When it is desired to substitute tofranil in patients receiving a , as long an interval should elapse as the clinical situation will allow, with a minimum of 14 days. A daily dose greater than 75 mg does not enhance efficacy and tends to increase side effects. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.
Although a causal relationship between these effects and the drug could not be established, the possibility of fetal risk from the maternal ingestion of tofranil cannot be excluded. Poor metabolizers have higher than expected plasma concentrations of tricyclic (tcas) when given usual doses. An ecg recording should be taken prior to the initiation of larger-than-usual doses of tofranil and at appropriate intervals thereafter until steady state is achieved.
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. In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied.
An individual who is stable on a given dose of tca may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. This medication guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Revised apr 2017 although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the tricyclic drugs require that each of the reactions be considered when tofranil is administered.
These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in table 1. As a general rule, a woman taking a drug should not nurse since the possibility exists that the drug may be excreted in breast milk and be harmful to the child. Drug-placebo difference in number of cases of suicidality per 1000 patients treated no suicides occurred in any of the pediatric trials.
The pooled analyses of placebo-controlled trials in adults with mdd or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. A patient about antidepressant medicines, depression and other serious mental illness, and suicidal thoughts or actions is available for imipramine hydrochloride. Nevertheless, caution is indicated in the coadministration of tcas with any of the ssris and also in switching from one class to the other. The mode of action of the drug in controlling depending on the dosage in both species, toxic signs proceeded progressively from depression, irregular oral independent studies in three species (rat, mouse, and rabbit) revealed that when tofranil is administered orally in doses up to approximately 2-12 times the maximum human dose in the first 2 species and up to 25 times the maximum human dose in the third species, the drug is essentially free from potential. Critical manifestations of overdose include cardiac dysrhythmias, severe , restlessness, agitation, hyperactive reflexes, muscle rigidity, athetoid and choreiform movements.
These may vary in severity depending upon factors such as the amount of drug absorbed, the age of the patient, and the interval between drug ingestion and the start of treatment. Depending on the fraction of drug metabolized by p450 2d6, the increase in plasma concentration may be small, or quite large (8-fold increase in plasma auc of the tca). It should be kept in mind that the possibility of suicide in seriously depressed patients is inherent in the illness and may persist until significant remission occurs. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. Clinical studies of tofranil in the original application did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Patient information tofranil (to-fra-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 members antidepressant medicine. 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. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Children who relapse when the drug is discontinued do not always respond to a subsequent course of treatment.
Confusional states (especially in the elderly) with hallucinations, disorientation, delusions anxiety, restlessness, agitation insomnia and nightmares , itching, photosensitization edema (general or of face and tongue) drug fever cross-sensitivity with desipramine. Of particular importance, sufficient time must elapse before initiating tca treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary). Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with imipramine hydrochloride and should counsel them in its appropriate use. The complete text of the medication guide is reprinted at the end of this document. Children have been reported to be more sensitive than adults to an acute overdosage of imipramine hydrochloride. An acute overdose of any amount in infants or young children, especially, must be considered serious and potentially fatal. The pooled analyses of placebo-controlled trials in adults with mdd or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. Patients should be warned that imipramine hydrochloride may enhance the cns depressant effects of alcohol (see patients with major depressive disorder (mdd), both adult and pediatric, may experience worsening of their depression andor the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking occurs. However, evidence does exist from the rat studies that some systemic and embryotoxic potential is demonstrable.Find Lowest Prices on. Tofranil™ (imipramine hydrochloride) tablets USP ... A daily dose greater than 75 mg does not enhance efficacy and tends to increase ...