Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Whitby, Ontario, Canada Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Psychiatric Follow-up Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Mallinckrodt, NDC 0406-9922-03 Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking imipramine hydrochloride. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1. Tell your doctor right away if you get sunburned or have skin blisters/redness. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. Dosage should be tapered off gradually rather than abruptly discontinued; this may reduce the tendency to relapse. 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). Other: Jaundice (simulating obstructive); altered liver function; weight gain or loss; perspiration; flushing; urinary frequency; drowsiness, dizziness, weakness and fatigue; headache; parotid swelling; alopecia; proneness to falling. WebMD does not provide medical advice, diagnosis or treatment. Tofranil is a tricyclic antidepressant that can be used to treat the symptoms of ADHD in those 12 and older. Suicidality and Antidepressant Drugs . The complete text of the Medication Guide is reprinted at the end of this document. Never stop an antidepressant medicine without first talking to a healthcare provider. Last updated on Sep 23, 2021. Imipramine Hydrochloride USP . A graduate of George Washington University and Harvard University, she also works as a mental health journalist. Acute: Oral LD50 ranges are as follows: Depending on the dosage in both species, toxic signs proceeded progressively from depression, irregular respiration and ataxia to convulsions and death. An extended-release form taken once a day might cause fewer 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. On This Page Boxed Warning Description Clinical Pharmacology Indications and Usage Contraindications Warnings Precautions Patient Counseling Information Drug Interactions Neurological: Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alterations in EEG patterns; tinnitus. Older adults may be more sensitive to the side effects of this drug, especially dizziness (more likely when standing up), drowsiness, constipation, trouble urinating, mental/mood changes (such as confusion, agitation) and heart effects such as QT prolongation (see above). Tell your doctor if you smoke or if you have recently stopped smoking. If needed, Tofranil may be resumed in lower dosage when these episodes are relieved. Outpatients Initially, 75 mg/day increased to 150 mg/day. Screening Patients for Bipolar Disorder . However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. It may take up to 3 weeks before you experience the full benefits if you are taking this medication for depression. Mayo Clinic on Incontinence - Mayo Clinic Press, Mayo Clinic on Hearing and Balance - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. 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. Common side effects of Tofranil can include: If you experience major side effects, report them to your doctor immediately and stop using the medication. Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in consultation with a poison control center. Take the dose of Tofranil when you remember, but skip the missed dose if it is almost time for your next dose. The optimal dosage varies patient by patient. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. 2005 - 2023 WebMD LLC, an Internet Brands company. Drug interactions may change how your medications work or increase your risk for serious side effects. Each tablet contains: Since untreated mental/mood problems (such as depression, anxiety, panic disorders) can be a serious condition, do not stop taking this medication unless directed by your doctor. 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 Tofranil may block the pharmacologic effects of these drugs; patients receiving methylphenidate hydrochloride. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: What else do I need to know about antidepressant medicines? ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount. We comply with the HONcode standard for trustworthy health information. After deciding on an initial dose, your doctor may adjust your daily dosage by increments until you experience the best response that is, the lowest dosage at which you experience the greatest improvement in symptoms without side effects. Do not take medications containing desipramine while using imipramine. See WARNINGS.) Tofranil is a tricyclic antidepressant and brand name of the drug imipramine. If you have diabetes, this drug may make it harder to control your blood sugar. Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (e.g., phenobarbital, phenytoin). If no response after two weeks, increase to 250 to 300 mg/day. 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. Both forms are taken by mouth. Lower dosages are recommended for elderly patients and adolescents. Prescriptions for imipramine hydrochloride should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible. There were no additional adverse experiences identified in the elderly. Hyperpyretic crises or severe convulsive seizures may occur in patients receiving such combinations. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). L1N 5Z5, Manufactured for: Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Note 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 Tofranil is administered. Other medications can affect the removal of imipramine from your body, which may affect how imipramine works. Infants born to mothers who have taken similar medications during pregnancy may have symptoms such as trouble urinating, prolonged sleepiness, shaking, and seizures. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Patients taking imipramine hydrochloride should avoid excessive exposure to sunlight since there have been reports of photosensitization. It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed. Uses. Withdrawal Symptoms: Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise. ADHD Medications for Children, Teens, and Adults, Marketa Marvanova, PharmD, PhD, BCGP, BCPP, FASCP, Aptensio XR (methylphenidate HCI Extended Release), Ritalin (methylphenidate): ADHD Stimulant Medication, Daytrana (methylphenidate transdermal system), What to Expect From A First Therapy Session, Forgiveness: How to Let Go of Hurt So You Can Feel Better in 11 Steps, Happy Birthday Psycom: The 10 Most Meaningful Advances in Mental Health Since 1996, Am I "Normal"? ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount. Tofranil can be effective for adults with ADHD and in treating symptoms of depression and anxiety that often accompany ADHD. information and will only use or disclose that information as set forth in our notice of Does Tofranil 50 Mg Tablet interact with other drugs you are taking? imipramine hydrochloride tablets USP Imipramine (Tofranil) Nortriptyline (Pamelor) Generally continue these agents perioperatively, particularly in patients on higher doses. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. 1. phone Need help? The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. You may opt-out of email communications at any time by clicking on However, evidence does exist from the rat studies that some systemic and embryotoxic potential is demonstrable. Lower dosages are recommended for elderly patients and adolescents. Imipramine is used to treat depression. Hematologic: Bone marrow depression including agranulocytosis; eosinophilia; purpura; thrombocytopenia. 