NORTRIPTYLINE HYDROCHLORIDE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

NORTRIPTYLINE HYDROCHLORIDE (UNII: 00FN6IH15D) (NORTRIPTYLINE - UNII:BL03SY4LXB)

Tilgjengelig fra:

DIRECT RX

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states. - Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with nortriptyline hydrochloride or within 14 days of stopping treatment with nortriptyline hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of nortriptyline hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (seeWARNINGSandDOSAGE AND ADMINISTRATION). Starting nortriptyline hydrochloride in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (seeWARNINGS and DOSAGE AND ADMINISTRATION). Hypersensitivity to Tricyclic Antidepressants Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a pos

Produkt oppsummering:

Nortriptyline hydrochloride capsules USP, equivalent to 10 mg, 25 mg, 50 mg or 75 mg base, are available as follows: Nortriptyline hydrochloride capsules USP, 10 mg: #3 capsules with a white body and an orange cap, imprinted "TEVA" on the cap and "10mg"-"0810" on the body, in bottles of 100, and 500. Nortriptyline hydrochloride capsules USP, 25 mg: #4 capsules with a white body and an orange cap, imprinted "TEVA"-"TEVA" on the cap and "25mg"-"0811" on the body, in bottles of 100, and 500. Nortriptyline hydrochloride capsules USP, 50 mg: #1 capsules with a white body and a white cap, imprinted "TEVA" on the cap and "50mg"-"0812" on the body, in bottles of 100, and 500. Store and Dispense Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense contents in a tight container as defined in the USP, with a child-resistant closure (as required). TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. X 8/2014

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
DIRECT RX
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SPL MEDGUIDE SECTION
Nortriptyline Hydrochloride Capsules USP
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
Rx only
Read the Medication Guide that comes with your or your family
member’s antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant medicines.
Talk to your, or your family member’s, healthcare provider about:
all risks and benefits of treatment with antidepressant medicines all
treatment choices for depression or
other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers, and
young adults within the first few months of treatment. Depression and
other serious mental illnesses are
the most important causes of suicidal thoughts and actions. Some
people may have a particularly high risk
of having suicidal thoughts or actions. These include people who have
(or have a family history of)
bipolar illness (also called manic-depressive illness) or suicidal
thoughts or actions. How can I watch for
and try to prevent suicidal thoughts and actions in myself or a family
member? 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.
Call a healthcare provider right away if you or your family member has
any of the following symptoms,
especially if they are

Preparatomtale

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
DIRECT RX
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NORTRIPTYLINE HYDROCHLORIDE
BOXED WARNING SECTION
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 nortriptyline
hydrochloride or any other antidepressant in a child, adolescent, or
young adult must balance this
risk with the clinical need. Short-term studies did not show an
increase in the risk of 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. Nortriptyline hydrochloride is not approved for
use in pediatric patients (see
WARNINGS, Clinical Worsening and Suicide Risk; PRECAUTIONS,
Information for Patients;
and PRECAUTIONS, Pediatric Use).
DESCRIPTION SECTION
Nortriptyline hydrochloride, USP is 1-propanamine,
3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-
ylidene)-N-methyl-, hydrochloride.
The structural formula is as follows:
Nortriptyline hydrochloride, USP is a white to off-white powder,
having a slight, characteristic odor. It
is soluble in water and in chloroform; sparingly soluble in methanol;
and practically insoluble in most
organic solvents.
Each capsule, for oral administration, contains nortriptyline
hydrochloride, USP equivalent to 10 mg, 25
mg, 50 mg or 75 mg nortriptyline.
In addition, each capsule contains the following inactiv