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Mirtazapine 15 mg Tablet, Orally Disintegrating, 100-count — NDC 65862-0021-01 package photo

Mirtazapine 15 mg Tablet, Orally Disintegrating, 100-count

by Aurobindo Pharma Limited · 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-01)
NDC 65862-0021-01
🏷️ FDA NDC (as labeled) 65862-021-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes6 compare ↓
Also priced by: Part D plans $0.6361/unit — full pricing hub ↓
Also comes in: 6 tablets 65862-0021-06 30 tablets 65862-0021-30 60 tablets 65862-0021-60 90 tablets 65862-0021-90 8000 tablets 65862-0021-81
On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 65862-021-01
Product NDC 65862-021
11-digit billing NDC 65862002101
SPL Set ID 3a8a4490-9243-4201-944d-cea27d3d69f5
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-12-08
Dosage form TABLET, ORALLY DISINTEGRATING
Substance MIRTAZAPINE
GPI-14 58030050007215
GPI class Mirtazapine
GCN Seq No 047453
GCN 12529
HICL code 011505
Ingredient (HICL) Mirtazapine
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7B
Therapeutic class — specific (HIC3) Alpha-2 Receptor Antagonist Antidepressants
AHFS code 28:16.04.24
AHFS class Serotonin Modulators
FDB label name MIRTAZAPINE 15 MG ODT
FDB brand name Mirtazapine
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 65862-021-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65862-0021-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerAurobindo Pharma Limited
Labeler code65862
First marketedDec 2005
Product typeDrug For Further Processing
Portfolio1,452 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name MIRTAZAPINE 15 MG ODT Ingredient Mirtazapine
📖 What it is MedlinePlus · NLM

Mirtazapine is used to treat depression. Mirtazapine is in a class of medications called antidepressants. It works by increasing certain types of activity in the brain to maintain mental balance.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Mirtazapine is prescribed to treat major depressive disorder (MDD) in adults. That's a medical condition involving a persistently low mood, loss of interest in daily activities, ch...
  • Mirtazapine causes significant drowsiness — it's one of its most common effects. Taking it in the evening before bed means that sleepiness works in your favor rather than interferi...
  • Why is it recommended to take mirtazapine in the evening?
  • Yes, weight gain and increased appetite are well-documented side effects of mirtazapine. In clinical trials, about 12% of patients on mirtazapine gained weight, compared to 2% on p...
📖 Read our full Mirtazapine guide →
1
Nutrient depletion considerations

