País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30)
Keltman Pharmaceuticals Inc.
TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE 50 mg
ORAL
PRESCRIPTION DRUG
Trazodone hydrochloride tablets are indicated for the treatment of depression. The efficacy of trazodone 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, III.a Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least two 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 patients hypersensitive to tra
Trazodone hydrochloride tablets USP, 50 mg are round, white, film-coated, single scored tablets debossed "93" – "637". Trazodone hydrochloride tablets USP, 100 mg are round, white, film-coated, single scored tablets debossed "93" – "638". They are supplied by Keltman Pharmaceuticals Inc. as follows:
Abbreviated New Drug Application
TRAZODONE HYDROCHLORIDE - TRAZODONE HYDROCHLORIDE TABLET Keltman Pharmaceuticals Inc. ---------- MEDICATION GUIDE Rx only 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? • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. • 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. • 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, Leia o documento completo
TRAZODONE HYDROCHLORIDE - TRAZODONE HYDROCHLORIDE TABLET KELTMAN PHARMACEUTICALS INC. ---------- TRAZODONE HYDROCHLORIDE 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 TRAZODONE HYDROCHLORIDE 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. TRAZODONE HYDROCHLORIDE 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 Trazodone hydrochloride 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. It has a structural formula as follows: Each tablet for oral administration contains 50 mg or 100 mg of trazodone hydrochloride. Trazodone hydrochloride tablets 50 mg and 100 mg contain the inactive ing Leia o documento completo