NORTRIPTYLINE HCI capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct_Rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nortriptyline hydrochloride 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 possibility. My

Product summary:

Nortriptyline Hydrochloride Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are as follows: 10 mg: Opaque light green cap and body, imprinted "TARO" on the cap and "NTP10" on the body. Bottles of 30 Bottles of 90 Bottles of 100 Bottles of 500 25 mg: Opaque ivory cap and body, imprinted "TARO" on the cap and "NTP25" on the body. Bottles of 30 Bottles of 60 Bottles of 90 Bottles of 100 Bottles of 500 50 mg: Opaque dark green cap with an opaque white body, imprinted "TARO" on the cap and "NTP50" on the body. Bottles of 30 Bottles of 90 Bottles of 100 Bottles of 500 75 mg: Opaque dark green cap and body, imprinted "TARO" on the cap and "NTP75" on the body. Bottles of 30 Bottles of 90 Bottles of 100 Bottles of 500 Store and Dispense Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP) with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NORTRIPTYLINE HCI- NORTRIPTYLINE HCI 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.
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?
1.
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers, and young
adults within the first few months of treatment.
2.
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.
3.
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:
thoughts about suicide or dying
attempts to commit suicide
new or worse depression
new or worse anxiety
feeling very agitated or

Summary of Product characteristics

NORTRIPTYLINE HCI- NORTRIPTYLINE HCI CAPSULE
DIRECT_RX
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NORTRIPTYLINE HCL
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).
Rx only
Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel
2624761
Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Revised: June 2019
70997-0619-8
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:
[Chemical Structure]
C19H21N∙HCl MW = 299.84
Each capsule, for oral administration, contains nortriptyline
hydrochloride equivalent to
10 mg, 25 mg, 50 mg, and 75 mg of nortriptyline hydrochloride USP.
In addition, each capsule contains the following inactive ingredients:
black iron oxide,
colloidal silicon dioxide,