nortriptyline hydrochloride- nortriptyline hydrochloride solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

nortriptyline hydrochloride (UNII: 00FN6IH15D) (Nortriptyline - UNII:BL03SY4LXB)

Saadav alates:

Ranbaxy Laboratories Limited

INN (Rahvusvaheline Nimetus):

nortriptyline hydrochloride

Ravimvorm:

SOLUTION

Koostis:

10 mg in 5 mL

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 concurrent use of nortriptyline hydrochloride or other tricyclic antidepressants 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 discontinue the MAO inhibitor at least 2 weeks before treatment with nortriptyline hydrochloride is to be started. Patients hypersensitive to nortriptyline hydrochloride should not be given the drug. Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. Nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.

Toote kokkuvõte:

Liquid, Oral Solution: 10 mg * /5 mL -- (16 fl oz) NDC 63304-202-01 * Equivalent to base. Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ohm Laboratories Inc. Gloversville, NY 12078 USA August 2007

Infovoldik

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE SOLUTION
Ranbaxy Laboratories Limited
----------
MEDICATION GUIDE
ANTIDEPRESSANT MEDICINES, DEPRESSION AND OTHER SERIOUS MENTAL
ILLNESS 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?
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 ahealthcare provider right away if your family member has any of
the following symptoms,especially
if they are new,worse, or worry

Toote omadused

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE SOLUTION
RANBAXY LABORATORIES LIMITED
----------
NORTRIPTYLINE HYDROCHLORIDE ORAL SOLUTION, USP
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 ORAL SOLUTION 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. Its molecular weight is 299.8,
and its molecular formula is
C
H N•HCl.
The oral solution contains nortriptyline hydrochloride equivalent to
10 mg/5 mL (38.0 µmol) of the base
and 4% alcohol. It also contains benzoic acid, flavors, sorbitol, and
water.
The structural formula is as follows:
ACTIONS
The mood elevating mechanism of tricyclic antidepressants is at
present unknown. Nortriptyline
hydrochloride is not a monoamine