Mirtazapine Tablets

Name: Mirtazapine Tablets

Uses of Mirtazapine Tablets

  • It is used to treat low mood (depression).
  • It may be given to you for other reasons. Talk with the doctor.

What are some things I need to know or do while I take Mirtazapine Tablets?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not stop taking this medicine (mirtazapine tablets) all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this medicine, you will want to slowly stop it as ordered by your doctor.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (mirtazapine tablets) affects you.
  • Some people may have a higher chance of eye problems with this medicine. Your doctor may want you to have an eye exam to see if you have a higher chance of these eye problems. Call your doctor right away if you have eye pain, change in eyesight, or swelling or redness in or around the eye.
  • Low white blood cell counts have rarely happened with this medicine (mirtazapine tablets). This may lead to a higher chance of getting an infection. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
  • Avoid drinking alcohol while taking this medicine (mirtazapine tablets).
  • Talk with your doctor before you use other drugs and natural products that slow your actions.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (mirtazapine tablets) while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some other side effects of Mirtazapine Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling sleepy.
  • Dizziness.
  • Hard stools (constipation).
  • Dry mouth.
  • More hungry.
  • Weight gain.
  • Feeling tired or weak.
  • Strange or odd dreams.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Mirtazapine Tablets?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Adverse Reactions

Associated with Discontinuation of Treatment

Approximately 16% of the 453 patients who received Mirtazapine Tablets in US 6-week controlled clinical trials discontinued treatment due to an adverse experience, compared to 7% of the 361 placebo-treated patients in those studies. The most common events (≥1%) associated with discontinuation and considered to be drug related (i.e., those events associated with dropout at a rate at least twice that of placebo) are included in Table 2.

Table 2 : Common Adverse Events Associated with Discontinuation of Treatment in 6-week US Mirtazapine Tablets Trials

Adverse Event

Percentage of Patients Discontinuing with Adverse Event

Mirtazapine Tablets
(n=453)

Placebo
(n=361)

Somnolence

10.4%

2.2%

Nausea

1.5%

0%

Commonly Observed Adverse Events in US Controlled Clinical Trials

The most commonly observed adverse events associated with the use of Mirtazapine Tablets (incidence of 5% or greater) and not observed at an equivalent incidence among placebo-treated patients (Mirtazapine Tablets incidence at least twice that for placebo) are listed in Table 3.

Table 3: Common Treatment-emergent Adverse Events Associated with the Use of Mirtazapine Tablets in 6-week US Trials

Adverse Event

Percentage of Patients Reporting Adverse Event

Mirtazapine Tablets
(n=453)

Placebo
(n=361)

Somnolence

54%

18%

Increased Appetite

17%

2%

Weight Gain

12%

2%

Dizziness

7%

3%

Adverse Events Occurring at an Incidence of 1% or More Among Mirtazapine Tablet-treated Patients

Table 4 enumerates adverse events that occurred at an incidence of 1% or more, and were more frequent than in the placebo group, among mirtazapine tablet-treated patients who participated in short-term US 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 one episode of an event at some time during their treatment. Reported adverse events were classified using a standard COSTART-based dictionary terminology. 

The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side-effect incidence rate in the population studied.

Table 4: Incidence of Adverse Clinical Experiences* (≥ 1%) in Short-term US Controlled Studies

Body System Adverse Clinical Experience

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%

1%

Nervous System

Somnolence

54%

18%

Dizziness

7%

3%

Abnormal Dreams

4%

1%

Thinking Abnormal

3%

1%

Tremor

2%

1%

Confusion

2%

0%

Respiratory System

Dyspnea

1%

0%

Urogenital System

Urinary Frequency

2%

1%

*Events reported by at least 1% of patients treated with Mirtazapine Tablets are included, except the following events, which had an incidence on placebo greater than or equal to Mirtazapine Tablets: headache, infection, pain, chest pain, palpitation, tachycardia, postural hypotension, nausea, dyspepsia, diarrhea, flatulence, insomnia, nervousness, libido decreased, hypertonia, pharyngitis, rhinitis, sweating, amblyopia, tinnitus, taste perversion.

