What is Mirtazapine and how is it used?
Mirtazapine tablets, USP is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
Talk to your healthcare provider if you do not think that your condition is getting better with Mirtazapine tablets, USP treatment.
What are the possible side effects of Mirtazapine tablets, USP?
Mirtazapine tablets, USP may cause serious side effects:
- See “What is the most important information I should know about Mirtazapine tablets, USP?
The most common side effects of Mirtazapine tablets, USP include:
These are not all the possible side effects of Mirtazapine tablets, USP.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA-1088.
How should I store Mirtazapine tablets, USP?
- Store Mirtazapine tablets, USP at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep Mirtazapine tablets, USP away from light.
- Keep Mirtazapine tablets, USP bottle closed tightly.
Keep Mirtazapine tablets, USP and all medicines out of the reach of children.
General information about the safe and effective use of Mirtazapine tablets, USP
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Mirtazapine tablets, USP for a condition for which it was not prescribed. Do not give Mirtazapine tablets, USP to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Mirtazapine tablets, USP that is written for healthcare professionals.
Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder.
The efficacy of mirtazapine 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 (see CLINICAL PHARMACOLOGY).
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 in hospitalized depressed patients has not been adequately studied.
The efficacy of mirtazapine, USP 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, USP for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY).
DOSAGE AND ADMINISTRATION
The recommended starting dose for Mirtazapine tablets, USP is 15 mg/day, administered in a single dose, preferably in the evening prior to sleep. In the controlled clinical trials establishing the efficacy of mirtazapine in the treatment of major depressive disorder, the effective dose range was generally 15 to 45 mg/day. While the relationship between dose and satisfactory response in the treatment of major depressive disorder for mirtazapine has not been adequately explored, patients not responding to the initial 15-mg dose may benefit from dose increases up to a maximum of 45 mg/day. Mirtazapine has an elimination half-life of approximately 20 to 40 hours; therefore, dose changes should not be made at intervals of less than 1 to 2 weeks in order to allow sufficient time for evaluation of the therapeutic response to a given dose.
Elderly And Patients With Renal Or Hepatic Impairment
The clearance of mirtazapine is reduced in elderly patients and in patients with moderate to severe renal or hepatic impairment. Consequently, the prescriber should be aware that plasma mirtazapine levels may be increased in these patient groups, compared to levels observed in younger adults without renal or hepatic impairment (see PRECAUTIONS and CLINICAL PHARMACOLOGY).
It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of Mirtazapine tablets, USP has demonstrated that its efficacy in major depressive disorder is maintained for periods of up to 40 weeks following 8 to 12 weeks of initial treatment at a dose of 15 to 45 mg/day (see CLINICAL PHARMACOLOGY). Based on these limited data, it is unknown whether or not the dose of mirtazapine needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
Switching A Patient To Or From A Monoamine Oxidase Inhibitor (MAOI) Intended To Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Mirtazapine tablets, USP. Conversely, at least 14 days should be allowed after stopping mirtazapine before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).
Use of Mirtazapine With Other MAOIs, Such as Linezolid or Methylene Blue Do not start mirtazapine in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS). In some cases, a patient already receiving therapy with mirtazapine may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, mirtazapine should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with mirtazapine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS). The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with mirtazapine is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
Discontinuation of Mirtazapine Treatment Symptoms associated with the discontinuation or dose reduction of Mirtazapine tablets, USP have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or during dosage reduction. A gradual reduction in the dose over several weeks, rather than abrupt cessation, is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient’s clinical response (see PRECAUTIONS and ADVERSE REACTIONS).
Information for Patients Patients should be advised that taking mirtazapine can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.
Storage Store at 20° to 25°C (68° to 77°F); excursions permitted 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Protect from light and moisture.