PAROXETINE- paroxetine hydrochloride hemihydrate tablet, film coated, extended release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

PAROXETINE HYDROCHLORIDE HEMIHYDRATE (UNII: X2ELS050D8) (PAROXETINE - UNII:41VRH5220H)

Disponible des:

Bryant Ranch Prepack

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Paroxetine Extended-Release Tablets, USP are indicated in adults for the treatment of: - Major depressive disorder (MDD) - Panic disorder (PD) - Social anxiety disorder (SAD) - Premenstrual dysphoric disorder (PMDD) Paroxetine Extended-Release Tablets are contraindicated in patients: - Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7)]. - Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions (5.3), Drug Interactions (7)] . - Taking pimozide because of risk of QT prolongation [see Warnings and Precautions (5.3), Drug Interactions (7)] . - With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or to any of the inactive ingredients in Paroxetine Extended-Release Tablets [see Adverse Reactions (6.1, 6.2)] . [see Warnings and Precautions (5.4)] Epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations. If paroxetine is used during pregnancy, or if the patient becomes pregnant while taking paroxetine, advise the patient of the potential hazard to the fetus. - A study based on Swedish national registry data demonstrated that infants exposed to paroxetine during pregnancy (n = 815) had an increased risk of cardiovascular malformations (2% risk in paroxetine-exposed infants) compared to the entire registry population (1% risk), for an odds ratio (OR) of 1.8 (95% confidence interval 1.1 to 2.8). No increase in the risk of overall congenital malformations was seen in the paroxetine-exposed infants. The cardiac malformations in the paroxetine-exposed infants were primarily ventricular septal defects (VSDs) and atrial septal defects (ASDs). Septal defects range in severity from those that resolve spontaneously to those which require surgery. - A separate retrospective cohort study from the United States (United Healthcare data) evaluated 5,956 infants of mothers dispensed antidepressants during the first trimester (n = 815 for paroxetine). This study showed a trend towards an increased risk for cardiovascular malformations for paroxetine (risk of 1.5%) compared to other antidepressants (risk of 1%), for an OR of 1.5 (95% confidence interval 0.8 to 2.9). Of the 12 paroxetine-exposed infants with cardiovascular malformations, 9 had VSDs. This study also suggested an increased risk of overall major congenital malformations including cardiovascular defects for paroxetine (4% risk) compared to other (2% risk) antidepressants (OR 1.8; 95% confidence interval 1.2 to 2.8). - Two large case-control studies using separate databases, each with >9,000 birth defect cases and >4,000 controls, found that maternal use of paroxetine during the first trimester of pregnancy was associated with a 2- to 3-fold increased risk of right ventricular outflow tract obstructions. In one study the OR was 2.5 (95% confidence interval, 1.0 to 6.0, 7 exposed infants) and in the other study the OR was 3.3 (95% confidence interval, 1.3 to 8.8, 6 exposed infants). Other studies have found varying results as to whether there was an increased risk of overall, cardiovascular, or specific congenital malformations. A meta-analysis of epidemiological data over a 16-year period (1992 to 2008) on first trimester paroxetine use in pregnancy and congenital malformations included the above-noted studies in addition to others (n = 17 studies that included overall malformations and n = 14 studies that included cardiovascular malformations; n = 20 distinct studies). While subject to limitations, this meta-analysis suggested an increased occurrence of cardiovascular malformations (prevalence odds ratio [POR] 1.5; 95% confidence interval 1.2 to 1.9) and overall malformations (POR 1.2; 95% confidence interval 1.1 to 1.4) with paroxetine use during the first trimester. It was not possible in this meta-analysis to determine the extent to which the observed prevalence of cardiovascular malformations might have contributed to that of overall malformations, nor was it possible to determine whether any specific types of cardiovascular malformations might have contributed to the observed prevalence of all cardiovascular malformations. Unless the benefits of paroxetine to the mother justify continuing treatment, consideration should be given to either discontinuing paroxetine therapy or switching to another antidepressant [see Warnings and Precautions (5.7)] . For women who intend to become pregnant or are in their first trimester of pregnancy, paroxetine should only be initiated after consideration of the other available treatment options [see Warnings and Precautions (5.4)] . Treatment of Pregnant Women During Their Third Trimester : Neonates exposed to SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs), including Paroxetine Extended-Release Tablets, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions (5.2)]. Exposure to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. There have also been postmarketing reports of premature births in pregnant women exposed to paroxetine or other SSRIs. When treating a pregnant woman with paroxetine during the third trimester, the physician should carefully consider both the potential risks and benefits of treatment [see Dosage and Administration (2.5)]. A prospective longitudinal study of 201 women with a history of major depression who were euthymic at the beginning of pregnancy. The women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication. Animal Findings : Reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered during organogenesis. These doses are approximately 6 (rat) and less than 2 (rabbit) times the maximum recommended human dose (MRHD – 75 mg) on an mg/m2 basis. These studies have revealed no evidence of malformations. However, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation. This effect occurred at a dose of 1 mg/kg/day or approximately one-thirteens of the MRHD on an mg/m2 basis. The no-effect dose for rat pup mortality was not determined. The cause of these deaths is not known. Like many other drugs, paroxetine is secreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Paroxetine Extended-Release Tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The safety and effectiveness of Paroxetine Extended-Release Tablets in pediatric patients have not been established [see Boxed Warning, Warnings and Precautions (5.1)]. Three placebo-controlled trials in 752 pediatric patients with MDD have been conducted with immediate-release paroxetine, and effectiveness was not established in pediatric patients. Decreased appetite and weight loss have been observed in association with the use of SSRIs. In placebo-controlled clinical trials conducted with pediatric patients, the following adverse reactions were reported in at least 2% of pediatric patients treated with immediate-release paroxetine hydrochloride and at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation. Adverse reactions upon discontinuation of treatment with immediate-release paroxetine hydrochloride in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients and at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain. SSRIs and SNRIs, including Paroxetine Extended-Release Tablets, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.9)]. In premarketing clinical trials with immediate-release paroxetine hydrochloride, 17% of paroxetine treated patients (approximately 700) were 65 years or older. Pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; however, no overall differences in safety or effectiveness were observed between these subjects and younger subjects [see Dosage and Administration (2.5), Clinical Pharmacology (12.3)]. Increased plasma concentrations of paroxetine occur in patients with renal and hepatic impairment. The initial dosage should be reduced in patients with severe renal impairment and patients with severe hepatic impairment [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3)].