Mirtazapine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Mirtazapine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeRound
Imprint38;A
Size1 mm
ScoringNot scored
FlavorStrawberry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.6361 $63.61 / 100 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mirtazapine 15 mg 57237-0011-06 Rising 6 tablets $0.332 AB Availability likely —
Mirtazapine 15 mg 72578-0103-84 Viona 30 tablets $0.332 AB Availability likely —
Mirtazapine 15 mg 55154-8335-06 Cardinal 6 tablets — AB FDA listed —
Mirtazapine 15 mgthis 65862-0021-01 Aurobindo 100 tablets — — FDA listed —
Mirtazapine 15 mg 76483-0110-00 SQUARE 30 tablets — AB FDA listed —
Remeronsoltab 15 mg 78206-0156-01 Organon 6 tablets — AB FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2005
On the market since
Dec 2005
📍
2026
Currently FDA-listed
21 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
6 tablets65862-0021-06 14,068 Rx · $280,513
100 tablets this page65862-0021-01 No Medicaid data
30 tablets65862-0021-30 No Medicaid data
60 tablets65862-0021-60 No Medicaid data
90 tablets65862-0021-90 No Medicaid data
8000 tablets65862-0021-81 No Medicaid data
Drug total (last 4 qtrs): 14,068 Rx · 462,083 units · $280,513 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Mirtazapine (matched by generic name) — the program that covers self-administered drugs. 11 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Mirtazapine. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$39.56M
Claims incl. refills
2.2M
Beneficiaries
1.1M
Spend / beneficiary
$35.27
Spend / claim
$18.20
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
65862-0021-01 You're viewing this 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-01) — — 2005-12-08 Active
65862-0021-06 5 BLISTER PACK in 1 CARTON (65862-021-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK $0.3322 / ea $9.97 2005-12-08 Active
65862-0021-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-30) — — 2005-12-08 Active
65862-0021-60 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-60) — — 2005-12-08 Active
65862-0021-90 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-90) — — 2005-12-08 Active
65862-0021-81 8000 TABLET, ORALLY DISINTEGRATING in 1 BAG (65862-021-81) — — — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 65862-0021-01?
NDC 65862-0021-01 is a 100-count package — 100 tablet, orally disintegrating in 1 bottle.
What is the difference between NDC 65862-0021-01 and NDC 65862-0021-30?
Both are Mirtazapine 15 mg Tablet, Orally Disintegrating — the drug itself is identical. NDC 65862-0021-01 is the 100-count package, while NDC 65862-0021-30 is the 30 tablets package.
What NDC number is used to bill for this package of Mirtazapine 15 mg Tablet, Orally Disintegrating?
Bill NDC 65862-0021-01 — the 11-digit billing format is 65862002101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Aurobindo Pharma Limited supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 65862-021-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 65862-0021-01, written without dashes as 65862002101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 65862-0021-01, the first segment (65862) is the labeler code FDA assigned to Aurobindo Pharma Limited; the middle segment (0021) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aurobindo Pharma Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 6 tablets (65862-0021-06), 30 tablets (65862-0021-30), 60 tablets (65862-0021-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aurobindo Pharma Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 124 words ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ]. Mirtazapine orally disintegrating tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4) ].

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 )

🎯 Indications and Usage 44 words ▾

1 INDICATIONS AND USAGE 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 indicated for the treatment of major depressive disorder (MDD) in adults. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 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 )

2.1Recommended Dosage The recommended starting dose of mirtazapine orally disintegrating tablets is 15 mg once daily, administered orally, preferably in the evening prior to sleep. If patients do not have an adequate response to the initial 15 mg dose, increase the dose up to a maximum of 45 mg per day. Dose changes should not be made in intervals of less than 1 to 2 weeks to allow sufficient time for evaluation of response to a given dose [see Clinical Pharmacology (12.3) ].

2.2Administration of Mirtazapine Orally Disintegrating Tablets The tablet should remain in the blister pack or container pack until the patient is ready to take it. The patient or caregiver should use dry hands to open the blister or container. As soon as the blister or container is opened, the tablet should be removed and placed on the patient’s tongue.

Use mirtazapine orally disintegrating tablets immediately after removal from its blister or container; once removed, it cannot be stored. The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing. Do not attempt to split the tablet.

The tablet will disintegrate in saliva so that it can be swallowed.

2.3Screen for Bipolar Disorder Prior to Starting Mirtazapine Orally Disintegrating Tablets Prior to initiating treatment with mirtazapine orally disintegrating tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.9) ].

2.4Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of mirtazapine orally disintegrating tablets. In addition, at least 14 days must elapse after stopping mirtazapine orally disintegrating tablets before starting an MAOI antidepressant [see Contraindications (4) and Warnings and Precautions (5.3) ].

2.5Dosage Modifications Due to Drug Interactions Strong CYP3A Inducers An increase in dosage of mirtazapine orally disintegrating tablets may be needed with concomitant strong CYP3A inducer (e.g., carbamazepine, phenytoin, rifampin) use. Conversely, a decrease in dosage of mirtazapine orally disintegrating tablets may be needed if the CYP3A inducer is discontinued [see Drug Interactions (7) ]. Strong CYP3A Inhibitors A decrease in dosage of mirtazapine orally disintegrating tablets may be needed with concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin).

Conversely, an increase in dosage of mirtazapine orally disintegrating tablets may be needed if the CYP3A4 inhibitor is discontinued [see Drug Interactions (7) ]. Cimetidine A decrease in dosage of mirtazapine orally disintegrating tablets may be needed with concomitant use of cimetidine. Conversely, an increase in dosage of mirtazapine orally disintegrating tablets may be needed if cimetidine is discontinued [see Drug Interactions (7) ].

