IMIPRAMINE HYDROCHLORIDE tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Sandoz Inc

INN (इंटरनेशनल नाम):

IMIPRAMINE HYDROCHLORIDE

रचना:

IMIPRAMINE HYDROCHLORIDE 10 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 in patients receiving a monoamine oxidase inhibitor, as long an interval should elapse as the cl

उत्पाद समीक्षा:

Imipramine hydrochloride tablets, USP for oral administration are available as: 10 mg: Round, film-coated, yellow tablets, debossed GG on one side and 41 on the reverse side, and supplied as: NDC 0781-1762-01 bottles of 100 25 mg: Round, film-coated, beige tablets, debossed GG on one side and 47 on the reverse side, and supplied as: NDC 0781-1764-01 bottles of 100 NDC 0781-1764-10 bottles of 1000 50 mg: Round, film-coated, green tablets, debossed GG on one side and 42 on the reverse side, and supplied as: NDC 0781-1766-01 bottles of 100 NDC 0781-1766-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense contents in a tight, light-resistant container, as defined in the USP with a child-resistant closure, as required. Do not use if printed inner seal of bottle is broken or missing. KEEP OUT OF THE REACH OF CHILDREN.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

IMIPRAMINE HYDROCHLORIDE- IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED
Sandoz Inc
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MEDICATION GUIDE
IMIPRAMINE HYDROCHLORIDE TABLETS,
USP
(im-IP-rah-meen)
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 follow

उत्पाद विशेषताएं

IMIPRAMINE HYDROCHLORIDE- IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED
SANDOZ INC
----------
IMIPRAMINE HYDROCHLORIDE TABLETS, USP
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, 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. Structurally, it may be represented as
follows:
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 in
acetone, and insoluble in ether and in
benzene.
Each tablet, for oral administration, contains 10 mg, 25 mg or 50 mg
imipramine hydr