NORPRAMIN- desipramine hydrochloride tablet, sugar coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DESIPRAMINE HYDROCHLORIDE (UNII: 1Y58DO4MY1) (DESIPRAMINE - UNII:TG537D343B)

Available from:

Validus Pharmaceuticals LLC

INN (International Name):

DESIPRAMINE HYDROCHLORIDE

Composition:

DESIPRAMINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NORPRAMIN is indicated for the treatment of depression. The use of MAOIs intended to treat psychiatric disorders with NORPRAMIN or within 14 days of stopping treatment with NORPRAMIN is contraindicated because of an increased risk of serotonin syndrome. The use of NORPRAMIN within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated ( s ee WARNINGS and DOSAGE AND ADMINISTRATION ). Starting NORPRAMIN 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 ). NORPRAMIN is contraindicated in the acute recovery period following myocardial infarction.  It should not be used in those who have shown prior hypersensitivity to the drug. Cross-sensitivity between this and other dibenzazepines is a possibility.

Product summary:

10 mg blue coated tablets imprinted 68-7       NDC 30698-007-01: bottles of 100 25 mg yellow coated tablets imprinted NORPRAMIN 25       NDC 30698-011-01: bottles of 100 50 mg green coated tablets imprinted NORPRAMIN 50       NDC 30698-015-01: bottles of 100 75 mg orange coated tablets imprinted NORPRAMIN 75       NDC 30698-019-01: bottles of 100 100 mg peach coated tablets imprinted NORPRAMIN 100       NDC 30698-020-01: bottles of 100 150 mg white coated tablets imprinted NORPRAMIN 150       NDC 30698-021-05-: bottles of 50 Store at 77o F (25o C); excursions permitted to 59o   to  86o F (15o   to 30o C) [See USP Controlled Room Temperature]. Dispense in a tight container.  Protect from excessive heat.   Rx Only Manufactured for and Distributed by: Validus Pharmaceuticals LLC 119 Cherry Hill Road, Suite 310 Parsippany, NJ 07054 [e-mail] www.validuspharma.com 1-866-982-5438 (1-866-9VALIDUS)  Product of Finland © 2018 Validus Pharmaceuticals LLC 60040-02                         November 2018

Authorization status:

New Drug Application

Patient Information leaflet

NORPRAMIN- DESIPRAMINE HYDROCHLORIDE TABLET, SUGAR COATED
Validus Pharmaceuticals LLC
----------
Medication Guide
Norpramin® (desipramine hydrochloride tablets USP)
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
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:
•
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.
Who should not take NORPRAMIN?
•
You should not take NORPRAMIN if you take a monoami

Summary of Product characteristics

NORPRAMIN- DESIPRAMINE HYDROCHLORIDE TABLET, SUGAR COATED
VALIDUS PHARMACEUTICALS LLC
----------
NORPRAMIN
NORPRAMIN
(DESIPRAMINE HYDROCHLORIDE TABLETS 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 NORPRAMIN
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. NORPRAMIN IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. _(SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS:_
_INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC USE)._
DESCRIPTION
NORPRAMIN (desipramine hydrochloride USP) is an antidepressant drug of
the tricyclic
type, and is chemically:
5_H_-Dibenz[_bƒ_]azepine-5-propanamine,10,11-dihydro-_N_-methyl-,
monohydrochloride.
Each NORPRAMIN tablet contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or
150 mg of
desipramine hydrochloride for oral administration.
INACTIVE INGREDIENTS
®
®
The following inactive ingredients are contained in all dosage
strengths: acacia, calcium
carbonate, corn starch, D&C Red No. 30 and D&C Yellow No. 10 (except
10 mg and 150
mg), FD&C Blue No. 1 (except 25 mg, 75 mg, and 100 mg), hydrogenated
soy oil, iron
ox