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:

Clinical Solutions Wholesale, LLC

INN (International Name):

NORTRIPTYLINE HYDROCHLORIDE

Composition:

NORTRIPTYLINE 10 mg

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. 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 (

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 NDC 51672-4001-6 Bottles of 90 NDC 51672-4001-5 Bottles of 100 NDC 51672-4001-1 Bottles of 500 NDC 51672-4001-2 25 mg: Opaque ivory cap and body, imprinted "TARO" on the cap and "NTP25" on the body. Bottles of 30 NDC 51672-4002-6 Bottles of 60 NDC 51672-4002-4 Bottles of 90 NDC 51672-4002-5 Bottles of 100 NDC 51672-4002-1 Bottles of 500 NDC 51672-4002-2 50 mg: Opaque dark green cap with an opaque white body, imprinted "TARO" on the cap and "NTP50" on the body. Bottles of 30 NDC 51672-4003-6 Bottles of 90 NDC 51672-4003-5 Bottles of 100 NDC 51672-4003-1 Bottles of 500 NDC 51672-4003-2 75 mg: Opaque dark green cap and body, imprinted "TARO" on the cap and "NTP75" on the body. Bottles of 30 NDC 51672-4004-6 Bottles of 90 NDC 51672-4004-5 Bottles of 100 NDC 51672-4004-1 Bottles of 500 NDC 51672-4004-2 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 HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
Clinical Solutions Wholesale, LLC
----------
MEDICATION GUIDE
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 fol

Summary of Product characteristics

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
CLINICAL SOLUTIONS WHOLESALE, LLC
----------
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:
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, D&C Yellow #10 (aluminum lake), D&C Yellow #10, FD&C Blue #1
(aluminum lake), FD&C
Blue #2 (aluminum lake), FD&C Green #3