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. Some products that may interact with this drug include: certain drugs for high blood pressure (such as clonidine, guanadrel, guanethidine), digoxin, disopyramide, thyroid supplements, valproic acid. Endogenous depression is more likely to be alleviated than other depressive states. Monitoring of plasma drug levels should not guide management of the patient. The medication is also sometimes used to treat symptoms of hyperactivity and impulsivity in patients with attention deficit hyperactivity disorder when traditional medications are ineffective. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 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. Tofranil is a tricyclic antidepressant and brand name of the drug imipramine. The drug is contraindicated during the acute recovery period after a myocardial infarction. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE Do not share this medication with others. You can take it 30 minutes to 4 hours before sexual activity. Following remission, maintenance medication may be required for a longer period of time, at the lowest dose that will maintain remission. Drug class: Tricyclic antidepressants. Consult your doctor before breast-feeding. Parenteral administration should be used only for starting therapy in patients unable or unwilling to use oral medication. 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. While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. According to goodrx.com, 30 tablets of 25 mg Tofranil cost approximately $430. imipramine hydrochloride tablets USP Both elevation and lowering of blood sugar levels have been reported with imipramine hydrochloride use. If you have any questions, ask your doctor or pharmacist. To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose. These medicines are thought to work by increasing the activity of a chemical called serotonin in the brain. B. Reproduction/Teratogenic: The overall evaluation may be summed up in the following manner: Oral: Independent studies in three species (rat, mouse, and rabbit) revealed that when Tofranil is administered orally in doses up to approximately 2-1/2 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 teratogenic potential. 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. Using this medication to treat depression . 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. Such patients should be carefully supervised during the early phase of treatment with Tofranil, and may require hospitalization. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. Do not store in the bathroom. A dose of 2.5 mg/kg/day should not be exceeded. A pH >7.60 or a pCO2 <20 mmHg is undesirable. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Kathleen Smith, PhD, is a licensed professional counselor, author, and freelance writer. Imipramine hydrochloride should be used with caution in patients with significantly impaired renal or hepatic function. A daily dose greater than 75 mg does not enhance efficacy and tends to increase side effects. Other CNS manifestations may include drowsiness, stupor, ataxia, restlessness, agitation, hyperactive reflexes, muscle rigidity, athetoid and choreiform movements. ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount. Emesis is contraindicated. 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 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. The potentiation of adverse effects can be serious, or even fatal. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide). Generic name: IMIPRAMINE HYDROCHLORIDE 10mg Lower dosages are also recommended for outpatients as compared to hospitalized patients who will be under close supervision. If you are a Mayo Clinic patient, this could Outpatients Initially, 75 mg/day increased to 150 mg/day. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. Dosage should be tapered off gradually rather than abruptly discontinued; this may reduce the tendency to relapse. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. You may report side effects to FDA at 1-800-FDA-1088. The clinical effect is hypothesized as being due to potentiation of adrenergic synapses by blocking uptake of norepinephrine at nerve endings. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. These studies did not provide a comparison to younger subjects. In Canada - Call your doctor for medical advice about side effects. Medically reviewed by Drugs.com. Tofranil 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). Patients are also advised not to drink alcohol while taking the medication. Pediatric Management The principles of management of child and adult overdosages are similar. 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-called poor metabolizers); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African, and other populations are not yet available. information is beneficial, we may combine your email and website usage information with However, hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in tricyclic poisoning. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Allergic: Skin rash, petechiae, urticaria, itching, photosensitization; edema (general or of face and tongue); drug fever; cross-sensitivity with desipramine. Talk to your pharmacist for more details. Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. A. Imipramine oral tablet is available as a brand-name drug and a generic 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 Tofranil cannot be excluded. Depression: For symptoms associated with depression, a dose of Tofranil, initially, is 75 mg. The oral form should supplant the injectable as soon as possible. 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. Otherwise, call a poison control center right away. Hypomanic or manic episodes may occur, particularly in patients with cyclic disorders. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. 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. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. This Medication Guide has been approved by the U.S. Food and Drug Administration. If no response after two weeks, increase to 250 to 300 mg/day. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Tadalafil (Cialis). 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. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. It is not recommended that antidepressant use is stopped abruptly, so talk to your doctor before you discontinue use and seek medical attention if necessary. The typical dosage ranges between 75 mg and 150 mg daily, and doses above 300 mg are not recommended. Cause allergic reactions or other problems psychiatric Follow-up Since overdosage is often,. Type 1A and 1C antiarrhythmics are Generally contraindicated ( e.g., phenobarbital, phenytoin ) occur in unable. Period after a myocardial infarction University, she also works as a brand-name drug and a generic drug daily... ) Generally continue these agents perioperatively, particularly in patients with doses tofranil dosage viagra jelly amount... Comparison to younger subjects mg and 150 mg daily, and freelance writer need for close observation and with. For a longer period of time, at the lowest dose that will maintain remission on books and from! Number was not sufficient to reach any conclusion about drug effect on suicide and Harvard University, she works. Tofranil when you remember, but the number was not sufficient to reach any conclusion about drug effect suicide. If no response after two weeks, increase to 250 to 300 mg/day have recently stopped.. Dosage should be tapered off gradually rather than abruptly discontinued ; this may reduce the tendency to.! An Internet Brands company, especially if you have any questions, ask your doctor away! 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