IMIPRAMINE PAMOATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IMIPRAMINE PAMOATE (UNII: MC34P30298) (IMIPRAMINE - UNII:OGG85SX4E4)

Available from:

LUPIN LIMITED

INN (International Name):

IMIPRAMINE PAMOATE

Composition:

IMIPRAMINE PAMOATE 75 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. The use of MAOIs intended to treat psychiatric disorders with imipramine pamoate or within 14 days of stopping treatment with imipramine pamoate is contraindicated because of an increased risk of serotonin syndrome. The use of imipramine pamoate within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION). Starting imipramine pamoate in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION). The drug is contraindicated during the acute recovery period after a myocardial infarction. Patients with a known hypersensitivity to this compound should not be given the

Product summary:

Imipramine Pamoate Capsules 75 mg are size "2" capsule with brown cap and brown body, imprinted with "LU" in black ink on cap and "U01" in black ink on body, containing pale yellow to yellow granular powder. They are supplied as follows: NDC 68180-314-06       Bottles of 30's NDC 68180-314-01       Bottles of 100's Imipramine Pamoate Capsules 100 mg are size "1" capsule with brown cap and dark yellow body, imprinted with "LU" in black ink on cap and "U02" in black ink on body, containing pale yellow to yellow granular powder. They are supplied as follows: NDC 68180-315-06       Bottles of 30's NDC 68180-315-01       Bottles of 100's Imipramine Pamoate Capsules 125 mg are size "1" capsule with brown cap and light yellow body, imprinted with "LU" in black ink on cap and "U03" in black ink on body, containing pale yellow to yellow granular powder. They are supplied as follows: NDC 68180-316-06       Bottles of 30's NDC 68180-316-01       Bottles of 100's Imipramine Pamoate Capsules 150 mg are size "0" capsule with brown cap and brown body, imprinted with "LU" in black ink on cap and "U04" in black ink on body, containing pale yellow to yellow granular powder. They are supplied as follows: NDC 68180-317-06       Bottles of 30's NDC 68180-317-01       Bottles of 100's Store at 20°C to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP) with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

IMIPRAMINE PAMOATE- IMIPRAMINE PAMOATE CAPSULE
LUPIN LIMITED
----------
MEDICATION GUIDE
Imipramine Pamoate (ih-MIH-pra-meen pam-OH-ate)
Capsules
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
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 has
any of the following symptoms,

Summary of Product characteristics

IMIPRAMINE PAMOATE- IMIPRAMINE PAMOATE CAPSULE
LUPIN LIMITED
----------
FOR ORAL ADMINISTRATION
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 PAMOATE 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
PAMOATE 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 pamoate capsules are a tricyclic antidepressant, available
as capsules for oral administration.
The 75-, 100-, 125-, and 150-mg capsules contain imipramine pamoate
equivalent to 75, 100, 125, and
150 mg of imipramine hydrochloride. Imipramine pamoate is
5-[3-(dimethylamino)propyl]-10,11-
dihydro-_5H-_dibenz[b,f]azepine 4,
4'-methylenebis-(3-hydroxy-2-naphthoate) (2:1), and its structural
formula is
IMIPRAMINE PAMOATE
Imipramine pamoate is a fine, yellow, tasteless, odorless powder. It
is soluble in ethanol, in acetone, in
ether, in chloroform, and in carbon tetrachloride, and is insoluble in
water.
_Inacti