MIRTAZAPINE tablet, orally disintegrating

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Aurobindo Pharma Limited

INN (nemzetközi neve):

MIRTAZAPINE

Összetétel:

MIRTAZAPINE 15 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. Mirtazapine orally disintegrating 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 (5.3), Drug Interactions (7)]. - With a known hypersensitivity to mirtazapine or to any of the excipients in mirtazapine orally disintegrating tablets. 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 mirtazapine orally disintegrating tablets [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 mirtazapine orally disintegrating tablets have not been established in pediatric patients with MDD. Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with mirtazapine, and the data were insufficient to establish the safety and effectiveness of mirtazapine orally disintegrating tablets 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 mirtazapine-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 mirtazapine-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 mirtazapine. Mirtazapine orally disintegrating tablets are 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 mirtazapine orally disintegrating tablets, may cause confusion and over-sedation in the elderly. Elderly patients may be at greater risk of developing hyponatremia. Caution is indicated when administering mirtazapine orally disintegrating tablets 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 mirtazapine orally disintegrating tablets 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)]. Mirtazapine orally disintegrating tablets contain phenylalanine, a component of aspartame. Mirtazapine orally disintegrating tablets contain the following amount of phenylalanine: 1.5 mg in 15 mg orally disintegrating tablet, 3 mg in 30 mg orally disintegrating tablet, and 4.5 mg in 45 mg orally disintegrating tablet [see Warnings and Precautions (5.16)].

Termék összefoglaló:

Mirtazapine orally disintegrating tablets, USP are supplied as:                                                         15 mg Tablets – White, round tablets debossed with ‘36’ on one side and ‘A’ on the other side with an embossed circular edge.                              Box of 30 5 x 6 Unit dosage forms     NDC 65862-021-06                              Bottles of 30                                        NDC 65862-021-30                              Bottles of 60                                        NDC 65862-021-60                              Bottles of 90                                        NDC 65862-021-90                              Bottles of 100                                      NDC 65862-021-01 30 mg Tablets – White, round tablets debossed with ‘37’ on one side and ‘A’ on the other side with an embossed circular edge.                            Box of 30 5 x 6 Unit dosage forms       NDC 65862-022-06                            Bottles of 30                                          NDC 65862-022-30                            Bottles of 60                                          NDC 65862-022-60                            Bottles of 90                                          NDC 65862-022-90                            Bottles of 100                                        NDC 65862-022-01 45 mg Tablets – White, round tablets debossed with ‘38’ on one side and ‘A’ on the other side with an embossed circular edge.                         Box of 30 5 x 6 Unit dosage forms          NDC 65862-023-06                         Bottles of 30                                             NDC 65862-023-30                         Bottles of 60                                             NDC 65862-023-60                         Bottles of 90                                             NDC 65862-023-90                         Bottles of 100                                           NDC 65862-023-01 Storage 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]. Protect from light and moisture. The tablet should be used immediately after removal from its blister or container. Keep the container tightly closed.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

Aurobindo Pharma Limited
----------
MEDICATION GUIDE
Mirtazapine Orally Disintegrating Tablets, USP
(mir taz’ a peen)
for oral use
What is the most important information I should know about mirtazapine
orally disintegrating tablets?
Mirtazapine
orally
disintegrating
tablets
may
cause
serious
side
effects,
including:
•
Increased risk of suicidal thoughts or actions in some children and
young adults. Mirtazapine
orally disintegrating tablets, 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. Mirtazapine orally
disintegrating tablets 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
on
dangerous
impulses
• acting
aggressive,
being
angry
or
violent
• thoughts
about
suicide
or
dying
• new
or
worse
depression
• new
or
worse
anxiety
• panic
attacks
• feeling
very
agitated
or
restless
• new
or
worse
irritability
• trouble
sleeping
• an
extreme
increase
in
activity
or
talking
(mania)
• other unusual changes in behavior or mood
What

Termékjellemzők

MIRTAZAPINE - MIRTAZAPINE TABLET, ORALLY DISINTEGRATING
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MIRTAZAPINE ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MIRTAZAPINE ORALLY DISINTEGRATING TABLETS.
MIRTAZAPINE ORALLY DISINTEGRATING TABLETS, FOR ORAL USE
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.
MIRTAZAPINE ORALLY DISINTEGRATING TABLETS ARE 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
Mirtazapine orally disintegrating tablets are 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 mirtazapine orally disintegrating tablets immediately after
removal from blister pack or
container pack. (2.2)
Reduce dose gradually when discontinuing mirtazapine orally
disintegrating tablets. (2.6, 5.14)
DOSAGE FORMS AND STRENGTHS
_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
mirtazapine orally disintegrating
tablets. (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 mirtazapine orally disinteg