Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (UNII: X2ELS050D8) (PAROXETINE - UNII:41VRH5220H)
ACETRIS HEALTH, LLC
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
PAROXETINE 10 mg
ORAL
PRESCRIPTION DRUG
Major Depressive Disorder Paroxetine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of paroxetine in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL PHARMACOLOGY: Clinical Trials ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: Change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The effects of paroxetine in hospitalized depressed patients have not been adequately studied. The efficacy
Paroxetine Tablets USP, 10 mg are yellow colored film-coated modified capsule shaped, biconvex tablets debossed with ‘C 55’ on one side and a deep breakline on the other side. Bottles of 30 NDC 52343-073-30 Bottles of 90 NDC 52343-073-90 Bottles of 1000 NDC 52343-073-99 Paroxetine Tablets USP, 20 mg are pink colored film-coated modified capsule shaped, biconvex tablets debossed with ‘56’ on one side and ‘C’ with a deep breakline on the other side. Bottles of 30 NDC 52343-074-30 Bottles of 90 NDC 52343-074-90 Bottles of 1000 NDC 52343-074-99 Paroxetine Tablets USP, 30 mg are blue colored film-coated modified capsule shaped, biconvex tablets debossed with ‘F’ on one side and ‘12’ on the other side. Bottles of 30 NDC 52343-075-30 Bottles of 90 NDC 52343-075-90 Bottles of 1000 NDC 52343-075-99 Paroxetine Tablets USP, 40 mg are pink colored film-coated modified capsule shaped, biconvex tablets debossed with ‘A 59’ on one side and plain on the other side. Bottles of 30 NDC 52343-076-30 Bottles of 90 NDC 52343-076-90 Bottles of 1000 NDC 52343-076-99 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense with Medication Guide available at http://www.acetrishealth.com/med-guides.html Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810 Issued: 11/2017
Abbreviated New Drug Application
PAROXETINE - PAROXETINE HYDROCHLORIDE TABLET, FILM COATED ACETRIS HEALTH, LLC ---------- MEDICATION GUIDE Paroxetine Tablets, USP (par ox' e teen) Read the Medication Guide that comes with paroxetine tablets before you start taking them 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. Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about paroxetine tablets? Paroxetine tablets and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Paroxetine 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 paroxetine 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 Đọc toàn bộ tài liệu
PAROXETINE - PAROXETINE HYDROCHLORIDE TABLET, FILM COATED ACETRIS HEALTH, LLC ---------- PAROXETINE TABLETS, USP RX ONLY BOXED WARNING 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 PAROXETINE 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. PAROXETINE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC USE.) DESCRIPTION Paroxetine tablets, USP are an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-_trans_-4_R_-(4'-fluorophenyl)-3_S_-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C H FNO •HCl•1/2H O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is: Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Each film-coated tablet contains paroxet Đọc toàn bộ tài liệu