Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)
Rebel Distributors Corp
VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE 25 mg
ORAL
PRESCRIPTION DRUG
Venlafaxine hydrochloride tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. Th
Venlafaxine Hydrochloride Tablets equivalent to 25 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of bisect is debossed with logo of "ZC" and other side is debossed with "64" and other side is plain and are supplied as follows: NDC 42254-050-30 in bottles of 30 tablets NDC 42254-050-60 in bottles of 60 tablets Venlafaxine Hydrochloride Tablets equivalent to 75 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "67" and other side is plain and are supplied as follows: NDC 42254-144-30 in bottles of 30 tablets Venlafaxine Hydrochloride Tablets equivalent to 100 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "68" and other side is plain and are supplied as follows: NDC 42254-115-60 in bottles of 60 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a well-closed container as defined in the USP.
Abbreviated New Drug Application
VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET Rebel Distributors Corp ---------- Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions Read the Medication Guide that comes with you 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 any of the following symptoms, especially if they are new, worse, or worry you: • th read_full_document
VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET REBEL DISTRIBUTORS CORP ---------- VENLAFAXINE HYDROCHLORIDE TABLETS 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 TABLETS 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 TABLETS ARE 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 is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C H NO HCl. Its molecular weight is 313.87. The structural formula is shown below. VENLAFAXINE HYDROCHLORIDE Venlafaxine hydrochloride is a white crystalline powder. It is freely soluble in water and dilute hydrochloric acid, soluble in ethanol and chloroform and insoluble in ether. Each ven read_full_document