fluvoxamine maleate- Fluvoxamine maleate tablet, film coated

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

Fluvoxamine maleate (UNII: 5LGN83G74V) (Fluvoxamine - UNII:O4L1XPO44W)

Disponibbli minn:

Synthon Pharmaceuticals, Inc.

INN (Isem Internazzjonali):

Fluvoxamine maleate

Għamla farmaċewtika:

TABLET, FILM COATED

Kompożizzjoni:

25 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD), as defined in the DSM-III-R. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Fluvoxamine Maleate Tablets was established in three 10-week trials with obsessive compulsive outpatients with the diagnosis of Obsessive Compulsive Disorder as defined in DSM-III-R. (See Clinical Trials under CLINICAL PHARMACOLOGY.) Obsessive Compulsive Disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego- dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The effectiveness of Fluvoxamine Maleate Tablets for long-term use, i.e., for more than 10 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, t

Sommarju tal-prodott:

Tablets 25 mg: White to off-white, round, biconvex, film-coated tablets. The tablets are unscored and embossed with FLM 25" on one side. Bottles of 30................................................................ NDC 063672-1025-1 Bottles of 100.............................................................. NDC 063672-1025-2 Bottles of 500.............................................................. NDC 063672-1025-4 Tablets 50 mg: White to off-white, round, biconvex, film-coated tablets. The tablets are scored on both sides and embossed with FLM 50" on one side. Bottles of 30................................................................ NDC 063672-1050-1 Bottles of 100.............................................................. NDC 063672-1050-2 Bottles of 500.............................................................. NDC 063672-1050-4 Tablets 100 mg: White to off-white, round, biconvex, film-coated tablets. The tablets are scored on both sides and embossed with FLM 100" on one side. Bottles of 30................................................................ NDC 063672-1100-1 Bottles of 100.............................................................. NDC 063672-1100-2 Bottles of 250.............................................................. NDC 063672-1100-3 Fluvoxamine Maleate Tablets should be protected from high humidity and stored at controlled room temperature, 15°-30° C (59°- 86° F). Dispense in tight containers.

Fuljett ta 'informazzjoni

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, FILM COATED
Synthon Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
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 symptoms,
especially if they are new, worse, o

Karatteristiċi tal-prodott

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE TABLET, FILM COATED
SYNTHON PHARMACEUTICALS, INC.
----------
FLUVOXAMINE MALEATE TABLETS
25 MG, 50 MG AND 100 MG
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
FLUVOXAMINE MALEATE 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.
FLUVOXAMINE IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS EXCEPT FOR PATIENTS WITH
OBSESSIVE COMPULSIVE
DISORDER (OCD). (SEE WARNINGS AND PRECAUTIONS: PEDIATRIC USE.) (SEE
WARNINGS: CLINICAL
WORSENING AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND
PRECAUTIONS:
PEDIATRIC USE)
DESCRIPTION
Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor
(SSRI) belonging to a new
chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It
is chemically unrelated to other
SSRIs and clomipramine. It is chemically designated as
5-methoxy-4'-(trifluoromethyl)valerophenone-
(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the empirical formula
C
H O N F • C H O . Its
molecular weight is 434.4.
The structural formula is:
Fluvoxamine maleate is a white or off white, odorle