IMIPRAMINE PAMOATE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Hikma Pharmaceuticals USA Inc

INN (Internationale Bezeichnung):

IMIPRAMINE PAMOATE

Zusammensetzung:

IMIPRAMINE HYDROCHLORIDE 75 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Imipramine Pamoate Capsules, USP 75 mg capsules are supplied as light caramel opaque cap and light caramel opaque body with “54 591” printed on the cap and body, containing a light yellow to yellow powder. NDC 0054-0273-13: Bottle of 30 Capsules NDC 0054-0273-25: Bottle of 100 Capsules 100 mg capsules are supplied as light caramel opaque cap and rich yellow opaque body with “54 758” printed on the cap and body, containing a light yellow to yellow powder. NDC 0054-0274-13: Bottle of 30 Capsules NDC 0054-0274-25: Bottle of 100 Capsules 125 mg capsules are supplied as light caramel opaque cap and ivory opaque body with “54 466” printed on the cap and body, containing a light yellow to yellow powder. NDC 0054-0275-13: Bottle of 30 Capsules 150 mg capsules are supplied as light caramel opaque cap and light caramel opaque body with “54 161” printed on the cap and body, containing a light yellow to yellow powder. NDC 0054-0276-13: Bottle of 30 Capsules NDC 0054-0276-25: Bottle of 100 Capsules Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, child-resistant container as defined in the USP/NF.

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

IMIPRAMINE PAMOATE- IMIPRAMINE PAMOATE CAPSULE
Hikma Pharmaceuticals USA Inc
----------
MEDICATION GUIDE
Imipramine Pamoate Capsules, USP
(im ip’ ra meen)
Rx Only
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or Actions
This product contains FD&C Yellow No. 5 (tartrazine) which may cause
allergic-type reactions (including
bronchial asthma) in certain susceptible persons. Although the overall
incidence of FD&C Yellow No. 5
(tartrazine) sensitivity in the general population is low, it is
frequently seen in patients who also have aspirin
hypersensitivity.
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

Fachinformation

IMIPRAMINE PAMOATE- IMIPRAMINE PAMOATE CAPSULE
HIKMA PHARMACEUTICALS USA INC
----------
IMIPRAMINE PAMOATE CAPSULES, USP
FOR ORAL ADMINISTRATION
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
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, USP are a tricyclic antidepressant,
available as capsules
for oral administration. The 75 mg, 100 mg, 125 mg, and 150 mg
capsules contain
imipramine pamoate, USP equivalent to 75 mg, 100 mg, 125 mg, and 150
mg of
imipramine hydrochloride. Imipramine pamoate, USP is
5-[3-(dimethylamino)propyl]-
10,11-dihydro-5_H_-dibenz[b,f]azepine 4,
4'-methylenebis-(3-hydroxy-2-naphthoate) (2:1),
and its structural formula is:
(C
H N ) ●C
H O M.W. = 949.18
Imipramine pamoate, USP is a slightly yellow, crystalline powder. It
is soluble in ethanol,
in acetone, in ether, in chloroform