Mirtazapine 15 mg Tablet, Film Coated
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other antidepressants class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Mirtazapine — tap one for details:
Mirtazapine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 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.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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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.
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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.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
10 inactive ingredients listed in the exact product block matched to this NDC.
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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
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💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.065 | $6.45 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2754 | $27.54 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.6699 | $66.99 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Mirtazapine 15 mg 00378-3515-01 | Mylan | 100 tablets | $0.065 | AB | Availability likely | — |
| Mirtazapine 15 mg 00904-6519-61 | Major | 1 tablet | $0.065 | AB | Availability likely | — |
| Mirtazapine 15 mg 51079-0086-20 | Mylan | 1 tablet | $0.065 | AB | Availability likely | — |
| Mirtazapine 15 mg 57237-0008-05 | Rising | 500 tablets | $0.065 | AB | Availability likely | — |
| Mirtazapine 15 mg 57664-0499-18 | Sun | 1000 tablets | $0.065 | AB | Availability likely | — |
| Mirtazapine 15 mg 60505-0247-01 | Apotex | 30 tablets | $0.065 | AB | Availability likely | — |
| Mirtazapine 15 mgthis 63739-0098-10 | McKesson | 10 tablets | $0.065 | AB | Availability likely | — |
| Mirtazapine 15 mg 66993-0607-04 | Prasco | 500 tablets | $0.065 | AB | Availability likely | — |
| Mirtazapine 15 mg 68084-0119-01 | American | 1 tablet | $0.065 | AB | Availability likely | — |
| Remeron 15 mg 78206-0160-01 | Organon | 30 tablets | $6.363 | AB | Availability likely | +9759% |
| Mirtazapine 15 mg 00615-8268-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 13107-0031-01 | Aurolife | 100 tablets | — | AB | FDA listed | — |
| mirtazapine 15 mg 31722-0408-05 | Camber | 500 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 48433-0076-20 | Safecor | 1 tablet | — | AB | FDA listed | — |
| Mirtazapine 15 mg 50090-2140-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 50090-2800-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 51407-0350-10 | Golden | 1000 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 55154-5355-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Mirtazapine 15 mg 55154-7297-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Mirtazapine 15 mg 61919-0153-60 | Direct_Rx | 60 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 63187-0206-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 63629-2366-01 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 63629-2367-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 65862-0031-01 | Aurobindo | 100 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 67046-1590-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 68788-7251-01 | Preferred | 15 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 70518-0180-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 70518-1397-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 70518-1838-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 70518-2453-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 70518-4322-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 71205-0481-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 71335-0286-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 71335-0664-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 71335-1055-01 | Bryant | 30 tablets | — | AB | Discontinued | — |
| Mirtazapine 15 mg 71610-0115-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 71610-0475-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 71610-0717-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 71610-0853-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 72162-1639-00 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 80425-0305-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 87441-0058-01 | Unit | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 55154-0280-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| mirtazapine 15 mg 72865-0369-05 | XLCare | 500 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 67046-0319-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Mirtazapine 15 mg 68071-2784-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63739-0098-10 You're viewing this | 10 BLISTER PACK in 1 BOX (63739-098-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 2019-11-15 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 tablets is not approved for use in pediatric patients. (5.1, 8.4)
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Mirtazapine Tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. Mirtazapine Tablets is indicated for the treatment of major depressive disorder (MDD) in adults. (1)
⏱️ Dosage and Administration ▾
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) • Reduce dose gradually when discontinuing mirtazapine tablets. (2.6, 5.14)
2.1Recommended Dosage The recommended starting dose for mirtazapine 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)].
2.3Screen for Bipolar Disorder Prior to Starting Mirtazapine Tablets Prior to initiating treatment with mirtazapine tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.8)].
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 tablets. In addition, at least 14 days must elapse after stopping mirtazapine 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 tablets may be needed with concomitant strong CYP3A inducer (e.g., carbamazepine, phenytoin, rifampin) use. Conversely, a decrease in dosage of mirtazapine tablets may be needed if the CYP3A inducer is discontinued [see Drug Interactions (7)]. Strong CYP3A Inhibitors A decrease in dosage of mirtazapine tablets may be needed with concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin).
Conversely, an increase in dosage of mirtazapine tablets may be needed if the CYP3A inhibitor is discontinued [see Drug Interactions (7)]. Cimetidine A decrease in dosage of mirtazapine tablets may be needed with concomitant use of cimetidine. Conversely, an increase in dosage of mirtazapine tablets may be needed if cimetidine is discontinued [see Drug Interactions (7)].
