Doxepin (oral)

Doxepin (oral)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]

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Black Box Warning

Suicidality and Antidepressant Drugs See full prescribing information for complete Boxed Warning. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of doxepin hydrochloride oral solution or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Doxepin hydrochloride oral solution is not approved for use in pediatric patients.

Overview

Doxepin (oral) is a Tricyclic antidepressant that is FDA approved for the {{{indicationType}}} of alcoholism - anxiety - depression, anxiety - depression, anxiety - depression - psychoneurotic personality disorder, insomnia, pruritus. There is a Black Box Warning for this drug as shown here. Common adverse reactions include constipation, nausea, xerostomia, dizziness, somnolence, urinary retention, upper respiratory infection.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Alcoholism - Anxiety - Depression

• Very mild, 25 to 50 mg/day orally initially, gradually increase as needed (max, 300 mg/day).

Alcoholism - Anxiety - Depression

• Mild to moderate, 75 mg ORALLY per day in single or divided doses, increase as needed; usual range is 75 to 150 mg/day (max, 300 mg/day).

Anxiety - Depression

• Very mild, 25 to 50 mg/day ORALLY initially, gradually increase as needed (max, 300 mg/day)
• 75 mg ORALLY per day in single or divided doses, increase as needed; usual range is 75 to 150 mg/day (max, 300 mg/day).

Anxiety - Depression - Psychoneurotic personality disorder

• Outpatients: 75 mg/day ORALLY (divided into 1 to 3 doses); may increase up to a MAX of 150 mg/day
• Inpatients: 150 mg/day ORALLY (divided into 1 to 3 doses); may increase up to a MAX of 300 mg/day

Insomnia

• Less than 65: 6 mg ORALLY once daily; take within 30 minutes of bedtime
• 65 years and older initial dose, 3 mg ORALLY once daily; may increase to 6 mg once daily; take within 30 minutes of bedtime

Pruritus

• Atopic dermatitis or lichen simplex chronicus: 10 mg ORALLY at bedtime; may gradually increase to 25 mg ORALLY at bedtime.
• Atopic dermatitis or lichen simplex chronicus: apply a thin film TOPICALLY to skin 4 times a day (3-4 hr between applications) for a MAX of 8 days.
• Very mild, 25 to 50 mg/day ORALLY initially, gradually increase as needed (max, 300 mg/day
• Mild to moderate, 75 mg ORALLY per day in single or divided doses, increase as needed; usual range is 75 to 150 mg/day (max, 300 mg/day).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Doxepin in adult patients.

Non–Guideline-Supported Use

Urticaria

• 10 to 30 milligrams daily.

• There is limited information about Off-Label Non–Guideline-Supported Use of Doxepin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Doxepin (oral) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Doxepin in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Doxepin in pediatric patients.

Contraindications

• Condition 1
• Condition 2
• Condition 3
• Condition 4
• Condition 5

Warnings

Suicidality and Antidepressant Drugs See full prescribing information for complete Boxed Warning. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of doxepin hydrochloride oral solution or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Doxepin hydrochloride oral solution is not approved for use in pediatric patients.

Conidition 1

(Description)

Adverse Reactions

Clinical Trials Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

(list/description of adverse reactions)

Gastrointestinal

(list/description of adverse reactions)

Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

(list/description of adverse reactions)

Postmarketing Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

(list/description of adverse reactions)

Gastrointestinal

(list/description of adverse reactions)

Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

(list/description of adverse reactions)

Drug Interactions

• (Drug 1)

• (Description)

• (Drug 2)

• (Description)

• (Drug 3)

• (Description)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Doxepin (oral) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Doxepin (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Doxepin (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Doxepin (oral) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Doxepin (oral) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Doxepin (oral) in geriatric settings.

Gender

There is no FDA guidance on the use of Doxepin (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Doxepin (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Doxepin (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Doxepin (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Doxepin (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Doxepin (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Doxepin (oral) Administration in the drug label.

Monitoring

There is limited information regarding Doxepin (oral) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Doxepin (oral) and IV administrations.

Overdosage

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.

• Manifestations

Critical manifestations of overdose include: cardiac dysrhythmias, severe hypotension, 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, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the symptoms listed under *ADVERSEREACTIONS. Deaths have been reported involving overdose of doxepin.

• General Recommendations

• 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 strongly advised. If signs of toxicity occur at any time during this period, extended monitoring is recommended. 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 ≥ 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 > 7.60 or a pCO2 < 20 mm Hg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin. Type 1A and 1C 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.
• Psychiatric Follow-up

Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.

• Pediatric Management

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.

Pharmacology

There is limited information regarding Doxepin (oral) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Doxepin (oral) Mechanism of Action in the drug label.

Structure

There is limited information regarding Doxepin (oral) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Doxepin (oral) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Doxepin (oral) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Doxepin (oral) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Doxepin (oral) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Doxepin (oral) How Supplied in the drug label.

Storage

There is limited information regarding Doxepin (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Doxepin (oral) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Doxepin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Doxepin (oral) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Doxepin (oral) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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