NORTRIPTYLINE HYDROCHLORIDE capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

Nortriptyline Hydrochloride (UNII: 00FN6IH15D) (Nortriptyline - UNII:BL03SY4LXB)

Dostupné z:

Preferred Pharmaceuticals Inc.

INN (Medzinárodný Name):

Nortriptyline Hydrochloride

Zloženie:

Nortriptyline 25 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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  Error! Hyperlink reference not valid. 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 du

Prehľad produktov:

Nortriptyline Hydrochloride Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are as follows: 25 mg: Opaque ivory cap and body, imprinted "TARO" on the cap and "NTP25" on the body. Bottles of 30 NDC 68788-9830-3 Bottles of 60 NDC 68788-9830-6 Bottles of 90 NDC 68788-9830-9 Bottles of 100 NDC 68788-9830-1 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.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Preferred Pharmaceuticals Inc.
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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:
1.
all risks and benefits of treatment with antidepressant medicines
2.
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?
1.2.
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.
2.2.
Call the healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
3.2.
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:
1.
thoughts about suicide or dying
2.
attempts to commit suicide
3.
new

Súhrn charakteristických

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
PREFERRED PHARMACEUTICALS INC.
----------
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:
C19H21N∙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 (aluminum l