NORTRIPTYLINE HYDROCHLORIDE solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

PAI Holdings, LLC

INN (Jina la Kimataifa):

Nortriptyline Hydrochloride

Tungo:

Nortriptyline 10 mg in 5 mL

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Nortriptyline hydrochloride oral solution 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 oral solution or within 14 days of stopping treatment with nortriptyline hydrochloride oral solution is contraindicated because of an increased risk of serotonin syndrome. The use of nortriptyline hydrochloride oral solution within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (See WARNINGS and DOSAGE AND ADMINISTRATION ). Starting nortriptyline hydrochloride oral solution 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 ADMINI

Bidhaa muhtasari:

Nortriptyline Hydrochloride Oral Solution USP, 10 mg*/5 mL, is a clear, cherry-flavored solution. Alcohol content is 4%. It is available as: NDC 0121-0678-16:  16 fl oz (473 mL) bottle *Equivalent to base. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers as defined in the USP.

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE SOLUTION
PAI Holdings, LLC
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MEDICATION GUIDE
Nortriptyline Hydrochloride Oral Solution USP
(nor trip te len)
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 suicide or dying
�

Tabia za bidhaa

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE SOLUTION
PAI HOLDINGS, LLC
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NORTRIPTYLINE HYDROCHLORIDE ORAL SOLUTION 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 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
The oral solution contains nortriptyline hydrochloride equivalent to
10 mg/5 mL (38.0
μmol) of the base and 4% alcohol. It also contains cherry flavor,
citric acid anhydrous,
purified water, sodium benzoate, and sorbitol.
CLINICAL PHARMACOLOGY
The mechanism of mood elevation by tricyclic antidepressants is at
present unknown.
Nortriptyline hydrochloride is not a monoamine oxidase inhibitor.