Country: United States
Language: English
Source: NLM (National Library of Medicine)
MIRTAZAPINE (UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q)
REMEDYREPACK INC.
MIRTAZAPINE
MIRTAZAPINE 15 mg
ORAL
PRESCRIPTION DRUG
REMERON (mirtazapine) Tablets are indicated for the treatment of major depressive disorder. The efficacy of REMERON 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 REMERON in hospitalized depressed
REMERON (mirtazapine) Tablets are supplied as: 15 mg Tablets — oval, scored, yellow, coated, with "Organon" debossed on 1 side and " T 3 Z " on the other side. 15 mg Tablets — oval, scored, yellow, coated, with "MSD" debossed on 1 side and " T 3 Z " on the other side. 30 mg Tablets — oval, scored, red-brown, coated, with "Organon" debossed on 1 side and " T 5 Z " on the other side. 30 mg Tablets — oval, scored, red-brown, coated, with "MSD" debossed on 1 side and " T 5 Z " on the other side. 45 mg Tablets — oval, white, coated, with "Organon" debossed on 1 side and " T 7 Z " on the other side. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.
New Drug Application
REMEDYREPACK INC. ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 05/2018 MEDICATION GUIDE REMERON® (rĕm' - ĕ – rŏn) (mirtazapine) Tablets What is the most important information I should know about REMERON®? REMERON and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • REMERON 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 REMERON 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 have any of the following symptoms, or call 911 if an emergency. REMERON may be associated with these serious side effects: 2. Manic episodes: • greatly increased energy • reckless behavior • talking more or faster than usual • severe trouble sleeping • unusually grand ideas • racing thoughts • excessive happiness or irritabil Read the complete document
REMERON- MIRTAZAPINE TABLET, FILM COATED REMEDYREPACK INC. ---------- REMERON (MIRTAZAPINE) TABLETS 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 REMERON (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. REMERON IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC USE) DESCRIPTION REMERON (mirtazapine) Tablets are an orally administered drug. Mirtazapine 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 is a white to creamy white crystalline powder which is slightly soluble in water. REMERON is supplied for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containi Read the complete document