Remeron Soltab (mirtazapine)

An increase in the dosage of mirtazapine may be needed when used concomitantly with a strong cytochrome P-450 (CYP) 3A inducer (e.g., carbamazepine, phenytoin, rifampin). Conversely, a decrease in the dosage of mirtazapine may be needed if the CYP3A inducer is discontinued.

A decrease in the dosage of mirtazapine may be needed when used concomitantly with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin). Conversely, an increase in the dosage of mirtazapine may be needed if the CYP3A4 inhibitor is discontinued.

A decrease in the dosage of mirtazapine may be needed when used concomitantly with cimetidine. Conversely, an increase in the dosage of mirtazapine may be needed if cimetidine is discontinued.

Mirtazapine is administered orally as conventional or orally disintegrating tablets. The drug is administered once daily, usually at bedtime. Since food does not appear to substantially affect GI absorption of mirtazapine, the drug generally can be administered without regard to meals.

Patients receiving mirtazapine orally disintegrating tablets (ODT) should be instructed not to remove a tablet from the blister until just prior to dosing; once removed, it cannot be stored. With dry hands, the blister backing should be peeled completely off the blister. The tablet should then be gently removed and immediately placed on the tongue to dissolve and be swallowed with the saliva without chewing or crushing; administration with liquid is not necessary. In addition, patients should be advised not to break the tablet.

Store mirtazapine tablets and orally disintegrating tablets at 20-25degreesC; excursions permitted between 15-30degreesC.

No dosing information is available for this tab.

No dosing information is available for this tab.

Mirtazapine is metabolized by cytochrome P-450 (CYP) isoenzymes, principally CYP3A; in vitro studies indicate that CYP2D6 and CYP1A2 are also involved.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to mirtazapine, or to any ingredient in its formulations.

*Concurrent or recent (i.e., within 14 days) therapy with monoamine oxidase (MAO) inhibitors, including linezolid and IV methylene blue.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in >=5% of patients receiving mirtazapine include somnolence, increased appetite, weight gain, and dizziness.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

The safety and effectiveness of mirtazapine in pediatric patients for the treatment of major depressive disorder have not been established; mirtazapine is not approved for use in pediatric patients. In 2 placebo-controlled trials, there were insufficient data to establish the safety and efficacy of mirtazapine for the treatment of major depressive disorder in pediatric patients. Additionally, in an 8-week-long clinical trial, 49% of pediatric patients receiving mirtazapine had a weight gain of at least 7% versus 5.7% of pediatric patients receiving placebo. The average weight increase for those in the mirtazapine group was 4 kg compared to a 1-kg weight increase in the placebo group.

An increased risk of suicidal thoughts and behaviors was observed in pediatric patients treated with antidepressants.

A National Pregnancy Registry for Antidepressants is available that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Clinicians are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or by visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregi stry/antidepressants/.

Available evidence has not reliably identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal reproductive studies, no evidence of teratogenic effects were observed when oral mirtazapine was administered during the period of organogenesis at doses up to 20 and 17 times the maximum recommended human dose (MRHD) of 45 mg on a mg/m2 body surface area basis in rats and rabbits, respectively. However, there was an increase in postimplantation loss at 20 times the MRHD in rats. Also, an increase in pup deaths and a decrease in pup birth weights at doses 20 times the MRHD was observed with oral administration of mirtazapine to rats during pregnancy and lactation.

There are risks associated with untreated depression in pregnancy. In a prospective, longitudinal study, women who discontinued antidepressants during pregnancy were more likely to experience a relapse in major depression than women who continued antidepressants. Consider the risk of untreated depression when discontinuing or changing antidepressants during pregnancy and postpartum.

Mirtazapine is present at low levels in human milk with relative infant doses for mirtazapine ranging from 0.6-2.8% of the maternal weight-adjusted dose. There have been no adverse effects on the breast-fed infant reported in most cases of maternal use of mirtazapine. There are no data on the effects of mirtazapine on milk production.

Consider the developmental and health benefits of breast-feeding, the mother's clinical need for mirtazapine, and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

Caution should be used when administering mirtazapine to geriatric patients; dosage selection should be conservative, usually starting at the low end of the dosing range, due to age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.

In clinical trials with mirtazapine, approximately 190 patients were >=65 years of age. Mirtazapine is primarily eliminated by kidney excretion; pharmacokinetic studies showed a decreased clearance of mirtazapine in geriatric patients.

Sedating drugs such as mirtazapine may cause confusion and over-sedation in geriatric patients; geriatric patients may also be at greater risk of developing hyponatremia.

Mirtazapine should be used with caution in geriatric patients. Dosage selection should be conservative in this population, starting at the low end of the dosing range to reflect the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.