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Basic Drug Info
Drug Name:imipramine pamoate
Manufacturer:Mallinckrodt Inc.
Other Info:

Oral: Imipramine pamoate was fed to male and female albino rats for 28 weeks through two breeding cycles at dose levels of 15 mg/kg/day and 40 mg/kg/day (equivalent to 2 1/2 and 7 times the maximum human dose).No abnormalities which could be related to drug administration were noted in gross inspection.

Autopsies performed on pups from the second breeding likewise revealed no pathological changes in organs or tissues; however, a decrease in mean litter size from both matings was noted in the drug-treated groups and significant growth suppression occurred in the nursing pups of both sexes in the high group as well as in the females of the low-level group.

Finally, the lactation index (pups weaned divided by number left to nurse) was significantly lower in the second litter of the high-level group.Tofranil and are registered trademarks of Mallinckrodt Inc.tycoHealthcareMallinckrodtManufactured byPatheon Inc.Whitby, Ontario, CanadaL1N 5Z5Manufactured forMallinckrodt Inc.St.

Louis, MO 63134Printed in U.S.A.

Rev 081106



Clinical Trials:


Indications and Usage

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.
Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Contraindications

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 should be kept in mind.
Convulsive Seizures --

Adverse effects -- Problems that occur when treatment affects tissues or organs other than the ones meant to be affected by the treatment. Common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

Myocardial Infarction -- NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs.

There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients.

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.Pooled analyses of short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with MDD, OCD, or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal behavior or thinking (suicidality) during the first few months of treatment in those receiving antidepressants.

The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%.

There was considerable variation in risk among drugs, but a tendency toward an increase for almost all drugs studied.

The risk of suicidality was most consistently observed in the MDD trials, but there were signals of risk arising from some trials in other psychiatric indications (obsessive compulsive disorder and social anxiety disorder) as well.

No suicides occurred in any of these trials.

It is unknown whether the suicidality risk in pediatric patients extends to longer-term use, i.e., beyond several months.

It is also unknown whether the suicidality risk extends to adults.All pediatric patients being treated with antidepressants for any indication should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

Such observation would generally include at least weekly face-to-face contact with patients or their family members or caregivers during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks.

Additional contact by telephone may be appropriate between face-to-face visits.Adults with MDD or co-morbid depression in the setting of other psychiatric illness being treated with antidepressants should be observed similarly for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.

Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.Families and caregivers of pediatric patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers.

Such monitoring should include daily observation by families and caregivers.

Prescriptions for imipramine pamoate should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Families and caregivers of adults being treated for depression should be similarly advised.
Branded Drugs
The following US Branded drugs contain imipramine pamoate


TOFRANIL-PM -- TYCO HEALTHCARE GROUP LP


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