Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Pamelor™ (nortriptyline HCl) Capsules USP Pamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows: 10 mg: Light orange opaque cap printed “ PAMELOR 10 mg” in black and white opaque body printed “ ” in black. Bottles of 30..................NDC 0406-9910-03 25 mg: Light orange opaque cap printed “ PAMELOR 25 mg” in black and white opaque body printed “ “ in black. Bottles of 30..................NDC 0406-9911-03 50 mg: White opaque cap printed “ PAMELOR 50 mg” in black and white opaque body printed “ ” in black. Bottles of 30..................NDC 0406-9912-03 75 mg: Light orange opaque cap printed “ PAMELOR 75 mg” in black and light orange opaque body printed “ ” in black. Bottles of 30..................NDC 0406-9913-03 Arch Imprint Code Boxed M Arch Imprint Code Boxed M Arch Imprint Code Boxed M Arch Imprint Code Boxed M Store and Dispense Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP) with a child-resistant closure. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company. © 2024 Mallinckrodt. Product of Canada, Active Ingredient made in Ireland Manufactured by: Patheon Inc. Whitby, Ontario, Canada L1N 5Z5 Manufactured for: SpecGx LLC Webster Groves, MO 63119 USA Rev 09/2024 Mallinckrodt™ Pharmaceuticals; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 10 mg Bottle NDC 0406-9910-03 30 Capsules Pamelor™ (nortriptyline HCl) capsules USP equivalent to 10 mg base Rx only PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE Mallinckrodt ™ Rev 09/2024 2000017779 Pamelor 10 mg Bottle Label; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 25 mg Bottle NDC 0406-9911-03 30 Capsules Pamelor™ (nortriptyline HCl) capsules USP equivalent to 25 mg base Rx only PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE Mallinckrodt™ Rev 09/2024 2000017780 Pamelor 25 mg Bottle Label; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 50 mg Bottle NDC 0406-9912-03 30 Capsules Pamelor™ (nortriptyline HCl) capsules USP equivalent to 50 mg base Rx only PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE Mallinckrodt™ Rev 09/2024 2000017781 Pamelor 50 mg Bottle Label; PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 75 mg Bottle NDC 0406-9913-03 30 Capsules Pamelor™ (nortriptyline HCl) capsules USP equivalent to 75 mg base Rx only PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE Mallinckrodt ™ Rev 09/2024 2000017782 Pamelor 75 mg Bottle Label
- HOW SUPPLIED Pamelor™ (nortriptyline HCl) Capsules USP Pamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows: 10 mg: Light orange opaque cap printed “ PAMELOR 10 mg” in black and white opaque body printed “ ” in black. Bottles of 30..................NDC 0406-9910-03 25 mg: Light orange opaque cap printed “ PAMELOR 25 mg” in black and white opaque body printed “ “ in black. Bottles of 30..................NDC 0406-9911-03 50 mg: White opaque cap printed “ PAMELOR 50 mg” in black and white opaque body printed “ ” in black. Bottles of 30..................NDC 0406-9912-03 75 mg: Light orange opaque cap printed “ PAMELOR 75 mg” in black and light orange opaque body printed “ ” in black. Bottles of 30..................NDC 0406-9913-03 Arch Imprint Code Boxed M Arch Imprint Code Boxed M Arch Imprint Code Boxed M Arch Imprint Code Boxed M Store and Dispense Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP) with a child-resistant closure. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company. © 2024 Mallinckrodt. Product of Canada, Active Ingredient made in Ireland Manufactured by: Patheon Inc. Whitby, Ontario, Canada L1N 5Z5 Manufactured for: SpecGx LLC Webster Groves, MO 63119 USA Rev 09/2024 Mallinckrodt™ Pharmaceuticals
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 10 mg Bottle NDC 0406-9910-03 30 Capsules Pamelor™ (nortriptyline HCl) capsules USP equivalent to 10 mg base Rx only PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE Mallinckrodt ™ Rev 09/2024 2000017779 Pamelor 10 mg Bottle Label
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 25 mg Bottle NDC 0406-9911-03 30 Capsules Pamelor™ (nortriptyline HCl) capsules USP equivalent to 25 mg base Rx only PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE Mallinckrodt™ Rev 09/2024 2000017780 Pamelor 25 mg Bottle Label
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 50 mg Bottle NDC 0406-9912-03 30 Capsules Pamelor™ (nortriptyline HCl) capsules USP equivalent to 50 mg base Rx only PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE Mallinckrodt™ Rev 09/2024 2000017781 Pamelor 50 mg Bottle Label
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 75 mg Bottle NDC 0406-9913-03 30 Capsules Pamelor™ (nortriptyline HCl) capsules USP equivalent to 75 mg base Rx only PHARMACIST: PLEASE DISPENSE WITH ATTACHED MEDICATION GUIDE Mallinckrodt ™ Rev 09/2024 2000017782 Pamelor 75 mg Bottle Label
Overview
Pamelor ™ (nortriptyline HCl) is 1-propanamine, 3-(10,11-dihydro- 5H -dibenzo[ a,d ] cyclohepten-5-ylidene)- N -methyl-, hydrochloride. The structural formula is as follows: Chemical Structure 10 mg, 25 mg, 50 mg, and 75 mg Capsules Active Ingredient: nortriptyline hydrochloride USP. 10 mg, 25 mg, and 75 mg Capsules Inactive Ingredients: D&C Yellow #10, FD&C Yellow #6, gelatin, silicone fluid, starch, and titanium dioxide. 50 mg Capsules Inactive Ingredients: gelatin, silicone fluid, starch, and titanium dioxide.
