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:

sanofi-aventis U.S. 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 (see 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 0068-0007-01: bottles of 100 25 mg yellow coated tablets imprinted NORPRAMIN 25         NDC 0068-0011-01: bottles of 100 50 mg green coated tablets imprinted NORPRAMIN 50         NDC 0068-0015-01: bottles of 100 75 mg orange coated tablets imprinted NORPRAMIN 75         NDC 0068-0019-01: bottles of 100 100 mg peach coated tablets imprinted NORPRAMIN 100         NDC 0068-0020-01: bottles of 100 150 mg white coated tablets imprinted NORPRAMIN 150         NDC 0068-0021-50: bottles of 50 Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from excessive heat. Dispense in tight container.

Authorization status:

New Drug Application

Patient Information leaflet

NORPRAMIN- DESIPRAMINE HYDROCHLORIDE TABLET, SUGAR COATED
sanofi-aventis U.S. 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 monoamine oxi

Summary of Product characteristics

NORPRAMIN- DESIPRAMINE HYDROCHLORIDE TABLET, SUGAR COATED
SANOFI-AVENTIS U.S. LLC
----------
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
US E.)
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.
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 oxide,
light mineral oil, magnesium
stearate, mannitol, polyethylene glycol 8000, pregelatinized corn
starch, sodium benzoate (except 150
mg), sucrose, talc