REMERON- mirtazapine tablet, film coated REMERONSOLTAB- mirtazapine tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MIRTAZAPINE (UNII: A051Q2099Q) (MIRTAZAPINE - UNII:A051Q2099Q)

Available from:

Organon LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

REMERON/REMERONSolTab are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] . REMERON/REMERONSolTab is 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 (5.3), Drug Interactions (7)] . - With a known hypersensitivity to mirtazapine or to any of the excipients in REMERON/REMERONSolTab. Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have been reported following the use of REMERON/REMERONSolTab [see Warnings and Precautions (5.6), Adverse Reactions (6.2)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Risk Summary Prolonged experience with mirtazapine in pregnant women, based on published observational studies and postmarketing reports, has not reliably identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated depression in pregnancy (see Clinical Considerations). In animal reproduction studies, oral administration of mirtazapine to pregnant rats and rabbits during the period of organogenesis revealed no evidence of teratogenic effects up to 20 and 17 times the maximum recommended human dose (MRHD) of 45 mg, respectively, based on mg/m2 body surface area. However, in rats, there was an increase in postimplantation loss at 20 times the MRHD based on mg/m2 body surface area. Oral administration of mirtazapine to pregnant rats during pregnancy and lactation resulted in an increase in pup deaths and a decrease in pup birth weights at doses 20 times the MRHD based on mg/m2 body surface area (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Data Animal Data Mirtazapine was administered orally to pregnant rats and rabbits during the period of organogenesis at doses of 2.5, 15, and 100 mg/kg/day and 2.5, 10, and 40 mg/kg/day, respectively, which are up to 20 and 17 times the maximum recommended human dose (MRHD) of 45 mg based on mg/m2 body surface area, respectively. No evidence of teratogenic effects was observed. However, in rats, there was an increase in postimplantation loss in dams treated with mirtazapine at 100 mg/kg/day which is 20 times the MRHD based on mg/m2 body surface area. Oral administration of mirtazapine at doses of 2.5, 15, and 100 mg/kg/day to pregnant rats during pregnancy and lactation resulted in an increase in pup deaths during the first 3 days of lactation and a decrease in pup birth weights at 20 times the MRHD based on mg/m2 body surface area. The cause of these deaths is not known. The no effect dose level is 3 times the MRHD based on mg/m2 body surface area. Risk Summary Data from published literature report the presence of mirtazapine in human milk at low levels with relative infant doses for mirtazapine ranging between 0.6 and 2.8% of the maternal weight-adjusted dose (see Data) . No adverse effects on the breastfed infant have been reported in most cases of maternal use of mirtazapine. There are no data on the effects of mirtazapine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mirtazapine and any potential adverse effects on the breastfed infant from mirtazapine or from the underlying maternal condition. Data In a published pooled analysis of 8 breastfeeding mother-infant pairs, the mean (min, max) total relative infant doses for mirtazapine and its desmethyl metabolite were 1.5% (0.6%, 2.8%) and 0.4% (0.1%, 0.7%) of the maternal weight-adjusted dose (median (min, max) dose of 38 mg (30 mg, 120 mg), respectively). No adverse drug effects were reported for any of the infants. The safety and effectiveness of REMERON/REMERONSolTab have not been established in pediatric patients with MDD. Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with REMERON, and the data were insufficient to establish the safety and effectiveness of REMERON/REMERONSolTab in pediatric patients with MDD. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning and Warnings and Precautions (5.1)] . In an 8-week-long clinical trial in pediatric patients receiving doses between 15 to 45 mg per day, 49% of REMERON-treated patients had a weight gain of at least 7%, compared to 5.7% of placebo-treated patients. The mean increase in weight was 4 kg (2 kg SD) for REMERON-treated patients versus 1 kg (2 kg SD) for placebo-treated patients [see Warnings and Precautions (5.7)] . Approximately 190 patients ≥65 years of age participated in clinical studies with REMERON. REMERON/REMERONSolTab is known to be substantially excreted by the kidney (75%), and the risk of decreased clearance of this drug is greater in patients with impaired renal function. Pharmacokinetic studies revealed a decreased clearance of mirtazapine in the elderly [see Clinical Pharmacology (12.3)] . Sedating drugs, including REMERON/REMERONSolTab, may cause confusion and over-sedation in the elderly. Elderly patients may be at greater risk of developing hyponatremia. Caution is indicated when administering REMERON/REMERONSolTab to elderly patients [see Warnings and Precautions (5.12), (5.15) and Clinical Pharmacology (12.3)] . In general, dose selection for an elderly patient should be conservative, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The clearance of mirtazapine is reduced in patients with moderate to severe renal or hepatic impairment. Consequently, plasma mirtazapine levels may be increased in these patient groups, compared to levels observed in patients without renal or hepatic impairment. Dosage decrease may be necessary when administering REMERON/REMERONSolTab to patients with moderate to severe renal or hepatic impairment [see Warnings and Precautions (5.13), Use in Specific Populations (8.5), and Clinical Pharmacology (12.3)] . REMERONSolTab contains phenylalanine, a component of aspartame. REMERONSolTab contains the following amount of phenylalanine: 2.6 mg in 15 mg orally disintegrating tablet, 5.2 mg in 30 mg orally disintegrating tablet, and 7.8 mg in 45 mg orally disintegrating tablet [see Warnings and Precautions (5.16)].

