Mirtazapine (Page 8 of 9)

OVERDOSAGE

Human Experience

There is very limited experience with mirtazapine tablets overdose. In premarketing clinical studies, there were eight reports of mirtazapine tablets overdose alone or in combination with other pharmacological agents. The only drug overdose death reported while taking mirtazapine tablets was in combination with amitriptyline and chlorprothixene in a non-US clinical study. Based on plasma levels, the mirtazapine tablets dose taken was 30 to 45 mg, while plasma levels of amitriptyline and chlorprothixene were found to be at toxic levels. All other premarketing overdose cases resulted in full recovery. Signs and symptoms reported in association with overdose included disorientation, drowsiness, impaired memory, and tachycardia. There were no reports of ECG abnormalities, coma, or convulsions following overdose with mirtazapine tablets alone.

However, based on postmarketing reports, there is a possibility of more serious outcomes (including fatalities) at dosages much higher than the therapeutic dose, especially with mixed overdoses. In these cases, QT prolongation and Torsades de Pointes have also been reported (see PRECAUTIONS, Drug Interactions and ADVERSE REACTIONS sections).

Overdose Management

Treatment should consist of those general measures employed in the management of overdose with any drug effective in the treatment of major depressive disorder. Ensure an adequate airway, oxygenation, and ventilation. Monitor ECG parameters (including cardiac rhythm) and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients. Activated charcoal should be administered. There is no experience with the use of forced diuresis, dialysis, hemoperfusion, or exchange transfusion in the treatment of mirtazapine overdosage. No specific antidotes for mirtazapine are known.

In managing overdosage, consider the possibility of multiple-drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the Physicians’ Desk Reference (PDR).

DOSAGE AND ADMINISTRATION

Initial Treatment

The recommended starting dose for mirtazapine tablets is 15 mg/day, administered in a single dose, preferably in the evening prior to sleep. In the controlled clinical trials establishing the efficacy of mirtazapine in the treatment of major depressive disorder, the effective dose range was generally 15 to 45 mg/day. While the relationship between dose and satisfactory response in the treatment of major depressive disorder for mirtazapine tablets has not been adequately explored, patients not responding to the initial 15-mg dose may benefit from dose increases up to a maximum of 45 mg/day. Mirtazapine tablets has an elimination half-life of approximately 20 to 40 hours; therefore, dose changes should not be made at intervals of less than one to two weeks in order to allow sufficient time for evaluation of the therapeutic response to a given dose.

Elderly and Patients with Renal or Hepatic Impairment

The clearance of mirtazapine is reduced in elderly patients and in patients with moderate to severe renal or hepatic impairment. Consequently, the prescriber should be aware that plasma mirtazapine levels may be increased in these patient groups, compared to levels observed in younger adults without renal or hepatic impairment (see PRECAUTIONS and CLINICAL PHARMACOLOGY).

Maintenance/Extended Treatment

It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of mirtazapine tablets has demonstrated that its efficacy in major depressive disorder is maintained for periods of up to 40 weeks following 8 to 12 weeks of initial treatment at a dose of 15 to 45 mg/day (see CLINICAL PHARMACOLOGY). Based on these limited data, it is unknown whether or not the dose of mirtazapine tablets needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with mirtazapine tablets. Conversely, at least 14 days should be allowed after stopping mirtazapine tablets before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

Use of Mirtazapine Tablets With Other MAOIs, Such as Linezolid or Methylene Blue

Do not start mirtazapine tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

In some cases, a patient already receiving therapy with mirtazapine may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Mirtazapine tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with mirtazapine tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with mirtazapine tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

Discontinuation of Mirtazapine Tablets, USP Treatment

Symptoms associated with the discontinuation or dose reduction of mirtazapine tablets have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or during dosage reduction. A gradual reduction in the dose over several weeks, rather than abrupt cessation, is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient’s clinical response (see PRECAUTIONS and ADVERSE REACTIONS).

Information for Patients

Patients should be advised that taking mirtazapine tablets can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.

HOW SUPPLIED

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:

Overbagged with 10 Tablets per bag, NDC 55154-8145-0

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:
Cardinal Health

Dublin, OH 43017

L56461870620

Revised: September 2019

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