تریمیپرامین
Trimipramine (Surmontil)
تریمیپرامین

نام ژنریک

Trimipramine

شکل دارویی

اشكال دارويي:


Tablet: 25, 100mg


Drop: 4%

موارد مصرف

موارد و مقدار مصرف


افسردگي


بزرگسالان: 150-50 ميلي‌گرم در روز به صورت يك جا در هنگام خواب تا حداكثر 200 ميلي‌گرم در روز در بيماران سرپائي و 300 ميلي‌گرم در روز در بيماران بستري


مكانيسم اثر


دارو از طريق مهار باز جذب سروتونين و يا نوراپينفرين باعث افزايش غلظت آن‌ها در فضاي بين سيناپسي مي‌گردد.

موارد منع مصرف

عوارض جانبي


به تك‌نگار آمي تريپتيلين مراجعه شود.


مسموميت و درمان


به تك‌نگار آمي تريپتيلين مراجعه شود.

موارد قابل توجه

-

مکانیزم اثر

فارماكوكینتیك

موارد منع مصرف و احتياط


موارد منع مصرف: سابقه حساسيت به دارو يا اجزاء فرمولاسيون، استفاده از مهار كننده‌هاي MAO در فاصله كمتر از 14 روز، بيماران در فاز بهبود MI.


موارد احتياط: افكار خودكشي.


تداخل دارويي


در افراد دريافت كننده تريميپرامين استفاده از اپي نفرين، نوراپي نفرين و فنيل‌افرين وريدي اثرات تنگي عروق بيشتري ايجاد مي‌كنند.


تريميپيرامين اثر دارو‌هاي كولينرژيك‌، تضعيف كننده‌هاي CNS و وارفارين را افزايش مي‌دهد.


مصرف همزمان تريميپرامين با مهار كننده‌هاي MAO باعث بروز سندرم سروتونين مي‌شود.


مهار كننده‌هاي CYP2C19 و 9 CYP2D6 و CYP3A4 باعث كاهش اثرات تريميپرامين مي‌شوند.


استفاده از همزمان ليتيوم با داروها‌ي سه حلقه‌اي ضد افسردگي باعث افزايش عوارض سميت عصبي مي‌شود.


القاء كننده‌هاي ‍‍ CYP2C19 و CYP3A4 باعث كاهش اثرات تريميپرامين مي‌شوند.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: ضد افسردگي سه حلقه‌اي.


طبقه‌بندي درماني: ضد اقسردگي.


طبقه‌بندي مصرف در بارداري: رده ‍C


ملاحظات اختصاصي


1- قبل از شروع درمان و در حين درمان فشار خون و تعداد ضربان قلب بايد بررسي شود.


2- بيمار بايد از لحاظ رواني و افكار خودكشي در شروع درمان و در هر بار افزايش دوز بايد بررسي شود.


3- در سالمندان مصرف دارو همراه با بررسي ECG انجام شود.


4- جهت كاهش عوارض گوارشي مصرف دارو با غذا توصيه مي‌شود.


نكات قابل توصيه به بيمار


1- به دليل احتمال بروز خواب آلودگي از انجام كارهائي كه نياز به هوشياري كامل دارند خودداري شود.


2- بيمار را از تأخير شروع اثرات درماني آگاه سازيد.


3- به دليل احتمال بروز يبوست شديد و احتباس ادراري به خصوص در افراد مسن، توصيه به مصرف مايعات كافي و نرم كننده‌هاي مدفوع ضروري است.


مصرف در سالمندان:


به دليل حساسيت سالمندان به بروز عوارض ناخواسته دارويي دوز مصرفي در ايشان بايد كاهش داده شود.


مصرف در كودكان: تجويز اين دارو در كودكان توصيه نمي‌شود.


مصرف در شيردهي: تجويز اين دارو در دوران شيردهي توصيه نمي‌شود.


توجه: جهت اطلاعات تكميلي به تك نگار Amitriptyline مراجعه شود.

