CITALOPRAM HYDROBROMIDE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Stat Rx USA

INN（国际名称）:

CITALOPRAM HYDROBROMIDE

组成:

CITALOPRAM HYDROBROMIDE 10 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 citalop

產品總結:

Citalopram Tablets USP contain citalopram hydrobromide USP, equivalent to 10, 20 or 40 mg citalopram base. Citalopram Tablets USP 10 mg Bottle of 30                           NDC 13668-009-30 Bottle of 100                         NDC 13668-009-01 Bottle of 500                         NDC 13668-009-05 Bottle of 9990                       NDC 13668-009-09 10 x 10 Unit Dose                NDC 13668-009-74 Tan coloured, round shaped, biconvex film coated tablets with ‘10’ debossed on one side and plain on the other side. Citalopram Tablets USP 20 mg Bottle of 30                           NDC 13668-010-30 Bottle of 100                         NDC 13668-010-01 Bottle of 500                         NDC 13668-010-05 Bottle of 5600                       NDC 13668-010-06 10 x 10 Unit Dose                NDC 13668-010-74 Tan coloured, oval shaped, biconvex film coated tablets with ‘2|0’ debossed (‘2’ on left side and ‘0’ on right side of the break line) on one side and ‘1010’ on the other side. Citalopram Tablets USP 40 mg Bottle of 30                           NDC 13668-011-30 Bottle of 100                         NDC 13668-011-01 Bottle of 500                         NDC 13668-011-05 Bottle of 2800                       NDC 13668-011-08 10 x 10 Unit Dose                NDC 13668-011-74 Tan coloured, oval shaped, biconvex film coated tablets with ‘4|0’ debossed (‘4’ on left side and ‘0’ on right side of the break line) on one side and ‘1011’ on the other side. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

授权状态:

Abbreviated New Drug Application

资料单张

CITALOPRAM HYDROBROMIDE - CITALOPRAM HYDROBROMIDE TABLET
Stat Rx USA
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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 worry you:
•
thoug

产品特点

CITALOPRAM HYDROBROMIDE - CITALOPRAM HYDROBROMIDE TABLET
STAT RX USA
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CITALOPRAM HYDROBROMIDE TABLET
DESCRIPTION
Citalopram HBr 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 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:
The molecular formula is C
H BrFN O and its molecular weight is 405.35.
Citalopram HBr occurs as a fine, white to off-white powder.Citalopram
HBr is sparingly soluble in
water and soluble in ethanol. Citalopram hydrobromide is available as
tablets.
Citalopram hydrobromide 10 mg tablets are film-coated, round shaped
tablets containing citalopram HBr
in strengths equivalent to 10 mg citalopram base. Citalopram
hydrobromide 20 mg and 40 mg tablets are
film-coated, oval shaped, scored tablets containing citalopram HBr in
strengths equivalent to 20 mg or
40 mg citalopram base. The tablets also contain the following inactive
ingredients: lactose
monohydrate, microcrystalline cellulose, starch, croscarmellose
sodium, copovidone, magnesium
stearate, hypromellose, titanium dioxide, ferric oxide red, ferric
oxide yellow, glycerin, and
polyethylene glycol.
CLINICAL PHARMACOLOGYPharmacodynamics
The mechanism of action of citalopram HBr as an antidepressant is
presumed to be linked to potentiation
of serotonergic activity in the central nervous system (CNS) resulting
from its inhibition of CNS
neuronal reuptake of serotonin (5-HT). _In vitro _and _in vivo
_studies in animals suggest that citalopram is a
highly selective serotonin reuptake inhibitor (SSRI) with minimal
effects on norepinephrine (NE) and
dopamine (DA) neuronal reuptake. Tolerance to the inhibition of 5-HT
uptake is not induced by long-
term (14-day) treatment of rats with citalopram. Citalopram is a
racemic mixture (50/50), an