Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
CITALOPRAM HYDROBROMIDE (UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V)
NCS HealthCare of KY, Inc dba Vangard Labs
CITALOPRAM HYDROBROMIDE
CITALOPRAM 20 mg
ORAL
PRESCRIPTION DRUG
Citalopram tablets 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 in hospitalized depressed patients has not been adequately studied. The efficacy of citalo
Citalopram Tablets USP are available as follows: 10 mg: light-beige, convex capsule-shaped, unscored tablets, debossed “4740” on one side and “93” on the other side containing citalopram hydrobromide equivalent to 10 mg citalopram. 20 mg: light-pink, convex capsule-shaped, scored tablets, debossed “4741” on one side and “9” score “3” on the other side containing citalopram hydrobromide equivalent to 20 mg citalopram, packaged in blisterpacks of 30, 31 and 15 tablets. 40 mg: white to off-white, convex capsule-shaped, scored tablets, debossed “4742” on one side and “9” score “3” on the other side containing citalopram hydrobromide equivalent to 40 mg citalopram. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Use child-resistant closure (as required).
Abbreviated New Drug Application
CITALOPRAM- CITALOPRAM TABLET NCS HealthCare of KY, Inc dba Vangard Labs ---------- MEDICATION GUIDE Citalopram Tablets USP 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: • 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. • 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 citalopram 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 mood Call your healthcare provider rig Прочитайте повний документ
CITALOPRAM- CITALOPRAM TABLET NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- CITALOPRAM 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 US E). 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: C H BrFN O M.W. 405.35 Citalopram HBr occurs as a fine, white to off-white powder. Citalopram HBr is sparingly soluble in water and soluble in ethanol. Each citalopram tablet USP, for oral administration, contains citalopram HBr equivale Прочитайте повний документ