देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)
Preferred Pharmaceuticals Inc.
VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE 150 mg
ORAL
PRESCRIPTION DRUG
Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: Venlafaxine hydrochloride extended-release capsules is contraindicated in patients: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including venlafaxine hydrochloride extended-release capsules, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research programs/pregnancyregistry/antidepressants/ . Risk Summary Available data from published epidemiologic studies on venlafaxine use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse fetal outcomes (see Data) . Available data from observational studies with venlafaxine have identified a potential increased risk for preeclampsia when used during mid to la
Venlafaxine Hydrochloride Extended-Release Capsules USP, 150 mg are white to off-white free flowing pellets filled in size '0' hard gelatin capsules with dark orange colored cap printed with "ZA-37" in black ink & white body printed with "150 mg" in black ink and are supplied as follows: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.
Abbreviated New Drug Application
Preferred Pharmaceuticals Inc. ---------- SPL MEDGUIDE Medication Guide Venlafaxine Hydrochloride (ven" la fax' een hye" droe klor' ide) Extended-Release Capsules, USP What is the most important information I should know about venlafaxine hydrochloride extended-release capsules? Venlafaxine hydrochloride extended-release capsules may cause serious side effects, including: Increased risk of suicidal thoughts and actions. Venlafaxine hydrochloride extended-release capsules and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. Venlafaxine hydrochloride extended-release capsules is not for use in children. o Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? o 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. o Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. o Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency help right away if you or a family member have any of the following symptoms, especially if they are new, worse, or worry you: • attempts to commit suicide • thoughts about suicide or dying • acting aggressive, being angry, or violent • acting on dangerous impulses • new or worse depression • new or worse anxiety • panic attacks • feeling very agitated or restless • new or worse irritability • trouble sleeping • an extreme increase in activity or talking (mania) • other unusual changes in behavior or mo पूरा दस्तावेज़ पढ़ें
VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE PREFERRED PHARMACEUTICALS INC. ---------- 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 ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN PEDIATRIC AND YOUNG ADULT PATIENTS IN SHORT-TERM STUDIES. CLOSELY MONITOR ALL ANTIDEPRESSANT-TREATED PATIENTS FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS _[SEE_ _WARNINGS AND PRECAUTIONS (5.1)]_ . VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS _[SEE USE IN SPECIFIC POPULATIONS (8.4)]._ RECENT MAJOR CHANGES Boxed Warning 8/2022 Dosage and Administration (2.10) 11/2021 Dosage and Administration (2.2, 2.3, 2.6, 2.8, 2.9, 2.11) 8/2022 Warnings and Precautions (5.13) 9/2021 Warnings and Precautions (5.7) 11/2021 Warnings and Precautions (5.1, 5.2, 5.4, 5.5, 5.6, 5.7, 5.8) 8/2022 INDICATIONS AND USAGE Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: • • • • DOSAGE AND ADMINISTRATION INDICATION STARTING DOSE TARGET DOSE MAXIMUM DOSE MDD (2.2) 37.5 mg/day to 75 mg/day 75 mg/day 225 mg/day GAD (2.3) 37.5 mg/day to 75 mg/day 75 mg/day 225 mg/day SAD (2.4) 75 mg/day 75 mg/day 75 mg/day PD (2.5) 37.5 mg/day 75 mg/day 225 mg/day • • • • Major Depressive Disorder (MDD) (1) Generalized Anxiety Disorder (GAD) (1) Social Anxiety Disorder (SAD) (1) Panic Disorder (PD) (1) Take once daily with food. Capsules should be taken whole; do not divide, crush, chew or dissolve (2.1). When discontinuing treatment, reduce the dose gradually (2.10, 5.7). R पूरा दस्तावेज़ पढ़ें