DOXEPIN HYDROCHLORIDE capsule

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

REMEDYREPACK INC.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 pa

Podsumowanie produktu:

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. NDC: 70518-2274-00 PACKAGING: 30 in 1 BLISTER PACK Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

DOXEPIN HYDROCHLORIDE- doxepin hydrochloride capsule
REMEDYREPACK INC.
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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:
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?
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
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:
•
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 bet

Charakterystyka produktu

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
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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
19
21
mg, 25 mg, 50 m