IMIPRAMINE HYDROCHLORIDE tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Key Therapeutics

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Depression -For the relief of symptoms of depression. Endogenous depression is more likely to be al l eviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Childhood Enuresis -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 in patients receiving a monoamine oxidase inhibitor, as long a

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

IMIPRAMINE HYDROCHLORIDE- IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED
Key Therapeutics
----------
Medication Guide
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or Actions
Dispense with Medication Guide
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 family
member’s, or your 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 ca led 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.
•
Ca11 the healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Keep a l follow-up visits with the healthcare provider as scheduled.
Ca l 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,
esp

Tabia za bidhaa

IMIPRAMINE HYDROCHLORIDE- IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED
KEY THERAPEUTICS
----------
IMIPRAMINE HYDROCHLORIDE
IMIPRAMINE HYDROCHLORIDE- IMIPRAMINE HYDROCHLORIDE TABLET KEY
THERAPEUTICS, LLC
IMIPRAMINE HYDROCHLORIDE TABLETS, USP
25 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 A L 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 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:
Imipramine hydrochloride USP is a white to off-white, odorless, or
practically odorless
crystalline powder. It is freely soluble in