Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
MIRTAZAPINE (UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q)
Actavis Pharma, Inc.
MIRTAZAPINE
MIRTAZAPINE 45 mg
ORAL
PRESCRIPTION DRUG
Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders – 3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The effectiveness of mirtazapine
Mirtazapine orally disintegrating tablets, USP are supplied as: 15 mg: White to off-white, round, flat-faced, beveled-edge, unscored tablet. Debossed with “2 469 ” on one side and “WPI ” on the other side. Blister package of 30 tablets NDC 0591-2469-15 30 mg: White to off-white, round, flat-faced, beveled-edge, unscored tablet. Debossed with “2 470 ” on one side and “WPI ” on the other side. Blister package of 30 tablets NDC 0591-2470-15 45 mg: White to off-white, round, flat-faced, beveled-edge, unscored tablet. Debossed with “2471 ” on one side and “WPI ” on the other side. Blister package of 30 tablets NDC 0591-2471-15 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Use immediately upon opening individual tablet blister. Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: January 2017
Abbreviated New Drug Application
MIRTAZAPINE- MIRTAZAPINE TABLET, ORALLY DISINTEGRATING Actavis Pharma, Inc. ---------- MEDICATION GUIDE Mirtazapine (mir-TAZ-a-peen) Orally Disintegrating Tablets, USP What is the most important information I should know about mirtazapine orally disintegrating tablets? Mirtazapine orally disintegrating tablets and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Mirtazapine orally disintegrating 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 mirtazapine orally disintegrating 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 you • other unusual changes in behavior or mood Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Mirtazapine orally disintegrating tablets may be associated with these serious side effects: 2. Manic episodes: • greatly increased energy • severe trouble sleeping • Belgenin tamamını okuyun
MIRTAZAPINE- MIRTAZAPINE TABLET, ORALLY DISINTEGRATING ACTAVIS PHARMA, INC. ---------- MIRTAZAPINE ODT ONCE-A-DAY MIRTAZAPINE ORALLY DISINTEGRATING TABLETS, USP Revised: January 2017 RX ONLY 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 MIRTAZAPINE ORALLY DISINTEGRATING 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. MIRTAZAPINE ORALLY DISINTEGRATING 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 Mirtazapine orally disintegrating tablets, USP are an orally administered drug. Mirtazapine, USP has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c] benzazepine and has the empirical formula of C H N . Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture: Mirtazapine, USP is a white to creamy white crystalline powder which is slightly solubl Belgenin tamamını okuyun