IMIPRAMINE PAMOATE capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

STAT RX USA LLC

INN (Medzinárodný Name):

IMIPRAMINE PAMOATE

Zloženie:

IMIPRAMINE HYDROCHLORIDE 75 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 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 pamoate capsules in patients receiving a monoamine oxidase inhibitor, as long an interval should elapse as the clinical situation will allow, with a minimum of 14 days. Initial dosage should be low and increases should be gradual and cautiously prescribed. 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 drug. The possibility of cross-sensitivity to other dibenzazepine compounds shoul

Prehľad produktov:

Capsules 75 mg - coral body imprinted in black “ ” and coral cap imprinted in black “75”. Bottles of 30............................................NDC 0406-9931-03 Capsules 100 mg - maize body imprinted in black “ ” and coral cap imprinted in black “100”. Bottles of 30...........................................NDC 0406-9932-03 Capsules 125 mg - ivory body imprinted in black “ ” and coral cap imprinted in black “125”. Bottles of 30...........................................NDC 0406-9933-03 Capsules 150 mg - coral body imprinted in black “ ” and coral cap imprinted in black “150”. Bottles of 30...........................................NDC 0406-9934-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP) with a child-resistant closure.

Stav Autorizácia:

New Drug Application

Príbalový leták

IMIPRAMINE PAMOATE - IMIPRAMINE PAMOATE CAPSULE
STAT RX USA LLC
----------
MEDICATION GUIDE
Antidepressant Medicines, Depression and other Serious Mental
Illnesses,
and Suicidal Thoughts or Actions
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,
especially if they are new, worse, or worry you:
•
thoughts

Súhrn charakteristických

IMIPRAMINE PAMOATE - IMIPRAMINE PAMOATE CAPSULE
STAT RX USA LLC
----------
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 is 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-5_H_-
dibenz[b,f]azepine 4, 4'-methylenebis- (3-hydroxy-2-naphthoate) (2:1),
and its structural formula is
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.
_Inactive Ingredients._ D&C Red No. 28, FD&C Blue No. 1, FD&C