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Amitriptyline Hydrochloride

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Overview

What is Amitriptyline Hydrochloride?

Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol.

It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5-dibenzo[a,d] cycloheptene-Δ, γ-propylamine hydrochloride. It has the following structural formula:

Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn) and titanium dioxide. The also includes D&C Red #27 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake; – D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake; – FD&C Blue #2 Aluminum Lake and FD&C Red #40 Aluminum Lake; – D&C Red #7 Calcium Lake and FD&C Blue #2 Aluminum Lake; – D&C Red #30 Aluminum Lake and D&C Yellow #10 Aluminum Lake; – D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake.



What does Amitriptyline Hydrochloride look like?



What are the available doses of Amitriptyline Hydrochloride?

Sorry No records found.

What should I talk to my health care provider before I take Amitriptyline Hydrochloride?

Sorry No records found

How should I use Amitriptyline Hydrochloride?

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.

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


What interacts with Amitriptyline Hydrochloride?

Amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it.


It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved.


Amitriptyline hydrochloride should not be given with cisapride due to the potential for increased QT interval and increased risk for arrhythmia.


This drug is not recommended for use during the acute recovery phase following myocardial infarction.



What are the warnings of Amitriptyline 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.

Table 1
Age Rangeper 1000 Patients Treated
Increases Compared to Placebo
14 additional cases
18-245 additional cases
Decreases Compared to Placebo
25-641 fewer case
≥656 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 amitriptyline hydrochloride is not approved for use in treating bipolar depression.

Amitriptyline hydrochloride may block the antihypertensive action of guanethidine or similarly acting compounds.

It should be used with caution in patients with a history of seizures and, because of its atropine-like action, in patients with a history of urinary retention, angle-closure glaucoma or increased intraocular pressure. In patients with angle-closure glaucoma, even average doses may precipitate an attack.

Patients with cardiovascular disorders should be watched closely. Tricyclic antidepressant drugs, including amitriptyline hydrochloride, particularly when given in high doses, have been reported to produce arrhythmias, sinus tachycardia, and prolongation of the conduction time. Myocardial infarction and stroke have been reported with drugs of this class.

Close supervision is required when amitriptyline hydrochloride is given to hyperthyroid patients or those receiving thyroid medication.

Amitriptyline may enhance the response to alcohol and the effects of barbiturates and other CNS depressants. 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. Delirium has been reported with concurrent administration of amitriptyline and disulfiram.

Usage in Pregnancy

Teratogenic effects were not observed in mice, rats, or rabbits when amitriptyline was given orally at doses of 2 to 40 mg/kg/day (up to 13 times the maximum recommended human dose). Studies in literature have shown amitriptyline to be teratogenic in mice and hamsters when given by various routes of administration at doses of 28 to 100 mg/kg/day (9 to 33 times the maximum recommended human dose), producing multiple malformations. Another study in the rat reported that an oral dose of 25 mg/kg/day (8 times the maximum recommended human dose) produced delays in ossification of fetal vertebral bodies without other signs of embryotoxicity. In rabbits, an oral dose of 60 mg/kg/day (20 times the maximum recommended human dose) was reported to cause incomplete ossification of cranial bones.

Amitriptyline has been shown to cross the placenta. Although a causal relationship has not been established, there have been a few reports of adverse events, including CNS effects, limb deformities, or developmental delay, in infants whose mothers had taken amitriptyline during pregnancy.

There are no adequate and well-controlled studies in pregnant women. Amitriptyline hydrochloride should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Nursing Mothers

Amitriptyline is excreted into breast milk. In one report in which a patient received amitriptyline 100 mg/day while nursing her infant, levels of 83 to 141 ng/mL were detected in the mother’s serum. Levels of 135 to 151 ng/mL were found in the breast milk, but no trace of the drug could be detected in the infant’s serum.

Because of the potential for serious adverse reactions in nursing infants from amitriptyline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Usage in Pediatric Patients

In view of the lack of experience with the use of this drug in pediatric patients, it is not recommended at the present time for patients under 12 years of age.