ECG Changes

The electrocardiograms for 338 patients who received Mirtazapine Tablets and 261 patients who received placebo in 6-week, placebo-controlled trials were analyzed. Prolongation in QTc ≥500 msec was not observed among mirtazapine-treated patients; mean change in QTc was +1.6 msec for mirtazapine and -3.1 msec for placebo. Mirtazapine was associated with a mean increase in heart rate of 3.4 bpm, compared to 0.8 bpm for placebo. The clinical significance of these changes is unknown.

The effect of mirtazapine on QTc interval was assessed in a clinical randomized trial with placebo and positive (moxifloxacin) controls involving 54 healthy volunteers using exposure response analysis. This trial showed a positive relationship between mirtazapine concentrations and prolongation of the QTc interval. However, the degree of QT prolongation observed with both 45 mg (therapeutic) and 75 mg (supratherapeutic) doses of mirtazapine was not at a level generally considered to be clinically meaningful.

Other Adverse Events Observed During the Premarketing Evaluation of Mirtazapine Tablets

During its premarketing assessment, multiple doses of Mirtazapine Tablets were administered to 2796 patients in clinical studies. The conditions and duration of exposure to mirtazapine varied greatly, and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories. 

In the tabulations that follow, reported adverse events were classified using a standard COSTART-based dictionary terminology. The frequencies presented, therefore, represent the proportion of the 2796 patients exposed to multiple doses of Mirtazapine Tablets who experienced an event of the type cited on at least one occasion while receiving Mirtazapine Tablets. All reported events are included except those already listed in Table 4, those adverse experiences subsumed under COSTART terms that are either overly general or excessively specific so as to be uninformative, and those events for which a drug cause was very remote. 

It is important to emphasize that, although the events reported occurred during treatment with Mirtazapine Tablets, they were not necessarily caused by it. 

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in fewer than 1/1,000 patients. Only those events not already listed in Table 4 appear in this listing. Events of major clinical importance are also described in the WARNINGS and PRECAUTIONS sections.

Body as a Whole

Frequent: malaise, abdominal pain, abdominal syndrome acute; infrequent: chills, fever, face edema, ulcer, photosensitivity reaction, neck rigidity, neck pain, abdomen enlarged; rare: cellulitis, chest pain substernal.

Cardiovascular System

Frequent: hypertension, vasodilatation; infrequent: angina pectoris, myocardial infarction, bradycardia, ventricular extrasystoles, syncope, migraine, hypotension; rare: atrial arrhythmia, bigeminy, vascular headache, pulmonary embolus, cerebral ischemia, cardiomegaly, phlebitis, left heart failure.

Digestive System

Frequent: vomiting, anorexia; infrequent: eructation, glossitis, cholecystitis, nausea and vomiting, gum hemorrhage, stomatitis, colitis, liver function tests abnormal; rare: tongue discoloration, ulcerative stomatitis, salivary gland enlargement, increased salivation, intestinal obstruction, pancreatitis, aphthous stomatitis, cirrhosis of liver, gastritis, gastroenteritis, oral moniliasis, tongue edema.

Endocrine System

Rare: goiter, hypothyroidism.

Hemic and Lymphatic System

Rare: lymphadenopathy, leukopenia, petechia, anemia, thrombocytopenia, lymphocytosis, pancytopenia.

Metabolic and Nutritional Disorders

Frequent: thirst; infrequent: dehydration, weight loss; rare: gout, SGOT increased, healing abnormal, acid phosphatase increased, SGPT increased, diabetes mellitus, hyponatremia.

Musculoskeletal System

Frequent: myasthenia, arthralgia; infrequent: arthritis, tenosynovitis; rare: pathologic fracture, osteoporosis fracture, bone pain, myositis, tendon rupture, arthrosis, bursitis.

