DOXEPIN HYDROCHLORIDE- 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:

Medsource Pharmaceuticals

INN (International Name):

DOXEPIN HYDROCHLORIDE

Composition:

DOXEPIN 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Doxepin Hydrochloride Capsules, USP 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 not recommended for use i

Product summary:

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. The 10 mg capsule is a hard-shell, gelatin capsule with a buff opaque cap and buff opaque body axially printed with MYLAN over 1049 in black ink on both the cap and the body. They are available as follows: NDC 0378-1049-01 bottles of 100 capsules NDC 0378-1049-10 bottles of 1000 capsules The 25 mg capsule is a hard-shell, gelatin capsule with an ivory opaque cap and white opaque body axially printed with MYLAN over 3125 in black ink on both the cap and the body. They are available as follows: NDC 0378-3125-01 bottles of 100 capsules NDC 0378-3125-10 bottles of 1000 capsules The 50 mg capsule is a hard-shell, gelatin capsule with an ivory opaque cap and ivory opaque body axially printed with MYLAN over 4250 in black ink on both the cap and the body. They are available as follows: NDC 0378-4250-01 bottles of 100 capsules NDC 0378-4250-10 bottles of 1000 capsules The 75 mg capsule is a hard-shell, gelatin capsule with a brite lite green opaque cap and brite lite green opaque body axially printed with MYLAN over 5375 in black ink on both the cap and the body. They are available as follows: NDC 0378-5375-01 bottles of 100 capsules NDC 0378-5375-10 bottles of 1000 capsules The 100 mg capsule is a hard-shell, gelatin capsule with a brite lite green opaque cap and white opaque body axially printed with MYLAN over 6410 in black ink on both the cap and the body. They are available as follows: NDC 0378-6410-01 bottles of 100 capsules NDC 0378-6410-10 bottles of 1000 capsules Store at 20° to 25°C (68° to 77°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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE
Medsource 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.
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
MEDSOURCE 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 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 crystalline powder freely soluble in water,
in ethanol (96%), and methylene
chloride. 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[
_b,e_]oxepin-11 (6 _H_)ylidene- _N,N_-dimethyl-hydrochloride.
Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for or