Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)
Aphena Pharma Solutions - Tennessee, LLC
VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE 75 mg
ORAL
PRESCRIPTION DRUG
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride extended-release capsules in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (seeClinical Trials). 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
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Venlafaxine Hydrochloride Extended-release Capsules, 37.5 mg are white to off-white free flowing pellets filled in size ‘3’ hard gelatin capsules with grey colored cap printed with "ZA-35" in black ink & white body printed with "37.5 mg" in black ink and are supplied as follows: NDC 60429-121-30 in bottle of 30 capsules NDC 60429-121-90 in bottle of 90 capsules Venlafaxine Hydrochloride Extended-release Capsules, 75 mg are white to off-white free flowing pellets filled in size ‘1’ hard gelatin capsules with peach colored cap printed with "ZA-36" in black ink & white body printed with "75 mg" in black ink and are supplied as follows: NDC 60429-122-30 in bottle of 30 capsules NDC 60429-122-90 in bottle of 90 capsules Venlafaxine Hydrochloride Extended-release Capsules, 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: NDC 60429-123-30 in bottle of 30 capsules NDC 60429-123-90 in bottle of 90 capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 Marketed/Packaged by: GSMS, Inc. Camarillo, CA 93012 Rev.: 01/13 Revision Date: 19/01/2013
Abbreviated New Drug Application
VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE Aphena Pharma Solutions - Tennessee, LLC ---------- MEDICATION GUIDE Venlafaxine Hydrochloride Extended-release Capsules Read the Medication Guide that comes with venlafaxine hydrochloride extended-release capsules 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 hydrochloride extended-release capsules? Venlafaxine hydrochloride extended-release capsules and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Venlafaxine hydrochloride extended-release capsules 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 hydrochloride extended-release capsules are 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 o Olvassa el a teljes dokumentumot
VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES 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 EXTENDED-RELEASE CAPSULES 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 EXTENDED-RELEASE CAPSULES ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC US E) DESCRIPTION Venlafaxine hydrochloride extended-release capsule for oral administration contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4- methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)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, USP is a white to off-white cryst Olvassa el a teljes dokumentumot