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Mirtazapine (Mirtazapine)

Trade Name : Mirtazapine

Amneal Pharmaceuticals of New York LLC

TABLET, ORALLY DISINTEGRATING

Strength 15 mg/1

MIRTAZAPINE

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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 (Mirtazapine) which is also known as Mirtazapine and Manufactured by Amneal Pharmaceuticals of New York LLC. It is available in strength of 15 mg/1 per ml. Read more

Mirtazapine (Mirtazapine) 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

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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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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
  • ONCE-A-DAYn- MIRTAZAPINE n- Orally Disintegrating Tabletsn- ,n- USP
  • Revised: u00a0January 2017
  • Rx Only
  • Suicidality and Antidepressant Drugs
  • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of n- mirtazapinen- u00a0n- on- rally n- dn- isintegrating n- tn- ablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not n- show an increase in the risk of n- suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. n- Mirtazapine orally disintegrating tabletsn- u00a0n- aren- not approved for use in pediatric patients. (See n- Arrayn- , n- Arrayn- , and n- Arrayn- .n- )
  • Mirtazapine orally disintegrating tablets, USPu00a0are 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 empirical formula of CHN. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:
  • Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine orally disintegrating tablets, USP are available for oral administration as an orally disintegrating tablet containing 15 mg, 30u00a0mg or 45 mg of mirtazapine, USP. It disintegrates in the mouth within seconds after placement on the tongue, allowing its contents to be subsequently swallowed with or without water. Mirtazapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial orange flavor, sodium stearyl fumarate and xylitol.
  • No data
  • Mirtazapine orally disintegrating tabletsu00a0u00a0are indicated for the treatment of major depressive disorder.
  • The efficacy of mirtazapine tablets 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 u2013 3rd edition (DSM-III) category of major depressive disorder (see ).
  • 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 orally disintegrating tablets 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 ).
  • No data
  • No data
  • No data
  • No data
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  • Mirtazapine orally disintegrating tablets, USPu00a0are supplied as:
  • 15 mg:nttu00a0u00a0u00a0u00a0u00a0ntWhite to off-white, round, flat-faced, beveled-edge, unscored tablet. Debossed with n on one side and on the other side.Blister package of 30 tablets NDC 0115-1653-08
  • 30 mg:nttu00a0u00a0u00a0u00a0u00a0ntWhite to off-white, round, flat-faced, beveled-edge, unscored tablet. Debossed with n on one side and on the other side. Blister package of 30 tablets NDC 0115-1654-08
  • 45 mg: White to off-white, round, flat-faced, beveled-edge, unscored tablet. Debossed with on one side and on the other side. Blister package of 30 tablets u00a0u00a0u00a0NDC 0115-1656-08
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Protect from light and moisture. Use immediately upon opening individual tablet blister.
  • Manufactured by:
  • Actavis Laboratories FL, Inc.
  • Fort Lauderdale, FL 33314 USA
  • Distributed by:
  • Impax Generics
  • Hayward, CA 94544
  • Revised: January 2017
  • Mirtazapinen- (mirn- -n- TAZn- -n- an- -n- peen)n- Orally Disintegrating Tabletsn- ,n- USP
  • What is the most important information I should know about n- mirtazapine orally disintegrating tabletsn- ?
  • Mirtazapine orally disintegrating tablets and other antidepressant medicines may cause serious side effects, including:
  • 1. Suicidal thoughts or actions:
  • Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
  • Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
  • Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. n- Mirtazapine orally disintegrating tabletsn- may be associated with these serious side effects:
  • 2. n- Manic episodes:
  • 3. n- Decreased White Blood Cells
  • 4. n- Serotonin Syndrome. This condition can be life-threatening and may includen- :
  • 5. Visual problems
