Preparation
Amiron 7.5 Tablet: Each tablet contains Mirtazapine BP 7.5 mg.
Amiron 15 Tablet: Each tablet contains Mirtazapine BP 15 mg.
Amiron 30 Tablet: Each tablet contains Mirtazapine BP 30 mg
Therapeutic Class
Atypical Anti-depressant Drugs
Indication
Amiron is indicated for the treatment Major Depressive Disorder (MDD) and Depression with Anxiety and depression with insomnia in adults.
Contraindication
Amiron is indicated in patients -
1. Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome.
2. With a known hypersensitivity to Mirtazapine or to any of the excipients in Mirtazapine. Severe skin reactions, including Stevens-Johnson syndrome, bullous dermatitis, erythema and toxic epidermal necrolysis have been reported following the use of Mirtazapine.
Dosage & Administration
The recommended starting dose of Amiron 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.
Side Effect
The most common side effects of Amiron are dizziness, drowsiness, dry mouth, increased appetite, weight gain etc.
Precaution
Epilepsy, hepatic or renal impairment, cardiac disorders, hypotension, history of epilepsy, hepatic or renal impairment, cardiac disorders, hypotension, history of urinary retention, angle-closure glaucoma, diabetes mellitus, psychoses (may aggravate psychotic symptoms), history of bipolar depression, avoid abrupt withdrawal.
Drug Interaction
Amiron has clinically significant drug-drug interactions with Monoamine Oxidase Inhibitors (MAOI) & other serotonergic drugs such as tryptophan, triptans, linezolid, serotonin reuptake inhibitors, venlafaxine, lithium, tramadol, or St. John's wort. Amiron may interrupt the metabolism or activity of Carbamazepine, Phenytoin or Cimetidine. Patient should avoid Alcohol & Diazepam while taking Amiron.
Presentation
Amiron 7.5 tablet: Each box contains 3x10's tablets in alu-alu blister pack.
Amiron 15 tablet: Each box contains 3x10's tablets in alu-alu blister pack.
Amiron 30 tablet: Each box contains 3x10's tablets in alu-alu blister pack.
Use Children
The safety and effectiveness of Amiron have not been established in pediatric patients with MDD.
Use Pregnancy Lactation
Pregnancy Category C. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during Amiron therapy. Patients should be advised to notify their physician if they are breastfeeding an infant.
Storage
Store below 30 ºC, keep in a dry place and protected from light. Keep all medicines out of reach of children.