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:

Bryant Ranch Prepack

INN (International Name):

NORTRIPTYLINE HYDROCHLORIDE

Composition:

NORTRIPTYLINE 25 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 (see WARNINGS and DOSAGE AND ADMINISTRATION ). Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. Nortriptyline hydrochloride is contraindicated during the acute recovery period a

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. NDC 71335-0426-1 30 CAPSULE in a BOTTLE NDC 71335-0426-2 60 CAPSULE in a BOTTLE NDC 71335-0426-3 90 CAPSULE in a BOTTLE NDC 71335-0426-4 100 CAPSULE in a BOTTLE NDC 71335-0426-5 120 CAPSULE in a BOTTLE NDC 71335-0426-6 15 CAPSULE in a BOTTLE 25 mg: Opaque ivory cap and body, imprinted "TARO" on the cap and "NTP25" on the body. NDC 71335-0083-2 60 CAPSULE in a BOTTLE NDC 71335-0083-4 30 CAPSULE in a BOTTLE NDC 71335-0083-5 90 CAPSULE in a BOTTLE NDC 71335-0083-6 50 CAPSULE in a BOTTLE NDC 71335-0083-7 100 CAPSULE in a BOTTLE NDC 71335-0083-8 120 CAPSULE in a BOTTLE NDC 71335-0083-9 28 CAPSULE in a BOTTLE 50 mg: Opaque dark green cap with an opaque white body, imprinted "TARO" on the cap and "NTP50" on the body. NDC 71335-0155-1 30 CAPSULE in a BOTTLE NDC 71335-0155-2 60 CAPSULE in a BOTTLE NDC 71335-0155-3 90 CAPSULE in a BOTTLE NDC 71335-0155-4 28 CAPSULE in a BOTTLE NDC 71335-0155-5 120 CAPSULE in a BOTTLE 75 mg: Opaque dark green cap and body, imprinted "TARO" on the cap and "NTP75" on the body. NDC 71335-1552-1 30 CAPSULE in a BOTTLE NDC 71335-1552-2 60 CAPSULE in a BOTTLE NDC 71335-1552-3 90 CAPSULE in a BOTTLE NDC 71335-1552-4 28 CAPSULE in a BOTTLE 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. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
Bryant Ranch Prepack
----------
MEDICATION GUIDE
Nortriptyline Hydrochloride (nor trip' ti leen hye'' droe klor' ide)
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

Summary of Product characteristics

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
BRYANT RANCH PREPACK
----------
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 MW = 299.84
C
H
N∙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, D&C Yellow #10 (aluminum lake), D&C Yellow
#10, FD&C Blue #1
(aluminum lake), FD&C Blue #2