CYP1A2, CYP2C, CYP2D6, CYP3A4. Nausea and vomiting, anorexia, epigastric distress, diarrhea; peculiar taste, stomatitis, abdominal cramps, black tongue. Cardiac abnormalities may include tachycardia and signs of congestive failure. Respiratory depression, cyanosis, shock, vomiting, hyperpyrexia, mydriasis, and diaphoresis may also be present. Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. 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.
However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. It is not known whether imipenem-cilastatin sodium is excreted in human milk. Imipramine hydrochloride tablets, USP may enhance the CNS depressant effects of alcohol. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. 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. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
Avoid exposure to sunlight or tanning beds. Imipramine can make you sunburn more easily. Wear protective clothing and use sunscreen SPF 30 or higher when you are outdoors. Animal reproduction studies have yielded inconclusive results. 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.
Dosage adjustment may be required when given concomitantly with methylphenidate. Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments. a b i j k See Worsening of Depression and Suicidality Risk under Cautions. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or planned surgery. Inhibitors of CYP2D6: Potential pharmacokinetic interaction increased plasma imipramine concentrations. a b Consider imipramine dosage adjustment whenever a CYP2D6 inhibitor is added or discontinued.
Pain at the injection site--0. Do not take an MAOI within 2 weeks of stopping Imipramine hydrochloride tablets, USP unless directed to do so by your physician. The total daily maintenance 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. 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. 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. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. 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. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Both elevation and lowering of blood sugar levels have been reported with Imipramine hydrochloride use. 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. Discuss the risks and benefits with your doctor. P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interaction may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the coadministration of TCAs with any of the SSRIs and also in switching from one class to the other. 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.
Has been used for the short-term management of acute depressive episodes in bipolar disorder. It is generally recommended that Imipramine Pamoate should not be used in children because of the increased potential for acute overdosage due to the high unit potency 75 mg, 100 mg, 125 mg, and 150 mg. Each capsule contains Imipramine Pamoate equivalent to 75 mg, 100 mg, 125 mg, or 150 mg imipramine hydrochloride. Anyone considering the use of Imipramine Pamoate in a child or adolescent must balance the potential risks with the clinical need. Treatment with Imipramine Pamoate and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated. Tablets 50 mg - round, green, compressed, film-coated tablet, debossed with "EP" and "135" on one side and plain on the other side. Food and Drug Administration. Antidepressant use in children, adolescents, and adults: class revisions to product labeling. Long-term, chronic use not recommended; gradually discontinue therapy following a period of satisfactory response. a To minimize risk of relapse, avoid abrupt discontinuance of therapy. In children with enuresis: Nervousness, sleep disorders, tiredness, mild GI disturbances. Oral: Independent studies in three species rat, mouse, and rabbit revealed that when Tofranil is administered orally in doses up to approximately 2 ½ 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 essentiality free from teratogenic potential. 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. Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. Dispense in tight container USP with a child-resistant closure. In the literature, there were four well-controlled, randomized, double-blind, parallel group comparison clinical studies done with Tofranil 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.
In my 74th year I have suffered for over 35 years with epigastric pain. I formerly had a resection of lower colon for diverticulosis in 1994. I suffered from debilitation abdominal pain almost ecvery day. By chance, a friend was taking this drug for depression and offered me a pill at bed time and said it will make "Me sleep better. Went on Imipramine for 1 year, then went off when wanted to have 2nd baby. Developed Irritable Bowel Syndrome. Went back on Imipramine as it is constipating and doctor thought I should try this pill again as I was better on it. Now 21 years later I still take a very low dosage 20 mg for my IBS. There are, however, no adequate and well-controlled studies in pregnant women. The MONOVIAL vial is not compatible with the ADD-Vantage diluent bags. 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. Patients with any evidence of cardiovascular disease require cardiac surveillance at all dosage levels of the drug.
Trying to focus at work was impossible. REM sleep was non-existent. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis. Possible conduction defects, arrhythmias, CHF, MI, strokes, and tachycardia, particularly at higher dosages. This dose should be given one hour before bedtime. Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. 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. Use a new patch each day, applying it at the same time each day to help you remember, usually when you wake up. After several weeks, you will gradually lower your dose strength of patch until you no longer need nicotine replacement. It is important to complete the treatment with this medication 8 to 10 weeks. Depending on the dosage in both species, toxic signs proceeded progressively from depression, irregular respiration and ataxia to convulsions and death. Many drugs can interact with imipramine. Not all possible interactions are listed here. How should I take imipramine Tofranil? 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.
