Mirtazapine Aurobindo, a piperazinoazepine tetracyclic antidepressant, enhances noradrenergic and serotonergic activity through blockade of central presynaptic adrenergic α2-receptors.
General effects and a note on suicidality
Mirtazapine Aurobindo is effective in treating moderate to severe depression and treats many symptoms normally associated with this condition. These symptoms may include disturbed sleep, lack of appetite, and anhedonia, in addition to anxiety.. It is important to note that suicidal ideation and behavior may emerge or increase during treatment with mirtazapine, as with any other antidepressant. This risk is especially pronounced in younger individuals. Patients, medical professionals, and families should monitor for suicidal thoughts, worsening depression, anxiety, agitation, sleep changes, irritable behavior, aggression, impulsivity, restlessness, and other unusual behavior when this drug is taken or the dose is adjusted. Do not administer mirtazapine to children. When deciding to prescribe this drug, carefully consider the increased risk of suicidal thoughts and behavior, especially in young adults.
Effects on appetite and weight gain
Mirtazapine Aurobindo Tablets are used for the treatment of major depressive disorder.
The efficacy of Mirtazapine Aurobindo in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders- 3rd edition (DSM-III) category of major depressive disorder
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.
The effectiveness of Mirtazapine Aurobindo in hospitalized depressed patients has not been adequately studied.
The efficacy of Mirtazapine Aurobindo in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Mirtazapine Aurobindo for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient
Mirtazapine Aurobindo is also used to associated treatment for these conditions: Depression, Dysthymic Disorder, Fibromyalgia, Generalized Anxiety Disorder (GAD), Hot Flushes, Insomnia, Major Depressive Disorder (MDD), Nausea and vomiting, Neurological Disorders, Obsessive Compulsive Disorder (OCD), PTSD Symptoms, Pain, Cancer, Panic Disorder, Poststroke depression, Schizophrenia, Sleep disorders and disturbances, Social Phobia, Substance Abuse Disorders, Tension Headache, Low body weight, Weight restoration
How Mirtazapine Aurobindo works
The mechanism of action of mirtazapine is not fully understood but may be explained by its effects on central adrenergic and serotonergic activity. This drug exhibits a fast onset of action, a high level of response, a manageable side-effect profile, and dual noradrenergic and serotonergic effects that are unique from the effects of other antidepressants.
Effects on various receptors
It has been shown that both noradrenergic and serotonergic activity increase following mirtazapine administration. The results of these studies demonstrate mirtazapine exerts antagonist activity at presynaptic α2-adrenergic inhibitory autoreceptors and heteroreceptors in the central nervous system. This is thought to lead to enhanced noradrenergic and serotonergic activity , which are known to improve the symptoms of depression and form the basis of antidepressant therapy.
Mirtazapine Aurobindo is a strong antagonist of serotonin 5-HT2 and 5-HT3 receptors. It has not been found to bind significantly to the serotonin 5-HT1A and 5-HT1B receptors but indirectly increases 5-HT1A transmission.
In addition to the above effects, mirtazapine is a peripheral α1-adrenergic antagonist. This action may explain episodes of orthostatic hypotension that have been reported after mirtazapine use. Mirtazapine Aurobindo is a potent histamine (H1) receptor antagonist, which may contribute to its powerful sedating effects. The pain-relieving effects of mirtazapine may be explained by its effects on opioid receptors.
|Trade Name||Mirtazapine Aurobindo|
|Mirtazapine Other Names||6-Azamianserin, Mepirzapine, Mirtazapin, Mirtazapina, Mirtazapine, Mirtazapinum|
|Related Drugs||Rexulti, sertraline, trazodone, Lexapro, Zoloft, citalopram, Cymbalta, Prozac|
|Weight||Average: 265.3529 |
|Protein binding|| |
Mirtazapine is about 85% bound to plasma proteins.
|Therapeutic Class||Atypical anti-depressant drugs|
|Last Updated:||June 7, 2022 at 8:55 pm|
Table Of contents
- Mirtazapine Aurobindo
- Side Effect
- Uses during Pregnancy
- Uses during Breastfeeding
- Accute Overdose
- Food Interaction
- Half Life
- Volume of Distribution
- Interaction With other Medicine
Mirtazapine Aurobindo dosage
Adult: Initially, 15 mg daily; may be increased gradually depending on clinical response. Change dose at intervals of at least 1-2 wk. Usual effective dose: 15-45 mg daily given as single dose, preferably at bedtime, or in 2 divided doses.
