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:

Ajanta Pharma USA Inc.

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 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

Product summary:

Doxepin Hydrochloride Capsules, USP are available containing doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin. The 10 mg capsule is a hard-shell, gelatin capsule with a buff opaque cap and buff opaque body imprinted with ‘ap’ logo on cap and ‘DXP10’ on body in black ink containing white to off-white colored powder. NDC 27241-167-01 Bottles of 100 capsules NDC 27241-167-10 Bottles of 1000 capsules The 25 mg capsule is a hard-shell, gelatin capsule with a ivory opaque cap and white opaque body imprinted with ‘ap’ logo on cap and ‘DXP25’ on body in black ink containing white to off-white colored powder. NDC 27241-168-01 Bottles of 100 capsules NDC 27241-168-10 Bottles of 1000 capsules The 50 mg capsule is a hard-shell, gelatin capsule with a ivory opaque cap and ivory opaque body imprinted with ‘ap’ logo on cap and ‘DXP50’ on body in black ink containing white to off-white colored powder. NDC 27241-169-01 Bottles of 100 capsules NDC 27241-169-10 Bottles of 1000 capsules The 75 mg capsule is a hard-shell, gelatin capsule with a light green opaque cap and light green opaque body imprinted with ‘ap’ logo on cap and ‘DXP75’ on body in black ink containing white to off-white colored powder. NDC 27241-170-01 Bottles of 100 capsules NDC 27241-170-10 Bottles of 1000 capsules The 100 mg capsule is a hard-shell, gelatin capsule with a light green opaque cap and white opaque body imprinted with ‘ap’ logo on cap and ‘DXP100’ on body in black ink containing white to off-white colored powder. NDC 27241-171-01 Bottles of 100 capsules NDC 27241-171-10 Bottles of 1000 capsules Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°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. Rx only Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807. Made in INDIA February 2020

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DOXEPIN HYDROCHLORIDE - doxepin hydrochloride capsule
Ajanta Pharma USA Inc.
----------
Medication Guide
Doxepin Hydrochloride
(dox' e pin hye'' droe klor' ide)
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

Summary of Product characteristics

DOXEPIN HYDROCHLORIDE - DOXEPIN HYDROCHLORIDE CAPSULE
AJANTA PHARMA USA INC.
----------
DOXEPIN HYDROCHLORIDE CAPSULES, USP
SUICIDALITY AND ANTIDEPRESSANT DRUGS
ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL
THINKING AND BEHAVIOUR (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, USP 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 or almost
white crystalline
powder freely soluble in water, alcohols and methylene chloride. It
may be represented
by the following structural formula.
19
21
Chemically, doxepin hydrochloride, USP 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