MIRTAZAPINE - mirtazapine tablet, film coated
MIRTAZAPINE - mirtazapine tablet, film coated
State of Florida DOH Central Pharmacy
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Table 1 |
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Age Range | Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated |
| Increases Compared to Placebo |
<18 | 14 additional cases |
18-24 | 5 additional cases |
| Decreases Compared to Placebo |
25-64 | 1 fewer case |
>65 | 6 fewer cases |
Common Adverse Events Associated with Discontinuation of Treatment in 6-Week US Mirtazapine Trials |
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Adverse Event | Percentage of Patients Discontinuing with Adverse Event |
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Mirtazapine (n=453) | Placebo (n=361) |
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Somnolence | 10.4% | 2.2% |
Nausea | 1.5% | 0% |
Common Treatment–Emergent Adverse Events Associated with the Use of Mirtazapine in 6-Week US Trials |
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Adverse Event | Percentage of Patients Reporting Adverse Event |
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Mirtazapine (n=453) | Placebo (n=361) |
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Somnolence | 54% | 18% |
Increased Appetite | 17% | 2% |
Weight Gain | 12% | 2% |
Dizziness | 7% | 3% |
1 Events reported by at least 1% of patients treated with mirtazapine are included, except the following events which had an incidence on placebo ≥ mirtazapine: 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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Body System Adverse Clinical Experience | Mirtazapine (n=453) | Placebo (n=361) |
Body as a Whole
|
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Asthenia | 8% | 5% |
Flu Syndrome | 5% | 3% |
Back Pain | 2% | 1% |
Digestive System
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Dry Mouth | 25% | 15% |
Increased Appetite | 17% | 2% |
Constipation | 13% | 7% |
Metabolic and Nutritional Disorders
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Weight Gain | 12% | 2% |
Peripheral Edema | 2% | 1% |
Edema | 1% | 0% |
Musculoskeletal System
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Myalgia | 2% | 1% |
Nervous System
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Somnolence | 54% | 18% |
Dizziness | 7% | 3% |
Abnormal Dreams | 4% | 1% |
Thinking Abnormal | 3% | 1% |
Tremor | 2% | 1% |
Confusion | 2% | 0% |
Respiratory System
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Dyspnea | 1% | 0% |
Urogenital System
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Urinary Frequency | 2% | 1% |
They are supplied by State of Florida DOH Central Pharmacy as follows:
NDC | Strength | Quantity/Form | Color | Source Prod. Code |
53808-0482-1 | 15 mg | 30 Tablets in a Blister Pack | YELLOW | 60505-0247 |
53808-0483-1 | 30 mg | 30 Tablets in a Blister Pack | PINK | 60505-0248 |
53808-0484-1 | 45 mg | 30 Tablets in a Blister Pack | WHITE | 60505-0249 |
This Product was Repackaged By:
State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States
MIRTAZAPINE
mirtazapine tablet, film coated |
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MIRTAZAPINE
mirtazapine tablet, film coated |
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MIRTAZAPINE
mirtazapine tablet, film coated |
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Labeler - State of Florida DOH Central Pharmacy (829348114) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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State of Florida DOH Central Pharmacy | 829348114 | repack |