Mirtazapine is the generic equivalent of the brand-name drug Mirtazapine. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Mirtazapine through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ]. Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults. (1)
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the prescribing information: • Hypersensitivity [see Contraindications (4)] • Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.1)] • Agranulocytosis [see Warnings and Precautions (5.2)] • Serotonin Syndrome [see Contraindications (4), Warnings and Precautions (5.3), Drug Interactions (7)] • Angle-Closure Glaucoma [see Warnings and Precautions (5.4)] • QT Prolongation and Torsades…
Drug Interactions
7 DRUG INTERACTIONS Table 5 includes clinically important drug interactions with mirtazapine tablets [see Clinical Pharmacology (12.3)]. Table 5: Clinically Important Drug Interactions with Mirtazapine Tablets Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of serotonergic drugs, including mirtazapine tablets, and MAOIs increases the risk of serotonin syndrome. Intervention Mirtazapine tablets are contraindicated in patients taking MAOIs, including MAOIs such as linezoli…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Starting dose: 15-mg once daily; may increase up to maximum recommended dose of 45 mg once daily. (2.1) • Administer orally once daily, preferably in the evening prior to sleep. (2.1) • Reduce dose gradually when discontinuing mirtazapine tablets. ( 2.6 , 5.14 ) 2.1 Recommended Dosage The recommended starting dose of mirtazapine tablets is 15 mg once daily, administered orally, preferably in the evening prior to sleep. If patients do not have an adequate response to…
Patient Counseling Information
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 during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions (5.1)]. Agranulocytosis Advise patients to contact their physician if they experience fever, chills, sore throat, mucous membrane ulceration, flu-like complaints, or other symptoms that…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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