البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (UNII: X2ELS050D8) (PAROXETINE - UNII:41VRH5220H)
Aphena Pharma Solutions - Tennessee, LLC
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
PAROXETINE 20 mg
ORAL
PRESCRIPTION DRUG
Paroxetine tablets are indicated for the treatment of major depressive disorder. The efficacy of paroxetine tablets 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 four of the following eight 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 tablets in hospitalized depressed patients have not been adequately studied. The efficacy of parox
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Paroxetine Tablets, USP are available as 10 mg, 20 mg, 30 mg and 40 mg tablets. The 10 mg tablet is a blue film-coated, modified capsule-shaped, scored tablet debossed with M on one side of the tablet and N to the left of the score and 1 to the right of the score on the other side. They are available as follows: NDC 0378-7001-93 bottles of 30 tablets NDC 0378-7001-01 bottles of 100 tablets NDC 0378-7001-10 bottles of 1000 tablets The 20 mg tablet is a blue film-coated, modified capsule-shaped, scored tablet debossed with M on one side of the tablet and N to the left of the score and 2 to the right of the score on the other side. They are available as follows: NDC 0378-7002-93 bottles of 30 tablets NDC 0378-7002-01 bottles of 100 tablets NDC 0378-7002-10 bottles of 1000 tablets The 30 mg tablet is a blue film-coated, round, unscored tablet debossed with M over N3 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-7003-93 bottles of 30 tablets NDC 0378-7003-01 bottles of 100 tablets NDC 0378-7003-10 bottles of 1000 tablets The 40 mg tablet is a blue film-coated, round, unscored tablet debossed with M over N4 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-7004-93 bottles of 30 tablets NDC 0378-7004-01 bottles of 100 tablets NDC 0378-7004-10 bottles of 1000 tablets Store at 20° to 25 °C (68° to 77°F). [See USP Controlled Room Temperature.] 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
PAROXETINE- PAROXETINE HYDROCHLORIDE HEMIHYDRATE TABLET, FILM COATED Aphena Pharma Solutions - Tennessee, LLC ---------- MEDICATION GUIDE PAROXETINE TABLETS, USP (PA ROX′ E TEEN HYE″ DROE KLOR′ IDE) Read the Medication Guide that comes with paroxetine 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. 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 • اقرأ الوثيقة كاملة
PAROXETINE- PAROXETINE HYDROCHLORIDE HEMIHYDRATE TABLET, FILM COATED APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- 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 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 Paroxetine hydrochloride is an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (3_S_-_trans_)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4- (4-fluorophenyl)-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 (hemihydrate), USP is an odorless, white or almost white crystalline powder, having a melting point range of 129° to 131°C and a solubility of 5.4 mg/mL in water. Each film-coat اقرأ الوثيقة كاملة