Trimipramine (Surmontil)

SURMONTIL®
(trimipramine maleate) Tablets

Suicidality and Antidepressant Drugs

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. Anyone considering the use of Surmontil 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. Surmontil is not approved for use in pediatric patients. (See WARNINGS - Clinical Worsening and Suicide Risk, PATIENT INFORMATION, and PRECAUTIONS -Pediatric Use)

DRUG DESCRIPTION

Surmontil (trimipramine maleate) is 5-(3-dimethylamino-2-methylpropyl)-10,11-dihydro-5Hdibenz (b,f) azepine acid maleate (racemic form).

SURMONTIL® (Trimipramine Maleate) Structural Formula Illustration

Molecular Formula: C20H26N2 •C4H4O4   Molecular Weight: 410.5

Surmontil capsules contain trimipramine maleate equivalent to 25 mg, 50 mg, or 100 mg of trimipramine as the base. The inactive ingredients present are black ink, FD&C Blue 1, gelatin, lactose, magnesium stearate, and titanium dioxide. The 25 mg dosage strength also contains benzyl alcohol, D&C Yellow 10, edetate calcium disodium, FD&C Yellow 6, parabens (butyl, propyl and methyl), sodium lauryl sulfate, and sodium propionate; the 50 mg dosage strength also contains benzyl alcohol, D&C Red 28, edetate calcium disodium, FD&C Red 40, FD&C Yellow 6, parabens (butyl, propyl and methyl), sodium lauryl sulfate, and sodium propionate.

Trimipramine maleate is prepared as a racemic mixture which can be resolved into levorotatory and dextrorotatory isomers. The asymmetric center responsible for optical isomerism is marked in the formula by an asterisk. Trimipramine maleate is an almost odorless, white or slightly cream-colored, crystalline substance, melting at 140°-144° C. It is very slightly soluble in ether and water, is slightly soluble in ethyl alcohol and acetone, and freely soluble in chloroform and methanol at 20° C.

What are the possible side effects of trimipramine (Surmontil)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • fast,...

Read All Potential Side Effects and See Pictures of Surmontil »

What are the precautions when taking trimipramine (Surmontil)?

See also the Warning section.

Before taking trimipramine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (e.g., amitriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a recent heart attack.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., agranulocytosis, thrombocytopenia), breathing problems (e.g., asthma, chronic obstructive pulmonary disorder-COPD), diabetes,...

Read All Potential Precautions of Surmontil »

Last reviewed on RxList: 12/26/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Surmontil is indicated for the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. In studies with neurotic outpatients, the drug appeared to be equivalent to amitriptyline in the less-depressed patients but somewhat less effective than amitriptyline in the more severely depressed patients. In hospitalized depressed patients, trimipramine and imipramine were equally effective in relieving depression.

DOSAGE AND ADMINISTRATION

Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance.

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. It is not possible to prescribe a single dosage schedule of Surmontil that will be therapeutically effective in all patients. The physical psychodynamic factors contributing to depressive symptomatology are very complex; spontaneous remissions or exacerbations of depressive symptoms may occur with or without drug therapy. Consequently, the recommended dosage regimens are furnished as a guide which may be modified by factors such as the age of the patient, chronicity and severity of the disease, medical condition of the patient, and degree of psychotherapeutic support.

Most antidepressant drugs have a lag period of ten days to four weeks before a therapeutic response is noted. Increasing the dose will not shorten this period but rather increase the incidence of adverse reactions.

Usual Adult Dose

Outpatients and Office PatientsInitially, 75 mg/day in divided doses, increased to 150 mg/day. Dosages over 200 mg/day are not recommended. Maintenance therapy is in the range of 50 to 150 mg/day. For convenient therapy and to facilitate patient compliance, the total dosage requirement may be given at bedtime.

Hospitalized Patients Initially, 100 mg/day in divided doses. This may be increased gradually in a few days to 200 mg/day, depending upon individual response and tolerance. If improvement does not occur in 2 to 3 weeks, the dose may be increased to the maximum recommended dose of 250 to 300 mg/day.

Adolescent and Geriatric Patients Initially, a dose of 50 mg/day is recommended, with gradual increments up to 100 mg/day, depending upon patient response and tolerance.

Maintenance Following remission, maintenance medication may be required for a longer period of time, at the lowest dose that will maintain remission. Maintenance therapy is preferably administered as a single dose at bedtime. To minimize relapse, maintenance therapy should be continued for about three months.