Titrate dosage carefully. c See Geriatric Patients under Dosage and Administration. Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of imipramine and vice versa. a b Also allow at least 5 weeks to elapse when switching from fluoxetine. 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. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants TCAs when given usual doses. 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. Prior to elective surgery, Imipramine Pamoate should be discontinued for as long as the clinical situation will allow. Do not consider WebMD User-generated content as medical advice. Never delay or disregard seeking professional medical advice from your doctor or other qualified healthcare provider because of something you have read on WebMD. You should always speak with your doctor before you start, stop, or change any prescribed part of your care plan or treatment. WebMD understands that reading individual, real-life experiences can be a helpful resource but it is never a substitute for professional medical advice, diagnosis, or treatment from a qualified health care provider. If you think you may have a medical emergency, call your doctor or dial 911 immediately. Therefore, close adherence to the dosing guidelines for these patients is recommended. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Patients should be advised that taking Imipramine Pamoate can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Tolerance tachyphylaxis to therapeutic effects possible with continuous administration of imipramine; consider instituting a drug-free period following an adequate therapeutic trial with favorable response.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed See How to Use section. NDC 0006-3666-59 in trays of 25 MONOVIAL vials. ADD-Vantage vials and reconstituted with the following diluents see maintains satisfactory potency for 4 hours at room temperature. 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. Such patients should be carefully supervised during the early phase of treatment with Tofranil, and may require hospitalization. Prescriptions should be written for the smallest amount feasible. Hypomanic or manic episodes may occur, particularly in patients with cyclic disorders. Such reactions may necessitate discontinuation of the drug. If needed, Tofranil may be resumed in lower dosage when these episodes are relieved. However, there have been reports of CNS adverse experiences in patients who had no recognized or documented underlying CNS disorder or compromised renal function. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis". Allergic: Skin rash, petechiae, urticaria, itching, photosensitization; edema general or of face and tongue; drug fever; cross-sensitivity with desipramine. Consult your doctor before -feeding. Stop using this product and tell your doctor if redness caused by the patch does not go away after 4 days. Not all antidepressant medicines prescribed for children are FDA approved for use in children. What should I avoid while taking imipramine Tofranil? Food does not affect absorption.
Sustained therapy may be required; administer lowest effective dosage and monitor periodically for need for continued therapy. The doctor gave me an additional 25 mg. each nite until I reached 100 mg. I cannot express what it was like to finally sleep, really sleep. I still remember having my 1st dream in years! Imipenem has in vitro activity against a wide range of gram-positive and gram-negative organisms. Imipenem has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections treated with the intravenous formulation of imipenem-cilastatin sodium as described in the section. Initially, 75 mg daily. a b May increase dosage to 150 mg daily and then if necessary to 200 mg daily. 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. Human studies show no definitive effect on sperm count, sperm motility, sperm morphology or volume of ejaculate. Food and Drug Administration. Medication guide: about using antidepressants in children or teenagers. Tofranil is a trademark of Mallinckrodt Inc. Nicotine and may harm an unborn baby.
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Food and Drug Administration. Use with caution and under close supervision in hyperthyroid patients or patients receiving thyroid agents; possible adverse cardiovascular effects. 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.
Possible pharmacokinetic decreased imipramine metabolism interaction with methylphenidate; imipramine dosage adjustments may be required. ECG changes, precipitation of congestive heart failure, stroke. FDA warns that a greater risk of suicidal thinking or behavior suicidality occurred during first few months of antidepressant treatment 4% compared with placebo 2% in children and adolescents with major depressive disorder, OCD, or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs SSRIs and others.
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Imipramine Pamoate. Maximum 300 mg daily. Excreted principally in urine as inactive metabolites within 24 hours 40% and within 72 hours 70%; small amounts excreted in feces via biliary elimination. Parenteral: In contradistinction to the oral data, Tofranil does exhibit a slight but definite teratogenic potential when administered by the subcutaneous route. Drug effects on both the mother and fetus in the rabbit are manifested in higher resorption rates and decrease in mean fetal birth weights, while teratogenic findings occurred at a level of 5 times the maximum human dose. In the mouse, teratogenicity occurred at 1 ½ and 6 ½ times the maximum human dose, but no teratogenic effects were seen at levels 3 times the maximum human dose. Thus, in the mouse, the findings are equivocal.
Risk of concomitant use with alcohol. 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. Lowers seizure threshold; use with caution in patients with a history of seizures.