Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30)
Dispensing Solutions, Inc.
TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE 50 mg
ORAL
PRESCRIPTION DRUG
Trazodone Hydrochloride Tablets USP are indicated for the treatment of depression. The efficacy of Trazodone Hydrochloride Tablets USP has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association’s Diagnostic and Statistical Manual, lll.a Major Depressive Episode 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 four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts. Trazodone hydrochloride tablets are contraindicated in
Trazodone Hydrochloride Tablets USP: 50 mg - White, round, scored, compressed tablets. Imprinted PLIVA 433 Available in bottles of 100, 500 and 1000 Tablets. 100 mg - White, round, scored, compressed tablets. Imprinted PLIVA 434 Available in bottles of 100, 500 and 1000 Tablets. 150 mg - White, trapezoid, bisected on one side, trisected on the other side. Imprinted PLIVA 441 on one side and 50 in each triangular segment on the other side. Available in bottles of 100 and 500 Tablets. Directions for using the correct score when breaking the tablet please refer to the following: -For 50 mg, break the score on either the left or right side of the tablet (one-third of a tablet). -For 75 mg, break the score down the middle of the tablet (one-half of a tablet). -For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 150 mg, use the entire tablet. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
TRAZODONE HYDROCHLORIDE - TRAZODONE HYDROCHLORIDE TABLET Dispensing Solutions, Inc. ---------- MEDICATION GUIDE Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions Read the Medication Guide that comes with your 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 Les hele dokumentet
TRAZODONE HYDROCHLORIDE - TRAZODONE HYDROCHLORIDE TABLET DISPENSING SOLUTIONS, INC. ---------- TRAZODONE HYDROCHLORIDE TABLETS, USP 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 TRAZODONE HCL 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. TRAZODONE HCL IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS, CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS, INFORMATION FOR PATIENTS, AND PRECAUTIONS, PEDIATRIC US E DESCRIPTION Trazodone Hydrochloride Tablets USP is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1, 2, 4-triazolo[4, 3-a]-pyridin- 3(2_H_)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows: Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal si Les hele dokumentet