VENLAFAXINE HYDROCHLORIDE capsule, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)

Dostupné z:

Dr.Reddy's Laboratories Ltd.

INN (Medzinárodný Name):

VENLAFAXINE HYDROCHLORIDE

Zloženie:

VENLAFAXINE 37.5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of generalized anxiety disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials. Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials.   Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials. Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation The use of MAOIs (intended to treat psychiat

Prehľad produktov:

Venlafaxine hydrochloride extended-release capsules USP are available containing 37.5 mg, 75 mg or 150 mg of venlafaxine. The 37.5 mg capsules are white to off-white, coated mini tablets filled in size “3” hard gelatin capsule shells with opaque gray colored cap and opaque pink colored body, imprinted “RDY” on cap and “453”on body with black ink and are supplied in bottles of 30’s,60’s,90’s,100’s,500’s and unit dose package of 100 (10x10).  Bottles of 30                                       NDC 55111-453-30 Bottles of 60                                       NDC 55111-453-60 Bottles of 90                                       NDC 55111-453-90 Bottles of 100                                     NDC 55111-453-01 Bottles of 500                                     NDC 55111-453-05 Unit Dose Package of 100(10x10)     NDC 55111-453-78  The 75 mg capsules are white to off-white, coated mini tablets filled in size “2” hard gelatin capsule shells with opaque pink colored cap and opaque pink colored body, imprinted “RDY” on cap and “454”on body with black ink and are supplied in bottles of 30’s,60’s,90’s,100’s,500’s and unit dose package of 100 (10x10).  Bottles of 30                                       NDC 55111-454-30 Bottles of 60                                       NDC 55111-454-60 Bottles of 90                                       NDC 55111-454-90 Bottles of 100                                     NDC 55111-454-01 Bottles of 500                                     NDC 55111-454-05 Unit Dose Package of 100(10x10)     NDC 55111-454-78  The 150 mg capsules are white to off-white, coated mini tablets filled in size “Oel” hard gelatin capsule shells with opaque Swedish orange colored cap and opaque Swedish orange colored body, imprinted “RDY” on cap and “455”on body with white ink and are supplied in bottles of 30’s,60’s,90’s,100’s,500’s and unit dose package of 100 (10x10).  Bottles of 30                                       NDC 55111-455-30 Bottles of 60                                       NDC 55111-455-60 Bottles of 90                                       NDC 55111-455-90 Bottles of 100                                     NDC 55111-455-01 Bottles of 500                                     NDC 55111-455-05 Unit Dose Package of 100(10x10)     NDC 55111-455-78  Storage Store at 20°C - 25°C (68°F - 77°F) [see USP controlled room temperature]  The unit of use package is intended to be dispensed as a unit.  

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
Dr.Reddy's Laboratories Ltd.
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MEDICATION GUIDE
Medication Guide
Venlafaxine Hydrochloride Extended-Release Capsules USP
(ven'' la fax' een hye'' droe klor' ide)
Read the Medication Guide that comes with venlafaxine hydrochloride
extended-release capsules before
you start taking them and each time you get a refill. There may be new
information. This Medication
Guide does not take the place of talking to your healthcare provider
about your medical condition or
treatment. Talk with your healthcare provider if there is something
you do not understand or want to learn
more about.
What is the most important information I should know about venlafaxine
hydrochloride extended-release
capsules? Venlafaxine hydrochloride extended-release capsules and
other antidepressant medicines may
cause serious side effects, including:
1. Suicidal thoughts or actions:
• Venlafaxine hydrochloride extended-release capsules and other
antidepressant medicines may increase
suicidal thoughts or actions in some children, teenagers, or young
adults within the first few months of
treatment or when the dose is changed.
• Depression or other serious mental illnesses are the most
important causes of suicidal thoughts or
actions.
• Watch for these changes and call your healthcare provider right
away if you notice.
• New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
• Pay particular attention to such changes when venlafaxine
hydrochloride extended-release capsules are
started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried about
symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency, especially if they are new, worse, or worry you:
• attempts to commit suicide
• acting on dangerous impulses
• acting aggressive or violent
• thoughts about suicide or dying
�

Súhrn charakteristických

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
DR.REDDY'S LABORATORIES LTD.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VENLAFAXINE HYDROCHLORIDE
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR VENLAFAXINE
HYDROCHLORIDE EXTENDED-RELEASE CAPSULES.
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS (5.1)
• MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND
BEHAVIORS (5.1)
• VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASECAPSULESARE NOT APPROVED
FOR USE IN PEDIATRIC PATIENTS (8.4)
RECENT MAJOR CHANGES
Warnings and Precautions, Serotonin Syndrome (5.2) 1/2017
INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules are serotonin and
norepinephrine reuptake inhibitor (SNRI)
indicated for the treatment of: (1)
• Major Depressive Disorder (MDD) (1)
• Generalized Anxiety Disorder (GAD) (1)
• Social Anxiety Disorder (SAD) (1)
• Panic Disorder (PD) (1)
DOSAGE AND ADMINISTRATION
INDICATION STARTING DOSE
TARGET DOSE MAXIMUM DOSE
MDD (2.1)
37.5 to75 mg/day 75 mg/day
225 mg/day
GAD (2.2)
37.5 to75 mg/day 75 mg/day
225 mg/day
SAD (2.3)
75 mg/day
75 mg/day
75 mg/day
PD (2.4)
37.5 mg/day
75 mg/day
225 mg/day
• Take once daily with food (2). Capsules should be taken whole; do
not divide, crush, chew, or dissolve (2).
• When discontinuing treatment, reduce the dose gradually (2.8,
5.7).
• Renal impairment: reduce the total daily dose by 25% to 50% in
patients with renal impairment. Reduce the total daily
dose by 50% or more in patients undergoing dialysis or with severe
renal impairment (2.6).
• Hepatic impairment: reduce the daily dose by 50% in patients with
mild to moderate hepatic impair