Resumen del producto:

Paroxetine Extended-Release Tablets, USP are supplied as: a round, extended-release tablet as follows: 25 mg Brown enteric coated, round, bi-convex tablets, with one side debossed 2272 and the other side blank: NDC 63629-9499-01 Bottles of 30 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Bryant Ranch Prepack
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MEDICATION GUIDE
PAROXETINE (PAR OX' E TEEN)
EXTENDED-RELEASE TABLETS, USP
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 03/2021
What is the most important information I should know about Paroxetine
Extended-Release Tablets?
Paroxetine Extended-Release Tablets can cause serious side effects,
including:
•
Increased risk of suicidal thoughts or actions. Antidepressant
medicines may increase suicidal
thoughts and actions in some children and young adults within the
first few months of treatment
or when the dose is changed. Paroxetine Extended-Release Tablets are
not for use in people
younger than 18 years of age.
How can I watch for and try to prevent suicidal thoughts and actions?
•
Depression or other serious mental illnesses are the most important
causes of suicidal
thoughts and actions.
•
Pay close attention to any changes, especially sudden changes in mood,
behavior, thoughts
or feelings or if you develop suicidal thoughts or actions. This is
very important when an
antidepressant medicine is started or when the dose is changed.
•
Call your healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts or feelings or if you develop suicidal thoughts or
actions.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
Call your healthcare provider or get emergency medical help right away
if you have any of the following
symptoms, especially if they are new, worse, or worry you:
•
attempts to commit suicide
•
acting aggressive or violent
•
new or worse depression
•
feeling agitated, restless, angry, or irritable
•
an increase in activity and talking more than
what is normal for you
•
acting on dangerous impulses
•
thoughts about suicide or dying
•
new or worse anxiety or panic attacks
•
trouble sleeping
•
other unusual changes in behavior or mood
What are Paroxetin

Fitxa tècnica

PAROXETINE- PAROXETINE HYDROCHLORIDE HEMIHYDRATE TABLET, FILM COATED,
EXTENDED RELEASE
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PAROXETINE EXTENDED-
RELEASE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR PAROXETINE
EXTENDED-RELEASE TABLETS, USP.
PAROXETINE EXTENDED-RELEASE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN PEDIATRIC AND
YOUNG ADULT PATIENTS
TAKING ANTIDEPRESSANTS. CLOSELY MONITOR ALL ANTIDEPRESSANT-TREATED
PATIENTS FOR CLINICAL
WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS. PAROXETINE
EXTENDED-
RELEASE TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (5.1,
8.4)
INDICATIONS AND USAGE
Paroxetine Extended-Release Tablets are a selective serotonin reuptake
inhibitor (SSRI) indicated in adults
for the treatment of (1):
Major Depressive Disorder (MDD)
Panic Disorder (PD)
Social Anxiety Disorder (SAD)
Premenstrual Dysphoric Disorder (PMDD)
DOSAGE AND ADMINISTRATION
Swallow tablet whole; do not chew or crush. (2.1)
Recommended starting and maximum daily dosage: (2.2, 2.3)
INDICATION
STARTING DOSE
MAXIMUM DOSE
MDD
25 mg/day
62.5 mg/day
PD
12.5 mg/day
75 mg/day
SAD
12.5 mg/day
37.5 mg/day
PMDD
12.5 mg/day
25 mg/day
For PMDD, dose continuously or intermittently (luteal phase only).
(2.3)
If inadequate response to starting dosage, titrate in 12.5 mg per day
increments once weekly. (2.2, 2.3)
Elderly patients, patients with severe renal impairment or severe
hepatic impairment: Starting dose is
12.5 mg per day. Do not exceed 50 mg per day for treatment of MDD and
PD and 37.5 mg per day for
treatment of SAD. (2.5)
When discontinuing Paroxetine Extended-Release Tablets, reduce dose
gradually. (2.7)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 12.5 mg, 25 mg, and 37.5 mg tablets. (3)
CONTRAINDICATIONS
Concomit