벤라팍신염산염서방성과립

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 ) 1.1 Major Depressive Disorder 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. 1.2 Social Anxiety Disorder Venlafaxine extended-release tablets are indicated for the treatment of Social Anxiety Disorder (SAD), also known as Social Phobia, as defined in DSM-IV. Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the …

Serotonin Syndrome and MAOIs: Do not use MAOI’s intended to treat psychiatric disorders with venlafaxine extended-release tablets or within 7 days of stopping treatment with venlafaxine extended-release tablets. Do not use venlafaxine extended-release tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start venlafaxine extended-release tablets in a patient who is being treated with linezolid or intravenous methylene blue ( 4.1 ). 4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOI’s intended to treat psychiatric disorders with venlafaxine extended-release tablets or within 7 days of stopping treatment with venlafaxine extended-release tablets is contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine extended-release tablets within 14 days of stopping, an MAOI intended to treat psychiatric disorders is also contraindicated [ see Dosage and Administration ( 2.6 ), and Warnings and Precautions ( …

Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including venlafaxine extended-release tablets, both when taken alone, but especially when co-administered with other serotonergic agents. If such symptoms occur, discontinue venlafaxine extended-release tablets and serotonergic agents and initiate supportive treatment. If concomitant use of venlafaxine extended-release tablets with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases. ( 5.2 ). Suicidality: Monitor for clinical worsening and suicide risk. ( 5.1 ) Sustained hypertension may occur. Blood pressure monitoring recommended. ( 5.3 ) Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.4 ) Abrupt discontinuation or dose reduction: Discontinuation symptoms may occur (generally self-limiting; serious symptoms possible). Dose reduction recommended to be gradual. ( 5.5 ) Activation of Mania/Hypomania has occurred. ( 5.10 ) Symptomatic hyponatremia may occur. ( 5.11 ) Seizures have been reported. Use with caution in patients with seizure history. ( 5.12 ) Abnormal bleeding (most commonly ecchymosis) has been reported. ( 5.13 ) Serum cholesterol: Clinically relevant cholesterol increases may occur. Cholesterol measurements should be considered during long-term …

8.1 Pregnancy Based on data from published observational studies, exposure to SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [ see Warnings and Precautions (5.13) and Clinical Considerations]. Teratogenic Effects 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/m 2 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 …