Doxepin Hydrochloride Prescribing Information
Antidepressants increase the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors
Dosage and Administration (2.4, 2.5, 2.6, 2.7, 2.8) 7/2025
Warnings and Precautions (5.2, 5.5) 7/2025
Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.
- Prior to initiating treatment with doxepin hydrochloride capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania. (2.1)
- Recommended starting oral dosage is 25 mg three times daily or 75 mg once daily. (2.2)
- Recommended target total dosage range is between 75 mg/day and 150 mg/day (may be given once daily or in divided doses). (2.2)
- Maximum recommended dosage is 100 mg three times daily. (2.2)
- Wait at least 14 days after discontinuation of a monoamine oxidase inhibitor (MAOI) before initiating therapy with doxepin hydrochloride capsules. (2.3)
- See the Full Prescribing Information for dosage modifications intended to reduce the risk of anticholinergic effects, for strong CYP2D6 inhibitors, and in known CYP2D6 and CYP2C19 poor metabolizers. (2.4, 2.5, 2.6).
- When discontinuing doxepin hydrochloride capsules, gradually reduce the dosage until discontinued. (2.7)
Capsules:
● 10 mg capsule is light yellow to yellow opaque cap / light yellow to yellow opaque body, hard gelatin capsule, imprinted with
on cap and "424" on body with black ink containing white to off white powder.
● 25 mg capsule is light yellow to yellow opaque cap / white to off white opaque body, hard gelatin capsule, imprinted with
on cap and "425" on body with black ink containing white to off white powder.
● 50 mg capsule is light yellow to yellow opaque cap and light yellow to yellow opaque body, hard gelatin capsule, imprinted with
on cap and "426" on body with black ink containing white to off white powder.
● 75 mg capsule is light green to green opaque cap and light green to green opaque body, hard gelatin capsule, imprinted with
on cap and "427" on body with black ink containing white to off white powder.
● 100 mg capsule is light green to green opaque cap and white to off white opaque body, hard gelatin capsule, imprinted with
on cap and "428" on body with black ink containing white to off white powder.
Active ingredients in the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, and 100 mg of doxepin.
- Pregnancy: Neonates exposed to TCAs, including doxepin hydrochloride, late in the third trimester have developed poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, irritability). Monitor neonates who were exposed to doxepin hydrochloride in the third trimester of pregnancy for poor neonatal adaptation syndrome. (8.1)
- Lactation: Breastfeeding not recommended. (8.2)
- Geriatric Use: May cause confusion and oversedation. (8.5)
- CYP2C19 and CYP2D6 Poor Metabolizers: Increased risk of doxepin hydrochloride -associated adverse reactions. (8.7)