Mirtazapine 30 mg Tablets

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 )

• Starting dose: 15 mg once daily; may increase up to maximum recommended dose of 45 mg once daily. • Administer orally once daily, preferably in the evening prior to sleep. • Reduce dose gradually when discontinuing mirtazapine tablets
• 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 the initial 15 mg dose, increase the dose up to a maximum of 45 mg per day
• Dose changes should not be made in intervals of less than 1 to 2 weeks to allow sufficient time for evaluation of response to a given dose [see Clinical Pharmacology ]
• Screen for Bipolar Disorder Prior to Starting Mirtazapine Tablets Prior to initiating treatment with mirtazapine tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ]
• Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of mirtazapine tablets
• In addition, at least 14 days must elapse after stopping mirtazapine tablets before starting an MAOI antidepressant [see Contraindications and Warnings and Precautions ]. …

Mirtazapine tablets USP are supplied as: • 7.5 mg tablets: White, biconvex, capsule shaped film coated tablets with “11” debossed on one side and “A” debossed on the other side. • 15 mg tablets: Yellow, biconvex, capsule shaped film coated tablets with a score line in between “0” and “8” on one side and “A” debossed on the other side. …

• The safety and effectiveness of mirtazapine have not been established
• In pediatric patients with MDD
• Two placebo-controlled trials in 258
• Pediatric patients with MDD have been conducted with mirtazapine, and the data were insufficient to establish the safety and effectiveness of mirtazapine
• In pediatric patients with MDD
• Antidepressants increased the risk of suicidal thoughts and behaviors
• In pediatric patients [see Boxed Warning and Warnings and Precautions ]. …

Approximately 190 patients ≥65 years of age participated in clinical studies with mirtazapine. Mirtazapine 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. Pharmacokinetic studies revealed a decreased clearance of mirtazapine in the elderly [see Clinical Pharmacology (12.3) ]. …

• Advise the patient to read the FDA-approved patient labeling ( Error! Hyperlink reference not valid. )
• 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 ]
• Agranulocytosis Advise patients to contact their physician if they experience fever, chills, sore throat, mucous membrane ulceration, flu-like complaints, or other symptoms that might suggest infection [see Warnings and Precautions ]. …

Mirtazapine tablets are 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 syndrome [see Warnings and Precautions (5.3) , Drug Interactions (7) ]. • With a known hypersensitivity to mirtazapine or to any of the excipients in mirtazapine tablets. …

Table 5 includes clinically important drug interactions with mirtazapine [see Clinical Pharmacology (12.3) ]. Table 5: Clinically Important Drug Interactions with Mirtazapine Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of serotonergic drugs, including mirtazapine, and MAOIs increases the risk of serotonin syndrome. Intervention Mirtazapine is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration (2.4) , Contraindications (4) , Warnings and Precautions (5.3) ]. …

• Agranulocytosis: If sore throat, fever, stomatitis or signs of infection occur, along with a low white blood cell count, treatment with mirtazapine should be discontinued and the patient should be closely monitored. ( 5.2 ) • Serotonin Syndrome: Increased risk when co-administered with other serotonergic drugs (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue mirtazapine and initiate supportive treatment. ( 2.4 , 4 , 5.3 , 7 ) • Angle-Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. …

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 de Pointes [see Warnings and Precautions (5.5) ] • Increased Appetite and Weight Gain [see Warnings and Precautions (5.6) ] • Somnolence [see Warnings and Precautions (5.7) ] • Activation of Mania or Hypomania [s …

8.1 Pregnancy Reproduction studies in pregnant rats and rabbits at doses up to 100 mg/kg and 40 mg/kg, respectively [20 and 17 times the maximum recommended human dose (MRHD) on an mg/m 2 basis, respectively], have revealed no evidence of teratogenic effects. However, in rats, there was an increase in post-implantation losses in dams treated with mirtazapine. …

Human Experience In premarketing clinical studies, there were reports of mirtazapine overdose alone or in combination with other pharmacological agents. Signs and symptoms reported in association with overdose included disorientation, drowsiness, impaired memory, and tachycardia. Based on postmarketing reports, serious outcomes (including fatalities) may occur at dosages higher than the recommended doses, especially with mixed overdoses. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.