NORTRIPTYLINE HYDROCHLORIDE capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

DIRECT RX

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Nortriptyline hydrochloride, USP is 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 (see WARNINGS and DOSAGE 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 (see WARNINGS and DOSAGE AND ADMINISTRATION). Hypersensitivity to Tricyclic Antidepressants Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a

Produkto santrauka:

Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg nortriptyline) are #3, opaque deep green and opaque white capsules imprinted NORTRIPTYLINE and DAN 10 mg supplied in bottles of 100 and 500. Nortriptyline Hydrochloride Capsules USP (equivalent to 25 mg nortriptyline) are #1, opaque deep green and opaque white capsules imprinted NORTRIPTYLINE and DAN 25 mg supplied in bottles of 100, 500 and 1000. Nortriptyline Hydrochloride Capsules USP (equivalent to 50 mg nortriptyline) are #1, opaque white capsules imprinted NORTRIPTYLINE and DAN 50 mg supplied in bottles of 100 and 500. Nortriptyline Hydrochloride Capsules USP (equivalent to 75 mg nortriptyline) are #1, opaque deep green capsules imprinted NORTRIPTYLINE and DAN 75 mg supplied in bottles of 100. Dispense in a tight container, as defined in the USP, with a child-resistant closure. Store at 20°–25°C (68°–77°F). [See USP controlled room temperature.] Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Watson Pharma, Inc. Parsippany, NJ 07054 USA Revised: March 2013 173679-1

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
DIRECT RX
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Nortriptyline Hydrochloride Capsules, USP
Antidepressant Medicines, Depression and other Serious Mental
Illnesses,
and Suicidal Thoughts or Actions
Read the Medication Guide that comes with you 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 new, worse, or worry you:
tho

Prekės savybės

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
DIRECT RX
----------
NORTRIPTYLINE
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).
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:
[The structural formula for Nortriptyline]
Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg, 25 mg,
50 mg and 75 mg
Nortriptyline), for oral administration, contain the following
inactive ingredients: colloidal silicon
dioxide, magnesium stearate, pregelatinized starch and sodium lauryl
sulfate. The 10 mg, 25 mg, 50 mg
and 75 mg capsule shells contain: gelatin, methylparaben,
propylparaben, sodium lauryl sulfate and
titanium dioxide. They may also contain: ben