2.6Discontinuation of Mirtazapine Orally Disintegrating Tablets Treatment Adverse reactions may occur upon discontinuation or dose reduction of mirtazapine orally disintegrating tablets [see Warnings and Precautions (5.14) ]. Gradually reduce the dosage of mirtazapine orally disintegrating tablets rather than stopping abruptly whenever possible.

💊 Dosage Forms and Strengths 101 words ▾

3 DOSAGE FORMS AND STRENGTHS Mirtazapine orally disintegrating tablets USP are supplied as: 15 mg orally disintegrating tablets: White, round tablets debossed with ‘36’ on one side and ‘A’ on the other side with an embossed circular edge. 30 mg orally disintegrating tablets: White, round tablets debossed with ‘37’ on one side and ‘A’ on the other side with an embossed circular edge. 45 mg orally disintegrating tablets: White, round tablets debossed with ‘38’ on one side and ‘A’ on the other side with an embossed circular edge.

Orally disintegrating tablets: 15 mg, 30 mg, and 45 mg. ( 3 )

⛔ Contraindications 143 words ▾

4 CONTRAINDICATIONS 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) ].

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 Cautions ~3 min read ▾

5 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 disintegrating tablets should be discontinued and the patient should be closely monitored. ( 5.2 ) Serotonin Syndrome: Increased risk when co-administered with other serotonergic drugs (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue mirtazapine orally disintegrating tablets and initiate supportive treatment.

( 2.4 , 4 , 5.3 , 7 ) Angle-Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.4 ) QT Prolongation: Use mirtazapine orally disintegrating tablets with caution in patients with risk factors for QT prolongation. ( 5.5 , 7 ) Drug Reaction with Eosinophilia and System Symptoms (DRESS): Discontinue Mirtazapine orally disintegrating tablets if DRESS is suspected.

( 5.6 ) Increased Appetite/Weight Gain: Mirtazapine orally disintegrating tablets have been associated with increased appetite and weight gain. ( 5.7 ) Somnolence: May impair judgment, thinking and/or motor skills. Use with caution when engaging in activities requiring alertness, such as driving or operating machinery.

( 5.8 , 7 ) Activation of Mania/Hypomania: Screen patients for bipolar disorder prior to initiating treatment. (2.3 , 5.9 ) Seizures: Use with caution in patients with a seizure disorder. ( 5.10 ) Elevated Cholesterol/Triglycerides: Has been reported with mirtazapine use.

( 5.11 ) Hyponatremia: May occur as a result of treatment with serotonergic antidepressants, including mirtazapine orally disintegrating tablets. ( 5.12 ) Transaminase Elevations: Clinically significant elevations have occurred. Use with caution in patients with impaired hepatic function.

( 5.13 )

5.1Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.

There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1. Table 1: Risk Differences of the Number of Patients with Suicidal Thoughts and Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Patients with Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 years old 14 additional patients 18 to 24 years old 5 additional patients Decreases Compared to Placebo 25 to 64 years old 1 fewer patient ≥65 years old 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months.

However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for any indication of clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare prov…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity [see Contraindications (4) ] Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.1) ] Agranulocytosis [see Warnings and Precautions (5.2) ] Serotonin Syndrome [see Contraindications (4) , Warnings and Precautions (5.3) , Drug Interactions (7) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.4) ] QT Prolongation and Torsades de Pointes [see Warnings and Precautions (5.5) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.6) ] Increased Appetite and Weight Gain [see Warnings and Precautions (5.7) ] Somnolence [see Warnings and Precautions (5.8) ] Activation of Mania or Hypomania [see Warnings and Precautions (5.9) ] Seizures [see Warnings and Precautions (5.10) ] Elevated Cholesterol and Triglycerides [see Warnings and Precautions (5.11) ] Hyponatremia [see Warnings and Precautions (5.12) ] Transaminase Elevations [see Warnings and Precautions (5.13) ] Discontinuation Syndrome [see Warnings and Precautions (5.14) ] Use in Patients with Concomitant Illness [see Warnings and Precautions (5.15) ] Most common adverse reactions (≥5% or greater and twice placebo) were somnolence, increased appetite, weight gain, and dizziness.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below are from clinical trials in which mirtazapine orally disintegrating tablets were administered to 2796 patients in phase 2 and 3 clinical studies. The trials consisted of double-blind controlled and open-label studies, inpatient and outpatient studies, fixed dose, and titration studies.

