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:

Alembic Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 capsule is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsule is not recommended for use in childre

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. Doxepin hydrochloride capsules USP, 10 mg are buff opaque cap/buff opaque body size ‘4’ hard gelatin capsule shell axially imprinted with ‘A 340’ on cap in black ink and filled with white to off white granular powder. Bottle of 100 capsules with child resistant closure, NDC 62332-637-31 Bottle of 1000 capsules, NDC 62332-637-91 Doxepin hydrochloride capsules USP, 25 mg are ivory opaque cap/white opaque body size ‘3’  hard gelatin capsule shell axially imprinted with ‘A 341’ on cap in black ink and filled with white to off white granular powder. Bottle of 100 capsules with child resistant closure, NDC 62332-638-31 Bottle of 1000 capsules, NDC 62332-638-91 Doxepin hydrochloride capsules USP, 50 mg are ivory opaque cap/ivory opaque body size ‘3’ hard gelatin capsule shell axially imprinted with ‘A 342’ on cap in black ink and filled with white to off white granular powder. Bottle of 100 capsules with child resistant closure, NDC 62332-645-31 Bottle of 1000 capsules, NDC 62332-645-91 Doxepin hydrochloride capsules USP, 75 mg are brite lite green opaque cap/brite lite green opaque body size ‘2’ hard gelatin capsule shell axially imprinted with ‘A 343’ on cap in black ink and filled with white to off white granular powder. Bottle of 100 capsules with child resistant closure, NDC 62332-639-31 Bottle of 1000 capsules, NDC 62332-639-91 Doxepin hydrochloride capsules USP, 100 mg are brite lite green opaque cap/white opaque body size ‘1’ hard gelatin capsule shell axially imprinted with ‘A 344’ on cap in black ink and filled with white to off white granular powder. Capsules should be free from physical defects. Bottle of 100 capsules with child resistant closure, NDC 62332-640-31 Bottle of 1000 capsules, NDC 62332-640-91 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Rx only Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 09/2021

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DOXEPIN HYDROCHLORIDE - doxepin hydrochloride capsule
Alembic Pharmaceuticals Inc.
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Medication Guide
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or Actions
Read the Medication Guide that comes with you 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 family member has
any of the following symptoms,
especially if they are new, worse, or wo

Summary of Product characteristics

DOXEPIN HYDROCHLORIDE - DOXEPIN HYDROCHLORIDE CAPSULE
ALEMBIC PHARMACEUTICALS 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
HYDROCHLORIDE 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 HYDROCHLORIDE 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, USP 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 316. It is a white or almost
white crystalline
powder. It is freely soluble in water, in alcohol and in methylene
chloride.
Doxepin HCl 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(6H)ylidene-_N,N_-dimethyl-,
hydrochloride.
Doxepin Hydrochloride
19
21
_Inactive Ingredients_: Microcrys