What are the precautions of Amitriptyline Hydrochloride?

Schizophrenic patients may develop increased symptoms of psychosis; patients with paranoid symptomatology may have an exaggeration of such symptoms. Depressed patients, particularly those with known manic-depressive illness, may experience a shift to mania or hypomania. In these circumstances the dose of amitriptyline may be reduced or a major tranquilizer such as perphenazine may be administered concurrently.

The possibility of suicide in depressed patients remains until significant remission occurs. Potentially suicidal patients should not have access to large quantities of this drug. Prescriptions should be written for the smallest amount feasible.

Concurrent administration of amitriptyline hydrochloride and electroshock therapy may increase the hazards associated with such therapy. Such treatment should be limited to patients for whom it is essential.

When possible, the drug should be discontinued several days before elective surgery.

Both elevation and lowering of blood sugar levels have been reported.

Amitriptyline hydrochloride should be used with caution in patients with impaired liver function.

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 amitriptyline 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 amitriptyline 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 amitriptyline 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 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.

While on therapy with amitriptyline hydrochloride, patients should be advised as to the possible impairment of mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.

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 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 coadministration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

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 coadministered with another drug known to be an inhibitor of P450 2D6.

Monoamine oxidase inhibitors – see section. Guanethidine or similarly acting compounds; thyroid medication; alcohol, barbiturates and other CNS depressants; and disulfiram – see section.

When amitriptyline is given with anticholinergic agents or sympathomimetic drugs, including epinephrine combined with local anesthetics, close supervision and careful adjustment of dosages are required.

Hyperpyrexia has been reported when amitriptyline is administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather.

Paralytic ileus may occur in patients taking tricyclic antidepressants in combination with anticholinergic-type drugs.

Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine. Increases in plasma levels of tricyclic antidepressants, and in the frequency and severity of side effects, particularly anticholinergic, have been reported when cimetidine was added to the drug regimen. Discontinuation of cimetidine in well-controlled patients receiving tricyclic antidepressants and cimetidine may decrease the plasma levels and efficacy of the antidepressants.

Caution is advised if patients receive large doses of ethchlorvynol concurrently. Transient delirium has been reported in patients who were treated with one gram of ethchlorvynol and 75 to 150 mg of amitriptyline hydrochloride.

Geriatric Use

Clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic function, concomitant disease and other drug therapy in elderly patients.

Geriatric patients are particularly sensitive to the anticholinergic side effects of tricyclic antidepressants including amitriptyline hydrochloride. Peripheral anticholinergic effects include tachycardia, urinary retention, constipation, dry mouth, blurred vision, and exacerbation of narrow-angle glaucoma. Central nervous system anticholinergic effects include cognitive impairment, psychomotor slowing, confusion, sedation, and delirium. Elderly patients taking amitriptyline hydrochloride may be at increased risk for falls. Elderly patients should be started on low doses of amitriptyline hydrochloride and observed closely (see ).

Pediatric Use

Safety and effectiveness in the pediatric population have not been established (see and ). Anyone considering the use of amitriptyline in a child or adolescent must balance the potential risks with the clinical need.


What are the side effects of Amitriptyline Hydrochloride?

Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when amitriptyline is administered.

Cardiovascular:

CNS and Neuromuscular:

Anticholinergic:

Allergic:

Hematologic:

Gastrointestinal:

Endocrine:

Other:

Withdrawal Symptoms

After prolonged administration, abrupt cessation of treatment may produce nausea, headache, and malaise. Gradual dosage reduction has been reported to produce, within two weeks, transient symptoms including irritability, restlessness, and dream and sleep disturbance.

These symptoms are not indicative of addiction. Rare instances have been reported of mania or hypomania occurring within 2 to 7 days following cessation of chronic therapy with tricyclic antidepressants.