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Surmontil. Conversely, at least 14 days should be allowed after stopping Surmontil before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

Use of Surmontil With Other MAOIs, Such as Linezolid or Methylene Blue

Do not start Surmontil in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

In some cases, a patient already receiving therapy with Surmontil may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Surmontil should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Surmontil may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Surmontil is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

HOW SUPPLIED

Surmontil® (trimipramine maleate) Capsules

25 mg — Opaque blue and yellow capsule in bottles of 100. Printed OP and 718
50 mg — Opaque blue and orange capsule in bottles of 100. Printed OP and 719.
100 mg — Opaque blue and white capsule in bottles of 100. Printed OP and 720

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Keep bottles tightly closed. Dispense in a tight container.

Manufacturer details: n/a. Revised November 2012

Last reviewed on RxList: 12/26/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Note: The pharmacological similarities among the tricyclic antidepressants require that each of the reactions be considered when Surmontil is administered. Some of the adverse reactions included in this listing have not in fact been reported with Surmontil.

Cardiovascular

Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke.

Psychiatric

Confusional states (especially the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia and nightmares; hypomania; exacerbation of psychosis.

Neurological

Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alterations in EEG patterns; tinnitus; syndrome of inappropriate ADH (antidiuretic hormone) secretion.

Anticholinergic

Dry mouth and, rarely, associated sublingual adenitis; blurred vision, disturbances of accommodation, mydriasis, constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract.

Allergic

Skin rash, petechiae, urticaria, itching, photosensitization, edema of face and tongue.

Hematologic

Bone-marrow depression including agranulocytosis, eosinophilia; purpura; thrombocytopenia. Leukocyte and differential counts should be performed in any patient who develops fever and sore throat during therapy; the drug should be discontinued if there is evidence of pathological neutrophil depression.

Gastrointestinal

Nausea and vomiting, anorexia, epigastric distress, diarrhea, peculiar taste, stomatitis, abdominal cramps, black tongue.

Endocrine

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.

Other

Jaundice (simulating obstructive); altered liver function; weight gain or loss; perspiration; flushing; urinary frequency; drowsiness, dizziness, weakness, and fatigue; headache; parotid swelling; alopecia.

Withdrawal Symptoms

Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.

Read the Surmontil (trimipramine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Cimetidine

There is evidence that cimetidine inhibits the elimination of tricyclic antidepressants. Downward adjustment of Surmontil dosage may be required if cimetidine therapy is initiated; upward adjustment if cimetidine therapy is discontinued.

Alcohol

Patients should be warned that the concomitant use of alcoholic beverages may be associated with exaggerated effects.

Catecholamines/Anticholinergics

It has been reported that tricyclic antidepressants can potentiate the effects of catecholamines. Similarly, atropine-like effects may be more pronounced in patients receiving anticholinergic therapy. Therefore, particular care should be exercised when it is necessary to administer tricyclic antidepressants with sympathomimetic amines, local decongestants, local anesthetics containing epinephrine, atropine or drugs with an anticholinergic effect. In resistant cases of depression in adults, a dose of 2.5 mg/kg/day may have to be exceeded. If a higher dose is needed, ECG monitoring should be maintained during the initiation of therapy and at appropriate intervals during stabilization of dose.

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 7-10% 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).

In addition, certain drugs inhibit the activity of the isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). 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. The extent to which SSRI TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration 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).

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.

Monoamine Oxidase Inhibitors (MAOIs)

(See CONTRAINDICATIONS, WARNINGS, and DOSAGE AND ADMINISTRATION.)

Serotonergic Drugs

(See CONTRAINDICATIONS, WARNINGS, and DOSAGE AND ADMINISTRATION.)

Last reviewed on RxList: 12/26/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Clinical Worsening and Suicide Risk

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. 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. 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 (aged 18-24) with major depressive disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older.

The pooled analysis of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders including a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. 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. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable with age strada and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1.

Table 1

Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated
Increases Compared to Placebo
< 18 14 additional cases
18-24 5 additional cases
Decreases Compared to Placebo
25-64 1 fewer case
≥ 65 6 fewer cases

No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. 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.

