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Uses

Depressive and Anxiety Disorders

Treatment of depression and/or anxiety in psychoneurotic patients. Psychoneurosis symptoms that respond well to doxepin include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension, and worry.

Treatment of depression and/or anxiety associated with alcoholism. (See Specific Drugs under Interactions.)

Treatment of depression and/or anxiety associated with organic disease; consider possible drug interactions if receiving other drugs concomitantly.

Treatment of psychotic depressive disorders with associated anxiety, including involutional depression and manic-depressive disorders.

Chronic Idiopathic Urticaria

Has been effective in the management of chronic idiopathic urticaria† and may be used as an alternative to antihistamines, which are generally considered first-line therapy in patients with this condition.

Dosage and Administration

General

Depressive and Anxiety Disorders

• Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of doxepin and vice versa. Also allow at least 5 weeks to elapse when switching from fluoxetine.
• Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments. (See Worsening of Depression and Suicidality Risk under Cautions.)
• Avoid abrupt discontinuance of therapy in patients receiving high dosages for prolonged periods. To avoid withdrawal reactions, taper dosage gradually. (See Withdrawal of Therapy under Cautions.)

Administration

Oral Administration

Administer orally in up to 3 divided doses or as a single daily dose (if ≤150 mg); may administer once-daily doses at bedtime to reduce daytime sedation.

Dilute each dose of oral concentrate with 120 mL of water, whole or skim milk, or orange, grapefruit, tomato, prune, or pineapple juice just prior to administration; solution is physically incompatible with many carbonated beverages. Patients on methadone maintenance may mix doxepin oral concentrate and methadone syrup with Gatorade^®, lemonade, orange juice, sugar water, Tang^®, or water but not with grape juice. Bulk dilution and storage not recommended by manufacturer.

Dosage

Available as doxepin hydrochloride; dosage expressed in terms of doxepin.

Individualize dosage carefully according to individual requirements and response.

When administered as a single daily dose, the maximum daily dose recommended is 150 mg. Commercially available 150-mg capsules of doxepin are intended for maintenance therapy only and are not recommended for initial therapy.

Pediatric Patients

Depressive and Anxiety Disorders

Oral

Adolescents ≥12 years of age should receive dosage recommended for adults. (See Adults under Dosage.)

Adults

Depressive and Anxiety Disorders

Oral

Patients with illness of mild to moderate severity: Initially, 75 mg daily. May adjust dosage as necessary based on response. Usual maintenance dosage: 75–150 mg daily.

More seriously ill patients: Higher dosages may be necessary; gradually increase dosage to ≤300 mg daily, if necessary.

Dosages >300 mg daily rarely provide additional therapeutic effect.

Patients with very mild symptomatology or emotional symptoms associated with organic brain syndrome: Lower dosages may be adequate; some patients respond to 25–50 mg daily.

Prescribing Limits

Pediatric Patients

Depressive and Anxiety Disorders

Oral

Adolescents ≥12 years of age: Maximum 300 mg daily.

Adults

Oral

Maximum 300 mg daily.

Special Populations

Geriatric Patients

Select dosage at the lower end of recommended range since decreased hepatic, renal, or cardiac function and concomitant illness and medications are more frequent; increase dosage more gradually and monitor closely.May administer before bedtime.(See Geriatric Use under Cautions.)