2.6Discontinuation of Mirtazapine Tablets Treatment Adverse reactions may occur upon discontinuation or dose reduction of mirtazapine tablets [see Warnings and Precautions (5.13)]. Gradually reduce the dosage of mirtazapine tablets rather than stopping abruptly whenever possible.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Mirtazapine Tablets, USP 15 mg are available for oral administration as pale yellow, oval-shaped, scored, film-coated tablets imprinted "APO" on one side and "MI" bisect "15" on the other side. Mirtazapine Tablets, USP 30 mg are available for oral administration as light pink, oval-shaped, scored, film-coated tablets imprinted "APO" on one side and "MI" bisect "30" on the other side. • Tablets: 15 mg scored and 30 mg scored. (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Mirtazapine 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 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 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 tablets. (4)
⚠️ Warnings and Cautions ▾
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 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 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 tablets with caution in patients with risk factors for QT prolongation. (5.5, 7) • Drug Reaction with Eosinophilia and System Symptoms (DRESS): Discontinue Mirtazapine tablets if DRESS is suspected.
(5.6) • Increased Appetite/Weight Gain: Mirtazapine 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 tablet use.
(5.11) • Hyponatremia: May occur as a result of treatment with serotonergic antidepressants, including mirtazapine 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 and Behaviour in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients 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 patients ≥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 provider.
Consider changing the therapeutic regimen, including poss…
🤒 Adverse Reactions ▾
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 (5.6)] • Somnolence [see Warnings and Precautions (5.7)] • Activation of Mania or Hypomania [see Warnings and Precautions (5.8)] • Seizures [see Warnings and Precautions (5.9)] • Elevated Cholesterol and Triglycerides [see Warnings and Precautions (5.10)] • Hyponatremia [see Warnings and Precautions (5.11)] • Transaminase Elevations [see Warnings and Precautions (5.12)] • Discontinuation Syndrome [see Warnings and Precautions (5.13)] • Use in Patients with Concomitant Illness [see Warnings and Precautions (5.14)] 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 Apotex Corp. at, at 1-800-706-5575 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 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 tablets in US 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 (>= 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 Tablets (n=453 ) Placebo (n=3 61) 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 tablets 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 Tablets (n=453) Placebo (n=3 61) 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 tablets-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 Tablets (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…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 5 includes clinically important drug interactions with Mirtazapine Tablets [see Clinical Pharmacology (12.3)]. • Strong CYP3A inducers: Dosage increase may be needed for mirtazapine tablets with concomitant use of strong CYP3A inducers. (2.5, 7) • Strong CYP3A inhibitors: Dosage decrease may be needed when mirtazapine tablets are coadministered with strong CYP3A inhibitors. (2.5, 7) • Cimetidine: Dosage decrease may be needed when mirtazapine tablets are coadministered with cimetidine.
(2.5, 7) • Warfarin: Monitor INR during concomitant use. (7) Table 5: Clinically Important Drug Interactions with Mirtazapine Tablets Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of serotonergic drugs, including Mirtazapine Tablets, and MAOIs increases the risk of serotonin syndrome. Intervention Mirtazapine 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 tablets increases 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 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 tablets decreases the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3)].
Intervention Increase the dose of mirtazapine tablets if needed with concomitant CYP3A inducer use. Conversely, a decrease in dosage of Mirtazapine 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 tablets may increase the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3)].
Intervention Decrease the dose of mirtazapine tablets if needed with concomitant strong CYP3A inhibitor use. Conversely, an increase in dosage of mirtazapine 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 tablets may increase the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3)] Intervention Decrease the dose of mirtazapine tablets if needed with concomitant cimetidine use.
Conversely, an increase in dosage of mirtazapine 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 tablets increases the impairment of cognitive and motor skills produced by mirtazapine tablets alone. Intervention Avoid concomitant use of benzodiazepines and alcohol with mirtazapine tablets [see Warnings and Precautions (5.7), 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 tablets, increase the risk of QT prolongation and/or ventricular arrhythmias (e.g., Torsades de Pointes). Intervention Use caution when using mirtazapine tablets concomitantly with drugs that prolong the QTc interval [see Warnings and Precautions (5.5), Clinical Pharmacology (1…
👥 Use in Specific Populations ▾
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) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide Revised: 02/2024
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/m2 body surface area. However, in rats, there was an increase in post implantation 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 post implantation 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 100mg/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.
