Patients and caregoivers of patients should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present. When used for the depressive component of schizophrenia, imipramine may aggravate psychotic symptoms.
In manic-depressives, a shift towards the manic phase may occur. Paranoid delusions, with or without associated hostility, may be aggravated. A major tranquilliser should be given concurrently in such cases, or dosage of imipramine reduced. Concurrent administration with ECT may increase the hazards of treatment, and should be limited to patients for whom it is deemed essential. The elderly are particularly prone to experience adverse reaction, especially agitation, confusion and postural hypotension.
Abrupt withdrawal should be avoided because of possible adverse reactions see Undesirable Effects section. Behavioural changes may present in children receiving Imipramine for the treatment of nocturnal enuresis. Interaction with other medicinal products and other forms of interaction MAO Inhibitors: The concurrent use of antidepressants having various mechanisms of action should be undertaken only with due recognition of their possible potentiation and with a thorough knowledge of their pharmacology.
Monoamine oxidase inhibitors can potentiate the effects of tricyclic antidepressants such as imipramine and hyperpyretic crises, severe convulsions and fatalities have occurred. A minimum of 3 weeks should elapse between discontinuing an MAOI and starting imipramine, which should be introduced cautiously and dosage increased gradually. Fluoxetine markedly inhibits Cyt P II D6, which is involved in the metabolism of a number of tricyclic antidepressants.
Patients should be monitored for increased antidepressant plasma levels and toxicity when Fluoxetine is used concurrently. Adjustment of the antidepressant dosage may be necessary. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet.
You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour. Check with your doctor or pharmacist before taking Imipramine tablets if you or your child if they are the patient: Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding Imipramine tablets should not be taken during pregnancy or if breast-feeding. If Imipramine tablets are taken in the last 3 months the baby may be born with breathing difficulties, lethargy, colic, irritability, changes in blood pressure, tremors, spasm.
Imipramine tablets should be withdrawn at least 7 weeks before the expected delivery date. Driving and using machines Imipramine may impair your alertness or cause drowsiness or blurred vision, alcohol can make these symptoms worse. If signs of toxicity occur at anytime during this period, extended monitoring is required. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination.
Monitoring of plasma drug levels should not guide management of the patient. Gastrointestinal Decontamination All patients suspected of tricyclic overdose should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal.
If consciousness is impaired, the airway should be secured prior to lavage. Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7. If the pH response is inadequate, hyperventilation may also be used. Concomitant use of hyperventilation and sodium bicarbonate should be done with extreme caution, with frequent pH monitoring. Type 1A and 1C antiarrhythmics are generally contraindicated e. In rare instances, hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity.
However, hemodialysis , peritoneal dialysis , exchange transfusions, and forced diuresis generally have been reported as ineffective in tricyclic poisoning. Seizures should be controlled with benzodiazepines , or if these are ineffective, other anticonvulsants e. Physostigmine is not recommended except to treat lifethreatening symptoms that have been unresponsive to other therapies, and then only in consultation with a poison control center.
Psychiatric Follow-Up Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate. Pediatric Management The principles of management of child and adult overdosages are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment. 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 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 crosssensitivity to other dibenzazepine compounds should be kept in mind. However, it does not act primarily by stimulation of the central nervous system. The clinical effect is hypothesized as being due to potentiation of adrenergic synapses by blocking uptake of norepinephrine at nerve endings. The mode of action of the drug in controlling childhood enuresis is thought to be apart from its antidepressant effect.
In the three species studied, only one instance of fetal abnormality occurred in the rabbit and in that study there was likewise an abnormality in the control group. 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 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 possibility of cross-sensitivity to other dibenzazepine compounds should be kept in mind. Families and caregivers of 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 healthcare providers.
Such monitoring should include daily observation by families and caregivers. Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. Patients taking imipramine pamoate should avoid excessive exposure to sunlight since there have been reports of photosensitization.
Both elevation and lowering of blood sugar levels have been reported with imipramine pamoate use. Imipramine pamoate should be used with caution in patients with significantly impaired renal or hepatic function. Patients who develop a fever and a sore throat during therapy with imipramine pamoate should have leukocyte and differential blood counts performed.
Imipramine pamoate should be discontinued if there is evidence of pathological neutrophil depression. Prior to elective surgery , imipramine pamoate should be discontinued for as long as the clinical situation will allow. Information for Patients Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with imipramine pamoate and should counsel them in its appropriate use.
The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.
The complete text of the Medication Guide is reprinted at the end of this document. Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking imipramine pamoate. Clinical Worsening and Suicide Risk 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.
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. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication. There have been no well-controlled studies conducted with pregnant women to determine the effect of imipramine on the fetus.
However, there have been clinical reports of congenital malformations associated with the use of the drug. Although a causal relationship between these effects and the drug could not be established, the possibility of fetal risk from the maternal ingestion of imipramine cannot be excluded.
Therefore, imipramine should be used in women who are or might become pregnant only if the clinical condition clearly justifies potential risk to the fetus. Nursing Mothers Limited data suggest that imipramine is likely to be excreted in human breast milk.
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