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MYLAN-MIRTAZAPINE is a brand name for Mirtazapine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MYLAN-MIRTAZAPINE (mirtazapine) is indicated for: the symptomatic relief of depressive illness. Long-term use of MYLAN-MIRTAZAPINE The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 - 12 weeks of initial open-label treatment was…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations TREATMENT OF PREGNANT WOMEN DURING THE THIRD TRIMESTER: Post-marketing reports indicate that some neonates exposed to SSRIs or other newer anti - depressants, such as mirtazapine, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support and tube feeding (see WARNINGS AND PRECAUTIONS).
When treating pregnant women with MYLAN-MIRTAZAPINE during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering MYLAN-MIRTAZAPINE in the third trimester.
Children:
MYLAN-MIRTAZAPINE is not indicated for use in children under 18 years of age (see WARNINGS AND PRECAUTIONS, General, Potential Association with Behavioural and Emotional Changes, Including Self-Harm).
ELDERLY AND PATIENTS WITH MODERATE TO SEVERE RENAL OR HEPATIC IMPAIRMENT:
In elderly patients, and patients with moderate to severe renal or hepatic impairment, limited pharmacokinetic data demonstrates increased serum concentration and/or reduced clearance of mirtazapine. MYLAN-MIRTAZAPINE should thus be dosed with care in these populations (see Pharmacokinetics).
2 Recommended Dose and Dosage Adjustment INITIAL TREATMENT ADULTS: MYLAN-MIRTAZAPINE Tablets should be administered as a single dose, preferably in the evening prior to sleep. The recommended initial dose is 15 mg daily. In clinical trials, patients generally received doses of mirtazapine in the range of 15 - 45 mg/day.
While a relationship between dose and anti-depressant response for mirtazapine has not been established, patients not responding to the initial 15 mg dose may benefit from dose increases MYLAN-MIRT AZAPINE (mirtazapine) Page 6 of 45 up to a maximum of 45 mg/day (see Clinical Trials Showing Efficacy).
Mirtazapine has an elimination half-life of approximately 20 - 40 hours, therefore, dose changes should occur in intervals of not less than one week. Dosage adjustments may be made according to the tolerance and based on the patient’s response.
LONGER-TERM TREATMENT It is generally agreed that acute episodes of depression require several months or longer of sustained therapy beyond response to the acute episode. Systematic evaluation of mirtazapine has demonstrated that its efficacy in major depressive disorder is maintained for periods of up to 40 weeks following 8 - 12 weeks of initial treatment at a dose 15 - 45 mg/day (see CLINICAL PHARMACOLOGY).
S. short-term controlled studies discontinued treatment due to an adverse event, compared to 7% of patients treated with placebo. The adverse event that accounted for more than 5% of discontinuations with mirtazapine was somnolence (10%).
S.
Short-Term Controlled Clinical Trials:
The most commonly observed adverse events related to the use of mirtazapine tablets (5% or greater drug-related incidence for mirtazapine tablets and at least twice that of placebo) were somnolence (54% vs. 18%), increased appetite (17% vs.
2%), weight gain (12% vs. 2%) and dizziness (7% vs. 3%). 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. S. short-term placebo-controlled trials, in which patients were dosed in a range of 5 to 60 mg/day. The investigators reported adverse clinical experiences using terms of their own choice.
Reported adverse events were then classified using the 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 patie nt 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 non -drug factors to the side effect incidence rate in the population studied.
General POTENTIAL ASSOCIATION WITH BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM Pediatrics: Placebo-Controlled Clinical Trial Data Recent analyses of placebo-controlled clinical trial safety databases from SSRIs (Selective Serotonin Reuptake Inhibitors) and other newer anti-depressants suggest that use of these drugs in patients under the age of 18 may be associated with behavioural and emotional changes, including an increased risk of suicidal ideation and behaviour over that of placebo.
The small denominators in the clinical trial database, as well as the variability in placebo rates, preclude reliable conclusions on the relative safety profiles among these drugs.
Adults and Pediatrics:
Additional Data There are clinical trial and post-marketing reports with SSRIs and other newer anti- Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients oral Tablets, 15, 30 and 45 mg Colloidal anhydrous silica, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose anhydrous, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, and titanium dioxide.
15 mg: Triacetin and yellow iron oxide 30 mg: Yellow, red and black iron oxides MYLAN-MIRT AZAPINE (mirtazapine) Page 9 of 45 depressants, in both pediatrics and adults, of severe agitation-type adverse events coupled with self-harm or harm to others.
