Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Doxepin Hydrochloride Capsules, USP are available containing doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg or 100 mg of doxepin. The 10 mg capsule is a hard-shell, gelatin capsule with a yellow opaque cap and yellow opaque body. The capsules are imprinted with “CE” in black ink on the cap and “68” on the body. They are available as follows: Bottles of 90 capsules (NDC 62135-560-90) The 25 mg capsule is a hard-shell, gelatin capsule with a light yellow opaque cap and white opaque body. The capsules are imprinted with "CE” in black ink on the cap and "69” on the body. They are available as follows: Bottles of 90 capsules (NDC 62135-561-90) The 50 mg capsule is a hard-shell, gelatin capsule with a light yellow opaque cap and light yellow opaque body. The capsules are imprinted with “CE” in black ink on the cap and “70” on the body. They are available as follows: Bottles of 90 capsules (NDC 62135-562-90) The 75 mg capsule is a hard-shell, gelatin capsule with a light green opaque cap and light green opaque body. The capsules are imprinted with “CE” in black ink on the cap and "71” on the body. They are available as follows: Bottles of 90 capsules (NDC 62135-563-90) The 100 mg capsule is a hard-shell, gelatin capsule with a light green opaque cap and a white opaque body. The capsules are imprinted with “CE” in black ink on the cap and “72” on the body. They are available as follows: Bottles of 90 capsules (NDC 62135-564-90) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for Chartwell RX, LLC Congers, NY 10920 L70893 Revised 11/2022 Print Medication Guide at: www.chartwellpharma.com/medguides; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Doxepin Hydrochloride Capsules, USP 10mg - NDC 62135-560-90 - 90's - Bottle-Label Doxepin Hydrochloride Capsules, USP 25mg - NDC 62135-561-90 - 90's - Bottle-Label Doxepin Hydrochloride Capsules, USP 50mg - NDC 62135-562-90 - 90's - Bottle-Label Doxepin Hydrochloride Capsules, USP 75mg - NDC 62135-563-90 - 90's - Bottle-Label Doxepin Hydrochloride Capsules, USP 100mg - NDC 62135-564-90 - 90's - Bottle-Label image description image description image description image description image description
- HOW SUPPLIED Doxepin Hydrochloride Capsules, USP are available containing doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg or 100 mg of doxepin. The 10 mg capsule is a hard-shell, gelatin capsule with a yellow opaque cap and yellow opaque body. The capsules are imprinted with “CE” in black ink on the cap and “68” on the body. They are available as follows: Bottles of 90 capsules (NDC 62135-560-90) The 25 mg capsule is a hard-shell, gelatin capsule with a light yellow opaque cap and white opaque body. The capsules are imprinted with "CE” in black ink on the cap and "69” on the body. They are available as follows: Bottles of 90 capsules (NDC 62135-561-90) The 50 mg capsule is a hard-shell, gelatin capsule with a light yellow opaque cap and light yellow opaque body. The capsules are imprinted with “CE” in black ink on the cap and “70” on the body. They are available as follows: Bottles of 90 capsules (NDC 62135-562-90) The 75 mg capsule is a hard-shell, gelatin capsule with a light green opaque cap and light green opaque body. The capsules are imprinted with “CE” in black ink on the cap and "71” on the body. They are available as follows: Bottles of 90 capsules (NDC 62135-563-90) The 100 mg capsule is a hard-shell, gelatin capsule with a light green opaque cap and a white opaque body. The capsules are imprinted with “CE” in black ink on the cap and “72” on the body. They are available as follows: Bottles of 90 capsules (NDC 62135-564-90) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for Chartwell RX, LLC Congers, NY 10920 L70893 Revised 11/2022 Print Medication Guide at: www.chartwellpharma.com/medguides
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Doxepin Hydrochloride Capsules, USP 10mg - NDC 62135-560-90 - 90's - Bottle-Label Doxepin Hydrochloride Capsules, USP 25mg - NDC 62135-561-90 - 90's - Bottle-Label Doxepin Hydrochloride Capsules, USP 50mg - NDC 62135-562-90 - 90's - Bottle-Label Doxepin Hydrochloride Capsules, USP 75mg - NDC 62135-563-90 - 90's - Bottle-Label Doxepin Hydrochloride Capsules, USP 100mg - NDC 62135-564-90 - 90's - Bottle-Label image description image description image description image description image description
Overview
Doxepin hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19 H 21 NO ∙ HCl having a molecular weight of 316. It is a white crystalline solid readily soluble in water, lower alcohols and chloroform. It may be represented by the following structural formula: Doxepin HCl Chemically, doxepin hydrochloride, USP 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 (6 H )ylidene- N,N -dimethyl-,hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin and titanium dioxide. In addition, the 10 mg empty gelatin capsule shells contain yellow iron oxide, 25 mg and 50 mg empty gelatin capsule shells contain D&C Yellow No. 10 and FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain yellow iron oxide and FD&C Blue No. 1. Black ink contains shellac glaze, isopropyl alcohol, black iron oxide, n-butyl alcohol, propylene glycol, and ammonium hydroxide. image description
Indications & Usage
Doxepin hydrochloride capsules are recommended for the treatment of: Psychoneurotic patients with depression and/or anxiety. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age.
Dosage & Administration
For most patients with illness of mild to moderate severity, a starting daily dose of 75 mg is recommended. Dosage may subsequently be increased or decreased at appropriate intervals and according to individual response. The usual optimum dose range is 75 mg/day to 150 mg/day. In more severely ill patients higher doses may be required with subsequent gradual increase to 300 mg/day if necessary. Additional therapeutic effect is rarely to be obtained by exceeding a dose of 300 mg/day. In patients with very mild symptomatology or emotional symptoms accompanying organic disease, lower doses may suffice. Some of these patients have been controlled on doses as low as 25 to 50 mg/day. The total daily dosage of doxepin (as hydrochloride) may be given on a divided or once-a-day dosage schedule. If the once-a-day schedule is employed, the maximum recommended dose is 150 mg/day. This dose may be given at bedtime. The 150 mg capsule strength is intended for maintenance therapy only and is not recommended for initiation of treatment. Anti-anxiety effect is apparent before the antidepressant effect. Optimal antidepressant effect may not be evident for two to three weeks.
Warnings & Precautions
WARNINGS
Boxed Warning
Suicidality and Antidepressant Drugs 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 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 is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk , PRECAUTIONS: Information for Patients and PRECAUTIONS: Pediatric Use .)
Contraindications
Doxepin is contraindicated in individuals who have shown hypersensitivity to the drug. Possibility of cross sensitivity with other dibenzoxepines should be kept in mind. Doxepin is contraindicated in patients with glaucoma or a tendency to urinary retention. These disorders should be ruled out, particularly in older patients.
Adverse Reactions
NOTE: Some of the adverse reactions noted below have not been specifically reported with doxepin use. However, due to the close pharmacological similarities among the tricyclics, the reactions should be considered when prescribing doxepin hydrochloride.
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