DOXEPIN HYDROCHLORIDE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Quality Care Products, LLC

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Doxepin hydrochloride capsules are 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 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 h

Περίληψη προϊόντος:

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 colored size “4” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 10 on body. 55700-783-30 Doxepin Hydrochloride Capsules USP, 25 mg are ivory and white colored size “3” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 25 on body. Doxepin Hydrochloride Capsules USP, 50 mg are ivory colored size “3” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 50 on body. Doxepin Hydrochloride Capsules USP, 75 mg are brite lite green colored size “2” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 75 on body. Doxepin Hydrochloride Capsules USP, 100 mg are brite lite green and white colored size “1” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 100 on body. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Issued: December 2018

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE
Quality Care Products, LLC
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MEDICATION GUIDE
Doxepin Hydrochloride Capsules USP
(dox’ e pin hye” droe klor’ ide)
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

Αρχείο Π.Χ.Π.

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE
QUALITY CARE PRODUCTS, LLC
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DOXEPIN HYDROCHLORIDE CAPSULES USP
RX ONLY
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 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 or almost
white
crystalline powder freely soluble in water, in alcohol and in
methylene chloride. Its
structural formula is:
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(6H)ylidene-N,N-dimethyl-,
hydrochloride. Each 10
mg, 25 mg, 5