NORTRIPTYLINE HCL capsule NORTRIPTYLINE HCI capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Kúpte ho teraz

Príbalový leták Príbalový leták (PIL)
11-03-2019

Aktívna zložka:

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

Dostupné z:

Direct_Rx

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Nortriptyline hydrochloride, USP is 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 possibilit

Prehľad produktov:

Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg nortriptyline) are #3, opaque deep green and opaque white capsules imprinted NORTRIPTYLINE and DAN 10 mg supplied in bottles of 100 and 500. Nortriptyline Hydrochloride Capsules USP (equivalent to 25 mg nortriptyline) are #1, opaque deep green and opaque white capsules imprinted NORTRIPTYLINE and DAN 25 mg supplied in bottles of 100, 500 and 1000. Nortriptyline Hydrochloride Capsules USP (equivalent to 50 mg nortriptyline) are #1, opaque white capsules imprinted NORTRIPTYLINE and DAN 50 mg supplied in bottles of 100 and 500. Nortriptyline Hydrochloride Capsules USP (equivalent to 75 mg nortriptyline) are #1, opaque deep green capsules imprinted NORTRIPTYLINE and DAN 75 mg supplied in bottles of 100. Dispense in a tight container, as defined in the USP, with a child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

                                NORTRIPTYLINE HCL- NORTRIPTYLINE HCL CAPSULE
NORTRIPTYLINE HCI- NORTRIPTYLINE HCI CAPSULE
Direct_Rx
----------
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. 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,
especially if they are new, worse, or worry you:
thoughts about 
                                
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Súhrn charakteristických

                                NORTRIPTYLINE HCL- NORTRIPTYLINE HCL CAPSULE
NORTRIPTYLINE HCI- NORTRIPTYLINE HCI CAPSULE
DIRECT_RX
----------
NORTRIPTYLINE HCL
Nortriptyline hydrochloride, USP is 1-propanamine,
3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-
ylidene)-N-methyl-, hydrochloride.
The structural formula is as follows:
[Chemical Structure]
C19H21·HCl M.W. 299.84
Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg,
50 mg and 75 mg
Nortriptyline), for oral administration, contain the following
inactive ingredients: colloidal silicon
dioxide, magnesium stearate, pregelatinized starch and sodium lauryl
sulfate. The 10 mg, 25 mg, 50 mg
and 75 mg capsule shells contain: gelatin, methylparaben,
propylparaben, sodium lauryl sulfate and
titanium dioxide. They may also contain: benzyl alcohol, butylparaben,
edetate calcium disodium, silicon
dioxide or sodium propionate.
The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No.
10 and FD&C Blue No. 1.
The mechanism of mood elevation by tricyclic antidepressants is at
present unknown. Nortriptyline
hydrochloride is not a monoamine oxidase inhibitor. It inhibits the
activity of such diverse agents as
histamine, 5-hydroxytryptamine, and acetylcholine. It increases the
pressor effect of norepinephrine but
blocks the pressor response of phenethylamine. Studies suggest that
nortriptyline hydrochloride
interferes with the transport, release, and storage of catecholamines.
Operant conditioning techniques in
rats and pigeons suggest that nortriptyline hydrochloride has a
combination of stimulant and depressant
properties.
Nortriptyline hydrochloride, USP is 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 o
                                
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