VENLAFAXINE HYDROCHLORIDE - venlafaxine hydrochloride capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Orchid Healthcare (a division of Orchid Chemicals & Pharmaceuticals Ltd.)

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Composition:

VENLAFAXINE 37.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Venlafaxine hydrochloride extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Venlafaxine hydrochloride extended-release capsules in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials ). 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 worthlessne

Product summary:

Venlafaxine hydrochloride extended-release capsules are available as follows: 37.5 mg: Grey cap/Caramel body, “Size 3” hard gelatin capsules with imprinting “105” on body and “VXR” on cap with red ink, filled with white to off white pellets. NDC 68820-105-39, bottle of 15 capsules in unit of use package. NDC 68820-105-19, bottle of 30 capsules in unit of use package. NDC 68820-105-22, bottle of 90 capsules in unit of use package. NDC 68820-105-10, bottle of 100 capsules. NDC 68820-105-03, blister of 10 capsules. NDC 68820-105-11, carton of 10 blister strips of 10 capsules each. 75 mg: Caramel cap/Caramel body, “Size 1” hard gelatin capsules with imprinting “106” on body and “VXR” on cap with red ink, filled with white to off white pellets. NDC 68820-106-39, bottle of 15 capsules in unit of use package. NDC 68820-106-19, bottle of 30 capsules in unit of use package. NDC 68820-106-22, bottle of 90 capsules in unit of use package. NDC 68820-106-10, bottle of 100 capsules. NDC 68820-106-03, blister of 10 capsules. NDC 68820-106-11, carton of 10 blister strips of 10 capsules each. 150 mg: Reddish Brown cap/Reddish Brown body, Size “0el” hard gelatin capsules with imprinting “107” on body and “VXR” on cap with white ink, filled with white to off white pellets. NDC 68820-107-39, bottle of 15 capsules in unit of use package. NDC 68820-107-19, bottle of 30 capsules in unit of use package. NDC 68820-107-22, bottle of 90 capsules in unit of use package. NDC 68820-107-10, bottle of 100 capsules. NDC 68820-107-03, blister of 10 capsules. NDC 68820-107-11, carton of 10 blister strips of 10 capsules each. Store at controlled room temperature, 20° to 25°C (68° to 77°F). The unit of use package is intended to be dispensed as a unit.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
Orchid Healthcare (a division of Orchid Chemicals & Pharmaceuticals
Ltd.)
----------
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
a

Summary of Product characteristics

VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS & PHARMACEUTICALS
LTD.)
----------
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES
RX ONLY
SUICIDALITY AND ANTIDEPRESSANT DRUGS
ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL
THINKING AND BEHAVIOR
(SUICIDALITY) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM
STUDIES OF MAJOR
DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE
CONSIDERING THE USE
OF VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES OR ANY OTHER
ANTIDEPRESSANT IN A
CHILD, ADOLESCENT, OR YOUNG ADULT MUST BALANCE THIS RISK WITH THE
CLINICAL NEED. SHORT-TERM
STUDIES DID NOT SHOW AN INCREASE IN THE RISK OF SUICIDALITY WITH
ANTIDEPRESSANTS COMPARED TO
PLACEBO IN ADULTS BEYOND AGE 24; THERE WAS A REDUCTION IN RISK WITH
ANTIDEPRESSANTS
COMPARED TO PLACEBO IN ADULTS AGED 65 AND OLDER. DEPRESSION AND
CERTAIN OTHER PSYCHIATRIC
DISORDERS ARE THEMSELVES ASSOCIATED WITH INCREASES IN THE RISK OF
SUICIDE. PATIENTS OF ALL
AGES WHO ARE STARTED ON ANTIDEPRESSANT THERAPY SHOULD BE MONITORED
APPROPRIATELY AND
OBSERVED CLOSELY FOR CLINICAL WORSENING, SUICIDALITY, OR UNUSUAL
CHANGES IN BEHAVIOR.
FAMILIES AND CAREGIVERS SHOULD BE ADVISED OF THE NEED FOR CLOSE
OBSERVATION AND
COMMUNICATION WITH THE PRESCRIBER. VENLAFAXINE HYDROCHLORIDE
EXTENDED-RELEASE CAPSULES IS
NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS: Clinical
Worsening and Suicide
Risk, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS:
PEDIATRIC USE)
DESCRIPTION
Venlafaxine hydrochloride extended-release capsule is for oral
administration that contains venlafaxine
hydrochloride, a structurally novel antidepressant. It is designated
(R/S)-1-[2-(dimethylamino)-1-(4-
methoxyphenyl)ethyl] cyclohexanol hydrochloride or
(±)-1-[α-[(dimethylamino)methyl]-p-
methoxybenzyl] cyclohexanol hydrochloride and has the empirical
formula of C
H NO HCl. Its
molecular weight is 313.87. The structural formula is shown below.
Venlafaxine