DOXEPIN HYDROCHLORIDE capsule

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Lifestar Pharma LLC

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

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 light yellow to yellow opaque cap / light yellow to yellow opaque body, hard gelatin capsule, imprinted with on cap and "424" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-424-11 bottles of 100 capsules, with child-resistant closure NDC 70756-424-51 bottles of 500 capsules. This package is not child resistant. The 25 mg capsule is light yellow to yellow opaque cap / white to off white opaque body, hard gelatin capsule, imprinted with on cap and "425" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-425-11 bottles of 100 capsules, with child-resistant closure NDC 70756-425-51 bottles of 500 capsules. This package is not child resistant. The 50 mg capsule is light yellow to yellow opaque cap and light yellow to yellow opaque body, hard gelatin capsule, imprinted with on cap and "426" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-426-11 bottles of 100 capsules, with child-resistant closure NDC 70756-426-51 bottles of 500 capsules. This package is not child resistant. The 75 mg capsule is light green to green opaque cap and light green to green opaque body, hard gelatin capsule, imprinted with on cap and "427" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-427-11 bottles of 100 capsules, with child-resistant closure NDC 70756-427-51 bottles of 500 capsules, This package is not child resistant. The 100 mg capsule is light green to green opaque cap and white to off white opaque body, hard gelatin capsule, imprinted with on cap and "428" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-428-11 bottles of 100 capsules, with child-resistant closure NDC 70756-428-51 bottles of 500 capsules, This package is not child resistant. 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. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Product of Italy Revised: January 2022, V-05

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

DOXEPIN HYDROCHLORIDE - doxepin hydrochloride capsule
Lifestar Pharma LLC
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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:
•

Valmisteyhteenveto

DOXEPIN HYDROCHLORIDE - DOXEPIN HYDROCHLORIDE CAPSULE
LIFESTAR PHARMA LLC
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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 to almost
white crystalline
powder freely soluble in water, in alcohol and methylene chloride. 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_-dimethyl