Nervous System

Frequent: hypesthesia, apathy, depression, hypokinesia, vertigo, twitching, agitation, anxiety, amnesia, hyperkinesia, paresthesia; infrequent: ataxia, delirium, delusions, depersonalization, dyskinesia, extrapyramidal syndrome, libido increased, coordination abnormal, dysarthria, hallucinations, manic reaction, neurosis, dystonia, hostility, reflexes increased, emotional lability, euphoria, paranoid reaction; rare: aphasia, nystagmus, akathisia (psychomotor restlessness), stupor, dementia, diplopia, drug dependence, paralysis, grand mal convulsion, hypotonia, myoclonus, psychotic depression, withdrawal syndrome, serotonin syndrome.

Respiratory System

Frequent: cough increased, sinusitis; infrequent: epistaxis, bronchitis, asthma, pneumonia; rare: asphyxia, laryngitis, pneumothorax, hiccup.

Skin and Appendages

Frequent: pruritus, rash; infrequent: acne, exfoliative dermatitis, dry skin, herpes simplex, alopecia; rare: urticaria, herpes zoster, skin hypertrophy, seborrhea, skin ulcer.

Special Senses

Infrequent: eye pain, abnormality of accommodation, conjunctivitis, deafness, keratoconjunctivitis, lacrimation disorder, angle-closure glaucoma, hyperacusis, ear pain; rare: blepharitis, partial transitory deafness, otitis media, taste loss, parosmia.

Urogenital System

Frequent: urinary tract infection; infrequent: kidney calculus, cystitis, dysuria, urinary incontinence, urinary retention, vaginitis, hematuria, breast pain, amenorrhea, dysmenorrhea, leukorrhea, impotence; rare: polyuria, urethritis, metrorrhagia, menorrhagia, abnormal ejaculation, breast engorgement, breast enlargement, urinary urgency.

Other Adverse Events Observed During Postmarketing Evaluation of Mirtazapine Tablets

Adverse events reported since market introduction, which were temporally (but not necessarily causally) related to mirtazapine therapy, include cases of the ventricular arrhythmia Torsades de Pointes. In the majority of these cases, however, concomitant drugs were implicated.

Cases of severe skin reactions, including Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have also been reported.

Increased creatine kinase blood levels and rhabdomyolysis have also been reported.

Drug Abuse and Dependence

Controlled Substance Class

Mirtazapine Tablets are not a controlled substance.

Physical and Psychologic Dependence

Mirtazapine Tablets have not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted and/or abused once marketed. Consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of Mirtazapine Tablets misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

Medication guide

Mirtazapine Tablets, USP
(mir taz’ a peen)

What is the most important information I should know about Mirtazapine Tablets, USP?

Mirtazapine Tablets and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

• Mirtazapine Tablets and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. • Watch for these changes and call your healthcare provider right away if you notice: 1. New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. 2. Pay particular attention to such changes when Mirtazapine Tablets are started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

1. attempts to commit suicide 2. acting on dangerous impulses 3. acting aggressive or violent 4. thoughts about suicide or dying 5. new or worse depression 6. new or worse anxiety or panic attacks 7. feeling agitated, restless, angry or irritable 8. trouble sleeping 9. an increase in activity or talking more than what is normal for you 10. other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Mirtazapine Tablets may be associated with these serious side effects:

2. Manic episodes:

1. greatly increased energy 2. severe trouble sleeping 3. racing thoughts 4. reckless behavior 5. unusually grand ideas 6. excessive happiness or irritability 7. talking more or faster than usual

3. Decreased White Blood Cells called neutrophils, which are needed to fight infections. Tell your doctor if you have any indication of infection such as fever, chills, sore throat, or mouth or nose sores, especially symptoms which are flu-like.

