IMIPRAMINE HYDROCHLORIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Strides Pharma Science Limited

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Depression: 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. 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 an

Produkt oppsummering:

Imipramine Hydrochloride Tablets, USP are available as follows: 10 mg are yellow, triangular, film coated tablets debossed "par" on one side and "54" on the other side and supplied in bottles of 100 (NDC 64380-169-01), and 1000 (NDC 64380-169-02) tablets. 25 mg are brown, round, film coated tablets debossed "par" on one side and "55" on the other side and supplied in bottles of 100 (NDC 64380-170-01), and 1000 (NDC 64380-170-02) tablets. 50 mg are green, round, film coated tablets debossed "par" on one side and "56" on the other side and supplied in bottles of 100 (NDC 64380-171-01), and 1000 (NDC 64380-171-02) tablets. Store between 15° to 25°C (59° to 77°F).

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Strides Pharma Science Limited
----------
Medication Guide
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
anti depressant
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 antide pressant
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 new, worse, or worry you:
• thoughts about suicide or dying
• atte

Preparatomtale

IMIPRAMINE HYDROCHLORIDE - IMIPRAMINE HYDROCHLORIDE TABLET
STRIDES PHARMA SCIENCE LIMITED
----------
IMIPRAMINE HYDROCHLORIDE TABLETS, USP
RX ONLY
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 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-_5H_-dibenz [b,f]azepine monohydrochloride. Its
structural formula is:
C
H
N ●HCl
MW:
316.87
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.
Imipramine hydrochlori