Adverse Reactions Leading to Discontinuation of Treatment Approximately 16% of the 453 patients who received mirtazapine in U.S. 6-week placebo-controlled clinical trials discontinued treatment due to an adverse reaction, compared to 7% of the 361 placebo-treated patients in those studies. The most common reactions leading to discontinuation (≥1% and at a rate at least twice that of placebo) are included in Table 2.

Table 2: Adverse Reactions (≥1% and at least twice placebo) Leading to Discontinuation of Mirtazapine in 6-Week Clinical Trials in Patients with MDD Mirtazapine (n=453) Placebo (n=361) Somnolence 10.4% 2.2% Nausea 1.5% 0% Common Adverse Reactions The most common adverse reactions (≥5% and twice placebo) associated with the use of mirtazapine are listed in Table 3. Table 3: Adverse Reactions (≥5% and twice placebo) in 6-Week U.S. Clinical Trials of Mirtazapine in Patients with MDD Mirtazapine (n=453) Placebo (n=361) Somnolence 54% 18% Increased Appetite 17% 2% Weight Gain 12% 2% Dizziness 7% 3% Table 4 enumerates adverse reactions that occurred in ≥1% of mirtazapine-treated patients, and were more frequent than the placebo-treated patients, who participated in 6-week, U.S. placebo-controlled trials in which patients were dosed in a range of 5 to 60 mg/day.

This table shows the percentage of patients in each group who had at least 1 episode of an adverse reaction at some time during their treatment. Table 4: Adverse Reactions (≥1% and greater than placebo) in 6-Week U.S. Clinical Studies of Mirtazapine in Patients with MDD Mirtazapine (n=453) Placebo (n=361) Body as a Whole Asthenia 8% 5% Flu Syndrome 5% 3% Back Pain 2% 1% Digestive System Dry Mouth 25% 15% Increased Appetite 17% 2% Constipation 13% 7% Metabolic and Nutritional Disorders Weight Gain 12% 2% Peripheral Edema 2% 1% Edema 1% 0% Musculoskeletal System Myalgia 2% 1% Nervous System Somnole…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 5 includes clinically important drug interactions with mirtazapine orally disintegrating tablets [see Clinical Pharmacology (12.3) ]. Table 5: Clinically Important Drug Interactions with Mirtazapine Orally Disintegrating Tablets Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of serotonergic drugs, including mirtazapine orally disintegrating tablets, and MAOIs increases the risk of serotonin syndrome. Intervention Mirtazapine orally disintegrating tablets are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration (2.4) , Contraindications (4) , Warnings and Precautions (5.3) ].

Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact The concomitant use of serotonergic drugs with mirtazapine orally disintegrating tablets increase the risk of serotonin syndrome. Intervention Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of mirtazapine orally disintegrating tablets and/or concomitant serotonergic drugs [see Warnings and Precautions (5.3) ].

Examples SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, amphetamines, St. John’s Wort, tramadol, tryptophan, buspirone Strong CYP3A Inducers Clinical Impact The concomitant use of strong CYP3A inducers with mirtazapine orally disintegrating tablets decrease the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3) ]. Intervention Increase the dose of mirtazapine orally disintegrating tablets if needed with concomitant CYP3A inducer use.

Conversely, a decrease in dosage of mirtazapine orally disintegrating tablets may be needed if the CYP3A inducer is discontinued [see Dosage and Administration (2.5) ]. Examples phenytoin, carbamazepine, rifampin Strong CYP3A Inhibitors Clinical Impact The concomitant use of strong CYP3A inhibitors with mirtazapine orally disintegrating tablets may increase the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3) ]. Intervention Decrease the dose of mirtazapine orally disintegrating tablets if needed with concomitant strong CYP3A inhibitor use.