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

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. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

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.

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and non-psychiatric, 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 health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Surmontil should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.

Screening Patients for Bipolar Disorder: A major depressive episode may be the initial presentation of bipolar disorder. 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. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depression 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 Surmontil is not approved for use in treating bipolar depression.

Serotonin Syndrome

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Surmontil, alone, but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.

The concomitant use of Surmontil with MAOIs intended to treat psychiatric disorders is contraindicated. Surmontil should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Surmontil. Surmontil should be discontinued before initiating treatment with the MAOI (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION).

If concomitant use of Surmontil with other serotonergic drugs, including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John's Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

Treatment with Surmontil and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.

General Consideration for Use

Extreme caution should be used when this drug is given to patients with any evidence of cardiovascular disease because of the possibility of conduction defects, arrhythmias, myocardial infarction, strokes, and tachycardia.

Caution is advised in patients with increased intraocular pressure, 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 or similar agents, since Surmontil (trimipramine maleate) may block the pharmacologic effects of these drugs.

Since the drug 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.

PRECAUTIONS

General

The possibility of suicide is inherent in any severely depressed patient and persists until a significant remission occurs. When a patient with a serious suicidal potential is not hospitalized, the prescription should be for the smallest amount feasible.

In schizophrenic patients activation of the psychosis may occur and require reduction of dosage or the addition of a major tranquilizer to the therapeutic regime.

Manic or hypomanic episodes may occur in some patients, in particular those with cyclic-type disorders. In some cases therapy with Surmontil must be discontinued until the episode is relieved, after which therapy may be reinstituted at lower dosages if still required.

Concurrent administration of Surmontil and electroshock therapy may increase the hazards of therapy. Such treatment should be limited to those patients for whom it is essential. When possible, discontinue the drug for several days prior to elective surgery.

Surmontil should be used with caution in patients with impaired liver function.

Chronic animal studies showed occasional occurrence of hepatic congestion, fatty infiltration, or increased serum liver enzymes at the highest dose of 60 mg/kg/day.

Both elevation and lowering of blood sugar have been reported with tricyclic antidepressants.

Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Surmontil 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 Surmontil. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Surmontil.

Clinical Worsening and Suicide Risk: Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-today 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Semen studies in man (four schizophrenics and nine normal volunteers) revealed no significant changes in sperm morphology. It is recognized that drugs having a parasympathetic effect, including tricyclic antidepressants, may alter the ejaculatory response.

Chronic animal studies showed occasional evidence of degeneration of seminiferous tubules at the highest dose of 60 mg/kg/day.

Pregnancy

Teratogenic Effects - Pregnancy Category C

Surmontil has shown evidence of embryotoxicity and/or increased incidence of major anomalies in rats or rabbits at doses 20 times the human dose. There are no adequate and well-controlled studies in pregnant women. Surmontil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established (see BOXED WARNING and WARNINGSClinical Worsening and Suicide Risk). Anyone considering the use of Surmontil in a child or adolescent must balance the potential risks with the clinical need.

Geriatric Use

Clinical studies of Surmontil® (trimipramine maleate) were not adequate to determine whether subjects aged 65 and over respond differently from younger subjects.

The pharmacokinetics of trimipramine were not substantially altered in the elderly (see CLINICAL PHARMACOLOGY).

Surmontil is known to be substantially excreted by the kidney. Clinical circumstances, some of which may be more common in the elderly, such as hepatic or renal impairment, should be considered (see PRECAUTIONS - General).

Greater sensitivity (e.g., confusional states, sedation) of some older individuals cannot be ruled out (see ADVERSE REACTIONS). In general, dose selection for an elderly patient should be cautious, usually starting at a lower dose (see DOSAGE AND ADMINISTRATION).

Last reviewed on RxList: 12/26/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose, therefore, hospital monitoring is required as soon as possible.

Manifestations

Critical manifestations of overdose include: cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity.

Other signs of overdose may include: confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the symptoms listed under ADVERSE REACTIONS.

