IMIPRAMINE HYDROCHLORIDE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

Imipramine Hydrochloride (UNII: BKE5Q1J60U) (Imipramine - UNII:OGG85SX4E4)

Prieinama:

Oxford Pharmaceuticals, LLC

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

Imipramine Hydrochloride Tablets, USP 10 mg – Peach, round, film coated, biconvex tablets debossed “425” on one side and “O” on the other. Available in: Bottles of 100 ………..……  … NDC-69584-425-10 Bottles of 1000 ………..……… NDC-69584-425-90 25 mg – Light orange, round, film coated, biconvex tablets debossed “426” on one side and “O” on the other. Available in: Bottles of 100 ……..………  … NDC-69584-426-10 Bottles of 1000 ………..……… NDC-69584-426-90 50 mg – Orange, round, film coated, biconvex tablets debossed “427” on one side and “O” on the other. Available in: Bottles of 100 …………..…  … NDC-69584-427-10 Bottles of 1000 ………..……… NDC-69584-427-90 Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container (USP) with a child-resistant closure. Dispense with Medication Guide available at: https://www.oxford-rx.com/med-guides

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

IMIPRAMINE HYDROCHLORIDE- IMIPRAMINE HYDROCHLORIDE TABLET
Oxford Pharmaceuticals, LLC
----------
MEDICATION GUIDE
Antidepressant Medicines, Depression and other Serious Mental
Illnesses,
and Suicidal Thoughts or Actions
Dispense with Medication Guide available at:
https://www.oxford-rx.com/med-guides
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 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 fam

Prekės savybės

IMIPRAMINE HYDROCHLORIDE- IMIPRAMINE HYDROCHLORIDE TABLET
OXFORD PHARMACEUTICALS, LLC
----------
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 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 water and in alcohol,
soluble in acetone, and
insoluble in ether and in benzene.
_Inactive