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:

SpecGx 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
SpecGx LLC
----------
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 has
any of the followi

Summary of Product characteristics

TOFRANIL- IMIPRAMINE HYDROCHLORIDE TABLET, SUGAR COATED
SPECGX LLC
----------
TOFRANIL™
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
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-5_H_-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 Ingr