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. You may report side effects to Health Canada at 1-866-234-2345. Cochrane Database Syst Rev. Side Effects. 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's currently no cure for depression, but plenty of treatment options can help keep symptoms at bay. Gastrointestinal Decontamination-A l patients suspected of tricyclic overdose should receive gastrointestinal decontamination. 2016 Jan 20;2016(1):CD002117. There were no additional adverse experiences identified in the elderly. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Dont stop taking this drug without talking to your doctor. You shouldnt use this drug if youve had a heart attack very recently. Stopping an antidepressant medicine suddenly can cause other symptoms. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. Inform your doctor if your condition lasts or gets worse. Your doctor may watch you more closely while youre taking this medication. Such reactions may necessitate discontinuation of the drug. Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. However, it does not act primarily by stimulation of the central nervous system. If consciousness is impaired, the airway should be secured prior to lavage. Examples include barbiturates (such as phenobarbital), cimetidine, haloperidol, certain drugs for heart rhythm (such as flecainide, propafenone), halofantrine, certain HIV protease inhibitors (such as fosamprenavir), phenothiazines (such as thioridazine), pimozide, certain anti-seizure drugs (such as phenytoin), trazodone, among others. The site is secure. Indication : Nocturnal enuresis Depression (off-label) Neuropathic pain Hyperactivity When it is desired to substitute Imipramine hydrochloride 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. Many drugs besides imipramine may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), sparfloxacin, among others. 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. Imipramine hydrochloride may potentiate the effects of CNS depressant drugs. You may need to decide whether to stop breastfeeding or stop taking this medication. However, it does not act primarily by stimulation of the central nervous system. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. To help avoid interactions, your doctor should manage all of your medications carefully. A patient Medication Guide about Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions is available for Imipramine hydrochloride. The mechanism of action of Imipramine hydrochloride is not definitely known. Always carry your medication with you. Patients of a l ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45 to 7.55. Hypomanic or manic episodes may occur, particularly in patients with cyclic disorders. Unauthorized use of these marks is strictly prohibited. This information is not a substitute for medical advice. No suicides occurred in any of the pediatric trials. Some may be better suited for you than others. That means you may need to take it with other medications. 2022 Nov 21. Antidepressant medicines have other side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, depression, memory problems), enlarged/painful breasts, unusual breast milk production, irregular/painful menstrual periods, muscle stiffness, restlessness, ringing in the ears, sexual problems (such as decreased sexual ability, changes in desire), shakiness (tremors), numbness/tingling of the hands/feet, pain/redness/swelling of arms or legs, trouble urinating, easy bruising/bleeding, signs of infection (such as sore throat that doesn't go away, fever), severe stomach/abdominal pain, dark urine, yellowing of eyes/skin. During pregnancy, this medication should be used only when clearly needed. Imipramine for neuropathic pain in adults. Our website services, content, and products are for informational purposes only. It treats depression by increasing the amounts of certain natural substances in the brain that are needed to maintain mental balance. 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. In children, dosage may also be based on body weight. The complete text of the Medication Guide is reprinted at the end of this document. official website and that any information you provide is encrypted Imipramine hydrochloride USP, the original tricyclic antidepressant, is a member of the dibenzazepine group of compounds. Families and caregivers should be advised of the need for close observation and communication with the prescriber. 2014 May 19;2014(5):CD010769. Hematologic: Bone marrow depression including agranulocytosis; eosinophilia; purpura; thrombocytopenia. 2023 May 26. QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. course of drug therapy, or at times of dose changes, either increases or decreases. Symptoms of an overdose of this drug can include: If you think youve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 1-800-222-1222 or through their online tool. