Mirtazapine description, usages, side effects, indications, overdosage, supplying and lots more!

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Mirtazapine

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

Suicidality and Antidepressant Drugs
Warnings: Clinical Worsening and Suicide RiskPrecautions: Information for PatientsPrecautions: Pediatric Use

MIRTAZAPINE DESCRIPTION


Mirtazapine




CLINICAL PHARMACOLOGY


PHARMACODYNAMICS








PHARMACOKINETICS






Special Populations

PRECAUTIONSDOSAGE AND ADMINISTRATION

PRECAUTIONS

Pharmacokinetics



PRECAUTIONSDOSAGE AND ADMINISTRATION

PRECAUTIONSDOSAGE AND ADMINISTRATION

Clinical Trials Showing Effectiveness




INDICATIONS & USAGE

CLINICAL PHARMACOLOGY


CLINICAL PHARMACOLOGY

MIRTAZAPINE CONTRAINDICATIONS



WARNINGS

Clinical Worsening and Suicide Risk










Agranulocytosis


MAO Inhibitors


PRECAUTIONS

General

Somnolence
Information for Patients

Dizziness


Increased Appetite/Weight Gain
PRECAUTIONS: Pediatric Use

Cholesterol/Triglycerides


Transaminase Elevations
CLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATION

Activation of Mania/Hypomania


Seizure


Use in Patients with Concomitant Illness


CLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATION

INFORMATION FOR PATIENTS



















LABORATORY TESTS



DRUG INTERACTIONS

CLINICAL PHARMACOLOGY









CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY









PREGNANCY




NURSING MOTHERS



PEDIATRIC USE

BOX WARNINGWARNINGSClinical Worsening and Suicide Risk
PRECAUTIONSIncreased Appetite/Weight Gain

GERIATRIC USE

CLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATION

MIRTAZAPINE ADVERSE REACTIONS

Associated with Discontinuation of Treatment



Commonly Observed Adverse Events in U.S. Controlled Clinical Trials



Adverse Events Occurring at an Incidence of 1% or More Among Mirtazapine Treated Patients



ECG Changes


Other Adverse Events Observed During the Premarketing Evaluation of Mirtazapine

WARNINGSPRECAUTIONS













Other Adverse Events Observed During Postmarketing Evaluation of Mirtazapine


DRUG ABUSE AND DEPENDENCE

Controlled Substance Class


Physical and Psychological Dependence


OVERDOSAGE

Human Experience


Overdose Management





DOSAGE & ADMINISTRATION

Initial Treatment



Elderly and Patients with Renal or Hepatic Impairment
PRECAUTIONSCLINICAL PHARMACOLOGY

Maintenance/Extended Treatment
CLINICAL PHARMACOLOGY

Switching Patients To or From a Monoamine Oxidase Inhibitor


HOW SUPPLIED














SPL MEDGUIDE



  • ●     all risks and benefits of treatment with antidepressant medicines
  • ●     all treatment choices for depression or other serious mental illness




  • ●               Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • ●               Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • ●               Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

  • ●     thoughts about suicide or dying
  • ●     attempts to commit suicide
  • ●     new or worse depression
  • ●     new or worse anxiety
  • ●     feeling very agitated or restless
  • ●     panic attacks
  • ●     trouble sleeping (insomnia)
  • ●     new or worse irritability
  • ●               acting aggressive, being angry, or violent
  • ●               acting on dangerous impulses
  • ●     an extreme increase in activity and talking (mania)
  • ●     other unusual changes in behavior or mood

  • ●     Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • ●     Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • ●     Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • ●     Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • ●     Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.










PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Mirtazapine

Mirtazapine

Mirtazapine

Mirtazapine TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-371(NDC:0591-1118)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MIRTAZAPINE Mirtazapine 30 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
cellulose, microcrystalline
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
polyethylene glycol
polysorbate 80
titanium dioxide
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
yellow 13 mm WPI;1118 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-371-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076336 2011-07-12


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Be sure to consult your doctor before taking any medication!
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