Management

General

Obtain an ECG and immediately initiate cardiac monitoring. Protect the patient's airway, establish an intravenous line and initiate gastric decontamination. A minimum of six hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during this period, extended monitoring is required. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination. Plasma drug levels may not reflect the severity of the poisoning. Therefore, monitoring of plasma drug levels alone should not guide management of the patient.

Gastrointestinal Decontamination

All patients suspected of tricyclic antidepressant 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.

Cardiovascular

A maximal limb-lead QRS duration of ≥ 0.10 seconds has been associated with an increased incidence of seizures. A QRS duration of ≥ 0.16 seconds has been associated with an increased incidence of ventricular dysrhythmias. Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45 to 7.55. 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. A pH > 7.60 or a pCO2 < 20 mm Hg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/ hyperventilation may respond to lidocaine, bretylium or phenytoin. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide).

In rare instances, hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity. However, hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in tricyclic antidepressant poisoning.

CNS

In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (e.g., phenobarbital, phenytoin). 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.

Psychiatric Follow-up

Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.

Pediatric Management

The principles of management of child and adult overdosages are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.

CONTRAINDICATIONS

Monoamine Oxidase Inhibitors (MAOIs)

The use of MAOIs intended to treat psychiatric disorders with Surmontil or within 14 days of stopping treatment with Surmontil is contraindicated because of an increased risk of serotonin syndrome. The use of Surmontil within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION).

Starting Surmontil in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION).

Hypersensitivity to Tricyclic Antidepressants

Cross-sensitivity between Surmontil and other dibenzazepines is a possibility.

Myocardial Infarction

The drug is contraindicated during the acute recovery period after a myocardial infarction.

*Poisindex® Toxicologic Management. Topic: Antidepressants, Tricyclic Micromedex Inc. Vol. 85.

Last reviewed on RxList: 12/26/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Surmontil is an antidepressant with an anxiety-reducing sedative component to its action. The mode of action of Surmontil on the central nervous system is not known. However, unlike amphetamine-type compounds it does not act primarily by stimulation of the central nervous system. It does not act by inhibition of the monoamine oxidase system.

The single-dose pharmacokinetics of trimipramine were evaluated in a comparative study of 24 elderly subjects and 24 younger subjects; no clinically relevant differences were demonstrated based on age or gender.

Last reviewed on RxList: 12/26/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Medication Guide

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.

Talk to your, or your family member's, healthcare provider about:

  • all risks and benefits of treatment with antidepressant medicines
  • all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

  1. 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?
    • 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.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

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:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

Who should not take Surmontil?

  • If you take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
  • Do not take an MAOI within 2 weeks of stopping Surmontil unless directed to do so by your physician.
  • Do not start Surmontil if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • 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.
  • 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.
  • 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.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Last reviewed on RxList: 12/26/2012
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Medication Guide

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.

Talk to your, or your family member's, healthcare provider about:

  • all risks and benefits of treatment with antidepressant medicines
  • all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

  1. 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?
    • 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.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

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:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

Who should not take Surmontil?

  • If you take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
  • Do not take an MAOI within 2 weeks of stopping Surmontil unless directed to do so by your physician.
  • Do not start Surmontil if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • 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.
  • 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.
  • 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.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Last reviewed on RxList: 12/26/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Surmontil Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

TRIMIPRAMINE - ORAL

(trye-MI-pra-meen)

COMMON BRAND NAME(S): Surmontil

WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. 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. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor immediately 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). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

USES: This medication is used to treat depression. It may help improve your mood and sense of well-being and allow you to enjoy everyday life more. Trimipramine is a tricyclic antidepressant. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

HOW TO USE: Read the Medication Guide available from your pharmacist. Consult your doctor or pharmacist if you have any questions.

Take this medication by mouth with or without food, usually one to three times daily or as directed by your doctor. If taking this medication once daily, take it at bedtime to decrease the risk of drowsiness. Dosage is based on your medical condition and response to therapy. Your doctor may start you at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

This medication does not work right away. It may take 2 to 4 weeks before you experience the full benefits.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.

It is important to continue taking this medication even if you feel well. Do not suddenly stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Nausea, headache and a feeling of being ill may also occur. Your dose may need to be gradually decreased.

Inform your doctor if your condition does not improve or if it worsens.

