DOXEPIN HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Doxepin Hydrochloride Capsules, USP 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 hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use i

Product summary:

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 tan opaque cap and tan opaque body, axially printed with TARO over D10 in black ink on both the cap and the body. They are available as follows: NDC 51672-4217-1 bottles of 100 capsules The 25 mg capsule is a hard-shell, gelatin capsule with a yellow opaque cap and white opaque body, axially printed with TARO over D25 in black ink on both the cap and the body. They are available as follows: NDC 51672-4218-1 bottles of 100 capsules The 50 mg capsule is a hard-shell, gelatin capsule with a yellow opaque cap and yellow opaque body, axially printed with TARO over D50 in black ink on both the cap and the body. They are available as follows: NDC 51672-4219-1 bottles of 100 capsules The 75 mg capsule is a hard-shell, gelatin capsule with a green opaque cap and green opaque body, axially printed with TARO over D75 in black ink on both the cap and the body. They are available as follows: NDC 51672-4220-1 bottles of 100 capsules The 100 mg capsule is a hard-shell, gelatin capsule with a green opaque cap and white opaque body, axially printed with TARO over D100 in black ink on both the cap and the body. They are available as follows: NDC 51672-4221-1 bottles of 100 capsules 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE
Taro Pharmaceuticals U.S.A., Inc.
----------
Dispense with Medication Guide available at:
https://www.taro.com/usa-medication-guides
Medication Guide
Antidepressant Medicines, Depression and Other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
Read the Medication Guide that comes with your or your family member's
antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant medicines.
Talk to your, or your family member's, healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
1. Antidepressant medicines may increase suicidal thoughts or actions
in some children, teenagers, and
young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most
important causes of suicidal thoughts and
actions. Some people may have a particularly high risk of having
suicidal thoughts or actions. These
include people who have (or have a family history of) bipolar illness
(also called manic-depressive
illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and
actions in myself or a family member?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or
feelings. This is very important when an antidepressant medicine is
started or when the dose is
changed.
•
Call the healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare provider
between visits as needed, especially if you have concerns about
symptoms.
Call a healthcare provider right away if you or your

Summary of Product characteristics

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE
TARO PHARMACEUTICALS U.S.A., INC.
----------
DOXEPIN HYDROCHLORIDE
CAPSULES, USP
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.)
DESCRIPTION
Doxepin hydrochloride is one of a class of psychotherapeutic agents
known as dibenzoxepin tricyclic
compounds. The molecular formula of the compound is C
H NO · HCl having a molecular weight of
315.84. It is a white crystalline powder freely soluble in water, in
ethanol (96%), and methylene
chloride. It may be represented by the following structural formula:
Chemically, doxepin hydrochloride 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