Country: United States
Language: English
Source: NLM (National Library of Medicine)
MIRTAZAPINE (UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
Mirtazapine 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 tablets
Mirtazapine Tablets, USP are available containing 15 mg, 30 mg or 45 mg of mirtazapine, USP. The 15 mg tablets are beige, film-coated, round, scored tablets debossed with M over 515 on one side of the tablet and bisected by a score on the other side. They are available as follows: NDC 0378-3515-93 bottles of 30 tablets NDC 0378-3515-01 bottles of 100 tablets NDC 0378-3515-10 bottles of 1000 tablets The 30 mg tablets are beige, film-coated, round, scored tablets debossed with M over 530 on one side of the tablet and bisected by a score on the other side. They are available as follows: NDC 0378-3530-93 bottles of 30 tablets NDC 0378-3530-01 bottles of 100 tablets NDC 0378-3530-05 bottles of 500 tablets The 45 mg tablets are beige, film-coated, round, unscored tablets debossed with M over 545 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3545-93 bottles of 30 tablets NDC 0378-3545-01 bottles of 100 tablets NDC 0378-3545-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and 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
REMEDYREPACK INC. ---------- MEDICATION GUIDE Mirtazapine Tablets, USP (mir taz' a peen) What is the most important information I should know about mirtazapine tablets? Mirtazapine tablets and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Mirtazapine 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 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 tablets may be associated with these serious side effects: 2. Manic episodes: • greatly increased energy • severe trouble sleeping • racing thoughts • reckless behavior • talking more or faster than usual • unusually grand ideas • excessive happiness or irritability 3. Decreased White Blood Cells called neutroph Read the complete document
MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED REMEDYREPACK INC. ---------- 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 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 Mirtazapine tablets, USP 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 molecular 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 soluble in water. Mirtazapine tablets are supplied for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of Read the complete document