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. Emesis is contraindicated. Bridge JA, Iyengar S, Salary CB. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. JAMA. Elderly patients and patients with cardiac disease or a prior history of cardiac disease are at special risk of developing the cardiac abnormalities associated with the use of Tofranil.
Clinical studies of Imipramine hydrochloride tablets, USP in the original application did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Post-marketing clinical experience has not identified differences in responses between the elderly and younger subjects. In general, dose selection for the elderly should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This dose should be given one hour before bedtime.
Since methylphenidate hydrochloride may inhibit the metabolism of Imipramine hydrochloride tablets, USP, downward dosage adjustment of Imipramine hydrochloride may be required when given concomitantly with methylphenidate hydrochloride. There have been no well-controlled studies conducted with pregnant women to determine the effect of Imipramine hydrochloride tablets, USP 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 hydrochloride tablets, USP cannot be excluded. Therefore, Imipramine hydrochloride tablets, USP should be used in women who are or might become pregnant only if the clinical condition clearly justifies potential risk to the fetus.
Prior to elective surgery, Imipramine hydrochloride should be discontinued for as long as the clinical situation will allow. In the literature, there were four well-controlled, randomized, double-blind, parallel group comparison clinical studies done with Imipramine Pamoate in the elderly population. There was a total number of 651 subjects included in these studies. These studies did not provide a comparison to younger subjects. There were no additional adverse experiences identified in the elderly. You be the judge.
Aylward GP. Understanding and treatment of childhood depression. J Pediatr. Use with caution in patients with moderate to severe renal impairment. The safety and effectiveness of Tofranil as temporary adjunctive therapy for nocturnal enuresis in children less than 6 years of age has not been established. What happens if I miss a dose Tofranil? Efficacy for this organism in this organ system was studied in fewer than 10 infections. 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. 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. See Bipolar Disorder under Cautions.
Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients as compared to hospitalized patients who will be under close supervision. Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time, at the lowest dose that will maintain remission. May block hypotensive actions of clonidine, guanethidine, and similar agents. Yellow No. 5. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze. Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking imipramine hydrochloride. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Hemodialysis, peritoneal dialysis, exchange transfusions and forced diuresis have been generally reported as ineffective because of the rapid fixation of imipramine in tissues. Blood and urine levels of imipramine may not correlate with the degree of intoxication, and are unreliable indicators in the clinical management of the patient. 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. Blood and urine levels of imipramine may not reflect the severity at poisoning; they have chiefly a qualitative rather than quantitative value, and are unreliable indicators in the clinical management of the patient. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs. Withdrawal Symptoms: Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise. Concurrent administration of Tofranil with electroshock therapy may increase the hazards; such treatment should be limited to those patients for whom it is essential, since there is limited clinical experience. Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. As an aside, i got a warning letter in the mail about this drug. As a old cynic watching the money cycle in drug companies, I think the drug companies sent this out to get you on a more expensive anti-depressent. that is its primary use I am told. This drug is cheap and I guess their monopoly on it has expired. Big Pharma's motto is "Make as much as you can as fast as you can. Open-angle glaucoma is not a risk factor for angle-closure glaucoma.
Whether any of the symptoms described above represent such a conversion is unknown. However, 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; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that Imipramine Pamoate is not approved for use in treating bipolar depression. The safety of the drug for long-term, chronic use as adjunctive therapy for nocturnal enuresis in pediatric patients 6 years of age or older has not been established; consideration should be given to instituting a drug-free period following an adequate therapeutic trial with a favorable response. Depending on the histological section of the testes examined, the findings consisted of a range of degenerative changes up to and including complete atrophy of the seminiferous tubules, with spermatogenesis usually arrested. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.
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. In enuretic children treated with Imipramine hydrochloride tablets, USP the most common adverse reactions have been nervousness, sleep disorders, tiredness, and mild gastrointestinal disturbances. These usually disappear during continued drug administration or when dosage is decreased. Other reactions which have been reported include constipation, convulsions, anxiety, emotional instability, syncope, and collapse. All of the adverse effects reported with adult use should be considered. Neurological: Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alterations in EEG patterns; tinnitus. Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache and malaise. Food and Drug Administration. Medication guide: about using antidepressants in children or teenagers. Food and Drug Administration. WebMD does not endorse any specific product, service, or treatment. See Worsening of Depression and Suicidality Risk under Cautions. Lower respiratory tract infections. This can help you by replacing the nicotine in cigarettes. Perform baseline ECG prior to initiation of therapy with larger than usual dosages and at periodic intervals thereafter until steady-state imipramine concentrations are achieved. Limited data suggest that imipramine is likely to be excreted in human breast milk. 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. 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. Postmarketing clinical experience has not identified differences in responses between the elderly and younger subjects. In general, dose selection for the elderly should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. There is no evidence that higher doses provide greater efficacy.
Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Obtain leukocyte and differential blood counts if fever and sore throat develop during therapy. For children who are early-night bed-wetters, better results may be obtained by administering 25 mg in midafternoon and again at bedtime. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Quinidine may cause a condition that affects the rhythm QT prolongation. Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6. 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.
The total daily dosage can be administered on a once-a-day basis, preferably at bedtime. In some patients it may be necessary to employ a divided-dose schedule. One three-month study was done in rats at dosage levels comparable to those of the dog studies. No adverse drug effect on the testes was noted in this study, as confirmed by histological examination. ECG changes of unknown clinical importance reported in pediatric patients receiving twice the recommended maximum daily dosage for enuresis. Consult WARNINGS section for additional precautions. As with all tricyclics, the antidepressant effect of imipramine may not be evident for one to three weeks in some patients. Anyone considering the use of this drug 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. Whether any of the symptoms described above represent such a conversion is unknown. However, 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; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that imipramine hydrochloride is not approved for use in treating bipolar depression. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Tofranil and are trademarks of Mallinckrodt Inc.
Sustained therapy may be required; administer lowest effective dosage and monitor periodically for need for continued therapy. Individualize dosage carefully according to individual requirements and response. Caution should be exercised when imipramine hydrochloride is used with agents that lower blood pressure. Imipramine hydrochloride may potentiate the effects of CNS depressant drugs. Has been used for the short-term management of acute depressive episodes in bipolar disorder. ECG at baseline and as appropriate during therapy. Do not use the patch if the individual pouch is open or damaged or if the patch is cut, torn, or damaged. Apply the patch to a different area on your body each time to avoid irritation. Wait at least a week before using the same application site. Apply a new patch if your patch falls off. In the alert patient, empty the stomach promptly by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage do not induce emesis. Instillation of activated charcoal slurry may help reduce absorption of imipramine. MAO inhibitor. a b See Specific Drugs under Interactions. Do not stop taking any medications without consulting your healthcare provider. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Therefore, close adherence to the dosing guidelines for these patients is recommended. Imipramine is used to treat symptoms of depression. Imipramine is sometimes used to treat bed-wetting in children ages 6 and older. Dosage adjustment may be required when given concomitantly with anticholinergic drugs. Measurement of MIC or minimum bactericidal concentration MBC and achieved antimicrobial compound concentrations may be appropriate to guide therapy in some infections. See section for further information on drug concentrations achieved in infected body sites and other pharmacokinetic properties of this antimicrobial drug product. In the literature, there were four well-controlled, randomized, double-blind, parallel group comparison clinical studies done with Imipramine hydrochloride tablets, USP in the elderly population. There was a total number of 651 subjects included in these studies. These studies did not provide a comparison to younger subjects. There were no additional adverse experiences identified in the elderly. Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. The daily dosage may be given at bedtime. In some patients it may be necessary to employ a divided-dose schedule. Cardiac abnormalities may include tachycardia and signs of congestive failure, Respiratory depression, cyanosis, shock, vomiting, hyperpyrexia, mydriasis, and diaphoresis may also be present. Parenteral administration should be used only for starting therapy in patients unable or unwilling to use oral medication. The oral form should supplant the injectable as soon as possible. The concomitant use of Imipramine Pamoate capsules with MAOIs intended to treat psychiatric disorders is contraindicated. Imipramine Pamoate should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. When comparable doses of imipenem-cilastatin sodium were given to non-pregnant rabbits, body weight loss, diarrhea, and deaths were also observed. This intolerance is not unlike that seen with other beta-lactam antibiotics in this species and is probably due to alteration of gut flora. Tofranil is a trademark of Mallinckrodt Inc. Trying to focus at work was impossible. REM sleep was non-existent. Imipramine Pamoate should be used with caution in patients with significantly impaired renal or hepatic function.