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 maternal weight-adjusted dose (see Data). No adve…
🤰 Pregnancy ▾
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/m2 body surface area. However, in rats, there was an increase in post implantation 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 post implantation 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 100mg/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.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of mirtazapine 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 tablets, and the data were insufficient to establish the safety and effectiveness of mirtazapine 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 tablets-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 tablets-treated patients versus 1 kg (2 kg SD) for placebo-treated patients [see Warnings and Precautions (5.7)].
🧓 Geriatric Use ▾
8.5Geriatric Use Approximately 190 patients≥ 65 years of age participated in clinical studies with mirtazapine tablets. Mirtazapine 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 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 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 ▾
10 OVERDOSAGE Human Experience In premarketing clinical studies, there were reports of mirtazapine tablets 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.
Overdose Management No specific antidotes for mirtazapine are known. Contact Poison Control (1-800-222-1222) for the latest recommendations.
🧬 Clinical Pharmacology ▾
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 α2-adrenergic inhibitory auto-receptors and heteroreceptors and enhancing central noradrenergic and serotonergic activity.
12.2Pharmacodynamics In preclinical studies, mirtazapine acts as an antagonist at α2-adrenergic inhibitory auto-receptors and heteroreceptors and as an antagonist at serotonin 5-HT2 and 5-HT3 receptors. Mirtazapine has no significant affinity for the 5-HT1A and 5-HT1B receptors. Mirtazapine also acts as an antagonist of histamine (H1) receptors, peripheral α1-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 (H1) receptors and peripheral α1-adrenergic receptors, respectively). Cardiac Electrophysiology The effect of mirtazapine tablets on QTc interval was assessed in healthy subjects. At a dose of 75 mg (1.67 times the maximum recommended dosage), mirtazapine tablets do 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 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 (5.14), 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 tablets. Patients with Renal Impairment When compared to subjects with no…
🧬 Mechanism of Action ▾
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 α2-adrenergic inhibitory auto-receptors and heteroreceptors and enhancing central noradrenergic and serotonergic activity.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Mirtazapine tablets are supplied as: Mirtazapine Tablets, USP 15 mg are available for oral administration as pale yellow, oval-shaped, scored, film-coated tablets imprinted “APO” on one side and “MI” bisect “15” on the other side. They are supplied as follows: Boxes of 10x10 UD 100 count NDC 63739-098-10 Mirtazapine Tablets, USP 30 mg are available for oral administration as light pink, oval-shaped, scored, film-coated tablets imprinted “APO” on one side and “MI” bisect “30” on the other side.
They are supplied as follows: Boxes of 10x10 UD 100 count NDC 63739-099-10 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.
📋 Description ▾
11 DESCRIPTION Mirtazapine tablets contain mirtazapine. 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 empirical formula of C17H19N3.
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 tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine.
Each tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. In addition, mirtazapine tablets, USP 15 mg and 30 mg contains iron oxide yellow and mirtazapine tablets, USP 30 mg contains iron oxide red 11 DESCRIPTION
💬 Medication Guide ▾
MEDICATION GUIDE Mirtazapine Tablets, USP (mir taz’ a peen) Medication Guide available at www1.apotex.com/products/us What is the most important information I should know about mirtazapine tablets? Mirtazapine tablets may cause serious side effects, including: • Increased risk of suicidal thoughts or actions in some children and young adults. Mirtazapine 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 tablets are not for use in children. ° Depression or other serious mental illnesses are the most important causes of suicidal thoughts or 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 impulses • thoughts about suicide or dying • new or worse anxiety • feeling very agitated or restless • trouble sleeping • other unusual changes in behavior or mood What are mirtazapine tablets?
Mirtazapine 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 tablets are safe and effective for use to treat MDD in children. Who should not take mirtazapine tablets?
Do not take mirtazapine 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 tablets. See the end of this Medication Guide for a complete list of ingredients in mirtazapine 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 tablets. Before taking mirtazapine 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 • are pregnant or plan to become pregnant.
It is not known if mirtazapine tablets will harm your unborn baby. • Talk to your healthcare provider if you become pregnant or think you may be pregnant during treatment with mirtazapine tablets. • If you become pregnant while taking mirtazapine tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185 or visiting online at http://womensmentalhealth.org/clinical-and-researchprograms/ pr…