Mirtazapine Tablets

1. Remeron (mirtazapine) is an antidepressant for depression. It is effective for symptoms such as anhedonia, psychomotor inhibition, poor sleep (early awakening) and weight loss. It can also be used for other symptoms such as loss of interest in things, suicidal tendencies and mood swings (good at night, bad in the morning). 2. Remeron takes effect one to two weeks after medication. 3. Mirtazapine, the active ingredient of Remeron, is a presynaptic alpha;2 receptor antagonist acting on the central nervous system, which can enhance adrenergic nerve conduction. It regulates the function of serotonin by interacting with the central 5-hydroxytryptamine receptors (5-HT2, 5-HT3). Both optical enantiomers of mirtazapine have antidepressant activity. The left-handed isoform blocks alpha;2 and 5-HT2 receptors, and the right-handed isoform blocks 5-HT3 receptors. The anti-histamine receptor (H1) property of mirtazapine plays a sedative role. The drug is well tolerated, has almost no anticholinergic effect, and its therapeutic dose has no effect on the cardiovascular system.

Mirtazapine

The onset of depression.

1. The tablets should be taken orally, with water if necessary, and should be swallowed rather than chewed. 2. Adults: The effective dose is usually 15-45 mg per day. The initial dose of treatment should be 15 or 30 mg (a higher dose should be taken at night). Patients with impaired liver and kidney function may have a reduced clearance of mirtazapine, and such patients should be careful when using Remeron. The half-life of mirtazapine, the active ingredient in Remeron, is 20 to 40 hours, so the drug is suitable for once-daily administration (preferably before bedtime). The drug can also be taken in divided doses (such as once in the morning and once in the evening). 3. Patients should take the drug continuously, preferably gradually stopping the drug four to six months after the symptoms have completely disappeared. When the dose is appropriate, the drug should have a significant effect within two to four weeks. If the effect is not significant enough, the dose can be increased to the maximum dose. However, if there is still no effect after the dose is increased for two to four weeks, the drug should be discontinued.

1. Because patients with depression often show symptoms caused by the disease itself, it is not possible to distinguish which adverse reactions are caused by the use of Remeron. 2. The most common adverse reactions reported, with an incidence of more than 5% in randomized placebo-controlled clinical trials of Remeron (see below), include somnolence, sedation, dry mouth, weight gain, increased appetite, dizziness and fatigue. The adverse reactions of Remeron have been evaluated in randomized placebo-controlled trials conducted in all patients (including those with conditions other than major depression). The meta-analysis included 20 clinical trials with a planned treatment duration of up to 12 weeks, with 1501 patients (134 person-years) receiving treatment with a maximum dose of 60 mg/day of mirtazapine and 850 patients (79 person-years) receiving placebo. The extension periods of these trials were excluded to maintain comparability with placebo treatment.

1. Patients who are allergic to mirtazapine and any of the ingredients of this product are contraindicated. 2. Concomitant use of mirtazapine and monoamine oxidase (MAO) inhibitors is prohibited (see [Drug Interactions]).

Precautions for children: Since the effectiveness and safety of this drug for children have not been confirmed, it is not recommended for children to use this drug. Precautions for pregnancy and lactation: 1. There are not enough clinical trial results to evaluate the effect of Remeron on pregnancy. In animal experiments, this drug has no teratogenic side effects such as toxicity to the embryo. 2. Although only a very small amount of drug ingredients can be secreted from the milk of animals, due to the lack of clinical trial data, it is not recommended for lactating patients to take this drug. Precautions for the elderly: The dosage is the same as that for adults, and the dosage should be gradually increased under the close observation of a doctor in order to achieve a satisfactory therapeutic effect.

1. In vitro data indicate that mirtazapine is a very weak competitive inhibitor of cytochrome P450 enzymes CYPIA2, CYP2D6, and CYP3A. Mirtazapine is metabolized by CYP2D6 and CYP3A4 and a small amount of CYPIA2. Interaction studies in healthy volunteers showed that the pharmacokinetics of mirtazapine at steady state were not affected by paroxetine (a CYP2D6 inhibitor). The effect of CYP3A4 inhibitors on the pharmacokinetics of mirtazapine in vivo is unknown. Caution should be exercised when strong CYP3A4 inhibitors, such as HIV protease inhibitors, cyclopentadiene antifungal agents, erythromycin, and nefazodone are used simultaneously with mirtazapine. Carbamazepine (an inducer of CYP3A4) increases the clearance of mirtazapine by approximately 2 times, resulting in a decrease in plasma levels of approximately 45-60%. When carbamazepine or other inducers of drug metabolites (such as rifampicin or phenytoin) are used with mirtazapine, the dose of mirtazapine should be increased, and if the inducer is discontinued, the dose of mirtazapine should be reduced. 2. When used with cimetidine, the bioavailability of mirtazapine will increase by more than 50%. When cimetidine is used at the beginning of treatment, the dose of mirtazapine should be reduced, and when cimetidine is used at the end of treatment, the dose of mirtazapine should be increased. 3. In in vivo studies of drug interactions, mirtazapine had no effect on the pharmacokinetics of risperidone or paroxetine (CYP2D6 medium), carbamazepine (CYP3A4 medium), amitriptyline and cimetidine. No clinically relevant effects or changes in the pharmacokinetics of mirtazapine and lithium were found when humans used mirtazapine and lithium at the same time. Mirtazapine can aggravate the inhibitory effect of alcohol on the central nervous system, so drinking should be prohibited during treatment. 4. Remeron should not be used in patients who have been taking monoamine oxidase inhibitors within two weeks or are currently taking them. 5. Mirtazapine may aggravate the sedative effect of benzodiazepines; caution should be exercised when benzodiazepines are used in combination with Remeron.

Store in a dry place away from light at a temperature below 30°C.

30 mg