REMERON Tablet / Orally disintegrating tablet (2020)
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Organon USA Inc.
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BOXED WARNING SECTION
<b>WARNING: SUICIDAL THOUGHTS AND BEHAVIORS</b> <b>Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all ...
1. Indications and Usage
REMERON/REMERONSolTab are indicated for the treatment of major depressive disorder (MDD) in adults <em>[see Clinical Studies (14)]</em>.
2. Dosage and Administration
2.1 Recommended Dosage The recommended starting dose of REMERON/REMERONSolTab is 15 mg once daily, administered orally, preferably in the evening prior to sleep. If patients do not have an adequate response ...
3. Dosage Forms and Strengths
REMERON is supplied as: 15 mg tablets: Oval, scored, yellow, with Organon debossed on one side and "<sup>T</sup><sub>3</sub><sup>Z</sup>" on the other side, on both sides of the score line 15 mg tablets: ...
4. Contraindications
REMERON / REMERONSolTab is contraindicated in patients: Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin ...
5. Warnings and Precautions
5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately ...
6. Adverse Reactions
The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity <em>[see Contraindications (4)]</em> Suicidal Thoughts and Behaviors <em> ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post-approval use of REMERON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
7. Drug Interactions
Table 5 includes clinically important drug interactions with REMERON/REMERONSolTab <em>[see Clinical Pharmacology (12.3)]</em>. <b>Table 5. Clinically Important Drug Interactions with REMERON/REMERONSolTab: ...
8. Use in Specific Populations
8.7 Patients with Phenylketonuria REMERONSolTab contains phenylalanine, a component of aspartame. REMERONSolTab contains the following amount of phenylalanine: 2.6 mg in 15 mg orally disintegrating tablet, ...
8.1. Pregnancy
Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register ...
8.2. Lactation
Risk Summary Data from published literature report the presence of mirtazapine in human milk at low levels with relative infant doses for mirtazapine ranging between 0.6 and 2.8% of the maternal weight-adjusted ...
8.4. Pediatric Use
The safety and effectiveness of REMERON/REMERONSolTab have not been established in pediatric patients with MDD. Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with ...
8.5. Geriatric Use
Approximately 190 patients ≥65 years of age participated in clinical studies with REMERON. REMERON/REMERONSolTab is known to be substantially excreted by the kidney (75%), and the risk of decreased clearance ...
8.6. Renal Impairment
The clearance of mirtazapine is reduced in patients with moderate to severe renal impairment. Consequently, plasma mirtazapine levels may be increased in these patient groups, compared to levels observed ...
8.7. Hepatic Impairment
The clearance of mirtazapine is reduced in patients with moderate to severe hepatic impairment. Consequently, plasma mirtazapine levels may be increased in these patient groups, compared to levels observed ...
10. Overdosage
Human Experience In premarketing clinical studies, there were reports of REMERON overdose alone or in combination with other pharmacological agents. Signs and symptoms reported in association with overdose ...
11. Description
REMERON and REMERONSolTab contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino ...
12.1. Mechanism of Action
The mechanism of action of mirtazapine for the treatment of major depressive disorder, is unclear. However, its efficacy could be mediated through its activity as an antagonist at central presynaptic α ...
12.2. Pharmacodynamics
In preclinical studies, mirtazapine acts as an antagonist at α<sub>2</sub>-adrenergic inhibitory autoreceptors and heteroreceptors and as an antagonist at serotonin 5-HT<sub>2</sub> and 5-HT<sub>3</sub> ...
12.3. Pharmacokinetics
Plasma levels of mirtazapine are linearly related to dose over a dose range of 15 to 80 mg (1.78 times the maximum recommended dose). Steady state plasma levels of mirtazapine are attained within 5 days, ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis Carcinogenicity studies were conducted with mirtazapine given in the diet at doses of 2, 20, and 200 mg/kg/day to mice and 2, 20, and 60 mg/kg/day to rats. The highest doses used are approximately ...
14. Clinical Studies
The efficacy of REMERON as a treatment for major depressive disorder was established in 4 placebo-controlled, 6-week trials in adult outpatients meeting DSM-III criteria for major depressive disorder. ...
16.1. How Supplied
REMERON tablets are supplied as: Tablet Strength Tablet Color/Shape Tablet Markings Package Configuration NDC Code 15 mg Yellow, oval tablet Scored with Organon debossed on one side and "<sup> ...
16.2. Storage and Handling
<u>REMERON tablets:</u> Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. <u>REMERON SolTab ...
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early ...