Storage Instructions
Venlor XR Capsules (Generic Venlafaxine XR
Capsules) 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
Clinical Worsening/Suicide Risk: Monitor for clinical worsening and
suicide risk.
Serotonin Syndrome: Risk increases with concomitant use of other
serotonergic drugs. Discontinue Venlor XR and initiate supportive
treatment if serotonin syndrome occurs.
Elevations in Blood Pressure: Control hypertension before initiating
treatment. Monitor blood pressure regularly during treatment.
Abnormal Bleeding: Venlor XR may increase risk of bleeding events.
Caution patients about the risk of bleeding associated with the
concomitant use of Venlor XR and NSAIDs, aspirin, or other drugs that
affect coagulation.

Warnings
Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients
with untreated anatomically narrow angles treated with antidepressants.
Activation of Mania/Hypomania: Use cautiously in patients with bipolar
disorder. Caution patients about the risk of activation of mania/hypomania.
The risk of suicide should be considered in all patients. Young adults and
patients with history of suicide-related events or ideation should be carefully
monitored.
Venlafaxine capsules have been associated with reports of aggression and
psychomotor restlessness.
Use with caution in patients with established cardiac disease that may
increase the risk of ventricular arrhythmias, renal or hepatic impairment,
narrow angle glaucoma, mania or a history of epilepsy.

Warnings
Patients should not drive or operate machinery if their ability to do so is
impaired.
Venlafaxine HCl should not be used with SSRIs unless on the advice of
a specialist.
Withdrawal reactions may occur especially on abrupt discontinuation
of treatment with Generic Venlafaxine Hcl capsules (Venlor XR).
Venlor XR is not approved for use in pediatric patients.
Patients should be advised to notify their doctor should an allergy
develop or if they become or intend to become pregnant.

Possible Side Effects
Most common Venlafaxine Hydrochloride (Venlor XR capsules) side
effects with an incidence rate 5% and at least twice the rate of
placebo reported during clinical trials include nausea, somnolence,
dry mouth, sweating, abnormal ejaculation, anorexia, constipation,
erectile dysfunction, and libido decreased.
Many of the frequently observed adverse events are dose related.
With continued treatment, these adverse effects generally decrease
in frequency and intensity, and usually do not require
discontinuation.

Possible Side Effects
Other side effects observed during Clinical Studies include:
Body as a whole – Photosensitivity reaction, chills
Cardiovascular system – Postural hypotension, syncope, hypotension, tachycardia
Digestive system – Gastrointestinal hemorrhage, bruxism
Hemic/Lymphatic system – Ecchymosis
Metabolic/Nutritional – Hypercholesterolemia, weight gain, weight loss
Nervous system – Seizures, manic reaction, agitation, confusion, akathisia,
hallucinations, hypertonia, myoclonus, depersonalization, apathy
Skin and appendages – Urticaria, pruritus, rash, alopecia
Special senses – Mydriasis, abnormality of accommodation, tinnitus, taste perversion
Urogenital system – Urinary retention, urination impaired, urinary incontinence, urinary
frequency increased, menstrual disorders associated with increased bleeding or
increased irregular bleeding (e.g., menorrhagia, metrorrhagia)

Venlor XR Overdosage
Somnolence was the most commonly reported symptom of Venlafaxine
Hydrochloride (Venlor XR capsules) overdose. Among the other reported
symptoms were paresthesia of all four limbs, moderate dizziness, nausea,
numb hands and feet, and hot-cold spells 5 days after the overdose. In
most cases, no signs or symptoms were associated with overdose.
The majority of the reports involved ingestion in which the total dose of
Venlafaxine taken was estimated to be no more than several-fold higher
than the usual therapeutic dose.
One patient who ingested 2.75 g of venlafaxine was observed to have two
generalized convulsions and a prolongation of QTc to 500 msec,
compared with 405 msec at baseline. Mild sinus tachycardia was reported
in two of the other patients.

Treatment of Venlor XR Overdosage
Actions taken to treat the Venlafaxine Hydrochloride (Venlor XR capsules)
overdose included no treatment, hospitalization and symptomatic
treatment, and hospitalization plus treatment with activated charcoal. All
patients recovered.
In case of an overdose, provide supportive care, including close medical
supervision and monitoring.
Treatment should consist of those general measures employed in the
management of overdosage with any drug. Consider the possibility of
multiple drug overdose. Ensure an adequate airway, oxygenation, and
ventilation. Monitor cardiac rhythm and vital signs. Provide supportive and
symptomatic measures.

Venlor XR Capsules During Pregnancy
Venlafaxine Hydrochloride (Venlor XR capsules) is classified by the US
FDA as Pregnancy Category C.
Venlafaxine did not cause malformations in offspring of rats or rabbits given
doses up to 2.5 times (rat) or 4 times (rabbit) the maximum recommended
human daily dose on a mg/m2 basis. However, in rats, there was a decrease
in pup weight, an increase in stillborn pups, and an increase in pup deaths
during the first 5 days of lactation, when dosing began during pregnancy and
continued until weaning.
The cause of these deaths is not known. These effects occurred at 2.5 times
(mg/m2) the maximum human daily dose.
There are no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human
response, this medicine should be used during pregnancy only if clearly
needed.

Venlor XR Capsules (Generic Venlafaxine
Hydrochloride XR Capsules) are manufactured by Cipla
Limited, India.

Venlor XR Capsules (Generic Venlafaxine Hydrochloride XR Capsules)

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