CITALOPRAM tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Contract Pharmacy Services-PA

INN (Jina la Kimataifa):

CITALOPRAM HYDROBROMIDE

Tungo:

CITALOPRAM 10 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Citalopram tablets (citalopram hydrobromide) are indicated for the treatment of depression. The efficacy of citalopram tablets in the treatment of depression was established in 4 to 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 tablets in hospitalized depressed patients has not b

Bidhaa muhtasari:

Citalopram Tablets, USP are available containing citalopram hydrobromide, USP equivalent to 10 mg, 20 mg or 40 mg of citalopram base. The 10 mg tablets are orange, film-coated, round, unscored tablets debossed with MX31 on one side of the tablet and blank on the other side. They are available as follows: NDC 67046-101-07 blisterpacks of 7 tablets NDC 67046-101-14 blisterpacks of 14 tablets NDC 67046-101-15 blisterpacks of 15 tablets NDC 67046-101-21 blisterpacks of 21 tablets NDC 67046-101-28 blisterpacks of 28 tablets NDC 67046-101-30 blisterpacks of 30 tablets The 20 mg tablets are pink, film-coated, round, scored tablets debossed with MX32 on one side of the tablet and scored on the other side. They are available as follows: NDC 67046-106-07 blisterpacks of 7 tablets NDC 67046-106-14 blisterpacks of 14 tablets NDC 67046-106-15 blisterpacks of 15 tablets NDC 67046-106-21 blisterpacks of 21 tablets NDC 67046-106-28 blisterpacks of 28 tablets NDC 67046-106-30 blisterpacks of 30 tablets The 40 mg tablets are white, film-coated, round, scored tablets debossed with MX33 on one side of the tablet and scored on the other side. They are available as follows: NDC 67046-102-07 blisterpacks of 7 tablets NDC 67046-102-14 blisterpacks of 14 tablets NDC 67046-102-15 blisterpacks of 15 tablets NDC 67046-102-21 blisterpacks of 21 tablets NDC 67046-102-28 blisterpacks of 28 tablets NDC 67046-102-30 blisterpacks of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

CITALOPRAM- CITALOPRAM TABLET, FILM COATED
Contract Pharmacy Services-PA
----------
MEDICATION GUIDE
Citalopram Tablets, USP
(sye tal′ oh pram)
Read the Medication Guide that comes with citalopram tablets before
you start taking them 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 citalopram
tablets?
Citalopram tablets and other antidepressant medicines may cause
serious side effects, including:
1.
Suicidal thoughts or actions:
2.
Citalopram 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.
3.
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
4.
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 citalopram tablets are
started or when the
dose is changed.
5.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried
about symptoms.
6.
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 mood
7.
Call

Tabia za bidhaa

CITALOPRAM- CITALOPRAM TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
----------
CITALOPRAM 10, 20 & 40 MG MYLAN 101 106 102
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 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. CITALOPRAM TABLETS ARE NOT APPROVED
FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS: CLINICAL WORSENING AND
SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS:
PEDIATRIC USE.)
DESCRIPTION
Citalopram hydrobromide is an orally administered 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
hydrobromide is a
racemic bicyclic phthalane derivative designated
(±)-1-(3-dimethylaminopropyl)-1-(4-
fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, hydrobromide
with the following
structural formula:
The molecular formula is C
H
BrFN
O and its molecular weight is 405.35.
Citalopram hydrobromide, USP occurs as a white to almost white,
crystalline powder.
Citalopram hydrobrom