NORTRIPTYLINE HYDROCHLORIDE capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Bryant Ranch Prepack

INN（国際名）:

NORTRIPTYLINE HYDROCHLORIDE

構図:

NORTRIPTYLINE 10 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 a possibility. Myocardial Infarction Nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.

製品概要:

NDC: 63629-3204-1: 30 Capsules in a BOTTLE NDC: 63629-3204-2: 60 Capsules in a BOTTLE NDC: 63629-3204-3: 90 Capsules in a BOTTLE NDC: 63629-3204-4: 100 Capsules in a BOTTLE NDC: 63629-3204-5: 120 Capsules in a BOTTLE NDC: 63629-3204-6: 15 Capsules in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
Bryant Ranch Prepack
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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 following sympto

製品の特徴

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
BRYANT RANCH PREPACK
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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 addition, each c