VENLAFAXINE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

St Marys Medical Park Pharmacy

INN (Algemene Internationale Benaming):

VENLAFAXINE HYDROCHLORIDE

Samenstelling:

VENLAFAXINE 37.5 mg

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

VENLAFAXINE- VENLAFAXINE TABLET
ST MARYS MEDICAL PARK PHARMACY
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VENLAFAXINE TABLETS, USP
BOXED WARNING
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 TABLETS, USP 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 TABLETS, USP IS NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS. (SEE WARNINGS:
CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR
PATIENTS, AND
PRECAUTIONS: PEDIATRIC USE).
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
The mechanism of the antidepressant action of venlafaxine in humans is
believed to be associated with
its potentiation of neurotransmitter activity in the CNS. Preclinical
studies have shown that venlafaxine
and its active metabolite, O-desmethylvenlafaxine (ODV), are potent
inhibitors of neuronal serotonin and
norepinephrine reuptake and weak inhibitors of dopamine reuptake.
Venlafaxine and ODV have no
significant affinity for muscarinic, histaminergic, or α-1 adrenergic
receptors _in vitro_. Pharmacologic
activity at these receptors is hypothesized to be associated with the
various anticholine