Children: Safety and efficacy not established.
Geriatric: Use with caution.
The most commonly reported adverse effects with mirtazapine are increase in appetite, weight gain, edema, drowsiness or sedation, dizziness, headache etc.
Oral LD50 was 830 mg/kg in male Swiss mice 24 hours after being administered mirtazapine.
Activated charcoal should be administered during an overdose to absorb excess mirtazapine. General supportive therapy should be employed, including maintenance of an adequate airway, oxygen therapy, and ventilation therapy. Vital signs and cardiac rhythm must be monitored. It is not advisable to induce vomiting. Gastric lavage with a large-bore orogastric tube with proper protection of the airway is recommended . There is no antidote for mirtazapine available currently. Consider the possibility of mirtazapine combined with other drugs in an overdose and ensure to contact the local poison control center for guidance on management.
At higher than normal doses, mirtazapine increased the incidence of hepatocellular adenomas and carcinomas in male mice. The highest doses administered to the mice were about 20 and 12 times the maximum recommended human dose (MRHD). Hepatocellular tumors and thyroid follicular adenoma/cystadenomas in male rats occurred at an increased rate at a higher mirtazapine dose (60 mg/kg/day). In female rats, both the medium (20 mg/kg/day) and higher (60 mg/kg/day) doses of mirtazapine increased the rate of hepatocellular adenomas. The relevance of these findings in humans is not known at this time.
Impairment of Fertility
Mirtazapine Aurobindo was administered to rats at doses reaching 100 mg/kg (equivalent to 20 times the maximum recommended human dose) in a fertility study. There was no impact on mating and conception, however, there was a disturbance of reproductive (estrous) cycling at higher doses. These doses were measured to be at least 3 times the maximum recommended human dose. Loss of fetus before implantation in the uterus occurred when doses equivalent to 20 times the maximum recommended dose were administered.
Use in pregnancy
This drug is categorized as a pregnancy category C drug. No adequate studies in pregnant women have been conducted. In rats, an increased rate of post-implantation demise occurred with mirtazapine administration. Additionally, an increase in deaths of rat pups during the first 3 days of lactation with a decrease in pup birth weight was noted. Studies on animals are not always relevant to human response. Mirtazapine Aurobindo should be used during pregnancy only if the clinical need outweighs the possible risks to the fetus.
Use in nursing
Whether this drug is excreted in human milk is unknown. Many drugs are found excreted in human breast milk, therefore caution is advised if this drug is used during nursing.
Mirtazapine Aurobindo should be used cautiously in patients with epilepsy or history of seizure, history of mania /hypomania, patients with hepatic or renal impairment; cardiac disorders e.g. conduction disturbances, angina pectoris, recent MI. Hypotension, DM, psychoses, history of bipolar disorder. Stop treatment if jaundice develops. Monitor patient for signs of bone marrow depression. Monitor patient for suicidal tendency. Avoid abrupt withdrawal. May impair ability to drive or operate machinery.
Mirtazapine Aurobindo potentiates sedative effects with alcohol or benzodiazepines, increased plasma levels with potent CYP3A4 inhibitors (e.g. HIV-protease inhibitors, azole antifungals including ketoconazole, erythromycin, nefazodone), reduced plasma levels with carbamazepine and other inducers of CYP3A4 and increased bioavailability with cimetidine.
- Avoid alcohol.
- Take with or without food. Food does not significantly affect absorption.