  • Only some people are at risk for these problems. You may want to undergo an eyeu00a0examination to see if you are at risk and receive preventative treatment if you are.
  • 6. n- Seizures
  • 7. n- Low salt (sodium) levels in the blood.
  • Elderly people may be at greater risk for this. Symptoms may include:
  • 8. n- Sleepiness. n- u00a0
  • 9. n- Severe skin reactions:
  • 10. n- Severe allergic reactions: trouble breathing, swelling of the face, tongue, eyes or mouth
  • 11. n- Increases in appetite or weight.
  • 12. n- Increased cholesterol and triglyceride levels in your blood
  • Do not stop n- mirtazapine orally disintegrating tabletsn- without first talking to your healthcare provider
  • What aren- u00a0n- mirtazapine orally disintegrating tablets?
  • Mirtazapine orally disintegrating tablets are a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
  • Talk to your healthcare provider if you do not think that your condition is getting better with mirtazapine orally disintegrating tablets treatment.
  • Who should not take n- mirtazapine orally disintegrating tabletsn- ?
  • Do not take n- mirtazapine orally disintegrating tabletsn- :n- u00a0
  • People who take n- mirtazapine orally disintegrating tabletsn- close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
  • What should I tell my healthcare provider before taking mirtazapine orally disintegrating tablets?
  • Before you take mirtazapine orally disintegrating tablets, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines that you taken- u00a0
  • Your healthcare provider or pharmacist can tell you if it is safe to take mirtazapine orally disintegrating tablets with your other medicines. Do not start or stop any medicine while taking mirtazapine orally disintegrating tablets without talking to your healthcare provider first. If you take mirtazapine orally disintegrating tablets, you should not take any other medicines that contain mirtazapine including mirtazapine tablets.
  • How should I take n- mirtazapine orally disintegrating tabletsn- ?
  • The symptoms of a possible overdose may include changes to your heart rhythm (fast, irregular heartbeat) or fainting, which could be symptoms of a life-threatening condition known as Torsades de Pointes.
  • What should I avoid while taking n- mirtazapine orally disintegrating tabletsn- ?
  • What are the possible side effects of n- mirtazapine orally disintegrating tabletsn- ?
  • Mirtazapine orally disintegrating tablets may cause serious side effects:
  • The most common side effects of mirtazapine orally disintegrating tablets include:
  • These are not all the possible side effects of mirtazapine orally disintegrating tablets.
  • Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. u00a0
  • How should I store n- mirtazapine orally disintegrating tabletsn- ?
  • Keep n- mirtazapine orally disintegrating tabletsn- and all medicines out of the reach of children.
  • General information about the safe and effective use of mirtazapine orally disintegrating tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mirtazapine orally disintegrating tablets for a condition for which it was not prescribed. Do not give mirtazapine orally disintegrating tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mirtazapine orally disintegrating tablets that is written for healthcare professionals.
  • What are the ingredients in n- mirtazapine orally disintegrating tabletsn- ?
  • Active ingredient:
  • Inactive ingredients 15n- u00a0n- mgn- ,n- u00a0n- 30 n- mgn- , n- and n- 45 mgn- tablets:
  • For more information about mirtazapine orally disintegrating tablets call 1-800-272-5525 or go to www.actavis.com.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:
  • Actavis Laboratories FL, Inc.
  • Fort Lauderdale, FL 33314 USA
  • Distributed by:
  • Impax Generics
  • Hayward, CA 94544
  • Revised:u00a0January 2017
  • NDC 0115-1653-08Rx onlyONCE-A-DAYMirtazapineOrally Disintegrating Tablets, USP15 mg30 TabletsPHARMACIST: Dispense the enclosedMedication Guide to each patient.Impaxn n
  • NDC 0115-1654-08Rx onlyONCE-A-DAYMirtazapineOrally Disintegrating Tablets, USP30 mg30 TabletsPHARMACIST: Dispense the enclosedMedication Guide to each patient.Impax
  • NDC 0115-1656-08Rx onlyONCE-A-DAYMirtazapineOrally Disintegrating Tablets, USP45 mg30 TabletsPHARMACIST: Dispense the enclosedMedication Guide to each patient.Impax

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