Conversely, an increase in dosage of mirtazapine orally disintegrating tablets may be needed if the CYP3A inhibitor is discontinued [see Dosage and Administration (2.5) ]. Examples itraconazole, ritonavir, nefazodone Cimetidine Clinical Impact The concomitant use of cimetidine, a CYP1A2, CYP2D6, and CYP3A inhibitor, with mirtazapine orally disintegrating tablets may increase the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3) ]. Intervention Decrease the dose of mirtazapine orally disintegrating tablets if needed with concomitant cimetidine use.

Conversely, an increase in dosage of mirtazapine orally disintegrating tablets may be needed if cimetidine is discontinued [see Dosage and Administration (2.5) ]. Benzodiazepines and Alcohol Clinical Impact The concomitant use of benzodiazepines or alcohol with mirtazapine orally disintegrating tablets increase the impairment of cognitive and motor skills produced by mirtazapine orally disintegrating tablets alone. Intervention Avoid concomitant use of benzodiazepines and alcohol with mirtazapine orally disintegrating tablets [see Warnings and Precautions (5.8) , Clinical Pharmacology (12.3) ].

Examples diazepam, alprazolam, alcohol Drugs that Prolong QTc Interval Clinical Impact The concomitant use of other drugs which prolong the QTc interval with mirtazapine orally disintegrating tablets, increase the risk of QT prolongation and/or ventricular arrhythmias (e.g., Torsades de Pointes). Intervention Use caution when using mirtazapine orally disintegrating tablets concomitantly with drugs that prolong the QTc interval [see Warnings and Precautions (5.5) , Clinical Ph…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Geriatric Use: Use with caution in elderly patients. ( 5.12 , 5.15 , 8.5 ) Renal impairment: Dosage decrease may be needed in patients with moderate to severe renal impairment. ( 8.6 ) Hepatic impairment: Dosage decrease may be needed in patients with hepatic impairment. ( 8.6 ) Patients with Phenylketonuria: mirtazapine orally disintegrating tablets contains phenylalanine. ( 5.16 , 8.7 )

8.1Pregnancy 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/m 2 body surface area. However, in rats, there was an increase in postimplantation loss at 20 times the MRHD based on mg/m 2 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/m 2 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/m 2 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/m 2 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/m 2 body surface area. The cause of these deaths is not known.

The no effect dose level is 3 times the MRHD based on mg/m 2 body surface area.

8.2Lactation 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 materna…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy 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/m 2 body surface area. However, in rats, there was an increase in postimplantation loss at 20 times the MRHD based on mg/m 2 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/m 2 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/m 2 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/m 2 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/m 2 body surface area. The cause of these deaths is not known.

The no effect dose level is 3 times the MRHD based on mg/m 2 body surface area.

🧒 Pediatric Use 141 words ▾

8.4Pediatric Use 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) ].

🧓 Geriatric Use 155 words ▾

8.5Geriatric Use 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.

🆘 Overdosage 103 words ▾

10 OVERDOSAGE Human Experience In premarketing clinical studies, there were reports of mirtazapine overdose alone or in combination with other pharmacological agents. Signs and symptoms reported in association with overdose included disorientation, drowsiness, impaired memory, and tachycardia. Based on postmarketing reports, serious outcomes (including fatalities) may occur at dosages higher than the recommended doses, especially with mixed overdoses.

In these cases, QT prolongation and Torsades de Pointes have also been reported [see Warnings and Precautions (5.5) , Adverse Reactions (6.2) , and Drug Interactions (7) ]. Overdose Management No specific antidotes for mirtazapine are known. Contact Poison Control (1-800-222-1222) for the latest recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of mirtazapine for the treatment of major depressive disorder, is unclear. However, its efficacy could be mediated through its activity as an antagonist at central presynaptic α 2 -adrenergic inhibitory autoreceptors and heteroreceptors and enhancing central noradrenergic and serotonergic activity.

