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DESIPRAMINE HYDROCHLORIDE
Overview
What is DESIPRAMINE HYDROCHLORIDE?
Desipramine hydrochloride USP is an antidepressant drug of the tricyclic type available as tablets of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg for oral administration. Its chemical name is 5-Dibenz[]azepine-5-propanamine, 10, 11-dihydro--methyl-, monohydrochloride.
Inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), and titanium dioxide.
What does DESIPRAMINE HYDROCHLORIDE look like?
What are the available doses of DESIPRAMINE HYDROCHLORIDE?
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What should I talk to my health care provider before I take DESIPRAMINE HYDROCHLORIDE?
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How should I use DESIPRAMINE HYDROCHLORIDE?
Desipramine hydrochloride is indicated for the treatment of depression.
Not recommended for use in children (see ).
Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients compared to hospitalized patients, who are closely supervised. Dosage should be initiated at a low level and increased according to clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a period of time and should be at the lowest dose that will maintain remission.
What interacts with DESIPRAMINE HYDROCHLORIDE?
Desipramine hydrochloride should not be given in conjunction with, or within 2 weeks of, treatment with an MAO inhibitor drug; hyperpyretic crises, severe convulsions, and death have occurred in patients taking MAO inhibitors and tricyclic antidepressants. When desipramine hydrochloride is substituted for an MAO inhibitor, at least 2 weeks should elapse between treatments. Desipramine hydrochloride should then be started cautiously and should be increased gradually.
Desipramine hydrochloride is contraindicated in the acute recovery period following myocardial infarction. It should not be used in those who have shown prior hypersensitivity to the drug. Cross-sensitivity between this and other dibenzazepines is a possibility.
What are the warnings of DESIPRAMINE HYDROCHLORIDE?
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 (ages 18 to 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 analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included 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 within age strata 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.
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 nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers.
| Age Range | 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 |
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 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 desipramine hydrochloride is not approved for use in treating bipolar depression.
General
Extreme caution should be used when this drug is given in the following situations:
a. In patients with cardiovascular disease, because of the possibility of conduction defects, arrhythmias, tachycardias, strokes, and acute myocardial infarction.
b. In patients who have a family history of sudden death, cardiac dysrhythmias, or cardiac conduction disturbances.
c. In patients with a history of urinary retention or glaucoma, because of the anticholinergic properties of the drug.
d. In patients with thyroid disease or those taking thyroid medication, because of the possibility of cardiovascular toxicity, including arrhythmias.
e. In patients with a history of seizure disorder, because this drug has been shown to lower the seizure threshold. Seizures precede cardiac dysrhythmias and death in some patients.
This drug is capable of blocking the antihypertensive effect of guanethidine and similarly acting compounds.
The patient should be cautioned that this drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
In patients who may use alcohol excessively, it should be borne in mind that the potentiation may increase the danger inherent in any suicide attempt or overdosage.
Use in Pregnancy
Safe use of desipramine hydrochloride during pregnancy and lactation has not been established; therefore, if it is to be given to pregnant patients, nursing mothers, or women of childbearing potential, the possible benefits must be weighed against the possible hazards to mother and child. Animal reproductive studies have been inconclusive.
Geriatric Use
Clinical studies of desipramine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Lower doses are recommended for elderly patients. (See .)
The ratio of 2-hydroxydesipramine to desipramine may be increased in the elderly, most likely due to decreased renal elimination with aging.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Desipramine hydrochloride use in the elderly has been associated with a proneness to falling as well as confusional states. (See .)
What are the precautions of DESIPRAMINE HYDROCHLORIDE?
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 desipramine hydrochloride and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions” is available for desipramine hydrochloride. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking desipramine hydrochloride.
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 observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established (see and ). Therefore, desipramine hydrochloride is not recommended for use in children.
Anyone considering the use of desipramine hydrochloride in a child or adolescent must balance the potential risks with the clinical need (see also ).
