IMIPRAMINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IMIPRAMINE HYDROCHLORIDE (UNII: BKE5Q1J60U) (IMIPRAMINE - UNII:OGG85SX4E4)

Available from:

Excellium Pharmaceutical, Inc

INN (International Name):

IMIPRAMINE HYDROCHLORIDE

Composition:

IMIPRAMINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration. The concomitant use of monoamine oxidase inhibiting compounds is contraindicated. Hyperpyretic crises or severe convulsive seizures may occur in patients receiving such combinations. The potentiation of adverse effects can be serious, or even fatal. When it is desired to substitute Imipramine Hydrochloride Tablets USP in patients receiving a monoamine oxidase inhibitor, as long an interval should elap

Product summary:

The three strengths of Imipramine Hydrochloride USP Tablets are available as follows: Tablets 10 mg - round, yellow, film-coated tablet, embossed with on " EP 133" one side and plain on the other side.   Bottles of 100 ............ NDC 64125-133-01   Bottles of 1000 ..........NDC 64125-133-10 Tablets 25 mg - round, brown, film-coated tablet, embossed with on "EP 134" one side and plain on the other side.   Bottles of 100 ............ NDC 64125-134-01   Bottles of 1000 ..........NDC 64125-134-10 Tablets 50 mg - round, green, film-coated tablet, embossed with on "EP 135" one side and plain on the other side.   Bottles of 100 ............ NDC 64125-135-01   Bottles of 1000 ...........NDC 64125-135-10 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

IMIPRAMINE HYDROCHLORIDE- IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED
Excellium Pharmaceutical, Inc
----------
MEDICATION GUIDE
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 ne

Summary of Product characteristics

IMIPRAMINE HYDROCHLORIDE- IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED
EXCELLIUM PHARMACEUTICAL, INC
----------
IMIPRAMINE HYDROCHLORIDE TABLETS USP
10 MG, 25 MG, AND 50 MG
RX ONLY
PRESCRIBING INFORMATION
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
IMIPRAMINE 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.
IMIPRAMINE 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
Imipramine Hydrochloride Tablets USP is supplied in tablet form for
oral administration.
Imipramine Hydrochloride USP, the original tricyclic antidepressant,
is a member of the dibenzazepine
group of compounds. It is designated 5-3-(Dimethylamino) propyl-10,
11-dihydro-5_H _dibenz [‘b, f]-
azepine monohydrochloride. Its structural formula is:
C H
N • HCI MW = 316.88
Imipramine Hydrochloride USP is a white to off-white, odorless, or
practically odorless crystalline
powder. It is freely soluble in water and in alcohol, soluble