NORTRIPTYLINE HYDROCHLORIDE capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Direct Rx

INN (Международно Name):

NORTRIPTYLINE HYDROCHLORIDE

Композиция:

NORTRIPTYLINE 10 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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. 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 possi

Каталог на резюме:

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, and 500. 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, and 500. 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, and 500. 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, and 500. 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. V 11/2012 MEDICATION GUIDE Nortriptyline Hydrochloride Capsules USP 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: 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? 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: Who should not take nortriptyline hydrochloride? Do not take nortriptyline hydrochloride if you: ° Do not take an MAOI within 2 weeks of stopping nortriptyline hydrochloride unless directed to do so by your physician. ° Do not start nortriptyline hydrochloride if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician. What else do I need to know about antidepressant medicines? Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This Medication Guide has been approved by the U.S. Food and Drug Administration. TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. F 11/2012

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
DIRECT RX
----------
NORTRIPTYLINE HYDROCHLORIDE
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
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:
C19H21N•HCl M.W. 299.8
Nortriptyline hydrochloride, USP 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, USP equivalent to 10 mg, 25
mg, 50 mg or 75 mg nortriptyline.
In addition, each capsule contains the fol