4. Serotonin Syndrome. This condition can be life-threatening and may include:

1. agitation, hallucinations, coma or other changes in mental status 2. coordination problems or muscle twitching (overactive reflexes) 3. racing heartbeat, high or low blood pressure 4. sweating or fever 5. nausea, vomiting, or diarrhea 6. muscle rigidity

5. Visual problems

1. eye pain 2. changes in vision 3. swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

6. Seizures

7. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

1. headache 2. weakness or feeling unsteady 3. confusion, problems concentrating or thinking or memory problems

8. Sleepiness. It is best to take Mirtazapine Tablets close to bedtime.

9. Severe skin reactions: Call your doctor right away if you have any or all of the following symptoms:

1. severe rash with skin swelling (including on the palms of the hands and soles of the feet) 2. painful reddening of the skin, blisters, or ulcers on the body or in the mouth

10. Severe allergic reactions: trouble breathing, swelling of the face, tongue, eyes or mouth

1. rash, itchy welts (hives) or blisters, alone or with fever or joint pain

11. Increases in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

12. Increased cholesterol and triglyceride levels in your blood

Do not stop Mirtazapine Tablets without first talking to your healthcare provider. Stopping Mirtazapine Tablets too quickly may cause potentially serious symptoms including:

1. dizziness 2. abnormal dreams 3. agitation 4. anxiety 5. fatigue 6. confusion 7. headache 8. shaking 9. tingling sensation 10. nausea, vomiting 11. sweating

What are Mirtazapine Tablets?

Mirtazapine Tablets are a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.

Talk to your healthcare provider if you do not think that your condition is getting better with Mirtazapine Tablets treatment.

Who should not take Mirtazapine Tablets?

Do not take Mirtazapine Tablets:

1. 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. 2. if you take a monoamine oxidase inhibitor (MAOI).  Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid. 3. Do not take an MAOI within 2 weeks of stopping Mirtazapine Tablets unless directed to do so by your healthcare provider. 4. Do not start Mirtazapine Tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.

People who take Mirtazapine Tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

1. high fever 2. uncontrolled muscle spasms 3. stiff muscles 4. rapid changes in heart rate or blood pressure 5. confusion 6. loss of consciousness (pass out)

What should I tell my healthcare provider before taking Mirtazapine Tablets?

Before you take mirtazapine tablets, tell your healthcare provider about all of your medical conditions, including if you:

1. are taking certain drugs such as: 1. Triptans used to treat migraine headache 2. Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, or antipsychotics 3. Tramadol used to treat pain 4. Over-the-counter supplements such as tryptophan or St. John’s wort 5. Phenytoin, carbamazepine, or rifampicin (these drugs can decrease your blood level of Mirtazapine Tablets) 6. Cimetidine or ketoconazole (these drugs can increase your blood level of Mirtazapine Tablets) 7. Medicines that may affect your hearts rhythm (such as certain antibiotics and some antipsychotics) 2. have or had: 8. liver problems 9. kidney problems 10. heart problems or certain conditions that may change your heart rhythm 11. seizures or convulsions 12. bipolar disorder or mania 13. a tendency to get dizzy or faint 3. are pregnant or plan to become pregnant. It is not known if Mirtazapine Tablets will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy 4. are breastfeeding or plan to breastfeed. Some mirtazapine may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Mirtazapine Tablets

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Mirtazapine Tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take mirtazapine tablets with your other medicines. Do not start or stop any medicine while taking mirtazapine tablets without talking to your healthcare provider first. If you take mirtazapine tablets, you should not take any other medicines that contain mirtazapine including mirtazapine tablets SolTab.

How should I take Mirtazapine Tablets?