Product summary:

REMERON tablets are supplied as: Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. REMERONSolTab orally disintegrating tablets are supplied as: Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Use immediately upon opening individual tablet blister.

Authorization status:

New Drug Application

Patient Information leaflet

REMERONSOLTAB- MIRTAZAPINE TABLET, ORALLY DISINTEGRATING
Organon LLC
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MEDICATION GUIDE
REMERON® (RĔM' - Ĕ – RŎN)
(MIRTAZAPINE)
TABLETS, FOR ORAL USE
REMERONSOLTAB® (RĔM' - Ĕ - RŎN - SŎL' – TĂB)
(MIRTAZAPINE)
ORALLY DISINTEGRATING TABLETS, FOR ORAL USE
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: 11/2021
What is the most important information I should know about REMERON and
REMERONSolTab?
REMERON and REMERONSolTab may cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions in some children and
young adults. REMERON,
REMERONSolTab, and other antidepressant medicines may increase
suicidal thoughts or actions
in some people 24 years of age and younger, especially within the
first few months of treatment
or when the dose is changed. REMERON and REMERONSolTab are not for use
in children.
•
Depression or other serious mental illnesses are the most important
causes of suicidal
thoughts or actions.
How can I watch for and try to prevent 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.
•
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 or your family
member have any of the following symptoms, especially if they are new,
worse, or worry you:
•
attempts to commit
suicide
•
acting aggressive, being
angry or violent
•
new or worse depression
•
panic attacks
•
new or worse irritability
•
an extreme increase in
activity or talking
(mania)
•
acting on dangerous impul

Summary of Product characteristics

REMERON- MIRTAZAPINE TABLET, FILM COATED
REMERONSOLTAB- MIRTAZAPINE TABLET, ORALLY DISINTEGRATING
ORGANON LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REMERON/REMERONSOLTAB SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
REMERON/REMERONSOLTAB.
REMERON (MIRTAZAPINE) TABLETS, FOR ORAL USE
REMERONSOLTAB (MIRTAZAPINE) ORALLY DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 1996
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.
REMERON/REMERONSOLTAB IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS.
(5.1, 8.4)
RECENT MAJOR CHANGES
Contraindications (4)
11/2021
Warnings and Precautions (5.6)
11/2021
INDICATIONS AND USAGE
REMERON/REMERONSolTab is indicated for the treatment of major
depressive disorder (MDD) in adults. (1)
DOSAGE AND ADMINISTRATION
Starting dose: 15-mg once daily; may increase up to maximum
recommended dose of 45 mg once
daily. (2.1)
Administer orally once daily, preferably in the evening prior to
sleep. (2.1)
Administer REMERONSolTab immediately after removal from blister pack.
(2.2)
Reduce dose gradually when discontinuing REMERON/REMERONSolTab. (2.6,
5.14)
DOSAGE FORMS AND STRENGTHS
_Tablets_: 15 mg scored and 30 mg scored. (3)
_Orally disintegrating tablets_: 15 mg, 30 mg, and 45 mg. (3)
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within
14 days of stopping MAOIs.
(2.4, 4, 7)
Known hypersensitivity to mirtazapine or any of the excipients in
REMERON/REMERONSolTab. (4)
WARNINGS AND PRECAUTIONS
_Agranulocytosis_: If sore throat, fever, stomatitis or signs of
infection occur, along with a low white blood
cell count, treatment with REMERON/REMERONSolTab should be
discontinued and the patient should be
clo