General
It is important that this drug be dispensed in the least possible quantities to depressed outpatients, since suicide has been accomplished with this class of drug (see ). Ordinary prudence requires that children not have access to this drug or to potent drugs of any kind; if possible, this drug should be dispensed in containers with child-resistant safety closures. Storage of this drug in the home must be supervised responsibly.
If serious adverse effects occur, dosage should be reduced or treatment should be altered. Desipramine hydrochloride therapy in patients with manic-depressive illness may induce a hypomanic state after the depressive phase terminates.
The drug may cause exacerbation of psychosis in schizophrenic patients.
Both elevation and lowering of blood sugar levels have been reported.
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 pathologic neutrophil depression.
Clinical experience in the concurrent administration of ECT and antidepressant drugs is limited. Thus, if such treatment is essential, the possibility of increased risk relative to benefits should be considered.
This drug should be discontinued as soon as possible prior to elective surgery because of possible cardiovascular effects. Hypertensive episodes have been observed during surgery in patients taking desipramine hydrochloride.
Drug Interactions
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).
In addition, certain drugs inhibit the activity of this 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 IC 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.
Close supervision and careful adjustment of dosage are required when this drug is given concomitantly with anticholinergic or sympathomimetic drugs.
Patients should be warned that while taking this drug their response to alcoholic beverages may be exaggerated.
If desipramine hydrochloride is to be combined with other psychotropic agents such as tranquilizers or sedative/hypnotics, careful consideration should be given to the pharmacology of the agents employed since the sedative effects of desipramine and benzodiazepines (e.g., chlordiazepoxide or diazepam) are additive. Both the sedative and anticholinergic effects of the major tranquilizers are also additive to those of desipramine.
What are the side effects of DESIPRAMINE HYDROCHLORIDE?
Included in the following listing are a few adverse reactions that have not been reported with this specific drug. However, the pharmacologic similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when desipramine hydrochloride is given.
Cardiovascular
Hypotension, hypertension, palpitations, heart block, myocardial infarction, stroke, arrhythmias, premature ventricular contractions, tachycardia, ventricular tachycardia, ventricular fibrillation, sudden death.
There has been a report of an “acute collapse” and “sudden death” in an 8-year old (18 kg) male, treated for 2 years for hyperactivity.
There have been additional reports of sudden death in children (see ).
Psychiatric
Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia and nightmares; hypomania; exacerbation of psychosis.
Neurologic
Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures; alterations in EEG patterns; tinnitus.
Symptoms attributed to Neuroleptic Malignant Syndrome have been reported during desipramine use with and without concomitant neuroleptic therapy.
Anticholinergic
Dry mouth, and rarely associated sublingual adenitis; blurred vision, disturbance of accommodation, mydriasis, increased intraocular pressure; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of urinary tract.
Allergic
Skin rash, petechiae, urticaria, itching, photosensitization (avoid excessive exposure to sunlight), edema (of face and tongue or general), drug fever, cross-sensitivity with other tricyclic drugs.
Hematologic
Bone marrow depressions including agranulocytosis, eosinophilia, purpura, thrombocytopenia.
Gastrointestinal
Anorexia, nausea and vomiting, epigastric distress, peculiar taste, abdominal cramps, diarrhea, stomatitis, black tongue, hepatitis, jaundice (simulating obstructive), altered liver function, elevated liver function tests, increased pancreatic enzymes.
Endocrine
Gynecomastia in the male, breast enlargement and galactorrhea in the female; increased or decreased libido, impotence, painful ejaculation, testicular swelling; elevation or depression of blood sugar levels; syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Other
Weight gain or loss; perspiration, flushing; urinary frequency, nocturia; parotid swelling; drowsiness, dizziness, proneness to falling, weakness and fatigue, headache; fever; alopecia; elevated alkaline phosphatase.
Withdrawal Symptoms
Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.
What should I look out for while using DESIPRAMINE HYDROCHLORIDE?