The agitation-type events include akathisia, agitation, disinhibition, emotional lability, hostility, aggression and depersonalization. In some cases, the events occurred within several weeks of starting treatment. Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages.
This includes monitoring for agitation-type emotional and behavioural changes. Discontinuation Symptoms Patients currently taking MYLAN-MIRTAZAPINE should NOT discontinue treatment abruptly, due to risk of discontinuation symptoms. At the time that a medical decision is made to discontinue an SSRI or other newer anti-depressant drug, a gradual reduction in the dose, rather than an abrupt cessation, is recommended.
MYLAN-MIRTAZAPINE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Monoamine Oxidase Inhibitors:
In patients receiving agents that may affect the serotonergic neurotransmitter systems in combination with a monoamine oxidase (MAO) inhibitor, there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma.
These reactions have also been reported in patients who have recently discontinued Selective Serotonin Reuptake Inhibitor (SSRI) treatment and have begun treatment on a MAO inhibitor. Some cases presented with features resembling serotonin toxicity or neuroleptic malignant MYLAN-MIRT AZAPINE (mirtazapine) Page 5 of 45 syndrome (see WARNINGS AND PRECAUTIONS, Neurologic, Serotonin Toxicity/Neuroleptic Malignant Syndrome).
Therefore, MYLAN-MIRTAZAPINE should not be used in combination with MAO inhibitors (including the antibiotic linezolid, and the thiazine dye methylthioninium blue (methylene blue), which are less well-known examples of MAO inhibitors) or within a minimum of 2 weeks of terminating treatment with MAO inhibitors.
Treatment with MYLAN - MIRTAZAPINE should then be initiated cautiously and dosage increased gradually until optimal response is reached. MAO inhibitors should not be introduced within 2 weeks of cessation of therapy with MYLAN-MIRTAZAPINE.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Mirtazapine in Canada.
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Based on these limited data, it is unknown whether or not the dose of mirtazapine needed for continuation treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for continuation treatment and the appropriate dose for such treatment.
DISCONTINUATION OF MYLAN-MIRTAZAPINE TREATMENT Symptoms associated with the discontinuation or dose reduction of mirtazapine have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or during dosage reduction (see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS).
A gradual reduction in the dose over several weeks, rather than abrupt cessation, is recommended whenever is 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 WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS).
3 Administration Administration of MYLAN-MIRTAZAPINE Tablets Patients should be instructed to take the tablets at the same time each day, preferably as a single evening dose (prior to sleep). The tablets should be swallowed with water, without chewing.
4 Reconstitution Not applicable. 5 Missed Dose Do not take a double dose to make up for forgotten doses. If a patient forgets to take the evening dose, advise the patient not to take the missed dose the next morning. Continue treatment in the evening (prior to sleep) with the normal dose.
MYLAN-MIRT AZAPINE (mirtazapine) Page 7 of 45
S. short-term placebo-controlled studies1,2,3 Body System Adverse Event MIRTAZAPINE N = 453 Placebo N = 361 Body as a Whole Asthenia 34 (8%) 17 (5%) Flu Syndrome 22 (5%) 9 (3%) Back Pain 9 (2%) 3 (1%) Digestive System Dry Mouth 112 (25%) 54 (15%) Increased Appetite 76 (17%) 7 (2%) Constipation 57 (13%) 24 (7%) Metabolic and Nutritional Disorders Weight Gain 54 (12%) 6 (2%) Peripheral Edema 11 (2%) 4 (1%) Edema 6 (1%) 1 (0%) Musculoskeletal System Myalgia 9 (2%) 3 (1%) Nervous System Somnolence 243 (54%) 65 (18%) Dizziness 33 (7%) 12 (3%) Abnormal Dreams 19 (4%) 5 (1%) Thinking Abnormal 15 (3%) 4 (1%) Tremor 7 (2%) 2 (1%) Confusion 9 (2%) 1 (0%) Respiratory System Dyspnea 5 (1%) 1 (0%) Urogenital System Urinary Frequency 8 (2%) 5 (1%) N= Number of Patients 1 % rounded off to the nearest whole integer.
