citalopram hydrobromide- Citalopram Hydrobromide tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

CITALOPRAM HYDROBROMIDE (UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V)

Dostupné s:

Watson Laboratories, Inc

INN (Mezinárodní Name):

Citalopram Hydrobromide

Léková forma:

TABLET

Složení:

10 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). 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 five of the following nine 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, a suicide attempt or suicidal ideation. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in mainta

Přehled produktů:

Citalopram Tablets USP are available as: 10 mg: White, round, biconvex film coated tablets debossed with WPI on one side and 3176 on the other side, supplied in bottles of 100 and 500. 20 mg: White, round, biconvex film coated tablets debossed with WPI and 3177 on one side and a bisecting score on the other side. The WPI curves across the top and the 3177 curves across the bottom. They are supplied in bottles of 100 and 500, and in unit dose packages of 10 x 10. 40 mg: White, round, biconvex film coated tablets debossed with WPI and 3178 on one side and a bisecting score on the other side. The WPI curves across the top and the 3178 curves across the bottom. They are supplied in bottles of 100 and 500, and in unit dose packages of 10 x 10. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]

Informace pro uživatele

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET
Watson Laboratories, 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, or wor

Charakteristika produktu

CITALOPRAM HYDROBROMIDE- CITALOPRAM HYDROBROMIDE TABLET
WATSON LABORATORIES, INC
----------
CITALOPRAM
REVISED: OCTOBER 2007
Rx only
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
CITALOPRAM 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.
CITALOPRAM IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS: CLINICAL
WORSENING AND SUICIDE
RISK,PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC
USE)
DESCRIPTION
Citalopram HBr is a selective serotonin reuptake inhibitor (SSRI) with
a chemical structure unrelated to
that of other SSRIs or of tricyclic, tetracyclic, or other available
antidepressant agents. Citalopram HBr
is a racemic bicyclic phthalane derivative designated
(±)-1-(3-dimethylaminopropyl)-1-(4-
fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the
following structural formula:
Citalopram HBr occurs as a fine, white to off-white powder with a
molecular formula of
C
H BrFN O and a molecular weight of 405.35. Citalopram HBr is sparingly
soluble in water and
soluble in ethanol.
Each Citalopram Tablet USP for oral ad