DOXEPIN HYDROCHLORIDE capsule DOXEPIN HYDROCHLORIDE- doxepn hydrochloride capsule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 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 no

उत्पाद समीक्षा:

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 Capsule, USP 10 mg is a Size ‘4’ Hard gelatin capsule with an ivory opaque cap and ivory opaque body imprinted with AC on cap and 527 on body filled with white to off-white blend. They are available as follows: NDC 23155-794-01     bottles of 100 capsules Doxepin Hydrochloride Capsule, USP 25 mg is a Size ‘3’ Hard gelatin capsule with light yellow opaque cap and white opaque body imprinted with AC on cap and 528 on body filled with white to off-white blend. They are available as follows: NDC 23155-795-01     bottles of 100 capsules Doxepin Hydrochloride Capsule, USP 50 mg is a Size ‘2’ Hard gelatin capsule with light yellow opaque cap and light yellow opaque body imprinted with AC on cap and 529 on body filled with white to off-white blend. They are available as follows: NDC 23155-796-01      bottles of 100 capsules Doxepin Hydrochloride Capsule, USP 75 mg is a Size ‘2’ Hard gelatin capsule with light green opaque cap and light green opaque body imprinted with AC on cap and 530 on body filled with white to off-white blend. They are available as follows: NDC 23155-797-01     bottles of 100 capsules Doxepin Hydrochloride Capsule, USP 100 mg is Size ‘1’ Hard gelatin capsule with light green opaque cap and white opaque body imprinted with AC on cap and 531 on body filled with white to off-white blend. They are available as follows: NDC 23155-798-01    bottles of 100 capsules  Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86º 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. PHARMACIST: Dispense a Medication Guide with each prescription. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

DOXEPIN HYDROCHLORIDE - doxepin hydrochloride capsule
Heritage Pharmaceuticals Inc. d/b/a Avet 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 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 family member has
any of the following symptoms,
especially

उत्पाद विशेषताएं

DOXEPIN HYDROCHLORIDE - DOXEPIN HYDROCHLORIDE CAPSULE
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
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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 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.
It may be
represented by the following structural formula:
19
21
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_]o