DOXEPIN HYDROCHLORIDE capsule

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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

Резиме производа:

Doxepin hydrochloride capsules, USP are available containing doxepin equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg. The 10 mg capsule is a #4 capsule with a buff opaque cap and buff opaque body imprinted with "Є529" in black ink on both the cap and body filled with white powder. They are available as follows: 10 mg– 100 count (NDC 24658-793-01) 10 mg– 1000 count (NDC 24658-793-10) The 25 mg capsule is a #3 capsule with an ivory opaque cap and white opaque body imprinted with "Є530" in black ink on both the cap and body filled with white powder. They are available as follows: 25 mg– 100 count (NDC 24658-794-01) 25 mg– 1000 count (NDC 24658-794-10) The 50 mg capsule is a #2 capsule with an ivory opaque cap and ivory opaque body imprinted with "Є531" in black ink on both the cap and body filled with white powder. They are available as follows: 50 mg– 100 count (NDC 24658-795-01) 50 mg– 1000 count (NDC 24658-795-10) The 75 mg capsule is a #2 capsule with a bright light green opaque cap and bright light green opaque body imprinted with "Є532" in black ink on both the cap and body filled with white powder. They are available as follows: 75 mg– 100 count (NDC 24658-796-01) 75 mg– 1000 count (NDC 24658-796-10) The 100 mg capsule is a #1 capsule with a bright light green opaque cap and white opaque body imprinted with "Є533" in black ink on both the cap and body filled with white powder. They are available as follows: 100 mg– 100 count (NDC 24658-797-01) 100 mg– 500 count (NDC 24658-797-05) 100 mg– 1000 count (NDC 24658-797-10) 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, with a child-resistant closure, as required. Dispense with Medication Guide available at: www.puracaplabs.com/medguide/Doxepin-Hydrochloride-Capsule.pdf Distributed by: PuraCap Laboratories, LLC DBA Blu Pharmaceuticals Greenvale, NY 11548 Rev. 12-2022-00 MF529BLUREV12/22 LN0011

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
www.puracaplabs.com/medguide/Doxepin-Hydrochloride-
Capsule.pdf
Doxepin Hydrochloride Capsules, USP
(dox' e pin hye'' droe klor' ide)
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 symptom

Карактеристике производа

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
----------
DOXEPIN HYDROCHLORIDE CAPSULES, USP
RX ONLY
SUICIDALITY AND ANTIDEPRESSANT DRUGS
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.
Inert ingredients for the capsule formulations are: microcrystalline
cellulose, partially
pregelatinized starch (corn), colloidal silicon dioxide, sodium lauryl
sulfate, magnesium
stearate. The empty gelatin capsule shells contain D&C Yellow No. 10,
gelatin, sodium
lauryl sulfate, capsule moisture, elemental iron and titanium dioxide.
In addition, the 10
mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow
No. 6 and the
75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No.
3.
The imprinting ink contains iron oxide black, D&C Yellow No. 10
Aluminum Lake, FD&C
Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No.
40
Aluminum Lake, propylene glycol, N-Butyl Alcohol and shellac glaze.
It meets USP Dissolution Test 3.
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
capsules 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