DOXEPIN HYDROCHLORIDE capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

TYA Pharmaceuticals

INN (국제 이름):

DOXEPIN HYDROCHLORIDE

구성:

DOXEPIN 75 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Doxepin is recommended for the treatment of: The target symptoms of psychoneurosis that respond particularly well to doxepin include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age. Doxepin is contraindicated in individuals who have shown hypersensitivity to the drug. Possibility of cross sensitivity with other dibenzoxepines should be kept in mind. Doxepin is contraindicated in patients with glaucoma or a tendency to urinary retention. These disorders should be ruled out, particularly in older patients.

제품 요약:

NDC:64725-5375-1 in a BOTTLE of 100 CAPSULES

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE
TYA Pharmaceuticals
----------
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.
These include people who have (or have a family history of) bipolar
illness also called manic-depressive
illness) or suicidal thoughts or actions. 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.
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:
•
t

제품 특성 요약

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE
TYA PHARMACEUTICALS
----------
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 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 IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE , AND .) WARNINGS:
CLINICAL WORSENING AND
SUICIDE RISKPRECAUTIONS: INFORMATION FOR PATIENTSPRECAUTIONS:
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
316. It is a white crystalline solid readily soluble in water, lower
alcohols and chloroform. It may be
represented by the following structural formula:
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[ ]oxepin-
11 (6 )ylidene- -dimethyl-hydrochloride. _b,eHN,N_
Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral
administration cont