Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
Citalopram Hydrobromide (UNII: I1E9D14F36) (Citalopram - UNII:0DHU5B8D6V)
Cosette Pharmaceuticals, Inc.
Citalopram Hydrobromide
Citalopram 10 mg
ORAL
PRESCRIPTION DRUG
Citalopram Tablets, USP are indicated for the treatment of depression. The efficacy of Citalopram Tablets, USP 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 ofmajor 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, USP in hospitalized depressed patients has not been adequately studied.
Citalopram Tablets, USP are available as follows: 10 mg: light-beige, convex capsule-shaped, unscored tablets, debossed “4740” on one side and plain on the other side containing citalopram hydrobromide, USP equivalent to 10 mg citalopram, packaged in bottles of 100 (NDC 0713-4740-01) and 500 (NDC 0713-4740-05) tablets. 20 mg: light-pink, convex capsule-shaped, scored tablets, debossed “4741” on one side and scored on the other side containing citalopram hydrobromide, USP equivalent to 20 mg citalopram, packaged in bottles of 100 (NDC 0713-4741-01) and 500 (NDC 0713-4741-05) tablets. 40 mg: white to off-white, convex capsule-shaped, scored tablets, debossed “4742” on one side and scored on the other side containing citalopram hydrobromide, USP equivalent to 40 mg citalopram, packaged in bottles of 100 (NDC 0713-4742-01) and 500 (NDC 0713-4742-05) 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, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
CITALOPRAM - CITALOPRAM TABLETS TABLET Cosette Pharmaceuticals, Inc. ---------- 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: • 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 healt Lugege kogu dokumenti
CITALOPRAM - CITALOPRAM TABLETS TABLET COSETTE PHARMACEUTICALS, INC. ---------- CITALOPRAM TABLETS, USP 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 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 Tablets, USP are 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, USP 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 hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide, USP is sparingly soluble in water and soluble in ethanol. Each Citalopram Tablet USP, for oral Lugege kogu dokumenti