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출처: NLM (National Library of Medicine)
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)
Bryant Ranch Prepack
VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE 50 mg
ORAL
PRESCRIPTION DRUG
Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride 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. The efficacy of venla
Venlafaxine Tablets are available as follows: 25 mg – Orange colored, oval, biconvex, film-coated tablets with side wall scored; debossed with “H” and “P” separated by score line on one side and “246” on the other side. Available in bottles of 20 (NDC 23155-246-07), 90 (NDC 23155-246-09),100 (NDC 23155-246-01) and 500 (NDC 23155-246-05). 37.5 mg – Orange colored, oval, biconvex, film-coated tablets with side wall scored; debossed with “H” and “P” separated by score line on one side and “247” on the other side Available in bottles of 20 (NDC 23155-247-07), 90 (NDC 23155-247-09),100 (NDC 23155-247-01) and 500 (NDC 23155-247-05). 50 mg – Orange colored, oval, biconvex, film-coated tablets with side wall scored; debossed with “H” and “P” separated by score line on one side and “248” on the other side. Available in bottles of 20 (NDC 23155-248-07), 90 (NDC 23155-248-09), 100 (NDC 23155-248-01) and 500 (NDC 23155-248-05). 75 mg – Orange colored, oval, biconvex, film-coated tablets with side wall scored; debossed with “H” and “P” separated by score line on one side and “249” on the other side. Available in bottles of 20 (NDC 23155-249-07), 90 (NDC 23155-249-09),100 (NDC 23155-249-01) and 500 (NDC 23155-249-05). 100 mg – Orange colored, oval, biconvex, film-coated tablets with side wall scored; debossed with “H” and “P” separated by score line on one side and “250” on the other side. Available in bottles of 20 (NDC 23155-250-07), 90 (NDC 23155-250-09), 100 (NDC 23155-250-01) and 500 (NDC 23155-250-05). Store at 20°-25°C (68°-77°F) in a dry place [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP. The unit of use package is intended to be dispensed as a unit. Manufactured by: Emcure Pharmaceuticals Ltd., India. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) Rev. 09/13
Abbreviated New Drug Application
VENLAFAXINE - VENLAFAXINE TABLET Bryant Ranch Prepack ---------- MEDICATION GUIDE Read the Medication Guide that comes with venlafaxine tablets, USP before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about venlafaxine tablets, USP? Venlafaxine tablets, USP and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Venlafaxine tablets, USP and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. • Watch for these changes and call your healthcare provider right away if you notice: • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. • Pay particular attention to such changes when venlafaxine tablets, USP is started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: • attempts to commit suicide • acting on dangerous impulses • acting aggressive or violent • thoughts about suicide or dying • new or worse depression • new or worse anxiety or panic attacks • feeling agitated, restless, angry or irritable • trouble sleeping • an increase in activity or talking more than what is normal for you • other unusual changes in behavior or mood Call your healthcare provider right away if you 전체 문서 읽기
VENLAFAXINE - VENLAFAXINE TABLET BRYANT RANCH PREPACK ---------- 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 HYDROCHLORIDE 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 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 USP 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 empirical formula of C H NO ( HCl. Its molecular weight is 313.87. The structural formula is shown below. VENLAFAXINE HYDROCHLORIDE Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride).Its octanol: water (0.2 M sodium chloride) parti 전체 문서 읽기