Indications & Usage
Pamelor™ (nortriptyline HCl) is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
Dosage & Administration
Pamelor is not recommended for children. Pamelor is administered orally in the form of capsules. Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients than for hospitalized patients who will be under close supervision. The physician should initiate dosage at a low level and increase it gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission. If a patient develops minor side effects, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur. Usual Adult Dose – 25 mg three or four times daily; dosage should begin at a low level and be increased as required. As an alternate regimen, the total daily dosage may be given once a day. When doses above 100 mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150 ng/mL. Doses above 150 mg/day are not recommended. Elderly and Adolescent Patients – 30 to 50 mg/day, in divided doses, or the total daily dosage may be given once a day. 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 Pamelor. Conversely, at least 14 days should be allowed after stopping Pamelor before starting an MAOI intended to treat psychiatric disorders ( see CONTRAINDICATIONS ). Use of Pamelor With Other MAOIs, Such as Linezolid or Methylene Blue Do not start Pamelor 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 Pamelor therapy 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, Pamelor should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Pamelor 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 Pamelor is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use ( see WARNINGS ).
Warnings & Precautions
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 (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 . 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 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. Prescriptions for nortriptyline hydrochloride 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 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 nortriptyline hydrochloride is not approved for use in treating bipolar depression. Patients with cardiovascular disease should be given Pamelor only under close supervision because of the tendency of the drug to produce sinus tachycardia and to prolong the conduction time. Myocardial infarction, arrhythmia, and strokes have occurred. The antihypertensive action of guanethidine and similar agents may be blocked. Because of its anticholinergic activity, Pamelor should be used with great caution in patients who have a history of urinary retention. Patients with a history of seizures should be followed closely when Pamelor is administered, inasmuch as this drug is known to lower the convulsive threshold. Great care is required if Pamelor is given to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop. Pamelor may impair the mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a car; therefore, the patient should be warned accordingly. Excessive consumption of alcohol in combination with nortriptyline therapy may have a potentiating effect, which may lead to the danger of increased suicidal attempts or overdosage, especially in patients with histories of emotional disturbances or suicidal ideation. The concomitant administration of quinidine and nortriptyline may result in a significantly longer plasma half-life, higher AUC, and lower clearance of nortriptyline. Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Pamelor, 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 changes (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 Pamelor with MAOIs intended to treat psychiatric disorders is contraindicated. Pamelor 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 Pamelor. Pamelor should be discontinued before initiating treatment with the MAOI ( see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION ). If concomitant use of Pamelor 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 Pamelor and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated. Unmasking of Brugada Syndrome There have been postmarketing reports of an association between treatment with Pamelor and the unmasking of Brugada syndrome. Brugada syndrome is a disorder characterized by syncope, abnormal electrocardiographic (ECG) findings, and a risk of sudden death. Pamelor should generally be avoided in patients with Brugada syndrome or those suspected of having Brugada syndrome. Angle-Closure Glaucoma The pupillary dilation that occurs following use of many antidepressant drugs including Pamelor may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Use in Pregnancy Safe use of Pamelor during pregnancy and lactation has not been established; therefore, when the drug is administered to pregnant patients, nursing mothers, or women of childbearing potential, the potential benefits must be weighed against the possible hazards. Animal reproduction studies have yielded inconclusive results.
