Mirtazapine (Page 6 of 9)

Nursing Mothers

Because some mirtazapine may be excreted into breast milk, caution should be exercised when mirtazapine tablets are administered to nursing women.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established (see BOXED WARNING and WARNINGS: Clinical Worsening and Suicide Risk). Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with mirtazapine tablets, and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of mirtazapine tablets in a child or adolescent must balance the potential risks with the clinical need.

In an 8-week-long pediatric clinical trial of doses between 15 to 45 mg/day, 49% of mirtazapine-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-treated patients versus 1 kg (2 kg SD) for placebo-treated patients (see PRECAUTIONS, Increased Appetite/Weight Gain).

Geriatric Use

Approximately 190 elderly individuals (≥65 years of age) participated in clinical studies with mirtazapine tablets. This drug is 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. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. Sedating drugs may cause confusion and over-sedation in the elderly. No unusual adverse age-related phenomena were identified in this group. Pharmacokinetic studies revealed a decreased clearance in the elderly. Caution is indicated in administering mirtazapine tablets to elderly patients (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

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.

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