Tablet, Generic Name: Mirtazapine USP, Manufacturer: Incepta Pharmaceuticals Ltd.
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Indications
Mirtazapine Tablets are used to treat major depressive disorder (MDD) (MDD).
Pharmacology
Pharmacodynamics: The component of activity of Mirtazapine as with other drugs successful within the treatment of major depressive clutter is obscure. Prove assembled in preclinical ponders recommends that Mirtazapine upgrades central noradrenergic and serotonergic action. These thinks about have appeared that Mirtazapine acts as an enemy at central presynaptic α2-adrenergic inhibitory autoreceptors and heteroreceptors, an activity that's hypothesized to result in an increment in central noradrenergic and serotonergic action. Mirtazapine may be a powerful adversary of 5- HT2 and 5-HT3 receptors. Mirtazapine has no critical partiality for the 5-HT1A and 5-HT1B receptors.
Mirtazapine may be a powerful antagonist of histamine (H1) receptors, a property which will clarify its conspicuous sedative effects. Mirtazapine could be a direct peripheral α1-adrenergic antagonist, a property that will clarify the intermittent orthostatic hypotension detailed in affiliation with its utilize. Mirtazapine could be a direct enemy at muscarinic receptors, a property that will clarify the moderately moo frequency of anticholinergic side impacts related with its utilize.
Pharmacokinetics: Mirtazapine, the active ingredient in Mirtazapine tablets, is rapidly and thoroughly absorbed following oral administration, reaching peak plasma levels in about 2 hours. Mirtazapine binds to plasma proteins about 85 percent of the time. Elimination has a half-life of 20-40 hours on average (26 hours in males, 37 hours in females). The elimination half-life is long enough to support once-daily dosage. Within the prescribed dose range, mirtazapine has linear pharmacokinetics. Mirtazapine is substantially processed and removed four days later through urine and feces. Demethylation and oxidation are the most common biotransformation processes, followed by conjugation.
Dosage & Administration
Adult dose: The recommended starting dose for Mirtazapine tablets is 15 mg/day, administered in a single dose, preferably in the evening or prior to sleep. The effective dose range was generally 15 to 45 mg/day and the patients not responding to the initial 15 mg dose may benefit from dose increases up to a 30 mg to maximum of 45 mg/day. Mirtazapine has an elimination half-life of approximately 20 to 40 hours; therefore, dose changes should be made at intervals of less than 1 to 2 weeks in order to allow sufficient time for the therapeutic response to a given dose.
Use in children: Use in children are not recommended to Mirtazapine.
Missed Dose: If anyone misses a dose of mirtazapine, take it as soon as remember unless it is close to when the next dose is due. If anyone missed a dose of medication and it is close to the time of next dose, skip the missed dose and should take next dose at the regularly scheduled time. One should not take double or more than prescribed dose.
Interaction
Monoamine Oxidase Inhibitors (MAOI) and other serotonergic medicines such as tryptophan, triptans, linezolid, serotonin reuptake inhibitors, venlafaxine, lithium, tramadol, or St. John's wort have clinically significant drug-drug interactions with mirtazapine. Carbamazepine, Phenytoin, and Cimetidine's metabolism and function may be disrupted by Mirtazapine. While using Mirtazapine, the patient should avoid alcohol and diazepam.
Contraindications
Hypersensitivity to Mirtazapine or any of the excipients: Mirtazapine is contraindicated in individuals who have a history of hypersensitivity to Mirtazapine or any of the excipients.
Monoamine Oxidase Inhibitors: Taking Mirtazapine plus a monoamine oxidase (MAO) inhibitor at the same time is not recommended. Mirtazapine should not be used within 14 days of starting or stopping monoamine oxidase inhibitor medication (MAOI).
Side Effects
Dizziness, tiredness, dry mouth, increased hunger, weight gain, and other adverse effects of Mirtazapine are the most common.
Pregnancy & Lactation
Pregnancy Classification: C. If a patient becomes pregnant or intends to become pregnant while taking Mirtazapine, they should tell their doctor. If a patient is breastfeeding a newborn, they should inform their physician.
Precautions & Warnings
Patients, their families, and their caregivers ought to be energized to be alarm to the development of uneasiness, tumult, freeze assaults, a sleeping disorder, peevishness, threatening vibe, forcefulness, impulsivity, akathisia (psychomotor anxiety), hypomania, lunacy, other abnormal changes in behavior, declining of sadness, and self-destructive ideation, particularly early amid upper treatment and when the measurements is balanced up or down. Patients who are to get Mirtazapine ought to be cautioned almost the hazard of creating agranulocytosis. Mirtazapine may disable judgment, considering, and especially, engine abilities, since of its noticeable narcotic impact. Clinically critical ALT (SGPT) heights (≥3 times the upper constrain of the typical run) may occur.
Therapeutic Class
Antidepressants that aren't conventional.
Storage Conditions
Light and dampness should be avoided. Keep the temperature below 30 degrees Celsius. Keep any medications out of children's reach.
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