Tricyclic antidepressant (TCA)
Each capsule contains: Doxepin (as hydrochloride) 10 or 25 mg
Treatment of psychoneurotic patients with depression and/or anxiety, depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol) or organic disease, and of psychotic depressive disorders with associated anxiety, including involutional depression and manic-depressive disorders.
Dosage and administration:
Very Mild Symptomatology/Emotional Symptoms Accompanying Organic Disease:
Mild to Moderate Severity:
More Severely Ill Patients:
May require higher doses with subsequent gradual increase to 300mg/day if necessary
Total daily dose may be given on a divided or qd schedule; if qd schedule employed, max dose is 150mg/day (may be given at bed time)
Pregnancy and breastfeeding:
Safety not known in pregnancy/nursing.
Hypersensitivity to any of product ingredients.
Glaucoma, tendency to urinary retention.
Warning and precautions:
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder and other psychiatric disorders. Monitor and observe closely for clinical worsening, suicidality, or unusual changes in behavior in patients who are started on antidepressant therapy.
Not approved for the treatment of bipolar depression.
May precipitate mixed/manic episode in patients at risk for bipolar disorder; screen for risk for bipolar disorder prior to initiating treatment.
Pupillary dilation that occurs following therapy may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Drowsiness may occur.
May impair mental/physical abilities.
May need to reduce dose or add a major tranquilizer if increased symptoms of psychosis or shift to manic symptomatology occurs.
Caution in elderly.
Drugs that inhibit CYP2D6 (eg, quinidine, cimetidine, many CYP2D6 substrates [eg, other antidepressants, phenothiazines, propafenone, flecainide]) may increase plasma concentrations; may require lower doses for either TCA or the other drug, and monitoring of TCA plasma levels.
Caution with SSRI coadministration and when switching between TCAs and SSRIs (eg, fluoxetine, sertraline, paroxetine); sufficient time must elapse before starting therapy when switching from fluoxetine (at least 5 weeks may be necessary).
Discontinue MAOIs at least 2 weeks before initiating treatment.
Cimetidine may cause fluctuations in steady-state serum concentration.
Avoid with alcohol if depression and/or anxiety are associated with alcoholism.
Alcohol may increase the danger inherent in any intentional or unintentional overdosage of drug.
Severe hypoglycemia reported with tolazamide.
Drowsiness, dry mouth, blurred vision, constipation, urinary retention, nausea, vomiting, indigestion, taste disturbances, diarrhea, anorexia, aphthous stomatitis, decreased/increased libido, decreased/increased blood sugar levels.
Store below 30 °C.
Protect from light.
Keep out of reach of children.