Desipramine hydrochloride should not be given in conjunction with, or within 2 weeks of, treatment with an MAO inhibitor drug; hyperpyretic crises, severe convulsions, and death have occurred in patients taking MAO inhibitors and tricyclic antidepressants. When desipramine hydrochloride is substituted for an MAO inhibitor, at least 2 weeks should elapse between treatments. Desipramine hydrochloride should then be started cautiously and should be increased gradually.
Desipramine hydrochloride is contraindicated in the acute recovery period following myocardial infarction. It should not be used in those who have shown prior hypersensitivity to the drug. Cross-sensitivity between this and other dibenzazepines is a possibility.
What might happen if I take too much DESIPRAMINE HYDROCHLORIDE?
Deaths may occur from overdosage with this class of drugs. Overdose of desipramine has resulted in a higher death rate compared to overdoses of other tricyclic antidepressants. 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. There is no specific antidote for desipramine overdosage.
How should I store and handle DESIPRAMINE HYDROCHLORIDE?
GEODON for Injection should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature] in dry form. Protect from light. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15°–30°C (59°–86°F) or up to 7 days refrigerated, 2°–8°C (36°–46°F).Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as:10 mg:NDC 0781-1971-01 bottles of 100NDC 0781-1971-10 bottles of 100025 mg:NDC 0781-1972-01 bottles of 100NDC 0781-1972-10 bottles of 1000NDC 0781-1972-13 unit dose packages of 10050 mg:NDC 0781-1973-01 bottles of 100NDC 0781-1973-10 bottles of 1000NDC 0781-1973-13 unit dose packages of 10075 mg:NDC 0781-1974-01 bottles of 100NDC 0781-1974-10 bottles of 1000100 mg:NDC 0781-1975-01 bottles of 100NDC 0781-1975-10 bottles of 1000150 mg:NDC 0781-1976-50 bottles of 50NDC 0781-1976-10 bottles of 1000Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Available evidence suggests that many depressions have a biochemical basis in the form of a relative deficiency of neurotransmitters such as norepinephrine and serotonin. Norepinephrine deficiency may be associated with relatively low urinary 3-methoxy-4-hydroxyphenyl glycol (MHPG) levels, while serotonin deficiencies may be associated with low spinal fluid levels of 5-hydroxyindoleacetic acid.
While the precise mechanism of action of the tricyclic antidepressants is unknown, a leading theory suggests that they restore normal levels of neurotransmitters by blocking the re-uptake of these substances from the synapse in the central nervous system. Evidence indicates that the secondary amine tricyclic antidepressants, including desipramine, may have greater activity in blocking the re-uptake of norepinephrine. Tertiary amine tricyclic antidepressants, such as amitriptyline, may have greater effect on serotonin re-uptake.
Desipramine hydrochloride is not a monoamine oxidase (MAO) inhibitor and does not act primarily as a central nervous system stimulant. It has been found in some studies to have a more rapid onset of action than imipramine. Earliest therapeutic effects may occasionally be seen in 2 to 5 days, but full treatment benefit usually requires 2 to 3 weeks to obtain.
Non-Clinical Toxicology
Desipramine hydrochloride should not be given in conjunction with, or within 2 weeks of, treatment with an MAO inhibitor drug; hyperpyretic crises, severe convulsions, and death have occurred in patients taking MAO inhibitors and tricyclic antidepressants. When desipramine hydrochloride is substituted for an MAO inhibitor, at least 2 weeks should elapse between treatments. Desipramine hydrochloride should then be started cautiously and should be increased gradually.Desipramine hydrochloride is contraindicated in the acute recovery period following myocardial infarction. It should not be used in those who have shown prior hypersensitivity to the drug. Cross-sensitivity between this and other dibenzazepines is a possibility.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with desipramine hydrochloride and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions” is available for desipramine hydrochloride. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking desipramine hydrochloride.
Included in the following listing are a few adverse reactions that have not been reported with this specific drug. However, the pharmacologic similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when desipramine hydrochloride is given.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).