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

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Nortriptyline Hydrochloride

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

NORTRIPTYLINE HYDROCHLORIDE DESCRIPTION


Nortriptyline Hydrochloride





CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY


INDICATIONS & USAGE

INDICATIONS AND USAGE


NORTRIPTYLINE HYDROCHLORIDE CONTRAINDICATIONS

CONTRAINDICATIONS




WARNINGS

Clinical Worsening and Suicide Risk















Use in Pregnancy


PRECAUTIONS

Information for Patients



Clinical Worsening and Suicide Risk







DRUG INTERACTIONS

Drug Interactions









PEDIATRIC USE

Pediatric Use
BOX WARNINGWARNINGSClinical Worsening and Suicide Risk

GERIATRIC USE

Geriatric Use
DOSAGE AND ADMINISTRATION

NORTRIPTYLINE HYDROCHLORIDE ADVERSE REACTIONS

ADVERSE REACTIONS












OVERDOSAGE

OVERDOSAGE


Manifestations

ADVERSE REACTIONS

Management










Psychiatric Follow


Pediatric Management


DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION






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.


































INACTIVE INGREDIENT

INACTIVE INGREDIENTS:
COLLOIDAL SILICON DIOXIDE

MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
GELATIN
METHYLPARABEN
PROPYLPARABEN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
BENZYL ALCOHOL

BUTYLPARABEN
EDETATE CALCIUM DISODIUM
SILICON DIOXIDE
SODIUM PROPIONATE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
STARCH, CORN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Nortriptyline Hydrochloride

Nortriptyline Hydrochloride

Nortriptyline Hydrochloride

Nortiptyline Hydrochloride CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-259(NDC:0591-5787)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE 25 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
GELATIN
METHYLPARABEN
PROPYLPARABEN
SODIUM LAURYL SULFATE
titanium dioxide
BENZYL ALCOHOL
BUTYLPARABEN
edetate calcium disodium
sodium propionate
D&C YELLOW NO. 10
FD&C BLUE NO. 1
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
green 19 mm NORTRIPTYLINE;DAN;25;MG CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-259-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073554 2011-03-30


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Be sure to consult your doctor before taking any medication!
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