venlafaxine- Venlafaxine hydrochloride tablet, extended release for oral use

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

venlafaxine hydrochloride (UNII: 7D7RX5A8MO) (venlafaxine - UNII:GRZ5RCB1QG)

MAH:

Osmotica Pharmaceutical Corp.

INN:

Venlafaxine hydrochloride

pharmaceutical_form:

TABLET, EXTENDED RELEASE

composition:

37.5 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Venlafaxine Extended Release Tablets (venlafaxine hydrochloride) are indicated for the treatment of major depressive disorder (MDD). Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [see Clinical Studies (14.1) ]. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. Venlafaxine Extended Release Tablets are indicated for the treatment of Social An

leaflet_short:

Venlafaxine Extended Release Tablets 37.5 mg are round, biconvex, white coated tablets with OS301 printed on one side. They are supplied as follows:   Bottles of 100 Tablets NDC 42843-301-10   Box of single units of 100 NDC 42843-301-11 Venlafaxine Extended Release Tablets 75 mg are round, biconvex, white coated tablets with OS302 printed on one side. They are supplied as follows:   Bottles of 100 Tablets NDC 42843-302-10   Box of single units of 100 NDC 42843-302-11 Venlafaxine Extended Release Tablets 150 mg are round, biconvex, white coated tablets with OS303 printed on one side. They are supplied as follows:   Bottles of 100 Tablets NDC 42843-303-10   Box of single units of 100 NDC 42843-303-11 Venlafaxine Extended Release Tablets 225 mg are round, biconvex, white coated tablets with OS304 printed on one side. They are supplied as follows:   Bottles of 100 Tablets NDC 42843-304-10   Box of single units of 100 NDC 42843-304-11 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.

PIL

VENLAFAXINE- VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE
Osmotica Pharmaceutical Corp.
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17.9 FDA-APPROVED MEDICATION GUIDE
Medication Guide
Antidepressant Medicines, Depression and Other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
Read the Medication Guide that comes with your or your family member's
antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant medicines.
Talk to your, or your family member's, healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
1.
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers, and
young adults within the first few months of treatment.
2.
Depression and other serious mental illnesses are the most important
causes of suicidal thoughts and
actions. Some people may have a particularly high risk of having
suicidal thoughts or actions. These
include people who have (or have a family history of) bipolar illness
(also called manic-depressive
illness) or suicidal thoughts or actions.
3.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family member?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or
feelings. This is very important when an antidepressant medicine is
started or when the dose is
changed.
•
Call the healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare provider
between visits as needed, especially if you have concerns about
symptoms.
Call a healthcare provider right away if you or your family member has
any of the following symptom

SPC

VENLAFAXINE- VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE
OSMOTICA PHARMACEUTICAL CORP.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
WARNING: SUICIDALITY AND ANTIDEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER
PSYCHIATRIC DISORDERS. VENLAFAXINE
EXTENDED RELEASE TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS. (5.1)
INDICATIONS AND USAGE
Venlafaxine Extended Release Tablets are a selective serotonin and
norepinephrine reuptake inhibitor (SNRI) indicated
for:
Major Depressive Disorder (MDD) (1.1)
Social Anxiety Disorder (SAD) (1.2)
DOSAGE AND ADMINISTRATION
Initial Treatment (2.1)
INDIC ATIO N
STARTING DOSE
DOSE INCREASE
MAXIMUM DOSE
Major Depressive Disorder
75 mg/day (in some patients,
37.5 mg/day for 4-7 days)
75 mg/day increments at
intervals of 4 days or longer
225 mg/day
Social Anxiety Disorder
75 mg/day
No benefit at higher doses
75 mg/day
Venlafaxine extended-release tablets should be taken as a single daily
dose with food in either the morning or evening
at the same time each day. (2)
Discontinuation: Gradual; individualized as necessary. (2.4)
DOSAGE FORMS AND STRENGTHS
37.5 mg, 75mg, 150 mg, and 225 mg tablets (3)
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitors (4)
WARNINGS AND PRECAUTIONS
Suicidality: Monitor for clinical worsening and suicide risk. (5.1)
Monoamine Oxidase Inhibitors (MAOIs): Serious interactions possible.
Concomitant use contraindicated. Avoidance of
MAOIs recommended for at least 14 days before starting venlafaxine. A
MAOI should not be started within 7 days after
stopping venlafaxine. (5.2)
Serotonin syndrome possible, in particular when combined with other
serotonergic drugs or inhibitors of serotonin
metabolism. (5.3)
Sustained hypertension may occur. Blood pressure monitoring
recommended. (5.4)
Mydriasis may occur. Patients with raised intraocular pressure or
tho