TOFRANIL- imipramine hydrochloride tablet, sugar coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IMIPRAMINE HYDROCHLORIDE (UNII: BKE5Q1J60U) (IMIPRAMINE - UNII:OGG85SX4E4)

Available from:

Thompson Medical Solutions LLC

INN (International Name):

IMIPRAMINE HYDROCHLORIDE

Composition:

IMIPRAMINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Tofranil in patients receiving a monoamine oxidase inhibitor, as long an interval sho

Product summary:

The three strengths of Tofranil™ (imipramine hydrochloride USP) are available as follows: Tablets 10 mg – triangular, biconvex, coral-reddish brown, sugar-coated tablet, imprinted with  on one side and “10” on the other side in black. Bottles of 30 ……………… NDC 0406-9920-03 Bottles of 100 ……………… NDC 0406-9920-01 Tablets 25 mg – round, biconvex, coral-reddish brown, sugar-coated tablet, imprinted with  on one side and “25” on the other side in black. Bottles of 30 ……………… NDC 0406-9921-03 Bottles of 100 ……………… NDC 0406-9921-01 Tablets 50 mg – round, biconvex, coral-reddish brown, sugar-coated tablet, imprinted with  on one side and “50” on the other side in black. Bottles of 30 ……………… NDC 0406-9922-03 Bottles of 100 ……………… NDC 0406-9922-01 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOFRANIL- IMIPRAMINE HYDROCHLORIDE TABLET, SUGAR COATED
Thompson Medical Solutions LLC
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MEDICATION GUIDE - TOFRANIL™ (TŌ-ˈFRĀ-
NIL)
IMIPRAMINE HYDROCHLORIDE TABLETS
USP
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 ha

Summary of Product characteristics

TOFRANIL- IMIPRAMINE HYDROCHLORIDE TABLET, SUGAR COATED
THOMPSON MEDICAL SOLUTIONS LLC
----------
TOFRANIL
IMIPRAMINE HYDROCHLORIDE TABLETS USP
(10 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
Tofranil™ is supplied in tablet form for oral administration.
Tofranil, 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-5H-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 Ingredients: Ca