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Nortriptyline Hydrochloride
Overview
What is Nortriptyline Hydrochloride?
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What does Nortriptyline Hydrochloride look like?
What are the available doses of Nortriptyline Hydrochloride?
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What should I talk to my health care provider before I take Nortriptyline Hydrochloride?
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How should I use Nortriptyline Hydrochloride?
Nortriptyline hydrochloride is indicated for the relief of symptoms of
depression. Endogenous depressions are more likely to be alleviated than are
other depressive states.
Nortriptyline hydrochloride is not recommended for children.
Nortriptyline hydrochloride is administered orally. 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
Elderly and Adolescent Patients
What interacts with Nortriptyline Hydrochloride?
The use of nortriptyline hydrochloride or other tricyclic antidepressants concurrently with a monoamine oxidase (MAO) inhibitor is contraindicated. Hyperpyretic crises, severe convulsions, and fatalities have occurred when similar tricyclic antidepressants were used in such combinations. It is advisable to have discontinued the MAO inhibitor for at least two weeks before treatment with nortriptyline hydrochloride is started. Patients hypersensitive to nortriptyline hydrochloride should not be given the drug.
Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility.
Nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.
What are the warnings of Nortriptyline Hydrochloride?
In late pregnancy, as with other NSAIDs, Flector® Patch should be
avoided because it may cause premature closure of the ductus arteriosus.
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 predicators of suicide. There has been a
long-standing concern 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
trails 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 18-24) 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.
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.
Screening Patients for Bipolar Disorder:
Patients with cardiovascular disease should be given nortriptyline
hydrochloride 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, nortriptyline hydrochloride should be used with great
caution in patients who have glaucoma or a history of urinary retention.
Patients with a history of seizures should be followed closely when
nortriptyline hydrochloride is administered, inasmuch as this drug is known to
lower the convulsive threshold. Great care is required if nortriptyline
hydrochloride is given to hyperthyroid patients or to those receiving thyroid
medication, since cardiac arrhythmias may develop.
Nortriptyline hydrochloride 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.
Safe use of nortriptyline hydrochloride 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.
What are the precautions of Nortriptyline Hydrochloride?
Prescribers or other health professionals should inform patients,
their families, and their caregivers about the benefits and risks associated
with treatment with nortriptyline hydrochloride 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 nortriptyline 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 nortriptyline hydrochloride.
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-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.
The use of nortriptyline hydrochloride in schizophrenic patients may result
in an exacerbation of the psychosis or may activate latent schizophrenic
symptoms. If the drug is given to overactive or agitated patients, increased
anxiety and agitation may occur. In manic-depressive patients, nortriptyline
hydrochloride may cause symptoms of the manic phase to emerge.
Troublesome patient hostility may be aroused by the use of nortriptyline
hydrochloride. Epileptiform seizures may accompany its administration, as is
true of other drugs of its class.
When it is essential, the drug may be administered with electroconvulsive
therapy, although the hazards may be increased. Discontinue the drug for several
days, if possible, prior to elective surgery.
The possibility of a suicidal attempt by a depressed patient remains after
the initiation of treatment; in this regard, it is important that the least
possible quantity of drug be dispensed at any given time.
Both elevation and lowering of blood sugar levels have been reported.
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
nortriptyline hydrochloride 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 1 C 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.
Safety and effectiveness in the pediatric population have not
been established (see and). Anyone considering the use of
nortriptyline hydrochloride in a child or adolescent must balance the potential
risks with the clinical need.
Clinical studies of nortriptyline HCI did not include sufficient
numbers of subjects aged 65 and over to determine whether they respond
differently from younger subjects. Other reported clinical experience indicates
that, as with other tricyclic antidepressants, hepatic adverse events
(characterized mainly by jaundice and elevated liver enzymes) are observed very
rarely in geriatric patients and deaths associated with cholestatic liver damage
have been reported in isolated instances. Cardiovascular function, particularly
arrhythmias and fluctuations in blood pressure, should be monitored. There have
also been reports of confusional states following tricyclic antidepressant
administration in the elderly. Higher plasma concentrations of the active
nortriptyline metabolite, 10-hydroxynortriptyline, have also been reported in
elderly patients. As with other tricyclic antidepressants, dose selection for an
elderly patient should usually be limited to the smallest effective total daily
dose (see).
