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REMERON RD is a brand name for Mirtazapine, supplied as a tablet (orally disintegrating). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: REMERON RD® (mirtazapine) is indicated for: • the symptomatic relief of depressive illness. Long-term use of REMERON RD® The efficacy of REMERON RD® Orally Disintegrating Tablets in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 - 12 weeks of initial open- label…
Verbatim from this product's HC label. Tap a section to expand.
REMERON RD® Orally Disintegrating Tablets are unique tablets that are designed to rapidly disintegrate on the tongue. No water is needed to take the tablets. 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 REMERON RD®, 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 REMERON RD® during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering REMERON RD® in the third trimester.
Children:
REMERON RD® 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 (see ACTION AND CLINICAL PHARMACOLOGY) demonstrates increased serum concentration and/or reduced clearance of REMERON® Tablets.
REMERON RD® should thus be dosed with care in these populations (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics). 2 Recommended Dose and Dosage Adjustment INITIAL TREATMENT ADULTS: REMERON RD® Orally Disintegrating 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 REMERON® Tablets 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 up to a maximum of 45 mg/day (see CLINICAL TRIALS, Clinical Trials Showing Efficacy).
REMERON RD® (mirtazapine) Page 6 of 41 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.
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 REMERON® Tablets was somnolence (10%).
S.
Short-Term Controlled Clinical Trials:
The most commonly observed adverse events related to the use of REMERON® Tablets (5% or greater drug-related incidence for REMERON® Tablets and at least twice that of placebo) were: somnolence (54% vs. 18%), increased appetite (17% vs.
2%), weight gain (12% vs. 2%), 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 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 non-drug factors to the side effect incidence rate in the population studied.
Hypersensitivity:
REMERON RD® is contraindicated in patients who are known to be hypersensitive to the drug or any of its components. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
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 syndrome (see WARNINGS AND PRECAUTIONS, Neurologic, Serotonin Toxicity/Neuroleptic Malignant Syndrome).
Therefore, REMERON RD® should not be used in combination with MAO inhibitors (including REMERON RD® (mirtazapine) Page 5 of 41 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 REMERON RD® 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 REMERON RD®.
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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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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 REMERON® 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 of 15 - 45 mg/day (see ACTION AND CLINICAL PHARMACOLOGY).
Based on these limited data, it is unknown whether or not the dose of REMERON RD® 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 REMERON RD® TREATMENT Symptoms associated with the discontinuation or dose reduction of REMERON RD® Tablets have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or during dosage reduction of REMERON RD® (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 REMERON RD® Orally Disintegrating Tablets Patients should be instructed to open the tablet blister pack with dry hands and place the tablet on the tongue. The tablet should be used immediately after removal from the blister; once removed, it cannot be stored.
REMERON RD® will disintegrate rapidly on the tongue and can be swallowed with saliva. No water is needed for taking the tablet. Patients should not attempt to split the tablets (see PATIENT MEDICATION INFORMATION ). 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.
S. short-term placebo-controlled studies1,2,3 Body System Adverse Event REMERON® Tablets 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%) REMERON RD® (mirtazapine) Page 16 of 41 Body System Adverse Event REMERON® Tablets N = 453 Placebo N = 361 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 > Remeron® Tablets: infection, pain, headache, nausea, diarrhea and insomnia. 3 Events which had an incidence of Remeron® Tablets 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 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, REMERON® Tablets were 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 categories.
It is important to emphasize that although the events occurred during treatment with REMERON® Tablets, they were not necessarily drug-related. Following the adverse experience 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; rare events REMERON RD® (mirtazapine) Page 17 of 41 are those […]