Boxed Warning
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 nortriptyline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Nortriptyline hydrochloride is not approved for use in pediatric patients ( see WARNINGS, Clinical Worsening and Suicide Risk ; PRECAUTIONS, Information for Patients ; and PRECAUTIONS, Pediatric Use ).
Contraindications
Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with Pamelor or within 14 days of stopping treatment with Pamelor is contraindicated because of an increased risk of serotonin syndrome. The use of Pamelor within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated ( see WARNINGS and DOSAGE AND ADMINISTRATION ). Starting Pamelor 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 Pamelor and other dibenzazepines is a possibility. Myocardial Infarction Pamelor is contraindicated during the acute recovery period after myocardial infarction.
Adverse Reactions
Note – Included in the following list 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 nortriptyline is administered. Cardiovascular – Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke. Psychiatric – Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia, panic, nightmares; hypomania; exacerbation of psychosis. Neurologic – Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alteration in EEG patterns; tinnitus. Anticholinergic – Dry mouth and, rarely, associated sublingual adenitis; blurred vision, disturbance of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract. Allergic – Skin rash, petechiae, urticaria, itching, photosensitization (avoid excessive exposure to sunlight); edema (general or of face and tongue), drug fever, cross-sensitivity with other tricyclic drugs. Hematologic – Bone marrow depression, including agranulocytosis; eosinophilia; purpura; thrombocytopenia. Gastrointestinal – Nausea and vomiting, anorexia, epigastric distress, diarrhea, peculiar taste, stomatitis, abdominal cramps, blacktongue. 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; syndrome of inappropriate ADH (antidiuretic hormone) secretion. Other – Jaundice (simulating obstructive), altered liver function; weight gain or loss; perspiration; flushing; urinary frequency, nocturia; drowsiness, dizziness, weakness, fatigue; headache; parotid swelling; alopecia. Withdrawal Symptoms – Though these are not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise. Postmarketing Experience The following adverse drug reaction has been reported during post-approval use of Pamelor. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate frequency. Cardiac Disorders – Brugada syndrome Eye Disorders – angle-closure glaucoma
Drug Interactions
Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a “stimulating” effect in some depressed patients. Close supervision and careful adjustment of the dosage are required when Pamelor is used with other anticholinergic drugs and sympathomimetic drugs. Concurrent administration of cimetidine and tricyclic antidepressants can produce clinically significant increases in the plasma concentrations of the tricyclic antidepressant. The patient should be informed that the response to alcohol may be exaggerated. A case of significant hypoglycemia has been reported in a type II diabetic patient maintained on chlorpropamide (250 mg/day), after the addition of nortriptyline (125 mg/day). Drugs Metabolized by P450 2D6 – The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7% to 10% of Caucasians are so called “poor metabolizers”); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available. 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 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 . )
Storage & Handling
Store and Dispense Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP) with a child-resistant closure. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company. © 2024 Mallinckrodt. Product of Canada, Active Ingredient made in Ireland Manufactured by: Patheon Inc. Whitby, Ontario, Canada L1N 5Z5 Manufactured for: SpecGx LLC Webster Groves, MO 63119 USA Rev 09/2024 Mallinckrodt™ Pharmaceuticals
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