DOXEPIN HYDROCHLORIDE solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Morton Grove Pharmaceuticals, Inc.

SNN (starptautisko nepatentēto nosaukumu):

Doxepin Hydrochloride

Kompozīcija:

Doxepin 10 mg in 1 mL

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Doxepin hydrochloride oral solution is 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 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 pediatric patients under 12

Produktu pārskats:

Doxepin Hydrochloride Oral Solution, USP (Concentrate), a clear colorless liquid, is available in 4 fl oz (118 mL) containers, with an accompanying dropper calibrated at 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Each mL contains doxepin hydrochloride equivalent to 10 mg doxepin. Immediately prior to taking this medication, dilute each dose with approximately 120 mL (4 ounces) of water, whole or skimmed milk, or orange, grapefruit, tomato, prune or pineapple juice. Doxepin hydrochloride oral solution (concentrate) is not physically compatible with a number of carbonated beverages. For those patients requiring antidepressant therapy who are on methadone maintenance, doxepin hydrochloride oral solution (concentrate) and methadone syrup can be mixed together with Gatorade® , lemonade, orange juice, sugar water, Tang® , or water; but not  with grape juice. Preparation and storage of bulk dilutions is not recommended. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx Only Product No.: 8651 Manufactured For: Wockhardt USA, LLC Parsippany, NJ 07054 Manufactured By: Morton Grove Pharmaceuticals, Inc. Morton Grove, IL 60053 28651 REV. 09-18 PHARMACIST - PATIENT MEDICATION GUIDE PROVIDED BELOW

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE SOLUTION
Morton Grove Pharmaceuticals, Inc.
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Medication Guide
Doxepin Hydrochloride Oral Solution, USP (Concentrate)
10 mg/mL
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

Produkta apraksts

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE SOLUTION
MORTON GROVE PHARMACEUTICALS, INC.
----------
DOXEPIN HYDROCHLORIDE ORAL SOLUTION, USP (CONCENTRATE) 10 MG/ML
RX ONLY
WARNINGS
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 ORAL SOLUTION, USP 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 ORAL SOLUTION, USP 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 Oral Solution, USP is one of a class of
psychotherapeutic agents known as
dibenzoxepin tricyclic compounds.
It is a white crystalline solid readily soluble in water, lower
alcohols and chloroform. The solution is
administered orally and contains doxepin hydrochloride equivalent to
10 mg doxepin per mL.
Inactive Ingredients: citric acid anhydrous, glycerin, peppermint oil,
polyethylene glycol, propylene
glycol, purified water, sodium benzoate, sodium citrate dihydrate, and
sorbitol solution.
Doxepin hydro