NORTRIPTYLINE HYDROCHLORIDE - 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:

Lake Erie Medical DBA Quality Care Products LLC

INN（国際名）:

NORTRIPTYLINE HYDROCHLORIDE

構図:

NORTRIPTYLINE 25 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. The use of nortriptyline hydrochloride or other tricyclic antidepressants concurrently with a monoamine oxidase (MAO) inhibitor is contraindicated. Hyperpyretic crises, severe convulsions, and fatalities have occurred when similar tricyclic antidepressants were used in such combinations. It is advisable to have discontinued the MAO inhibitor for at least two weeks before treatment with nortriptyline hydrochloride is started. Patients hypersensitive to nortriptyline hydrochloride should not be given the drug. Cross-sensitivity between nortriptyline and other dibenzazepines is a possibility. Nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.

製品概要:

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, 500, and 1000. 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, 500, and 1000. 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, 500, and 1000. 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, 500, and 1000. 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). TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. U 7/2010

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

NORTRIPTYLINE HYDROCHLORIDE - NORTRIPTYLINE HYDROCHLORIDE CAPSULE
Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
Rx only
Read the Medication Guide that comes with your 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?
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,
e

製品の特徴

NORTRIPTYLINE HYDROCHLORIDE - NORTRIPTYLINE HYDROCHLORIDE CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP
0810
0811
0812
0813
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 CAPSULES 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 CAPSULES ARE NOT APPROVED FOR USE IN
PEDIATRIC PATIENTS. (SEE
WARNINGS, CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS,
INFORMATION FOR
PATIENTS, AND PRECAUTIONS, PEDIATRIC USE.)
DESCRIPTION
DESCRIPTION
Nortriptyline hydrochloride 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. 299.8
Nortriptyline hydrochloride 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 equivalent to 10 m