Tyco healthcare-Mallinckrodt. Tofranil-PM imipramine pamoate prescribing information. 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. However, evidence does exist from the rat studies that some systemic and embryotoxic potential is demonstrable. This is manifested by reduced litter size, a slight increase in the stillborn rate, and a reduction in the mean birth weight. Imipramine may also be used for purposes not listed in this medication guide. Minimize external stimulation to reduce the tendency to convulsions. If anticonvulsants are necessary, diazepam and phenytoin may be useful. MAOI. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid. SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY ANAPHYLACTIC REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING THERAPY WITH BETA-LACTAMS. THESE REACTIONS ARE MORE APT TO OCCUR IN PERSONS WITH A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. 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. Prescriptions for Imipramine Pamoate should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose. Safety and effectiveness in the pediatric population other than pediatric patients with nocturnal enuresis have not been established see and . Anyone considering the use of imipramine hydrochloride in a child or adolescent must balance the potential risks with the clinical need. Tofranil may enhance the CNS depressant effects of alcohol. Therefore, it should be borne in mind that the dangers inherent in a suicide attempt or accidental overdosage with the drug may be increased for the patient who uses excessive amounts of alcohol. See PRECAUTIONS. Funny, I am not depressed at all, have a great life as a retired professional, have a boat, many homes, cars and doing just fine. I had MRIs cat scans, barium swallows etc. etc. and they found nothing. I short, I have my life back. The only down side is that I wake up early 4AMsometimes and feel a tad tired in the late afternoon. Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be coadministered with another drug known to be an inhibitor of P450 2D6. Your dosage may need to be adjusted. Less effective for insomnia and associated with more serious adverse reactions than conventional hypnotics. Do not take an MAOI within 2 weeks of stopping Tofranil unless directed to do so by your physician. Caution should be exercised when Imipramine hydrochloride is used with agents that lower blood pressure. Imipramine hydrochloride may potentiate the effects of CNS depressant drugs. Elderly patients and patients with cardiac disease or a prior history of cardiac disease are at special risk of developing the cardiac abnormalities associated with the use of imipramine hydrochloride.
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. An equivalent amount of cilastatin is also present in the solution. Each 125 mg, 250 mg, or 500 mg dose should be given by intravenous administration over 20 to 30 minutes. Each 750 mg or 1000 mg dose should be infused over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed. Where can I get more information? Talk to your doctor about using quinidine safely. Gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; inappropriate antidiuretic hormone ADH secretion syndrome. Food and Drug Administration.
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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 antidepressant drugs require that each of the reactions be considered when Imipramine hydrochloride tablets, USP is administered. Food and Drug Administration. Revisions to medication guide: antidepressant medicines, depression and other serious mental illnesses and suicidal thoughts or actions. This is used to treat or prevent many types of irregular heartbeats arrhythmias such as . can greatly improve your ability to perform normal activities by decreasing the number of irregular heartbeats you have. However, it may not stop all your irregular heartbeats completely. It works by blocking abnormal heartbeat signals.
What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 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. A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Imipramine hydrochloride. 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.
Do not Imipramine hydrochloride tablets, USP if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician. This drug is not approved for use in pediatric patients. CNS abnormalities may include drowsiness, stupor, coma, ataxia, restlessness, agitation, hyperactive reflexes, muscle rigidity, athetoid and choreiform movements, and convulsions. Patients who develop a fever and a sore throat during therapy with imipramine hydrochloride should have leukocyte and differential blood counts performed. Imipramine hydrochloride should be discontinued if there is evidence of pathological neutrophil depression.
Therapy in these age groups should be initiated with Imipramine Pamoate tablets at a total daily dosage of 25 to 50 mg, since Imipramine Pamoate capsules are not available in these strengths. ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount. The recommended treatment for overdosage with tricyclic antidepressants may change periodically. Therefore, it is recommended that the physician contact a poison control center for current information on treatment. Because CNS involvement, respiratory depression and cardiac arrhythmia can occur suddenly, hospitalization and close observation may be necessary, even when the amount ingested is thought to be small or the initial degree of intoxication appears slight or moderate. All patients with ECG abnormalities should have continuous cardiac monitoring and be closely observed until well after cardiac status has returned to normal; relapses may occur after apparent recovery.