Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)
Mylan Pharmaceuticals Inc.
VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE 25 mg
ORAL
PRESCRIPTION DRUG
Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine 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 four of the following eight 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 venlafa
Venlafaxine Tablets, USP are available containing venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of venlafaxine. The 25 mg tablets are yellow, round, scored tablets debossed with V above the score and 1 below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4881-01 bottles of 100 tablets The 37.5 mg tablets are yellow, round, scored tablets debossed with V above the score and 2 below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4882-01 bottles of 100 tablets The 50 mg tablets are yellow, round, scored tablets debossed with V above the score and 3 below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4883-01 bottles of 100 tablets The 75 mg tablets are yellow, round, scored tablets debossed with M above the score and V4 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4884-01 bottles of 100 tablets The 100 mg tablets are yellow, round, scored tablets debossed with M above the score and V5 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4885-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET Mylan Pharmaceuticals Inc. ---------- MEDICATION GUIDE Venlafaxine Tablets, USP (ven'' la fax' een) 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg Read the Medication Guide that comes with venlafaxine tablets before you start taking them 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? Venlafaxine tablets and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Venlafaxine tablets 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 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 or panic attacks • feeling agitated, restless, angry or irritable • trouble sleeping • an increase in activity or talking more than what is normal for yo Prečítajte si celý dokument
VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET MYLAN PHARMACEUTICALS INC. ---------- (EACH 25 MG, 37.5 MG, 50 MG, 75 MG AND 100 MG TABLET CONTAINS VENLAFAXINE HYDROCHLORIDE, USP EQUIVALENT TO 25 MG, 37.5 MG, 50 MG, 75 MG OR 100 MG VENLAFAXINE, RESPECTIVELY) 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 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 TABLETS 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 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- [(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 Venlafaxine hydrochloride, USP is a white to off-white crystalline Prečítajte si celý dokument