NORTRIPTYLINE HYDROCHLORIDE capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Zydus Pharmaceuticals (USA) Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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. 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 ). Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. Nortriptyline hydrochloride is contraindicated during the acute rec

Produkt oversigt:

Nortriptyline hydrochloride capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows: Nortriptyline hydrochloride capsules USP, 10 mg: White to off white granular powder filled in size "5" empty hard gelatin capsule having orange opaque colored cap imprinted with "1153" in black ink and white opaque colored body. Bottles of 30…………………………………………..…..….…NDC 70710-1153-3 Bottles of 100………………………………………….…..……NDC 70710-1153-1 Bottles of 500………………………………………….…..……NDC 70710-1153-5 Nortriptyline hydrochloride capsules USP, 25 mg: White to off white granular powder filled in size "4" empty hard gelatin capsule having orange opaque colored cap imprinted with "1154" in black ink and white opaque colored body. Bottles of 30…………………………………………..…..….…NDC 70710-1154-3 Bottles of 100………………………………………….…..……NDC 70710-1154-1 Bottles of 500………………………………………….…..……NDC 70710-1154-5 Nortriptyline hydrochloride capsules USP, 50 mg: White to off white granular powder filled in size "2" empty hard gelatin capsule having white opaque colored cap imprinted with "1155" in black ink and white opaque colored body. Bottles of 30…………………………………………..…..….…NDC 70710-1155-3 Bottles of 100………………………………………….…..……NDC 70710-1155-1 Bottles of 500………………………………………….…..……NDC 70710-1155-5 Nortriptyline hydrochloride capsules USP, 75 mg: White to off white granular powder filled in size "l" empty hard gelatin capsule having orange opaque colored cap imprinted with "1156" in black ink and orange opaque colored body. Bottles of 30…………………………………………..…..….…NDC 70710-1156-3 Bottles of 100………………………………………….…..……NDC 70710-1156-1 Bottles of 500………………………………………….…..……NDC 70710-1156-5 Store and Dispense 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. Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 11/19

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

NORTRIPTYLINE HYDROCHLORIDE - nortriptyline hydrochloride capsule
Zydus Pharmaceuticals (USA) Inc.
----------
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:
•
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:
•
thoug

Produktets egenskaber

NORTRIPTYLINE HYDROCHLORIDE - NORTRIPTYLINE HYDROCHLORIDE CAPSULE
ZYDUS PHARMACEUTICALS (USA) 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:
_10 MG, 25 MG, 50 MG, AND 75 MG CAPSULES_
_Active Ingredient: _nortriptyline hydrochloride, USP.
_Inactive Ingredients: _Colloidal silicon dioxide, magnesium stearate
and pregelatinized
starch.
In addition, each capsule contains gelatin, sodium lauryl sulphate and
titanium dioxide.
The 10 mg, 25 mg and 75 mg capsules also contains FD & C Red 40, D & C
Yellow 10.
The capsule is printed with black ph