Causal Relationship Unknown

Other reactions, reported under circumstances where a causal relationship could not be established, are listed to serve as alerting information to physicians:

Body as a Whole:

Digestive:

Postmarketing Adverse Events

A syndrome resembling neuroleptic malignant syndrome (NMS) has been very rarely reported after starting or increasing the dose of amitriptyline hydrochloride, with and without concomitant medications known to cause NMS. Symptoms have included muscle rigidity, fever, mental status changes, diaphoresis, tachycardia, and tremor.

Very rare cases of serotonin syndrome (SS) have been reported with amitriptyline hydrochloride in combination with other drugs that have a recognized association with SS.


What should I look out for while using Amitriptyline Hydrochloride?

Amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it.

It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved.

Amitriptyline hydrochloride should not be given with cisapride due to the potential for increased QT interval and increased risk for arrhythmia.

This drug is not recommended for use during the acute recovery phase following myocardial infarction.


What might happen if I take too much Amitriptyline 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.


How should I store and handle Amitriptyline Hydrochloride?

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000Amitriptyline hydrochloride tablets, USP for oral administration are available as:10 mg:NDC 0781-1486-31 bottles of 30NDC 0781-1486-01 bottles of 100NDC 0781-1486-10 bottles of 100025 mg:NDC 0781-1487-31 bottles of 30NDC 0781-1487-01 bottles of 100NDC 0781-1487-10 bottles of 100050 mg:NDC 0781-1488-31 bottles of 30NDC 0781-1488-01 bottles of 100NDC 0781-1488-10 bottles of 100075 mg:NDC 0781-1489-31 bottles of 30NDC 0781-1489-01 bottles of 100NDC 0781-1489-10 bottles of 1000100 mg:NDC 0781-1490-31 bottles of 30NDC 0781-1490-01 bottles of 100NDC 0781-1490-10 bottles of 1000150 mg:NDC 0781-1491-31 bottles of 30NDC 0781-1491-01 bottles of 100NDC 0781-1491-10 bottles of 1000


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Amitriptyline HCl is an antidepressant with sedative effects. Its mechanism of action in man is not known. It is not a monoamine oxidase inhibitor and it does not act primarily by stimulation of the central nervous system.

Amitriptyline inhibits the membrane pump mechanism responsible for uptake of norepinephrine and serotonin in adrenergic and serotonergic neurons. Pharmacologically, this action may potentiate or prolong neuronal activity since reuptake of these biogenic amines is important physiologically in terminating transmitting activity. This interference with reuptake of norepinephrine and/or serotonin is believed by some to underlie the antidepressant activity of amitriptyline.

Non-Clinical Toxicology
Amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it.

It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved.

Amitriptyline hydrochloride should not be given with cisapride due to the potential for increased QT interval and increased risk for arrhythmia.

This drug is not recommended for use during the acute recovery phase following myocardial infarction.

Schizophrenic patients may develop increased symptoms of psychosis; patients with paranoid symptomatology may have an exaggeration of such symptoms. Depressed patients, particularly those with known manic-depressive illness, may experience a shift to mania or hypomania. In these circumstances the dose of amitriptyline may be reduced or a major tranquilizer such as perphenazine may be administered concurrently.

The possibility of suicide in depressed patients remains until significant remission occurs. Potentially suicidal patients should not have access to large quantities of this drug. Prescriptions should be written for the smallest amount feasible.

Concurrent administration of amitriptyline hydrochloride and electroshock therapy may increase the hazards associated with such therapy. Such treatment should be limited to patients for whom it is essential.

When possible, the drug should be discontinued several days before elective surgery.

Both elevation and lowering of blood sugar levels have been reported.

Amitriptyline hydrochloride should be used with caution in patients with impaired liver function.

Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when amitriptyline is administered.

Cardiovascular:

CNS and Neuromuscular:

Anticholinergic:

Allergic:

Hematologic:

Gastrointestinal:

Endocrine:

Other:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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. 315.72
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Tips

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Interactions

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).