Mirtazapine is a brand of Mirtazapine.
Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ]. Mirtazapine tablets are.
What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.
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 )
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. …
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) ]. …
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.
Products with Mirtazapine as the active ingredient. Names differ between countries.
Other countries: check your pack's registration number and we point you to your regulator.
A recall usually affects certain batches only. Compare the lot number on your pack.
Type the registration number on the pack, or scan it with your camera.
Mirtazapine contains Mirtazapine. Other brands with the same active ingredient work the same way; the dose and strength on your pack are what matter.
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 ) (From the official U.S. FDA label.)
Follow your prescription or the leaflet in your pack. The official label says: • 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 , 5.13 ) 2.1 Recommended Dosage The recommended starting dose of mirtazapine tablets is 15 mg once daily, administered o…
Usually yes. Mirtazapine is a prescription medicine in most countries. Rules differ by country.
Mirtazapine is sold under names such as Remeron, Mirataz. Brand names differ between countries.
The official label lists: 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 Inter… Tell your doctor about any side effect that bothers you or does not go away.
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… Always use the dose for the child's age or weight on the pack or prescription.
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. … Ask your doctor or midwife first.
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 contra… Use the free interaction checker before combining medicines.
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 postmarket… Get medical help right away.
Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.
This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.