Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
PAROXETINE HYDROCHLORIDE (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H)
Physicians Total Care, Inc.
PAROXETINE HYDROCHLORIDE
PAROXETINE 12.5 mg
ORAL
PRESCRIPTION DRUG
Paroxetine hydrochloride extended-release tablets are indicated for the treatment of major depressive disorder. The efficacy of paroxetine hydrochloride extended-release tablets in the treatment of a major depressive episode was established in two 12 week controlled trials of outpatients whose diagnoses corresponded to the DSM-IV category of major depressive disorder (see CLINICAL PHARMACOLOGY: Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or loss of interest or pleasure in nearly all activities, representing a change from previous functioning and includes the presence of at least 5 of the following 9 symptoms during the same 2 week period: Depressed mood, markedly diminished interest or pleasure 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 impai
Paroxetine Hydrochloride Extended-release Tablets are available containing paroxetine hydrochloride (hemihydrate) USP, equivalent to 12.5 mg, 25 mg paroxetine. The 12.5 mg tablet is a white enteric film-coated, round, unscored tablet with M over P3 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: The 25 mg tablet is a lavender enteric film-coated, round, unscored tablet with M over P4 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: 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 HYDROCHLORIDE - PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE Physicians Total Care, Inc. ---------- MEDICATION GUIDE PAROXETINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS (pa rox′ e teen hye″ droe klor′ ide) 12.5 mg, 25 mg and 37.5 mg Read the Medication Guide that comes with paroxetine hydrochloride extended-release 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 hydrochloride extended-release tablets? Paroxetine hydrochloride extended-release tablets and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Paroxetine hydrochloride extended-release 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 hydrochloride extended- release 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 Přečtěte si celý dokument
PAROXETINE HYDROCHLORIDE - PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE PHYSICIANS TOTAL CARE, 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 PAROXETINE 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 hydrochloride extended-release tablets are an orally administered psychotropic drug with a chemical structure unrelated to other selective serotonin reuptake inhibitors or to tricyclic, tetracyclic or other available antidepressant or antipanic agents. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (3S-trans)-3-[(1,3-benzodioxol-5-yloxy)methyl)]4-(4-fluorophenyl)- piperidine hydrochloride hemihydrate and has the molecular formula of C H FNO • HCl • ½ H O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is: Paroxetine hydrochloride Přečtěte si celý dokument