PRISTIQ EXTENDED-RELEASE- desvenlafaxine succinate tablet, extended release

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

DESVENLAFAXINE SUCCINATE (UNII: ZB22ENF0XR) (DESVENLAFAXINE - UNII:NG99554ANW)

থেকে পাওয়া:

Physicians Total Care, Inc.

INN (আন্তর্জাতিক নাম):

DESVENLAFAXINE SUCCINATE

রচনা:

DESVENLAFAXINE 50 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

PRISTIQ, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [see Clinical Studies ( 14 ) and Dosage and Administration ( 2.1 ) ]. The efficacy of PRISTIQ has been established in four 8-week, placebo-controlled studies of outpatients who met DSM-IV criteria for major depressive disorder. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in th

পণ্য সারাংশ:

PRISTIQ® (desvenlafaxine) Extended-Release Tablets are available as follows: 50 mg, light pink, square pyramid tablet debossed with “W” (over) “50” on the flat side      NDC 54868-2932-0, bottle of 30 tablets in unit-of-use package Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Each tablet contains 76 or 152 mg of desvenlafaxine succinate equivalent to 50 or 100 mg of desvenlafaxine, respectively. The unit-of-use package is intended to be dispensed as a unit. The appearance of these tablets is a trademark of Wyeth Pharmaceuticals.

অনুমোদন অবস্থা:

New Drug Application

তথ্য লিফলেট

PRISTIQ EXTENDED-RELEASE- DESVENLAFAXINE SUCCINATE TABLET, EXTENDED
RELEASE
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
PRISTIQ® (pris-TEEK) Extended-Release Tablets
(desvenlafaxine)
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

পণ্য বৈশিষ্ট্য

PRISTIQ EXTENDED-RELEASE- DESVENLAFAXINE SUCCINATE TABLET, EXTENDED
RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRISTIQ SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR PRISTIQ.
PRISTIQ (DESVENLAFAXINE) EXTENDED-RELEASE TABLETS, ORAL
INITIAL U.S. APPROVAL: 2008
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER
PSYCHIATRIC DISORDERS. PRISTIQ IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS (5.1).
INDICATIONS AND USAGE
PRISTIQ, a selective serotonin and norepinephrine reuptake inhibitor
(SNRI), is indicated for the treatment of major
depressive disorder [MDD] (1).
DOSAGE AND ADMINISTRATION
Recommended dose: 50 mg once daily with or without food (2.1).
There was no evidence that doses greater than 50 mg/day confer any
additional benefit (2.1).
When discontinuing treatment, gradual dose reduction is recommended
whenever possible (2.1 and 5.9).
Tablets should be taken whole; do not divide, crush, chew, or dissolve
(2.1).
Renal Impairment: The recommended dose in patients with moderate renal
impairment is 50 mg/day. The
recommended dose in patients with severe renal impairment and
end-stage renal disease (ESRD) is 50 mg every other
day. The dose should not be escalated in patients with moderate or
severe renal impairment or ESRD (2.2).
Hepatic Impairment: Dose escalation above 100 mg/day is not
recommended (2.2).
DOSAGE FORMS AND STRENGTHS
PRISTIQ tablets are available as 50 and 100 mg tablets (3).
Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate
equivalent to 50 mg or 100 mg of desvenlafaxine (3).
CONTRAINDICATIONS
Hypersensitivity to desvenlafaxine succinate, venlafaxine
hydrochloride or any excipients in the PRISTIQ formulation
(4.1).
Do not use with an MAOI or within 14