Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
MIRTAZAPINE (UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q)
Contract Pharmacy Services-PA
MIRTAZAPINE
MIRTAZAPINE 15 mg
ORAL
PRESCRIPTION DRUG
Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine tablets, USP 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 - 3 rd 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 effectivenes
Mirtazapine Tablets, USP, for oral administration, are available as 15 mg Round, biconvex, yellow, film coated tablets, debossed " E " over "20" on one side and bisected on the other side and supplied as: NDC 67046-479-07 blisterpacks of 7 NDC 67046-479-14 blisterpacks of 14 NDC 67046-479-15 blisterpacks of 15 NDC 67046-479-20 blisterpacks of 20 NDC 67046-479-21 blisterpacks of 21 NDC 67046-479-28 blisterpacks of 28 NDC 67046-479-30 blisterpacks of 30 NDC 67046-479-60 blisterpacks of 60 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Protect from light and moisture. KEEP TIGHTLY CLOSED. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Abbreviated New Drug Application
MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED Contract Pharmacy Services-PA ---------- MEDICATION GUIDE Mirtazapine Tablets, USP (mer-TAH-zah-peen) Read the Medication Guide that comes with Mirtazapine Tablets before you start taking it 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. If you have any questions about Mirtazapine Tablets, talk to your healthcare provider. 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 provide Perskaitykite visą dokumentą
MIRTAZAPINE- MIRTAZAPINE TABLET, FILM COATED CONTRACT PHARMACY SERVICES-PA ---------- 479 MIRTAZAPINE 15 MG MIRTAZAPINE TABLETS, USP 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 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 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 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][2]-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 is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets, USP are supplied for oral administration as biconvex, bevel-edged, film-coated tablets containing 15 Perskaitykite visą dokumentą