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Manufactured For: Consideration should be given to instituting a drug free period following an adequate therapeutic trial with a favorable response. Simon GE, Heiligenstein J, Revicki D, VonKorff M, Katon WJ, Ludman E, Grothaus L, Wagner E. Arch Fam Med. Nevertheless, caution is indicated in the coadministration of TCAs with any of the SSRIs and also in switching from one class to the other. Examples of these drugs include: Disclaimer: Our goal is to provide you with the most relevant and current information. There are other drugs available to treat your condition. Prescriptions should be written for the smallest amount feasible. This medication does not work right away. Flowood, MS 39232, Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions. You may report side effects to FDA at 1-800- FDA-1088. Clipboard, Search History, and several other advanced features are temporarily unavailable. 25 mg Light orange, round, film coated, biconvex tablets debossed 426 on one side and O on the other. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Patients with a known hypersensitivity to this compound should not be given the drug. This drug may make you dizzy or drowsy or blur your vision. For this drug to work well, a certain amount needs to be in your body at all times. Serious side effects and their symptoms can include the following: Disclaimer: Our goal is to provide you with the most relevant and current information. Get medical help right away if you have any very serious side effects, including: chest pain, slow/fast/irregular heartbeat, fainting, seizures, trouble speaking, weakness on one side of the body, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night). An official website of the United States government. FOIA The clinical effect is hypothesized as being due to potentiation of adrenergic synapses by blocking uptake of norepinephrine at nerve endings. Keep it in your carry-on bag. Warnings nesses, and suicidal thoughts or actions? Examples of drugs that can cause interactions with imipramine are listed below. 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. For people with plans to have surgery: If you plan to have surgery, your doctor may tell you to stop taking this drug for a short time. Do not suddenly stop taking this medication without consulting your doctor. Dosages higher than 20 mg a day haven't been studied, and it's not known what . Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). You doctor may give you a lower dosage of imipramine. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium, or phenytoin. (Patients with any evidence of cardiovascular disease require cardiac surveillance at all dosage levels of the drug. Available for Android and iOS devices. Unlike sunscreen, you wont have to. Major depressive disorder is a mood disorder that interferes with daily life. For people with history of heart disease: If you have a history of heart failure, heart attack, stroke, or a fast heart rate, this drug may make your condition worse. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. The https:// ensures that you are connecting to the For pregnant women: The Food and Drug Administration (FDA) hasnt assigned a pregnancy category to imipramine. Drugs Metabolized by P450 2D6: The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7% to 10% of Caucasians are so-ca led "poor metabolizers"); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African, and other populations are not yet available. What to do if you miss a dose: Take your dose as soon as you remember. ), Animal reproduction studies have yielded inconclusive results (see also ANIMAL PHARMACOLOGY & TOXICOLOGY.). CONTRAINDICATIONS Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with Tofranil-PM or within 14 days of stopping treatment with Tofranil-PM is. Imipramine oral tablet may be used as part of a combination therapy. 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). TABLETS, USP 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. Since Imipramine hydrochloride may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as operating an automobile or machinery, the patient should be cautioned accordingly. 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. We avoid using tertiary references. Not a l antidepressant medicines prescribed for children are FDA approved for use in children. Side effects. Emesis is contraindicated. Do not store in the bathroom. PMC Children who relapse when the drug is discontinued do not always respond to a subsequent course of treatment. A class of drugs is a group of medications that work in a similar way. Using this medication to treat depression may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. Treasure Island (FL): StatPearls Publishing; 2023 Jan. This can be harmful or prevent the drug from working well. Learn about symptoms, causes, and treatment. Manufactured For: Obtain an ECG and immediately initiate cardiac monitoring. Talk to your doctor if you breastfeed your child. This activity reviews the indications, contraindications, activity, adverse events, and other key elements of imipramine therapy in the clinical setting as continuous monitoring of the drug and the acute management of tricyclic overdose. Check the labels on all your medicines (such as cough-and-cold products) because they may contain drowsiness-containing ingredients or decongestants that could increase your heart rate or blood pressure. It works by restoring the balance of certain natural substances (neurotransmitters such as norepinephrine) in the brain. Hyperpyretic crises or severe convulsive seizures may occur in patients receiving such combinations. In rare instances, hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity. These patients require cardiac surveillance at all dosage levels of the drug; patients with history of urinary retention, or history of narrow-angle glaucoma because of the drug's anticholinergic properties; hyperthyroid patients or those on thyroid medication because of the possibility of cardiovascular toxicity; patients with a history of seizure disorder because this drug has been shown to lower the seizure threshold; patients receiving guanethidine, clonidine, or similar agents, since Imipramine hydrochloride may block the pharmacologic effects of these drugs; patients receiving methylphenidate hydrochloride. This document does not contain all possible drug interactions. 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 we l as for other indications, both psychiatric and nonpsychiatric. Copyright 2023, StatPearls Publishing LLC. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. Use sunscreen and wear protective clothing when outdoors. Cardiac abnormalities may include tachycardia and signs of congestive failure. It may also cause other side effects. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). The effectiveness of treatment may decrease with continued drug administration. However, there have been clinical reports of congenital malformations associated with the use of the drug. The possibility of cross-sensitivity to other dibenzazepine compounds should be kept in mind. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness. ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount. Available in: Store at 20C to 25C (68 to 77F) [See USP Controlled Room Temperature]. In some cases, they may not be available in every strength or form as the brand-name drug. It should be noted that Imipramine hydrochloride is not approved for use in treating bipolar depression. Treasure Island (FL): StatPearls Publishing; 2023 Jan. Its also used as a part of treatment for enuresis (bed-wetting) in children. There have been no we l-controlled studies conducted with pregnant women to determine the effect of Imipramine hydrochloride on the fetus. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Tricyclic antidepressants were the first class of antidepressants shown to be effective in well-controlled studies. Cochrane Database Syst Rev. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate frequency. Cardiovascular-A maximal limb-lead QRS duration of 0.10 seconds may be the best indication of the severity of the overdose. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. breast swelling (in men or women). Imipramine hydrochloride should be discontinued if there is evidence of pathological neutrophil depression. Show More Uses This medication is used to treat depression. You should always consult your doctor or other healthcare professional before taking any medication. Before using imipramine, report all medications you are currently using to your doctor or pharmacist. A pH >7.60 or a pCO2 < 20 mmHg is undesirable. Does type 2 diabetes put you at a higher risk for depression? Endogenous depression is more likely to be alleviated than other depressive states. Visual problems: Only some people are at risk for these problems. Imipramine is a tricyclic antidepressant used to treat symptoms of 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. Post-marketing clinical experience has not identified differences in responses between the elderly and younger subjects. Bed-wetting is common for kids, and can be challenging for families. Psychiatric referral may be appropriate. CNS-In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Selected from data included with permission and copyrighted by First Databank, Inc. Imipramine should be used during pregnancy only if the potential benefit justifies the potential risk. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. If you have daytime drowsiness, your doctor may direct you to take the entire dose once daily at bedtime. . This can cause your body to process drugs more slowly. Imipramine hydrochloride may enhance the CNS depressant effects of alcohol. It is a tertiary amine tricyclic antidepressant. Both elevation and lowering of blood sugar levels have been reported with Imipramine hydrochloride use. Symptoms include agitation, delirium, coma, fast heart rate, dizziness, and sweating. In: StatPearls [Internet]. Imipramine oral tablet can interact with other medications, vitamins, or herbs you may be taking. Imipramine, an antidepressant; Midodrine, a medicine that constricts blood vessels; Chlorpheniramine and brompheniramine, antihistamines that help relieve allergies; Ephedrine, pseudoephedrine and phenylephrine, medicines that help relieve symptoms of the common cold; These medications help keep the bladder neck muscle closed during ejaculation. Last updated on Jul 1, 2022. Follow your doctor's instructions carefully. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. Key Therapeutics, LLC Dosage should be initiated at a low level and increased. 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