NORTRIPTYLINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

NORTRIPTYLINE HYDROCHLORIDE

Composition:

NORTRIPTYLINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 (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

Product summary:

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 (NDC 0093-0810-01), and 500 (NDC 0093-0810-05). 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 (NDC 0093-0811-01), and 500 (NDC 0093-0811-05). 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 (NDC 0093-0812-01), and 500 (NDC 0093-0812-05). Nortriptyline Hydrochloride Capsules, USP 75 mg: #1 capsules with an orange body and an orange cap, imprinted "TEVA" on the cap and "75mg"-"0813" on the body, in bottles of 100 (NDC 0093-0813-01), and 500 (NDC 0093-0813-05). 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). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In Czech Republic By: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. AA 9/2021

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NORTRIPTYLINE HYDROCHLORIDE- nortriptyline hydrochloride capsule
Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
Nortriptyline Hydrochloride (nor trip' ti leen hye'' droe klor' ide)
Capsules
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 followi

Summary of Product characteristics

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
TEVA PHARMACEUTICALS USA, INC.
----------
NORTRIPTYLINE HYDROCHLORIDE CAPSULES, USP
RX ONLY
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
Nortriptyline hydrochloride, USP is 1-propanamine,
3-(10,11-dihydro-5_H_-
dibenzo[_a,d_]cyclohepten-5-ylidene)-_N_-methyl-, hydrochloride.
The structural formula is as follows:
C
H
N•HCl M.W. 299.84
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 additi