Disclaimer

Surmontil Consumer (continued)

SIDE EFFECTS: See also the Warning section.

Dizziness, drowsiness, difficulty urinating, headache, weakness, changes in appetite/weight, dry mouth, blurred vision, and constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, mental/mood changes (e.g., confusion, depression, hallucinations, nervousness), numbness/tingling of the hands/feet, ringing in the ears, sexual problems, shakiness (tremors), severe vomiting/constipation.

Tell your doctor immediately if any of these rare but very serious side effects occur: slow/fast/irregular heartbeat, severe headache, pain/redness/swelling of arms or legs.

Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, slurred speech, weakness on one side of the body, vision changes, chest pain, jaw/left arm pain.

This medication may rarely cause serious blood problems (e.g., agranulocytosis, thrombocytopenia) or liver problems. Tell your doctor immediately if you notice any of the following rare but very serious side effects: easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), severe stomach/abdominal pain, dark urine, yellowing of the eyes/skin.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Surmontil (trimipramine) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: See also the Warning section.

Before taking trimipramine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (e.g., amitriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a recent heart attack.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., agranulocytosis, thrombocytopenia), breathing problems (e.g., asthma, chronic obstructive pulmonary disorder-COPD), diabetes, electroshock therapy, certain eye problems (e.g., glaucoma, increased intraocular pressure), heart problems (e.g., arrhythmias, coronary artery disease, heart failure), intestinal problems (e.g., chronic constipation, ileus), kidney problems, liver problems, other mental/mood conditions (e.g., bipolar disorder, psychosis), family history of mental/mood conditions (e.g., suicide, bipolar disorder), seizures, conditions that may increase your risk of seizures (e.g., bulimia, organic brain disease, alcohol withdrawal), overactive thyroid (hyperthyroidism), problems urinating (urinary retention, enlarged prostate).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This drug may infrequently make your blood sugar level rise, causing or worsening diabetes. If you have diabetes, check your blood sugar level regularly as directed by your doctor. Tell your doctor immediately if you have symptoms such as increased thirst or urination, unusual sweating, shakiness or hunger. Your anti-diabetic medication or diet may need to be adjusted.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug (e.g., dizziness, confusion).

Caution is advised when using this drug in children (see also the Warning section).

This medication should be used only when clearly needed during pregnancy. Infants born to mothers who have taken similar medications during pregnancy may develop trouble urinating, lethargy, shaking (tremors), and seizures. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Surmontil Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious (possibly fatal) interactions may occur: arbutamine, sibutramine.

Do not take this medication if you are taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) or have used MAO inhibitors within the 2 weeks before, during or after treatment with this medication. In some cases a serious, possibly fatal drug interaction may occur.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting trimipramine.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergics (e.g., atropine, belladonna alkaloids), bronchodilators/decongestants (e.g., albuterol, epinephrine, phenylephrine), clonidine, certain drugs for high blood pressure (e.g., guanadrel, guanethidine, reserpine), drugs affecting liver enzymes that remove this medication from your body (e.g., cimetidine, haloperidol, protease inhibitors such as amprenavir/fosamprenavir/ritonavir, drugs that affect heart rhythm such as flecainide/quinidine/propafenone, SSRI antidepressants such as fluoxetine/paroxetine), drugs for motion sickness (e.g., meclizine, scopolamine), stimulants (e.g., amphetamines, methylphenidate), St. Johns wort, thyroid medication.

Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with this medication such as bupropion, isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, tricyclic antidepressants (e.g., amitriptyline) or tramadol, among others. Consult your doctor or pharmacist for details.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine, phenytoin), medicines for sleep or anxiety (e.g., alprazolam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone)

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids, motion sickness) because they may contain drowsiness-causing ingredients, drying agents (anticholinergics) or stimulants/nasal decongestants that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products.

Do not use nonprescription cimetidine for stomach problems.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Overdose of this medication may be fatal, and symptoms include seizures, delirium and loss of consciousness.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood counts, kidney function, liver function) may be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all medical appointments so your doctor can monitor your progress closely or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at approximately 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

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. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised September 2011. Copyright(c) 2011 First Databank, Inc.