What are the side effects of Nortriptyline Hydrochloride?
Note:
Cardiovascular
Psychiatric
Neurologic
Anticholinergic
Allergic
Hematologic
Gastrointestinal
Endocrine
Other
Withdrawal Symptoms
What should I look out for while using Nortriptyline Hydrochloride?
The use of nortriptyline hydrochloride or other tricyclic
antidepressants concurrently with a monoamine oxidase (MAO) inhibitor is
contraindicated. Hyperpyretic crises, severe convulsions, and fatalities have
occurred when similar tricyclic antidepressants were used in such combinations.
It is advisable to have discontinued the MAO inhibitor for at least two weeks
before treatment with nortriptyline hydrochloride is started. Patients
hypersensitive to nortriptyline hydrochloride should not be given the drug.
Cross-sensitivity between nortriptyline hydrochloride and other
dibenzazepines is a possibility.
Nortriptyline hydrochloride is contraindicated during the acute recovery
period after myocardial infarction.
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 predicators of suicide. There has been a
long-standing concern 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
trails 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 18-24) 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.
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.
Screening Patients for Bipolar Disorder:
Patients with cardiovascular disease should be given nortriptyline
hydrochloride 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, nortriptyline hydrochloride should be used with great
caution in patients who have glaucoma or a history of urinary retention.
Patients with a history of seizures should be followed closely when
nortriptyline hydrochloride is administered, inasmuch as this drug is known to
lower the convulsive threshold. Great care is required if nortriptyline
hydrochloride is given to hyperthyroid patients or to those receiving thyroid
medication, since cardiac arrhythmias may develop.
Nortriptyline hydrochloride 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.
Safe use of nortriptyline hydrochloride 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.
What might happen if I take too much Nortriptyline Hydrochloride?
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.
Critical manifestations of overdose include: cardiac
dysrhythmias, severe hypotension, shock, congestive heart failure, pulmonary
edema, 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, restlessness, disturbed
concentration, transient visual hallucinations, dilated pupils, agitation,
hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting,
hypothermia, hyperpyrexia, or any of the acute symptoms listed under. There have been
reports of patients recovering from nortriptyline overdoses of up to 525
mg.
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. Monitoring
of plasma drug levels 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 greater than or equal to 0.10 seconds may be the best indication
of the severity of the overdose. 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 greater than 7.60 or a pC0 less than 20 mm Hg is undesirable. Dysrhythmias unresponsive to
sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium
or phenytoin. Type 1A and 1 C 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.
Since overdosage is often deliberate, patients may attempt
suicide by other means during the recovery phase. Psychiatric referral may be
appropriate.
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.
How should I store and handle Nortriptyline Hydrochloride?
Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg nortriptyline) are #3, opaque deep green and opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2835-2);bottles of 60 (NDC 54868-2835-1);bottles of 90 (NDC 54868-2835-4); and bottles of 100 (NDC 54868-2835-3).Nortriptyline Hydrochloride Capsules USP (equivalent to 25 mg nortriptyline) are #1, opaque deep green and opaque white capsules imprinted and supplied in bottles of 25 (NDC 54868-2480-4); bottles of 30 (NDC 54868-2480-2); bottles of 60 (NDC 54868-2480-1); and bottles of 100 (NDC 54868-2480-0).Nortriptyline Hydrochloride Capsules USP (equivalent to 50 mg nortriptyline) are #1, opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2481-2); bottles of 60 (NDC 54868-2481-3); and bottles of 100 (NDC 54868-2481-1).Nortriptyline Hydrochloride Capsules USP (equivalent to 75 mg nortriptyline) are #1, opaque deep green capsules imprinted and supplied in bottles of 30 (NDC 54868-2482-2); and bottles of 100 (NDC 54868-2482-0).Dispense in a tight container, as defined in the USP, with a child-resistant closure.Store at 20°–25°C (68°–77°F). [See USP controlled room temperature.]Watson Laboratories, Inc.Revised: August 20070807BRepackaging and Relabeling by: Tulsa, OK 74146 Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg nortriptyline) are #3, opaque deep green and opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2835-2);bottles of 60 (NDC 54868-2835-1);bottles of 90 (NDC 54868-2835-4); and bottles of 100 (NDC 54868-2835-3).Nortriptyline Hydrochloride Capsules USP (equivalent to 25 mg nortriptyline) are #1, opaque deep green and opaque white capsules imprinted and supplied in bottles of 25 (NDC 54868-2480-4); bottles of 30 (NDC 54868-2480-2); bottles of 60 (NDC 54868-2480-1); and bottles of 100 (NDC 54868-2480-0).Nortriptyline Hydrochloride Capsules USP (equivalent to 50 mg nortriptyline) are #1, opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2481-2); bottles of 60 (NDC 54868-2481-3); and bottles of 100 (NDC 54868-2481-1).Nortriptyline Hydrochloride Capsules USP (equivalent to 75 mg nortriptyline) are #1, opaque deep green capsules imprinted and supplied in bottles of 30 (NDC 54868-2482-2); and bottles of 100 (NDC 54868-2482-0).Dispense in a tight container, as defined in the USP, with a child-resistant closure.Store at 20°–25°C (68°–77°F). [See USP controlled room temperature.]Watson Laboratories, Inc.Revised: August 20070807BRepackaging and Relabeling by: Tulsa, OK 74146 Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg nortriptyline) are #3, opaque deep green and opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2835-2);bottles of 60 (NDC 54868-2835-1);bottles of 90 (NDC 54868-2835-4); and bottles of 100 (NDC 54868-2835-3).Nortriptyline Hydrochloride Capsules USP (equivalent to 25 mg nortriptyline) are #1, opaque deep green and opaque white capsules imprinted and supplied in bottles of 25 (NDC 54868-2480-4); bottles of 30 (NDC 54868-2480-2); bottles of 60 (NDC 54868-2480-1); and bottles of 100 (NDC 54868-2480-0).Nortriptyline Hydrochloride Capsules USP (equivalent to 50 mg nortriptyline) are #1, opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2481-2); bottles of 60 (NDC 54868-2481-3); and bottles of 100 (NDC 54868-2481-1).Nortriptyline Hydrochloride Capsules USP (equivalent to 75 mg nortriptyline) are #1, opaque deep green capsules imprinted and supplied in bottles of 30 (NDC 54868-2482-2); and bottles of 100 (NDC 54868-2482-0).Dispense in a tight container, as defined in the USP, with a child-resistant closure.Store at 20°–25°C (68°–77°F). [See USP controlled room temperature.]Watson Laboratories, Inc.Revised: August 20070807BRepackaging and Relabeling by: Tulsa, OK 74146 Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg nortriptyline) are #3, opaque deep green and opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2835-2);bottles of 60 (NDC 54868-2835-1);bottles of 90 (NDC 54868-2835-4); and bottles of 100 (NDC 54868-2835-3).Nortriptyline Hydrochloride Capsules USP (equivalent to 25 mg nortriptyline) are #1, opaque deep green and opaque white capsules imprinted and supplied in