IMIPRAMINE HYDROCHLORIDE- 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:

Bryant Ranch Prepack

INN (International Name):

IMIPRAMINE HYDROCHLORIDE

Composition:

IMIPRAMINE HYDROCHLORIDE 25 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 in patients receiving a monoamine oxidase inhibitor, as long an interval should elapse a

Product summary:

Imipramine Hydrochloride Tablets USP, containing 10 mg imipramine hydrochloride, are round, biconvex, yellow film-coated tablets debossed with "LU" on one side and "V11" on the other side. They are supplied as follows: NDC 68180-311-01           Bottles of 100’s NDC 68180-311-02           Bottles of 500’s Imipramine Hydrochloride Tablets USP, containing 25 mg imipramine hydrochloride, are round, biconvex, green film-coated tablets debossed with "LU" on one side and "V12" on the other side. They are supplied as follows: NDC 68180-312-01           Bottles of 100’s NDC 68180-312-02           Bottles of 500’s Imipramine Hydrochloride Tablets USP, containing 50 mg imipramine hydrochloride, are round, biconvex, reddish brown film-coated tablets debossed with "LU" on one side and "V13" on the other side. They are supplied as follows: NDC 68180-313-01           Bottles of 100’s NDC 68180-313-02           Bottles of 500’s Store at 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers. Dispense in tight container (USP) with a child-resistant closure. A. Acute: Oral LD50 ranges are as follows:       Rat      355 to 682 mg/kg       Dog     100 to 215 mg/kg Depending on the dosage in both species, toxic signs proceeded progressively from depression, irregular respiration and ataxia to convulsions and death. B. Reproduction/Teratogenic: The overall evaluation may be summed up in the following manner: Oral: Independent studies in three species (rat, mouse, and rabbit) revealed that when imipramine hydrochloride is administered orally in doses up to approximately 2-1/2 times the maximum human dose in the first 2 species and up to 25 times the maximum human dose in the third species, the drug is essentially free from teratogenic potential. In the three species studied, only one instance of fetal abnormality occurred (in the rabbit) and in that study there was likewise an abnormality in the control group. However, evidence does exist from the rat studies that some systemic and embryotoxic potential is demonstrable. This is manifested by reduced litter size, a slight increase in the stillborn rate, and a reduction in the mean birth weight.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

IMIPRAMINE HYDROCHLORIDE- IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED
Bryant Ranch Prepack
----------
MEDICATION GUIDE
Antidepressant Medicines, Depression and other Serious Mental
Illnesses,
and Suicidal Thoughts or Actions
Imipramine Hydrochloride Tablets USP
10 mg, 25 mg and 50 mg
Rx only
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 h

Summary of Product characteristics

IMIPRAMINE HYDROCHLORIDE- IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
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:
C
H N · HCL 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 in
acetone, and insoluble