Surmontil Patient Information Including Side Effects

Brand Names: Surmontil

Generic Name: trimipramine (Pronunciation: trye MI pra meen)

What is trimipramine (Surmontil)?

Trimipramine is in a group of drugs called tricyclic antidepressants. Trimipramine affects chemicals in the brain that may become unbalanced.

Trimipramine is used to treat symptoms of depression.

Trimipramine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of trimipramine (Surmontil)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heart rate;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • confusion, hallucinations, or seizure (convulsions);
  • easy bruising or bleeding, unusual weakness;
  • feeling light-headed, fainting;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • urinating more or less than usual;
  • extreme thirst with headache, nausea, vomiting, and weakness; or
  • skin rash, bruising, severe tingling, numbness, pain, and muscle weakness.

Less serious side effects may be more likely to occur, such as:

  • nausea, vomiting, stomach pain, loss of appetite;
  • constipation or diarrhea;
  • dry mouth, unpleasant taste;
  • weakness, lack of coordination;
  • numbness or tingly feeling;
  • feeling dizzy, or drowsy;
  • blurred vision, headache, ringing in your ears;
  • mild skin rash;
  • low fever;
  • breast swelling (in men or women); or
  • decreased sex drive, impotence, or difficulty having an orgasm.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Surmontil (trimipramine) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about trimipramine (Surmontil)?

Do not use this medication if you are allergic to trimipramine, or if you have recently had a heart attack.

Do not use trimipramine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Side Effects Centers

Surmontil Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking trimipramine (Surmontil)?

Do not use this medication if you are allergic to trimipramine, or if you have recently had a heart attack.

Do not use trimipramine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take trimipramine before the MAO inhibitor has cleared from your body.

Before taking trimipramine, tell your doctor if you are allergic to any drugs, or if you have:

  • heart disease;
  • a history of heart attack, stroke, or seizures;
  • bipolar disorder (manic-depression);
  • schizophrenia or other mental illness;
  • kidney disease;
  • overactive thyroid;
  • diabetes (trimipramine may raise or lower blood sugar);
  • glaucoma; or
  • problems with urination.

If you have any of these conditions, you may not be able to use trimipramine, or you may need a dosage adjustment or special tests during treatment.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA Pregnancy Category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Trimipramine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have side effects from this medication.

Do not give this medication to anyone under 18 years old without the advice of a doctor.

How should I take trimipramine (Surmontil)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Follow the directions on your prescription label.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking trimipramine. You may need to stop using the medicine for a short time.

Do not stop using trimipramine without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping this medication suddenly could cause you to have unpleasant side effects.

It may take up to 4 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment. Do not use this medication for longer than 3 months unless your doctor has told you to.

Store trimipramine at room temperature away from moisture and heat.

Side Effects Centers

Surmontil Patient Information including If I Miss a Dose

What happens if I miss a dose (Surmontil)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Surmontil)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of trimipramine can be fatal.

Symptoms of a trimipramine overdose may include uneven heartbeats, extreme drowsiness, agitation, vomiting, blurred vision, confusion, hallucinations, muscle stiffness, feeling light-headed, fainting, seizure (convulsions), or coma.

What should I avoid while taking trimipramine (Surmontil)?

Avoid drinking alcohol. It can cause dangerous side effects when taken together with trimipramine.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, medicine for seizures, or other antidepressants). They can add to sleepiness caused by trimipramine.

Grapefruit and grapefruit juice may interact with trimipramine. Discuss the use of grapefruit products with your doctor before increasing or decreasing the amount of grapefruit products in your diet.

Trimipramine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Trimipramine can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

What other drugs will affect trimipramine (Surmontil)?

Before taking trimipramine, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

Before taking trimipramine, tell your doctor if you are currently using any of the following drugs:

  • cimetidine (Tagamet);
  • guanethidine (Ismelin); or
  • heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute).

If you are using any of these drugs, you may not be able to use trimipramine, or you may need dosage adjustments or special tests during treatment.

There are many other medicines that can interact with trimipramine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist has information about trimipramine written for health professionals that you may read.


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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 8.04. Revision date: 12/15/2010.

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