bottles of 25 (NDC 54868-2480-4); bottles of 30 (NDC 54868-2480-2); bottles of 60 (NDC 54868-2480-1); and bottles of 100 (NDC 54868-2480-0).Nortriptyline Hydrochloride Capsules USP (equivalent to 50 mg nortriptyline) are #1, opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2481-2); bottles of 60 (NDC 54868-2481-3); and bottles of 100 (NDC 54868-2481-1).Nortriptyline Hydrochloride Capsules USP (equivalent to 75 mg nortriptyline) are #1, opaque deep green capsules imprinted and supplied in bottles of 30 (NDC 54868-2482-2); and bottles of 100 (NDC 54868-2482-0).Dispense in a tight container, as defined in the USP, with a child-resistant closure.Store at 20°–25°C (68°–77°F). [See USP controlled room temperature.]Watson Laboratories, Inc.Revised: August 20070807BRepackaging and Relabeling by: Tulsa, OK 74146 Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg nortriptyline) are #3, opaque deep green and opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2835-2);bottles of 60 (NDC 54868-2835-1);bottles of 90 (NDC 54868-2835-4); and bottles of 100 (NDC 54868-2835-3).Nortriptyline Hydrochloride Capsules USP (equivalent to 25 mg nortriptyline) are #1, opaque deep green and opaque white capsules imprinted and supplied in bottles of 25 (NDC 54868-2480-4); bottles of 30 (NDC 54868-2480-2); bottles of 60 (NDC 54868-2480-1); and bottles of 100 (NDC 54868-2480-0).Nortriptyline Hydrochloride Capsules USP (equivalent to 50 mg nortriptyline) are #1, opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2481-2); bottles of 60 (NDC 54868-2481-3); and bottles of 100 (NDC 54868-2481-1).Nortriptyline Hydrochloride Capsules USP (equivalent to 75 mg nortriptyline) are #1, opaque deep green capsules imprinted and supplied in bottles of 30 (NDC 54868-2482-2); and bottles of 100 (NDC 54868-2482-0).Dispense in a tight container, as defined in the USP, with a child-resistant closure.Store at 20°–25°C (68°–77°F). [See USP controlled room temperature.]Watson Laboratories, Inc.Revised: August 20070807BRepackaging and Relabeling by: Tulsa, OK 74146 Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg nortriptyline) are #3, opaque deep green and opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2835-2);bottles of 60 (NDC 54868-2835-1);bottles of 90 (NDC 54868-2835-4); and bottles of 100 (NDC 54868-2835-3).Nortriptyline Hydrochloride Capsules USP (equivalent to 25 mg nortriptyline) are #1, opaque deep green and opaque white capsules imprinted and supplied in bottles of 25 (NDC 54868-2480-4); bottles of 30 (NDC 54868-2480-2); bottles of 60 (NDC 54868-2480-1); and bottles of 100 (NDC 54868-2480-0).Nortriptyline Hydrochloride Capsules USP (equivalent to 50 mg nortriptyline) are #1, opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2481-2); bottles of 60 (NDC 54868-2481-3); and bottles of 100 (NDC 54868-2481-1).Nortriptyline Hydrochloride Capsules USP (equivalent to 75 mg nortriptyline) are #1, opaque deep green capsules imprinted and supplied in bottles of 30 (NDC 54868-2482-2); and bottles of 100 (NDC 54868-2482-0).Dispense in a tight container, as defined in the USP, with a child-resistant closure.Store at 20°–25°C (68°–77°F). [See USP controlled room temperature.]Watson Laboratories, Inc.Revised: August 20070807BRepackaging and Relabeling by: Tulsa, OK 74146 Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg nortriptyline) are #3, opaque deep green and opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2835-2);bottles of 60 (NDC 54868-2835-1);bottles of 90 (NDC 54868-2835-4); and bottles of 100 (NDC 54868-2835-3).Nortriptyline Hydrochloride Capsules USP (equivalent to 25 mg nortriptyline) are #1, opaque deep green and opaque white capsules imprinted and supplied in bottles of 25 (NDC 54868-2480-4); bottles of 30 (NDC 54868-2480-2); bottles of 60 (NDC 54868-2480-1); and bottles of 100 (NDC 54868-2480-0).Nortriptyline Hydrochloride Capsules USP (equivalent to 50 mg nortriptyline) are #1, opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2481-2); bottles of 60 (NDC 54868-2481-3); and bottles of 100 (NDC 54868-2481-1).Nortriptyline Hydrochloride Capsules USP (equivalent to 75 mg