Doxepin Hydrochloride

Doxepin Hydrochloride

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Questions & Answers

Side Effects & Adverse Reactions

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 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.

The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1

Table 1
Age RangeDrug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated
Increases Compared to Placebo
<1814 additional cases
18-245 additional cases
Decreases Compared to Placebo
25-641 fewer case
≥656 fewer cases

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

It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.

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

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for doxepin hydrochloride should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Screening Patients for Bipolar Disorder

A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that doxepin hydrochloride is not approved for use in treating bipolar depression.

The once-a-day dosage regimen of doxepin hydrochloride capsules in patients with intercurrent illness or patients taking other medications should be carefully adjusted. This is especially important in patients receiving other medications with anticholinergic effects.

Usage in Geriatrics

The use of doxepin hydrochloride capsules on a once-a-day dosage regimen in geriatric patients should be adjusted carefully based on the patient’s condition (seePRECAUTIONS-Geriatric Use).

Usage in Pregnancy

Reproduction studies have been performed in rats, rabbits, monkeys and dogs and there was no evidence of harm to the animal fetus. The relevance to humans is not known. Since there is no experience in pregnant women who have received this drug, safety in pregnancy has not been established. There has been a report of apnea and drowsiness occurring in a nursing infant whose mother was taking doxepin hydrochloride capsules.

Usage in Children

The use of doxepin hydrochloride capsules in children under 12 years of age is not recommended because safe conditions for its use have not been established.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Doxepin hydrochloride capsules are recommended for the treatment of:

  1. Psychoneurotic patients with depression and/or anxiety.

  2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).

  3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).

  4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.

The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.

Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use in children under 12 years of age.

History

There is currently no drug history available for this drug.

Other Information

Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. It is a white crystalline solid readily soluble in water, lower alcohols and chloroform.

CHEMISTRY

Doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N- dimethyl-, hydrochloride. The structural formula is as follows:

Image from Drug Label Content

C19H21NO•HCl                 M.W. 315.84

Doxepin Hydrochloride Capsules USP 10 mg, 25 mg, 50 mg, 75 mg and 100 mg contain the following inactive ingredients: magnesium stearate and sodium lauryl sulfate.

Doxepin Hydrochloride Capsules USP 10 mg and 25 mg also contain pregelatinized starch. The capsule shells contain: D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide.

Doxepin Hydrochloride Capsules USP 50 mg also contain starch (corn). The capsule shell contains: D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide.

Doxepin Hydrochloride Capsules USP 75 mg also contain starch (corn). The capsule shell contains: D&C Yellow No. 10, FD&C Green No. 3, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide.

Doxepin Hydrochloride Capsules USP 100 mg also contain starch (corn). The capsule shell contains: colloidal silicon dioxide, D&C Yellow No. 10, FD&C Green No. 3, gelatin, sodium lauryl sulfate and titanium dioxide.

Doxepin Hydrochloride Manufacturers


  • Watson Laboratories, Inc.
    Doxepin Hydrochloride (Doxepin Hydrochloride) Capsule [Watson Laboratories, Inc.]
  • Contract Pharmacy Services-pa
    Doxepin Hydrochloride Capsule [Contract Pharmacy Services-pa]
  • Physicians Total Care, Inc.
    Doxepin Hydrochloride Capsule [Physicians Total Care, Inc.]
  • Rebel Distributors Corp
    Doxepin Hydrochloride Capsule [Rebel Distributors Corp]
  • Remedyrepack Inc.
    Doxepin Hydrochloride Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Doxepin Hydrochloride Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Doxepin Hydrochloride Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Doxepin Hydrochloride (Doxepin Hydrochloride) Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Doxepin Hydrochloride (Doxepin Hydrochloride) Capsule [Remedyrepack Inc. ]
  • Pd-rx Pharmaceuticals, Inc.
    Doxepin Hydrochloride Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Stat Rx Usa Llc
    Doxepin Hydrochloride Capsule [Stat Rx Usa Llc]
  • H.j. Harkins Company, Inc.
    Doxepin Hydrochloride Capsule [H.j. Harkins Company, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Doxepin Hydrochloride Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Doxepin Hydrochloride Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Stat Rx Usa Llc
    Doxepin Hydrochloride Capsule [Stat Rx Usa Llc]
  • Remedyrepack Inc.
    Doxepin Hydrochloride Capsule [Remedyrepack Inc. ]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Doxepin Hydrochloride Capsule [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Doxepin Hydrochloride Capsule [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Unit Dose Services
    Doxepin Hydrochloride Capsule [Unit Dose Services]
  • Avkare, Inc.
    Doxepin Hydrochloride (Doxepin Hydrochloride) Capsule [Avkare, Inc.]
  • Bryant Ranch Prepack
    Doxepin Hydrochloride Capsule [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Doxepin Hydrochloride Capsule [Bryant Ranch Prepack]
  • A-s Medication Solutions Llc
    Doxepin Hydrochloride Capsule [A-s Medication Solutions Llc]
  • Aidarex Pharmaceuticals Llc
    Doxepin Hydrochloride Capsule [Aidarex Pharmaceuticals Llc]
  • Bryant Ranch Prepack
    Doxepin Hydrochloride Capsule [Bryant Ranch Prepack]
  • Mylan Pharmaceuticals Inc.
    Doxepin Hydrochloride Capsule [Mylan Pharmaceuticals Inc.]
  • Mylan Institutional Inc.
    Doxepin Hydrochloride Capsule [Mylan Institutional Inc.]
  • Cardinal Health
    Doxepin Hydrochloride Capsule [Cardinal Health]
  • Direct Rx
    Doxepin Hydrochloride Capsule [Direct Rx]
  • Direct Rx
    Doxepin Hydrochloride Capsule [Direct Rx]
  • Par Pharmaceutical Inc
    Doxepin Hydrochloride Capsule [Par Pharmaceutical Inc]
  • Tya Pharmaceuticals
    Doxepin Hydrochloride Capsule [Tya Pharmaceuticals]
  • Remedyrepack Inc.
    Doxepin Hydrochloride Capsule [Remedyrepack Inc. ]
  • Medsource Pharmaceuticals
    Doxepin Hydrochloride Capsule [Medsource Pharmaceuticals]
  • Medsource Pharmaceuticals
    Doxepin Hydrochloride Capsule [Medsource Pharmaceuticals]

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