VENLAFAXINE HYDROCHLORIDE tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

Venlafaxine hydrochloride (UNII: 7D7RX5A8MO) (Venlafaxine - UNII:GRZ5RCB1QG)

থেকে পাওয়া:

Dr. Reddy's Laboratories Limited

INN (আন্তর্জাতিক নাম):

Venlafaxine hydrochloride

রচনা:

Venlafaxine 25 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ). 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 should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlaf

পণ্য সারাংশ:

Venlafaxine Tablets USP are available containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of venlafaxine. The 25 mg are peach colored, round biconvex, uncoated tablets debossed with R and DY separated with a breakline on one side and “545” on the other side. They are supplied in bottles of 30, 60, 90, 100, 500 and unit dose package of 10 (1 x 10). Bottles of 30                                            NDC 55111-545-30 Bottles of 60                                            NDC 55111-545-60 Bottles of 90                                            NDC 55111-545-90 Bottles of 100                                          NDC 55111-545-01 Bottles of 500                                          NDC 55111-545-05 Unit dose package of 10 (1 × 10)            NDC 55111-545-79 The 37.5 mg are peach colored, round biconvex, uncoated tablets debossed with R and DY separated with a breakline on one side and “546” on the other side. They are supplied in bottles of 30, 60, 90, 100, 500 and unit dose package of 10 (1 x 10). Bottles of 30                                            NDC 55111-546-30 Bottles of 60                                            NDC 55111-546-60 Bottles of 90                                            NDC 55111-546-90 Bottles of 100                                          NDC 55111-546-01 Bottles of 500                                          NDC 55111-546-05 Unit dose package of 10 (1 × 10)            NDC 55111-546-79 The 50 mg are peach colored, round biconvex, uncoated tablets debossed with R and DY separated with a breakline on one side and “547” on the other side. They are supplied in bottles of 30, 60, 90, 100, 500 and unit dose package of 10 (1 x 10). Bottles of 30                                            NDC 55111-547-30 Bottles of 60                                            NDC 55111-547-60 Bottles of 90                                            NDC 55111-547-90 Bottles of 100                                          NDC 55111-547-01 Bottles of 500                                          NDC 55111-547-05 Unit dose package of 10 (1 × 10)            NDC 55111-547-79 The 75 mg are peach colored, round biconvex, uncoated tablets debossed with R and DY separated with a breakline on one side and “548” on the other side. They are supplied in bottles of 30, 60, 90, 100, 500 and unit dose package of 10 (1 x 10). Bottles of 30                                            NDC 55111-548-30 Bottles of 60                                            NDC 55111-548-60 Bottles of 90                                            NDC 55111-548-90 Bottles of 100                                          NDC 55111-548-01 Bottles of 500                                          NDC 55111-548-05 Unit dose package of 10 (1 × 10)            NDC 55111-548-79 The 100 mg are peach colored, round, flat bevel edged, uncoated tablets debossed with R and DY separated with a breakline on one side and “549” on the other side. They are supplied in bottles of 30, 60, 90, 100, 500 and unit dose package of 10 (1 x 10). Bottles of 30                                            NDC 55111-549-30 Bottles of 60                                            NDC 55111-549-60 Bottles of 90                                            NDC 55111-549-90 Bottles of 100                                          NDC 55111-549-01 Bottles of 500                                          NDC 55111-549-05 Unit dose package of 10 (1 × 10)            NDC 55111-549-79 Store at 20° to 25°C (68° to 77°F); in a dry place; excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP. The unit of use package is intended to be dispensed as a unit.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET
Dr. Reddy's Laboratories Limited
----------
Medication Guide
Venlafaxine Tablets USP
(ven la fax een)
Read the Medication Guide that comes with venlafaxine tablets before
you start taking it and each time
you get a refill. There may be new information. This Medication Guide
does not take the place of talking
to your healthcare provider about your medical condition or treatment.
Talk with your healthcare provider
if there is something you do not understand or want to learn more
about.
What is the most important information I should know about venlafaxine
tablets?
Venlafaxine tablets and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions: venlafaxine tablets and other
antidepressant medicines may increase
suicidal thoughts or actions in some children, teenagers, or young
adults within the first few months of
treatment or when the dose is changed.
•
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
•
Watch for these changes and call your healthcare provider right away
if you notice:
•
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if
severe.
•
Pay particular attention to such changes when venlafaxine tablets are
started or when the
dose is changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried about
symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency, especially if they are new, worse, or worry you:
•
attempts to commit suicide
•
acting on dangerous impulses
•
acting aggressive or violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worse anxiety or panic attacks
•
feeling agitated, restless, angry or irritable
•
trouble sleeping
•
an increase in activity or talking more than what is normal for you
•
other unusual changes in behavior or m

পণ্য বৈশিষ্ট্য

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET
DR. REDDY'S LABORATORIES LIMITED
----------
VENLAFAXINE TABLETS USP
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 VENLAFAXINE
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. VENLAFAXINE 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
Venlafaxine hydrochloride USP is a structurally novel antidepressant
for oral
administration. It is designated
(R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]
cyclohexanol hydrochloride or
(±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl]
cyclohexanol hydrochloride and has the molecular formula of C
H
NO HCl. Its
molecular weight is 313.87.
The structural formula is shown below.
17
27
2
Venlafaxine hydrochloride USP is an off-white to white crystalline
powder and soluble in
methanol.
Compressed tablets contain venlafaxine hydrochloride USP equivalent to
25 mg, 37.5
mg, 50 mg, 75 mg, or 100 mg venlaf