Mirtazapine (Remeron)

Trade Name : REMERON

Organon USA Inc.

TABLET, FILM COATED

Strength 15 mg/1

MIRTAZAPINE

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Mirtazapine (Remeron) which is also known as REMERON and Manufactured by Organon USA Inc.. It is available in strength of 15 mg/1 per ml. Read more

Mirtazapine (Remeron) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors . REMERON/REMERONSolTab is not approved for use in pediatric patients n
  • WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
  • See full prescribing information for complete boxed warning.
  • Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. REMERON/REMERONSolTab is not approved for use in pediatric patients. (, )
  • REMERON/REMERONSolTab are indicated for the treatment of major depressive disorder (MDD) in adults .
  • REMERON/REMERONSolTab is indicated for the treatment of major depressive disorder (MDD) in adults. ()
  • No data
  • Starting dose: 15-mg once daily; may increase up to maximum recommended dose of 45 mg once daily. ()
  • Administer orally once daily, preferably in the evening prior to sleep. ()
  • Administer REMERONSolTab immediately after removal from blister pack. ()
  • Reduce dose gradually when discontinuing REMERON/REMERONSolTab. (, )
  • REMERON is supplied as:
  • REMERONSolTab is supplied as:
  • Tablets
  • Orally disintegrating tablets
  • REMERON/REMERONSolTab is contraindicated in patients:
  • Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of stopping MAOIs. (, , )
  • Known hypersensitivity to mirtazapine or any of the excipients in REMERON/REMERONSolTab. ()
  • No data
  • Agranulocytosis
  • Serotonin Syndrome
  • Angle-Closure Glaucoma
  • QTc Prolongation
  • Increased Appetite/Weight Gain
  • Somnolence
  • Activation of Mania/Hypomania
  • Seizures
  • Elevated Cholesterol/Triglycerides
  • Hyponatremia
  • Transaminase Elevations
  • The following adverse reactions are described in more detail in other sections of the prescribing information:
  • Most common adverse reactions (u22655% or greater and twice placebo) were somnolence, increased appetite, weight gain, and dizziness. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Table 5 includes clinically important drug interactions with REMERON/REMERONSolTab n
  • Strong CYP3A
  • Strong CYP3A inhibitors
  • Cimetidine:
  • Warfarin
  • No data
  • Pregnancy
  • Nursing Mothers
  • Geriatric Use
  • Renal impairment:
  • Hepatic impairment:
  • Patients with Phenylketonuria
  • No data
  • REMERON and REMERONSolTab contain mirtazapine. Mirtazapine 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][2] benzazepine and has the empirical formula of CHN. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture:
  • Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water.
  • REMERON is available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine Each tablet contains the following inactive ingredients: colloidal silicon dioxide anhydrous, corn starch, ferric oxide (yellow), hydroxypropyl cellulose, hypromellose, magnesium stearate, lactose monohydrate, polyethylene glycol 8000, and titanium dioxide. The 30 mg tablets also contain ferric oxide (red).
  • REMERONSolTab is available for oral administration as an orally disintegrating tablet containing 15, 30, or 45 mg of mirtazapine. REMERONSolTab also contains the following inactive ingredients: aspartame, citric acid anhydrous fine granular, crospovidone, hypromellose, magnesium stearate, mannitol, granular mannitol 2080, microcrystalline cellulose, natural and artificial orange flavor, polymethacrylate (Eudragit E100), povidone, sodium bicarbonate, and sugar spheres (composed of starch and sucrose).
  • No data
  • No data
  • The efficacy of REMERON as a treatment for major depressive disorder was established in 4 placebo-controlled, 6-week trials in adult outpatients meeting DSM-III criteria for major depressive disorder. Patients were titrated with REMERON from a dose range of 5 mg to 35 mg/day. The mean mirtazapine dose for patients who completed these 4 studies ranged from 21 to 32 mg/day. Overall, these studies demonstrated REMERON to be superior to placebo on at least 3 of the following 4 measures: 21-Item Hamilton Depression Rating Scale (HDRS) total score; HDRS Depressed Mood Item; CGI Severity score; and Montgomery and Asberg Depression Rating Scale (MADRS). Superiority of REMERON over placebo was also found for certain factors of the HDRS, including anxiety/somatization factor and sleep disturbance factor.
  • Examination of age and gender subsets of the population did not reveal any differential responsiveness on the basis of these subgroupings.
  • In a longer-term study, patients meeting (DSM-IV) criteria for major depressive disorder who had responded during an initial 8 to 12 weeks of acute treatment on REMERON were randomized to continuation of REMERON or placebo for up to 40 weeks of observation for relapse. Response during the open phase was defined as having achieved a HAM-D 17 total score of u22648 and a CGI-Improvement score of 1 or 2 at 2 consecutive visits beginning with week 6 of the 8 to 12 weeks in the open-label phase of the study. Relapse during the double-blind phase was determined by the individual investigators. Patients receiving continued REMERON treatment experienced significantly lower relapse rates over the subsequent 40 weeks compared to those receiving placebo. This pattern was demonstrated in both male and female patients.
  • REMERON tablets are supplied as:
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Distributed by: Merck Sharp & Dohme Corp., a subsidiary of n Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 2020 Merck Sharp & Dohme B.V., a subsidiary of n All rights reserved.
  • uspi-mk8246-t-tod-2003r014
  • No data
  • NDC 0052-0109-30
  • REMERONn (mirtazapine)Tablets
  • 45 mg
  • Dispense the accompanyingMedication Guide to each patient.
  • Rx only
  • 30 Tablets
  • NDC 0052-0107-30
  • REMERONn (mirtazapine)Tablets
  • 30 mg
  • Dispense the accompanyingMedication Guide to each patient.
  • Rx only
  • 30 Tablets
  • NDC 0052-0105-30
  • REMERONn (mirtazapine)Tablets
  • 15 mg
  • Dispense the accompanyingMedication Guide to each patient.
  • Rx only
  • 30 Tablets
  • NDC 0052-4364-01
  • REMERONn (mirtazapine)Tablets
  • 15 mg
  • Dispense the accompanyingMedication Guide to each patient.
  • Rx only
  • 30 Tablets
  • NDC 0052-4365-01
  • REMERONn (mirtazapine)Tablets
  • 30 mg
  • Dispense the accompanyingMedication Guide to each patient.
  • Rx only
  • 30 Tablets
  • NDC 0052-0106-30
  • 30 Tablets
  • ONCE-A-DAY REMERONSolTabn (mirtazapine) Orally Disintegrating Tablets
  • Rx only
  • 15 mg
  • Dispense the accompanying Medication Guide to each patient.Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889, USA
  • Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116, USA
  • NDC 0052-0108-30
  • 30 Tablets
  • ONCE-A-DAY REMERONSolTabn (mirtazapine) Orally Disintegrating Tablets
  • Rx only
  • 30 mg
  • Dispense the accompanying Medication Guide to each patient. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889, USA
  • Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116, USA
  • NDC 0052-0110-30
  • 30 Tablets
  • ONCE-A-DAY REMERONSolTabn (mirtazapine) Orally Disintegrating Tablets
  • Rx only
  • 45 mg
  • Dispense the accompanying Medication Guide to each patient. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889, USA
  • Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116, USA

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