[Moderate] GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of CNS-active agents.
Use in combination may result in additive central nervous system depression and
MANAGEMENT: Patients receiving CNS-active agents should be warned of this interaction and advised to avoid or limit consumption of alcohol.
Ambulatory patients should be counseled to avoid hazardous activities requiring complete mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities.
Mirtazapine Aurobindo Cholesterol interaction
[Moderate] Mirtazapine Aurobindo may significantly elevate serum triglyceride and total cholesterol levels.
Patients with preexisting hyperlipidemia may require closer monitoring during mirtazapine therapy, and adjustments made accordingly in their lipid-lowering regimen.
Mirtazapine Aurobindo Drug Interaction
Major: duloxetine, escitalopram, sertraline
Moderate: aripiprazole, zolpidem, diphenhydramine, pregabalin, metoprolol, metoprolol, quetiapine, alprazolam
Unknown: amphetamine / dextroamphetamine, aspirin, omega-3 polyunsaturated fatty acids, atorvastatin, levothyroxine, acetaminophen, cyanocobalamin, ascorbic acid, cholecalciferol
Mirtazapine Aurobindo Disease Interaction
Major: renal/liver disease, pheochromocytoma, bipolar screening, depression, hypotension, neutropenia
Moderate: mania, ALT elevations, hyperlipidemia, hyponatremia, mania/hypomania, seizures, glaucoma
Volume of Distribution
The volume of distribution after an oral steady-state dose was measured to be 107 ± 42L in a pharmacokinetic study.
The absorption of this drug is rapid and complete. Due to first pass metabolism in the liver and metabolism in the gut wall, absolute bioavailability is about 50%. Peak blood concentrations are attained within about 2 hours after an oral dose. Food has little effect on the absorption of mirtazapine, and no dose adjustment is required if it is taken with food. Steady-state levels are achieved by about 5 days after the initial dose. Mirtazapine Aurobindo pharmacokinetics vary across gender and age range. Females and the elderly population have been shown to have higher blood concentrations in comparison to males and younger adults.
Total body clearance in males was found to be 31 L/h in a clinical pharmacokinetics study after intravenous administration.
Clearance in elderly patients
Mirtazapine Aurobindo clearance is slower in the elderly than in younger subjects. Exercise caution when this drug is given to elderly patients. In a clinical trial, elderly males showed a marked decrease in mirtazapine clearance when compared to young males taking the same dose. This difference was less significant when clearance was compared between elderly females and younger females taking mirtazapine.
Clearance in hepatic and renal impairment
Patients with hepatic and renal impairment have decreased rates of clearance and dosage adjustments may be necessary for these patients. Moderate renal impairment and hepatic impairment cause about a 30% decrease in mirtazapine clearance. Severe renal impairment leads to a 50% decrease in mirtazapine clearance.
This drug is mainly excreted by the kidney. It is 75% eliminated in the urine and 15% eliminated in the feces.
Pregnancy & Breastfeeding use
Mirtazapine Aurobindo Should not be used during pregnancy and lactation.
Mirtazapine Aurobindo is contraindicated in patients with hypersensitivity. Do not use with or within 2 weeks of stopping an MAOI; at least 1 week should elapse between discontinuing mirtazapine and initiating any drug which may provoke a serious reaction (e.g. phenelzine)
Symptoms: Disorientation, drowsiness, impaired memory, tachycardia.
Management: Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac functions. General supportive and symptomatic measures are also recommended. Do not induce emesis. Gastric lavage may be used if done soon after ingestion, or in symptomatic patients. Administer activated charcoal. No specific antidotes are known.
Store at 15-30° C . Protect from light and moisture.
Mirtazapine Aurobindo contains Mirtazapine see full prescribing information from innovator Mirtazapine Aurobindo Monograph, Mirtazapine Aurobindo MSDS, Mirtazapine Aurobindo FDA label
What is Mirtazapine Aurobindo used for?
