Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
MIRTAZAPINE (UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q)
Northstar Rx LLC
MIRTAZAPINE
MIRTAZAPINE 7.5 mg
ORAL
PRESCRIPTION DRUG
Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine 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 in hospitalized depres
Mirtazapine tablets, USP are supplied as: 7.5 mg tablets - Yellow colored, circular, biconvex, film coated tablets with “C” debossed on one side and plain on the other side. 7.5 mg Bottles of 30 NDC 16714-706-01 15 mg tablets -Yellow colored, oval, biconvex, film coated tablets with “499” debossed on one side and scored on the other side. 15 mg Bottles of 30 NDC 16714-707-01 30 mg tablets - Reddish-brown colored, oval, biconvex, film coated tablets with “500” debossed on one side and scored on the other side. 30 mg Bottles of 30 NDC 16714-708-01 45 mg tablets - White to off-white colored, oval, biconvex, film coated tablets with “501” debossed on one side and plain on the other side. 45 mg Bottles of 30 NDC 16714-709-01 45 mg Bottles of 1000 NDC 16714-709-02 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Protect from light and moisture. Medication Guide available at www.northstarrxllc.com/products or call 1-800-206-7821 Rx only Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvári Kabay János u. 29. Hungary Revised: 10/2019
Abbreviated New Drug Application
MIRTAZAPINE- MIRTAZAPINE TABLET Northstar Rx LLC ---------- SPL MEDGUIDE Medication Guide Mirtazapine (mir taz’ a peen) Tablets, USP What is the most important information I should know about Mirtazapine tablets, USP? Mirtazapine tablets, USP and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Mirtazapine tablets, USPand 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 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 impulse • 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 tablets, USPmay be associated with these serious side effects: 2. Manic episodes: • greatly increased energy • severe trouble sleeping • racing thoughts • reckless behavior • unusually grand ideas • excessive happiness or irritability • talking more Прочетете целия документ
MIRTAZAPINE- MIRTAZAPINE TABLET NORTHSTAR RX LLC ---------- MIRTAZAPINE TABLETS, USP 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 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 TABLETS, USP IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC USE) DESCRIPTION Mirtazapine 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 C17H19N3. 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 soluble in water. Mirtazapine tablets, USP are supplied for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored fi Прочетете целия документ