12.2Pharmacodynamics In preclinical studies, mirtazapine acts as an antagonist at α 2 -adrenergic inhibitory autoreceptors and heteroreceptors and as an antagonist at serotonin 5-HT 2 and 5-HT 3 receptors. Mirtazapine has no significant affinity for the 5-HT 1A and 5-HT 1B receptors. Mirtazapine also acts as an antagonist of histamine (H 1 ) receptors, peripheral α 1 -adrenergic receptors, and muscarinic receptors.

Actions at these receptors may explain some of the other clinical effects of mirtazapine (e.g., its prominent somnolent effects and orthostatic hypotension may be explained by its inhibition of histamine (H 1 ) receptors and peripheral α 1 -adrenergic receptors, respectively). Cardiac Electrophysiology The effect of mirtazapine on QTc interval was assessed in healthy subjects. At a dose of 75 mg (1.67 times the maximum recommended dosage), mirtazapine does not prolong the QTc interval to a clinically meaningful extent.

12.3Pharmacokinetics Plasma levels of mirtazapine are linearly related to dose over a dose range of 15 to 80 mg (1.78 times the maximum recommended dose). Steady state plasma levels of mirtazapine are attained within 5 days, with about 50% accumulation (accumulation ratio=1.5). The (–) enantiomer has an elimination half-life that is approximately twice as long as the (+) enantiomer and therefore achieves plasma levels that are about 3 times as high as that of the (+) enantiomer.

Absorption Mirtazapine has an absolute bioavailability of about 50% following oral administration. Peak plasma concentrations of mirtazapine are reached within about 2 hours post dose. Food Effect The presence of food in the stomach has a minimal effect on both the rate and extent of absorption.

Distribution Mirtazapine is approximately 85% bound to plasma proteins over a concentration range of 0.01 to 10 mcg/mL. Elimination Mirtazapine has a half-life of about 20 to 40 hours following oral administration of mirtazapine orally disintegrating tablets. Metabolism Mirtazapine is extensively metabolized after oral administration.

Major pathways of bio-transformation are demethylation and hydroxylation followed by glucuronide conjugation. In vitro data from human liver microsomes indicate that CYP2D6 and CYP1A2 are involved in the formation of the 8-hydroxy metabolite of mirtazapine, whereas CYP3A is considered to be responsible for the formation of the N-desmethyl and N-oxide metabolite. Several unconjugated metabolites possess pharmacological activity but are present in the plasma at very low levels.

Excretion Mirtazapine and its metabolites are eliminated predominantly (75%) via urine with 15% in feces. Specific Populations Geriatric Patients Following oral administration of mirtazapine tablets 20 mg/day for 7 days to subjects of varying ages (range 25 to 74 years old), oral clearance of mirtazapine was reduced in the elderly compared to the younger subjects. The clearance in elderly males was 40% lower compared to younger males, while the clearance was 10% lower in elderly females compared to younger females [see Warnings and Precautions (5.15) , Use in Specific Populations (8.5) ].

Male and Female Patients The mean elimination half-life of mirtazapine after oral administration ranges from approximately 20 to 40 hours across age and gender subgroups, with females of all ages exhibiting significantly longer elimination half-lives than males (mean half-life of 37 hours for females vs. 26 hours for males). Race There have been no clinical studies to evaluate the effect of race on the pharmacokinetics of mirtazapine.

Patients with Renal Impairment When compared t…

🧬 Mechanism of Action 48 words ▾

12.1Mechanism of Action The mechanism of action of mirtazapine for the treatment of major depressive disorder, is unclear. However, its efficacy could be mediated through its activity as an antagonist at central presynaptic α 2 -adrenergic inhibitory autoreceptors and heteroreceptors and enhancing central noradrenergic and serotonergic activity.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING 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.

📋 Description 135 words ▾

11 DESCRIPTION Mirtazapine orally disintegrating tablet, USP contains mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C 17 H 19 N 3 .

Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture: Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine orally disintegrating tablets, USP are available for oral administration as an orally disintegrating tablet containing 15 mg, 30 mg or 45 mg of mirtazapine USP.

Mirtazapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial peppermint flavor, and strawberry guarana flavor. chemical structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions (5.1) ]. Agranulocytosis Advise patients to contact their physician if they experience fever, chills, sore throat, mucous membrane ulceration, flu-like complaints, or other symptoms that might suggest infection [see Warnings and Precautions (5.2) ].

Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of mirtazapine orally disintegrating tablets with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Dosage and Administration (2.4) , Contraindications (4) , Warnings and Precautions (5.3) , Drug Interactions (7) ].

QT Prolongation and Torsades de Pointes Inform patients to consult their physician immediately if they feel faint, lose consciousness, or have heart palpitations [see Warnings and Precautions (5.5) , Drug Interactions (7) , Overdosage (10) ]. Advise patients to inform physicians that they are taking mirtazapine orally disintegrating tablets before any new drug is taken. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Advise patients to report to their healthcare provider at the earliest onset of fever, rash, swollen lymph nodes, or other signs and symptoms suggestive of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Contraindications (4) , Warnings and Precautions (5.6) ].

Somnolence Advise patients that mirtazapine orally disintegrating tablets may impair judgment, thinking, and particularly, motor skills, because of its prominent sedative effect. Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that mirtazapine orally disintegrating tablets therapy does not adversely affect their ability to engage in such activities . [see Warnings and Precautions (5.8) ]. Alcohol Advise patients to avoid alcohol while taking mirtazapine orally disintegrating tablets [see Warnings and Precautions (5.8) , Drug Interactions (7) ].

Activation of Mania/Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.9) ]. Discontinuation Syndrome Advise patients not to abruptly discontinue mirtazapine orally disintegrating tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when mirtazapine orally disintegrating tablets are discontinued [see Dosage and Administration (2.6) , Warnings and Precautions (5.14) ].

Allergic Reactions Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Contraindications (4) , Adverse Reactions (6.2) ]. Pregnancy Advise patients to notify their physician if they become pregnant or intend to become pregnant during mirtazapine orally disintegrating tablets therapy. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mirtazapine orally disintegrating tablets during pregnancy [see Use in Specific Populations (8.1) ] .

Lactation Advise patient…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Mirtazapine (mir taz’ a peen) Orally Disintegrating Tablets, USP 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 are mirtazapine orally disintegrating tablets?

Mirtazapine orally disintegrating tablets are prescription medicines used to treat a certain type of depression called Major Depressive Disorder (MDD) in adults. It is not known if mirtazapine orally disintegrating tablets are safe and effective for use to treat MDD in children. Who should not take mirtazapine orally disintegrating tablets?

Do not take mirtazapine orally disintegrating tablets if you: take a Monoamine Oxidase Inhibitor (MAOI) have stopped taking an MAOI in the last 14 days are being treated with the antibiotic linezolid or intravenous methylene blue if you are allergic to mirtazapine or any of the ingredients in mirtazapine orally disintegrating tablets. See the end of this Medication Guide for a complete list of ingredients in mirtazapine orally disintegrating tablets. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue.

Do not start taking an MAOI for at least 14 days after you stop treatment with mirtazapine orally disintegrating tablets. Before taking mirtazapine orally disintegrating tablets, tell your healthcare provider about all your medical conditions, including if you: have a history of suicide or depression have a history or family history of bipolar disorder, mania or hypomania have a low white blood cell count have glaucoma (high pressure in the eye) have or had heart problems or stroke have an abnormal heart beat called QT prolongation or a family history of QT prolongation have seizures have high cholesterol or triglyceride levels have low sodium levels in your blood have or had kidney or liver problems have low blood pressure have phenylketonuria (PKU).

Mirtazapine orally disintegrating tablets contain phenylalanine which is a part of aspartame. are pregnant or plan to become pregnant. It is not known if mirtazapine orally disintegrating tablets will harm your unborn baby. Talk to your healthcare provider if you become…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65862-0019-01 · Aurobindo 65862-0022-01 · Aurobindo →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.