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:

Lannett Company, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Doxepin hydrochloride is recommended for the treatment of:     1. Psychoneurotic patients with depression and/or anxiety.     2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).     3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).     4. 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 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 is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride is not recommended for use in children under 12 year

Product summary:

Doxepin Hydrochloride Capsules, USP are available as capsules containing doxepin HCl equivalent to: 10 mg – Size 4 capsule with opaque white cap imprinted in black with "Lannett " and opaque white body imprinted with "4062" in black and filled with powder. 100 count bottle                     NDC 0527-4062-37 1000 count bottle                   NDC 0527-4062-43 25 mg – Size 3 capsule with opaque yellow green cap imprinted in black with "Lannett " and opaque white body imprinted with "4063" in black and filled with powder. 100 count bottle                     NDC 0527-4063-37 1000 count bottle                   NDC 0527-4063-43 50 mg – Size 2 capsule with opaque yellow green cap imprinted in black with "Lannett " and opaque yellow green body imprinted with "4064" in black and filled with powder. 100 count bottle                     NDC 0527-4064-37 1000 count bottle                   NDC 0527-4064-43 75 mg – Size 2 capsule with opaque light green cap imprinted in black with "Lannett " and opaque light green body imprinted with "4065" in black and filled with powder. 100 count bottle                     NDC 0527-4065-37 1000 count bottle                   NDC 0527-4065-43 100 mg – Size 1 capsule with opaque light green cap imprinted in black with "Lannett " and opaque white body imprinted with "4066" in black and filled with powder. 100 count bottle                     NDC 0527-4066-37 1000 count bottle                   NDC 0527-4066-43 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light resistant container as defined in the USP with a child-resistant closure. Rx only Distributed by: Lannett Company, Inc. Philadelphia, PA 19136   CIB71955A Rev. 01/20

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE
Lannett Company, 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 worry you:

Summary of Product characteristics

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE
LANNETT COMPANY, 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 Capsules, USP are 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 crystalline solid readily
soluble in water, lower alcohols and
chloroform.
Inactive ingredients are: butyl alcohol, D&C Yellow No. 10, FD&C Blue
No. 1, FD&C Blue No. 2,
FD&C Red No. 40, ferrosoferric oxide, gelatin, magnesium stearate,
microcrystalline cellulose,
propylene glycol, shellac, silicon dioxide, sodium lauryl sulfate,
starch, titanium dioxide. The 25, 50,
75, and 100 mg capsules also co