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:

Amneal Pharmaceuticals NY LLC

INN (International Name):

DOXEPIN HYDROCHLORIDE

Composition:

DOXEPIN 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Doxepin HCl 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 HCl 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 HCl capsules 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.

Product summary:

Doxepin HCl capsules USP, 10 mg are supplied as hard gelatin capsule filled with white to off-white granular powder having “AMNEAL” printed on yellow opaque cap and “1166” printed on yellow opaque body with black ink. They are available as follows: Bottle of 30 Capsules:                           NDC 69238-1166-3 Bottle of 90 Capsules:                           NDC 69238-1166-9 Bottle of 1000 Capsules:                       NDC 69238-1166-1 Doxepin HCl capsules USP, 25 mg are supplied as hard gelatin capsule filled with white to off-white granular powder having “AMNEAL” printed on yellow opaque cap and “1170” printed on white opaque body with black ink. They are available as follows: Bottle of 30 Capsules:                           NDC 69238-1170-3 Bottle of 90 Capsules:                           NDC 69238-1170-9 Bottle of 1000 Capsules:                       NDC 69238-1170-1 Doxepin HCl capsules USP, 50 mg are supplied as hard gelatin capsule filled with white to off-white granular powder having “AMNEAL” printed on yellow opaque cap and “1171” printed on yellow opaque body with black ink. They are available as follows: Bottle of 30 Capsules:                           NDC 69238-1171-3 Bottle of 90 Capsules:                           NDC 69238-1171-9 Bottle of 1000 Capsules:                       NDC 69238-1171-1 Doxepin HCl capsules USP, 75 mg are supplied as hard gelatin capsule filled with white to off-white granular powder having “AMNEAL” printed on green opaque cap and “1172” printed on green opaque body with black ink. They are available as follows: Bottle of 30 Capsules:                           NDC 69238-1172-3 Bottle of 90 Capsules:                           NDC 69238-1172-9 Bottle of 1000 Capsules:                       NDC 69238-1172-1 Doxepin HCl capsules USP, 100 mg are supplied as hard gelatin capsule filled with white to off-white granular powder having “AMNEAL” printed on green opaque cap and “1173” printed on white opaque body with black ink. They are available as follows: Bottle of 30 Capsules:                           NDC 69238-1173-3 Bottle of 90 Capsules:                           NDC 69238-1173-9 Bottle of 1000 Capsules:                       NDC 69238-1173-1 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. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382220, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2021-03

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE
Amneal Pharmaceuticals NY LLC
----------
MEDICATION GUIDE
Doxepin (DOX-e-pin) Hydrochloride Capsules, USP
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
any of the following symptom

Summary of Product characteristics

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE
AMNEAL PHARMACEUTICALS NY LLC
----------
DOXEPIN HYDROCHLORIDE CAPSULES, USP
(10 MG, 25 MG, 50 MG, 75 MG AND 100 MG)
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 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 316. It is a white crystalline
solid readily soluble in
water, lower alcohols and chloroform. 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_]oxepin-11
(6_H_)ylidene-_N_,_N_-dimethy