1. Take Mirtazapine Tablets exactly as prescribed. Your healthcare provider may need to change the dose of Mirtazapine Tablets until it is the right dose for you. 2. Take Mirtazapine Tablets at the same time each day, preferably in the evening at bedtime. 3. Swallow Mirtazapine Tablets as directed. 4. It is common for antidepressant medicines such as Mirtazapine Tablets to take up to a few weeks before you start to feel better. Do not stop taking Mirtazapine Tablets if you do not feel results right away. 5. Do not stop taking or change the dose of Mirtazapine Tablets without first talking to your doctor, even if you feel better. 6. Mirtazapine Tablets may be taken with or without food. 7. If you miss a dose of Mirtazapine Tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Mirtazapine Tablets at the same time. 8. If you take too much Mirtazapine Tablets, call your healthcare provider or poison control center right away, or get emergency treatment. The signs of an overdose of mirtazapine tablets (without other medicines or alcohol) include: 1. confusion, 2. drowsiness 3. memory problems 4. increased heart rate.

The symptoms of a possible overdose may include changes to your heart rhythm (fast, irregular heartbeat) or fainting, which could be symptoms of a life-threatening condition known as Torsades de Pointes.

What should I avoid while taking Mirtazapine Tablets?

1. Mirtazapine Tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Mirtazapine Tablets affect you. 2. Avoid drinking alcohol or taking diazepam (a medicine used for anxiety, insomnia and seizures, for example) or similar medicines while taking Mirtazapine Tablets. If you are uncertain about whether certain medication can be taken with Mirtazapine Tablets, please discuss with your doctor.

What are the possible side effects of Mirtazapine Tablets?

Mirtazapine tablets may cause serious side effects:

1. See "What is the most important information I should know about mirtazapine tablets?"

The most common side effects of mirtazapine tablets include:

1. sleepiness 2. increased appetite 3. weight gain 4. abnormal dreams 5. constipation 6. dizziness 7. dry mouth

These are not all the possible side effects of mirtazepine tablets.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store Mirtazapine Tablets, USP?

1. Store mirtazapine tablets at room temperature between 68°F to 77°F (20°C to 25°C). 2. Keep Mirtazapine Tablets away from light. 3. Keep Mirtazapine Tablets bottle closed tightly.

Keep Mirtazapine Tablets, USP and all medicines out of the reach of children.

General information about the safe and effective use of Mirtazapine Tablets, USP.  

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Mirtazapine Tablets for a condition for which it was not prescribed. Do not give Mirtazapine Tablets to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Mirtazapine Tablets that is written for healthcare professionals.

What are the ingredients in Mirtazapine Tablets, USP?  

Active ingredient: mirtazapine.  

Inactive ingredients: 

1. 15mg tablets: Croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and iron oxide yellow.   2. 30mg tablets: Croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, iron oxide yellow and iron oxide red.   3. 45mg tablets: Croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.

For more information about Mirtazapine Tablets call 1-800-706-5575.

This Medication Guide has been approved by the U.S. Food and Drug Administration.  

APOTEX INC.
Mirtazapine Tablets, USP
15 mg, 30 mg and 45 mg

Manufactured by              Manufactured for
Apotex Inc.                        Apotex Corp.    
Toronto, Ontario                 Weston, Florida     
Canada M9L 1T9                33326 

Distributed by:

MAJOR® PHARMACEUTICALS

31778 Enterprise Dr.

Livonia, MI 48150 USA

LHC55310916      

Revised: August 2016  

Package/Label Display Panel

Mirtazapine Tablets, USP

15 mg

100 Tablets

MIRTAZAPINE 
mirtazapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0904-6519(NDC:60505-0247)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIRTAZAPINE (MIRTAZAPINE) MIRTAZAPINE 15 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
HYDROXYPROPYL CELLULOSE (1200000 MW)  
HYPROMELLOSE, UNSPECIFIED  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MICROCRYSTALLINE CELLULOSE  
POLYETHYLENE GLYCOL 8000  
TITANIUM DIOXIDE  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code APO;MI;15
Contains     
Packaging
# Item Code Package Description
1 NDC:0904-6519-61 100 BLISTER PACK in 1 BOX, UNIT-DOSE
1 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077666 08/22/2007
Labeler - Major Pharmaceuticals (191427277)
Registrant - Apotex Inc (209429182)
Revised: 04/2017   Major Pharmaceuticals
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