2 Events which had an incidence on placebo > mirtazapine: infection, pain, headache, nausea, diarrhea and insomnia. 3 Events which had an incidence of mirtazapine comparable to placebo: chest pain, palpitation, tachycardia, postural hypotension, dyspepsia, flatulence, libido decreased, hypertonia, nervousness, rhinitis, pharyngitis, sweating, amblyopia, tinnitus and taste perversion.
, increased appetite, dizziness and somnolence). S. short-term controlled trials were analyzed, in which the QTc calculations using the method of Fridericia was employed. Prolongation in QTc ≥ 500 MYLAN-MIRT AZAPINE (mirtazapine) Page 18 of 45 msec was not observed among mirtazapine-treated patients.
1 msec for placebo. 8 bpm for placebo. The clinical significance of these changes is unknown. 3 Less Common Clinical Trial Adverse Reactions (< 1%) During worldwide controlled and uncontrolled clinical trials, mirtazapine was administered to 2,796 patients.
The listing of events which follows includes those events which were judged by the investigator to be adverse clinical experiences. The investigators used terminology of their own choice to describe the adverse experiences. 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 catego ries.
It is important to emphasize that although the events occurred during treatment with mirtazapine, they were not necessarily drug-related. Following the adverse experiences tabulations, the incidence of clinically significant laboratory values which occurred at a rate of ≥ 1% of patients is presented.
In the tabulations that follow, adverse events as reported by the investigator were classified using a standard COSTART-based dictionary terminology. 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, and rare events are those occurring in fewer than 1/1,000 patients.
Only those events not already listed in Table 1 appear in this […]
, dizziness, abnormal dreams, sensory disturbances (including paresthesia and electric shock sensations), agitation, anxiety, fatigue, confusion, headache, tremor, nausea, vomiting and sweating or other symptoms which may be of clinical significance (see ADVERSE REACTIONS).
A gradual reduction in the dosage 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 ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).
Lactose Lactose is a non-medicinal ingredient in MYLAN-MIRTAZAPINE tablets. Therefore, patients with rare hereditary problems of galactose intolerance or glucose -galactose malabsorption should not take MYLAN-MIRTAZAPINE tablets. Agranulocytosis In pre-marketing clinical trials, two (one with Sjögren’s Syndrome) out of 2,796 patients treated with mirtazapine tablets and one patient treated with imipramine developed agranulocytosis.
In all three cases, the patients recovered after the drug with which they were being treated was stopped. In the post-marketing period with mirtazapine, very rare cases of agranulocytosis have been reported, mostly reversible, but in some cases fatal.
Fatal cases have mostly concerned patients above 65 years of age, although there has been at least one such fatality in a younger patient. Patients who are to receive mirtazapine should be warned about the risk of developing agranulocytosis and advised to contact their physician if they experience any indication of infection such as fever, chills, sore throat, mucous membrane ulceration.
If a patient develops a sore throat, fever, stomatitis or other signs of infection, along with a low white blood cell (WBC) count, treatment with MYLAN-MIRTAZAPINE Tablets should be discontinued and the patient should be closely monitored.
MYLAN-MIRT AZAPINE (mirtazapine) Page 10 of 45 The following additional precautions are listed alphabetically. Carcinogenesis and Mutagenesis Cardiovascular QT Prolongation / Torsade de Pointes: Cases of QT prolongation, torsades de pointes (TdeP), ventricular tachycardia, ventricular fibrillation, cardiac arrest, and sudden death, have been reported during the post-marketing use of mirtazapine.
The majority of reports occurred in association with overdose or in patients with other risk factors for QT prolongation, including concomitant use of QTc prolonging medicines (see DRUG INTERACTIONS, Drug-Drug Interactions and OVERDOSAGE).
Caution should be exercised when MYLAN-MIRTAZAPINE is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products thought to prolong the QTc interval.
Torsade de pointes may be asymptomatic or experienced by the patient as dizziness, palpitations, syncope, or seizures. If sustained, torsade de pointes can progress to ventricular fibrillation and sudden cardiac death. The effect of mirtazapine on QTc interval was assessed in a randomised, placebo and positive controlled (moxifloxacin 400 and 800 mg) clinical trial using exposure response analysis in 54 healthy volunteers.
This study revealed that both 45 mg (therapeutic) and 75 mg (supratherapeutic) doses of mirtazapine, unlike moxifloxacin, did not affect the QTc interval to a clinically significant meaningful extent. However, because TdeP, including ventricular fibrillation and sudden death have been reported during postmarketing use of mirtazapine, it should be taken into consideration that, under certain situations, these […]