NEFAZODONE HYDROCHLORIDE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

Nefazodone hydrochloride (UNII: 27X63J94GR) (nefazodone - UNII:59H4FCV1TF)

Verfügbar ab:

Ranbaxy Pharmaceuticals Inc.

INN (Internationale Bezeichnung):

Nefazodone hydrochloride

Darreichungsform:

TABLET

Zusammensetzung:

50 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Nefazodone hydrochloride tablets, USP is indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride tablets, USP treatment (see WARNINGS ). In many cases, this would lead to the conclusion that other drugs should be tried first. The efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6-week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks). It must include either depressed mood or loss of interest or pleasure and at least five of the following nine symptoms: depressed

Produktbesonderheiten:

Nefazodone hydrochloride tablets, USP 50 mg are light pink colored, uncoated, round tablets debossed with “RX 541” on one side and plain on the other side. They are supplied as follows: NDC 63304-541-30 unit of use bottles of 30 NDC 63304-541-05 bottles of 500 Nefazodone hydrochloride tablets, USP 100 mg are white colored, uncoated, round tablets debossed with “RX 542” and a scoreline on one side and plain on the other side. They are supplied as follows: NDC 63304-542-30 unit of use bottles of 30 NDC 63304-542-05 bottles of 500 Nefazodone hydrochloride tablets, USP 150 mg are peach colored, uncoated, round tablets debossed with “RX 543” and a scoreline on one side and plain on the other side. They are supplied as follows: NDC 63304-543-30 unit of use bottles of 30 NDC 63304-543-05 bottles of 500 Nefazodone hydrochloride tablets, USP 200 mg are light yellow colored, uncoated, round tablets debossed with “RX 544” on one side and plain on the other side. They are supplied as follows: NDC 63304-544-30 unit of use bottles of 30 NDC 63304-544-05 bottles of 500 Nefazodone hydrochloride tablets, USP 250 mg are white colored, uncoated, round tablets debossed with “RX 545” on one side and plain on the other side. They are supplied as follows: NDC 63304-545-30 unit of use bottles of 30 NDC 63304-545-05 bottles of 500 Dispense in a tight container. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Gebrauchsinformation

NEFAZODONE HYDROCHLORIDE- NEFAZODONE HYDROCHLORIDE TABLET
Ranbaxy Pharmaceuticals Inc.
----------
MEDICATION GUIDE
NEFAZODONE HYDROCHLORIDE TABLETS, 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

Fachinformation

NEFAZODONE HYDROCHLORIDE- NEFAZODONE HYDROCHLORIDE TABLET
RANBAXY PHARMACEUTICALS INC.
----------
RX ONLY
(PATIENT INFORMATION INCLUDED)
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
NEFAZODONE HYDROCHLORIDE TABLETS 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.
NEFAZODONE HYDROCHLORIDE TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS. (SEE
WARNINGS, CLINICAL WORSENING AND SUICIDE RISK; PRECAUTIONS,
INFORMATION FOR
PATIENTS; AND PRECAUTIONS, PEDIATRIC USE.)
Before prescribing nefazodone hydrochloride tablets, the physician
should be thoroughly familiar with
the details of this prescribing information.
WARNING
CASES OF LIFE-THREATENING HEPATIC FAILURE HAVE BEEN REPORTED IN
PATIENTS TREATED WITH
NEFAZODONE HYDROCHLORIDE TABLETS. THE REPORTED RATE IN THE UNITED
STATES IS ABOUT 1 CASE OF
LIVER FAILURE RESULTING IN DEATH OR TRANSPLANT PER 250,000 TO 300,000
PATIENT-YEARS OF
NEFAZODONE HYDROCHLORIDE TREATMENT. THE TOTAL PATIENT-YEARS IS A
SUMMATION OF EACH
PATIENT’S DURATION OF EXPOSURE EXPRESSED IN YEARS. FOR EXAMPLE, 1
PATIENT-YEAR IS EQUAL TO 2
PAT