Drug Catalog - Product Detail
MIRTAZAPINE 30MG TAB 30CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 57664-0500-83 | SUN PHARMACEUTICALS | 30 | 30MG | TABLET |
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Description
DESCRIPTION Mirtazapine tablets, USP are an orally administered drug. Mirtazapine, USP has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c] benzazepine and has the molecular formula of C 17 H 19 N 3 . Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture: Structural Formula: Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets, USP are supplied as scored tablets containing 15 mg or 30 mg of mirtazapine, USP, and unscored tablets, USP containing 7.5 mg or 45 mg of mirtazapine, USP. Each tablet contains lactose monohydrate, corn starch, pregelatinized starch, colloidal silicon dioxide, magnesium stearate. Opadry 20A colorants contain the following inactive ingredients: The 7.5 mg and 15 mg tablets are coated with a yellow colored film (opadry 20A52767) that is made of iron oxide yellow, hydroxypropyl cellulose, hypromellose 2910 and titanium dioxide. The 30 mg tablets are coated with a reddish brown colored film (opadry 20A56666) that is made of iron oxides yellow, red and black, hydroxypropyl cellulose, hypromellose 2910 and titanium dioxide. The 45 mg tablets are coated with a white colored film (opadry 20A58916) that is made of hydroxypropyl cellulose, hypromellose 2910 and titanium dioxide. Mirtazapine Label
How Supplied
HOW SUPPLIED Mirtazapine tablets, USP are supplied as: 7.5 mg Tablets - Yellow colored, circular, biconvex, film coated tablets with “C” debossed on one side and plain on the other side. 7.5 mg Bottles of 30 NDC 57664-510-83 7.5 mg Bottles of 100 NDC 57664-510-88 7.5 mg Bottles of 500 NDC 57664-510-13 7.5 mg Bottles of 1000 NDC 57664-510-18 15 mg Tablets - Yellow colored, oval, biconvex, film coated tablets with “499” debossed on one side and scored on the other side. 15 mg Bottles of 30 NDC 57664-499-83 15 mg Bottles of 100 NDC 57664-499-88 15 mg Bottles of 500 NDC 57664-499-13 15 mg Bottles of 1000 NDC 57664-499-18 30 mg Tablets - Reddish-brown colored, oval, biconvex, film coated tablets with “500” debossed on one side and scored on the other side. 30 mg Bottles of 30 NDC 57664-500-83 30 mg Bottles of 100 NDC 57664-500-88 30 mg Bottles of 500 NDC 57664-500-13 30 mg Bottles of 1000 NDC 57664-500-18 45 mg Tablets - White to off-white colored, oval, biconvex, film coated tablets with “501” debossed on one side and plain on the other side. 45 mg Bottles of 30 NDC 57664-501-83 45 mg Bottles of 100 NDC 57664-501-88 45 mg Bottles of 500 NDC 57664-501-13 45 mg Bottles of 1000 NDC 57664-501-18 Storage Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Rx only CARACO PHARMACEUTICAL LABORATORIES, LTD. DETROIT, MI 48202 C.S.No. 5447T09
Indications & Usage
INDICATIONS AND USAGE Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine tablets, USP in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders - 3rd edition (DSM-lll) 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 five of the following nine 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 8–12 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 re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY ).
Dosage and Administration
DOSAGE AND ADMINISTRATION Initial Treatment The recommended starting dose for mirtazapine tablet, 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 tablets, USP in the treatment of major depressive disorder, the effective dose range was generally 15-45 mg/day. While the relationship between dose and satisfactory response in the treatment of major depressive disorder for mirtazapine tablet, USP 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 tablet, USP has an elimination half-life of approximately 20-40 hours; therefore, dose changes should not be made at intervals of less than one to two 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 tablet, USP 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 tablet, USP 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 ). Maintenance/Extended Treatment 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 8–12 weeks of initial treatment at a dose of 15–45 mg/day (see CLINICAL PHARMACOLOGY ). Based on these limited data, it is unknown whether or not the dose of mirtazapine tablet, USP 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 Patients To or From a Monoamine Oxidase Inhibitor At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with mirtazapine tablet, USP. In addition, at least 14 days should be allowed after stopping mirtazapine tablet, USP before starting an MAOI.