nortriptyline) are #1, opaque deep green capsules imprinted and supplied in bottles of 30 (NDC 54868-2482-2); and bottles of 100 (NDC 54868-2482-0).Dispense in a tight container, as defined in the USP, with a child-resistant closure.Store at 20°–25°C (68°–77°F). [See USP controlled room temperature.]Watson Laboratories, Inc.Revised: August 20070807BRepackaging and Relabeling by: Tulsa, OK 74146 Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg nortriptyline) are #3, opaque deep green and opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2835-2);bottles of 60 (NDC 54868-2835-1);bottles of 90 (NDC 54868-2835-4); and bottles of 100 (NDC 54868-2835-3).Nortriptyline Hydrochloride Capsules USP (equivalent to 25 mg nortriptyline) are #1, opaque deep green and opaque white capsules imprinted and supplied in bottles of 25 (NDC 54868-2480-4); bottles of 30 (NDC 54868-2480-2); bottles of 60 (NDC 54868-2480-1); and bottles of 100 (NDC 54868-2480-0).Nortriptyline Hydrochloride Capsules USP (equivalent to 50 mg nortriptyline) are #1, opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2481-2); bottles of 60 (NDC 54868-2481-3); and bottles of 100 (NDC 54868-2481-1).Nortriptyline Hydrochloride Capsules USP (equivalent to 75 mg nortriptyline) are #1, opaque deep green capsules imprinted and supplied in bottles of 30 (NDC 54868-2482-2); and bottles of 100 (NDC 54868-2482-0).Dispense in a tight container, as defined in the USP, with a child-resistant closure.Store at 20°–25°C (68°–77°F). [See USP controlled room temperature.]Watson Laboratories, Inc.Revised: August 20070807BRepackaging and Relabeling by: Tulsa, OK 74146 Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg nortriptyline) are #3, opaque deep green and opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2835-2);bottles of 60 (NDC 54868-2835-1);bottles of 90 (NDC 54868-2835-4); and bottles of 100 (NDC 54868-2835-3).Nortriptyline Hydrochloride Capsules USP (equivalent to 25 mg nortriptyline) are #1, opaque deep green and opaque white capsules imprinted and supplied in bottles of 25 (NDC 54868-2480-4); bottles of 30 (NDC 54868-2480-2); bottles of 60 (NDC 54868-2480-1); and bottles of 100 (NDC 54868-2480-0).Nortriptyline Hydrochloride Capsules USP (equivalent to 50 mg nortriptyline) are #1, opaque white capsules imprinted and supplied in bottles of 30 (NDC 54868-2481-2); bottles of 60 (NDC 54868-2481-3); and bottles of 100 (NDC 54868-2481-1).Nortriptyline Hydrochloride Capsules USP (equivalent to 75 mg nortriptyline) are #1, opaque deep green capsules imprinted and supplied in bottles of 30 (NDC 54868-2482-2); and bottles of 100 (NDC 54868-2482-0).Dispense in a tight container, as defined in the USP, with a child-resistant closure.Store at 20°–25°C (68°–77°F). [See USP controlled room temperature.]Watson Laboratories, Inc.Revised: August 20070807BRepackaging and Relabeling by: Tulsa, OK 74146
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of mood elevation by tricyclic antidepressants is at present
unknown. Nortriptyline hydrochloride is not a monoamine oxidase inhibitor. It
inhibits the activity of such diverse agents as histamine, 5-hydroxytryptamine,
and acetylcholine. It increases the pressor effect of norepinephrine but blocks
the pressor response of phenethylamine. Studies suggest that nortriptyline
hydrochloride interferes with the transport, release, and storage of
catecholamines. Operant conditioning techniques in rats and pigeons suggest that
nortriptyline hydrochloride has a combination of stimulant and depressant
properties.
Non-Clinical Toxicology
The use of nortriptyline hydrochloride or other tricyclic antidepressants concurrently with a monoamine oxidase (MAO) inhibitor is contraindicated. Hyperpyretic crises, severe convulsions, and fatalities have occurred when similar tricyclic antidepressants were used in such combinations. It is advisable to have discontinued the MAO inhibitor for at least two weeks before treatment with nortriptyline hydrochloride is started. Patients hypersensitive to nortriptyline hydrochloride should not be given the drug.Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility.
Nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.
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 predicators of suicide. There has been a long-standing concern 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 trails 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 18-24) 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.
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.
Screening Patients for Bipolar Disorder:
Patients with cardiovascular disease should be given nortriptyline hydrochloride 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, nortriptyline hydrochloride should be used with great caution in patients who have glaucoma or a history of urinary retention. Patients with a history of seizures should be followed closely when nortriptyline hydrochloride is administered, inasmuch as this drug is known to lower the convulsive threshold. Great care is required if nortriptyline hydrochloride is given to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop.
Nortriptyline hydrochloride 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.
Safe use of nortriptyline hydrochloride 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.
(Seeand Clinically or potentially significant drug interactions between fluconazole and the following agents/classes have been observed. These are described in greater detail below:
Oral hypoglycemicsCoumarin-type anticoagulantsPhenytoinCyclosporineRifampinTheophyllineTerfenadineCisaprideAstemizoleRifabutinTacrolimusShort-term benzodiazepines
Astemizole:
Fluconazole tablets coadministered with ethinyl estradiol- and levonorgestrel-containing oral contraceptives produced an overall mean increase in ethinyl estradiol and levonorgestrel levels; however, in some patients there were decreases up to 47% and 33% of ethinyl estradiol and levonorgestrel levels. (See .) The data presently available indicate that the decreases in some individual ethinyl estradiol and levonorgestrel AUC values with fluconazole treatment are likely the result of random variation. While there is evidence that fluconazole can inhibit the metabolism of ethinyl estradiol and levonorgestrel, there is no evidence that fluconazole is a net inducer of ethinyl estradiol or levonorgestrel metabolism. The clinical significance of these effects is presently unknown.
Physicians should be aware that interaction studies with medications other than those listed in the section have not been conducted, but such interactions may occur.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with nortriptyline hydrochloride 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 nortriptyline 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 nortriptyline hydrochloride.
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-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.
The use of nortriptyline hydrochloride in schizophrenic patients may result in an exacerbation of the psychosis or may activate latent schizophrenic symptoms. If the drug is given to overactive or agitated patients, increased anxiety and agitation may occur. In manic-depressive patients, nortriptyline hydrochloride may cause symptoms of the manic phase to emerge.
Troublesome patient hostility may be aroused by the use of nortriptyline hydrochloride. Epileptiform seizures may accompany its administration, as is true of other drugs of its class.
When it is essential, the drug may be administered with electroconvulsive therapy, although the hazards may be increased. Discontinue the drug for several days, if possible, prior to elective surgery.
The possibility of a suicidal attempt by a depressed patient remains after the initiation of treatment; in this regard, it is important that the least possible quantity of drug be dispensed at any given time.
Both elevation and lowering of blood sugar levels have been reported.
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 nortriptyline hydrochloride 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 1 C 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.
Safety and effectiveness in the pediatric population have not been established (see and). Anyone considering the use of nortriptyline hydrochloride in a child or adolescent must balance the potential risks with the clinical need.
Clinical studies of nortriptyline HCI did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience indicates that, as with other tricyclic antidepressants, hepatic adverse events (characterized mainly by jaundice and elevated liver enzymes) are observed very rarely in geriatric patients and deaths associated with cholestatic liver damage have been reported in isolated instances. Cardiovascular function, particularly arrhythmias and fluctuations in blood pressure, should be monitored. There have also been reports of confusional states following tricyclic antidepressant administration in the elderly. Higher plasma concentrations of the active nortriptyline metabolite, 10-hydroxynortriptyline, have also been reported in elderly patients. As with other tricyclic antidepressants, dose selection for an elderly patient should usually be limited to the smallest effective total daily dose (see).
Note:
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Withdrawal Symptoms
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
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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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Interactions
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).