Mirtazapine 15 mg

INDICATIONS AND USAGE 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 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY ).

Aphena Pharma Solutions - Tennessee, LLC

FDA Reported Adverse Reactions
`[1] dyspnoea` `[2] drug ineffective` `[3] fatigue` `[4] nausea` `[5] headache` `[6] pain` `[7] diarrhoea` `[8] off label use` `[9] dizziness` `[10] pneumonia`

3 years ago

OVAL YELLOW 0 8 A

3 years ago

0 8 A OVAL YELLOW

HOW SUPPLIED Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Mirtazapine tablets, USP are supplied as: 7.5 mg Tablets – white, biconvex, capsule shaped film coated tablets with “11” debossed on one side and “A” debossed on the other side. Bottles of 30 NDC 13107-001-30 Bottles of 60 NDC 13107-001-60 Bottles of 90 NDC 13107-001-90 Bottles of 100 NDC 13107-001-01 Bottles of 500 NDC 13107-001-05 15 mg Tablets – yellow, biconvex, capsule shaped film coated tablets with a score line in between “0” and “8” on one side and “A” debossed on the other side. Bottles of 30 (120 cc container) NDC 13107-031-30 Bottles of 30(30 cc container) NDC 13107-031-34 Bottles of 60 NDC 13107-031-60 Bottles of 90 NDC 13107-031-90 Bottles of 100 NDC 13107-031-01 Bottles of 500 NDC 13107-031-05 30 Unit-of-use packaging NDC 13107-031-32 30 mg Tablets – Reddish brown, biconvex, capsule shaped film coated tablets with a score line in between “0” and “9” on one side and “A” debossed on the other side. Bottles of 30 (120 cc container) NDC 13107-003-30 Bottles of 30(30 cc container) NDC 13107-003-34 Bottles of 60 NDC 13107-003-60 Bottles of 90 NDC 13107-003-90 Bottles of 100 NDC 13107-003-01 Bottles of 500 NDC 13107-003-05 30 Unit-of-use packaging NDC 13107-003-32 45 mg Tablets – white, biconvex, capsule shaped film coated tablets with “10” debossed on one side and “A” debossed on the other side. Bottles of 30(30 cc container) NDC 13107-032-34 Bottles of 60 NDC 13107-032-60 Bottles of 90 NDC 13107-032-90 Bottles of 100 NDC 13107-032-01 Bottles of 500 NDC 13107-032-05 30 Unit-of-use packaging NDC 13107-032-32 Storage Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [ see USP Controlled Room Temperature] . Protect from light and moisture. Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 Revised: 01/2013

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