Mirtazapine Aurobindo is an atypical antidepressant, and as such is used primarily to treat depression. Its effects may take up to four weeks, but can also manifest as early as one to two weeks. It is often used in cases of depression complicated by anxiety or insomnia.
How safe is Mirtazapine Aurobindo?
Mirtazapine Aurobindo is relatively safe in overdose. Many clinicians consider Mirtazapine Aurobindo a second-line or even third-line antidepressant, to be used when older antidepressants are not tolerated or are ineffective.
How does Mirtazapine Aurobindo work?
Mirtazapine Aurobindo works by increasing the activity of mood-enhancing chemicals called noradrenaline and serotonin in the brain.
What are the common side effects of Mirtazapine Aurobindo?
Common side effects of Mirtazapine Aurobindo are include:
- dry mouth.
- increased appetite and weight gain.
- feeling sleepy.
Is Mirtazapine Aurobindo safe during pregnancy?
Mirtazapine Aurobindo seems to be safe in pregnancy, especially regarding incidence of congenital malformations.
Is Mirtazapine Aurobindo safe during breastfeeding?
Mirtazapine Aurobindo can be used during breastfeeding. It has been used by many breastfeeding mothers usually without any problems. Mirtazapine Aurobindo passes into breast milk in small amounts. It has been linked with side effects in very few breastfed babies.
Can I drink alcohol with Mirtazapine Aurobindo?
You can drink alcohol while taking Mirtazapine Aurobindo but it may make you feel sleepy and unsteady on your feet. It might be best to stop drinking alcohol for the first few days of treatment until you see how the medicine affects you. Drinking alcohol every day or in large amounts can make your symptoms worse.
Can I drive after taking Mirtazapine Aurobindo?
Mirtazapine Aurobindo can cause sleepiness or dizziness. For this reason, a person should avoid using heavy equipment or driving after taking Mirtazapine Aurobindo.
When should be taken of Mirtazapine Aurobindo?
It's best to take Mirtazapine Aurobindo before you go to bed as it can make you sleepy.
How often can I take Mirtazapine Aurobindo?
You'll usually take Mirtazapine Aurobindo once a day.
How long can I take Mirtazapine Aurobindo?
You may see an improvement in your symptoms after a week although it usually takes between 4 and 6 weeks before you feel the full benefits.
Who should not take Mirtazapine Aurobindo?
You should not take Mirtazapine Aurobindo if you are also taking tryptophan.
Do not use Mirtazapine Aurobindo if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine and others.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention. Overdose symptoms may include confusion, memory problems, drowsiness, and fast heart rate.
How long does Mirtazapine Aurobindo stay in my system?
Mirtazapine Aurobindo usually stays in the body anywhere between four and eight days, depending on the individual's health and dosage amount. Mirtazapine has a half-life of 20 to 40 hours, so most of the drug is out of the body within four days after the last dose.
Is it safe to just stop taking Mirtazapine Aurobindo?
Don't stop taking Mirtazapine Aurobindo without talking to your doctor. Stopping it suddenly can cause withdrawal symptoms. These include anxiety, agitation, shaking, and tingling or electric shock-like feelings.
Does Mirtazapine Aurobindo make me clam down?
Mirtazapine Aurobindo should help you feel calm and relaxed.
Can Mirtazapine Aurobindo affect my fertility?
There's no firm evidence to suggest that taking Mirtazapine Aurobindo affects male or female fertility. Speak to your doctor if you're planning to get pregnant or become pregnant while taking Mirtazapine Aurobindo.
Can Mirtazapine Aurobindo affect my heart rate?
Mirtazapine Aurobindo was associated with a mean increase in heart rate of 3.4 bpm, compared to 0.8 bpm for placebo. The clinical significance of these changes is unknown.
Can Mirtazapine Aurobindo affects my liver?
Mirtazapine Aurobindo is extensively metabolized by the liver. Mirtazapine Aurobindoand venlafaxine are associated with reversible liver injury upon discontinuation of the agent.