País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
sertraline hydrochloride (UNII: UTI8907Y6X) (sertraline - UNII:QUC7NX6WMB)
Life Line Home Care Services
sertraline hydrochloride
sertraline 50 mg
ORAL
PRESCRIPTION DRUG
Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients
Sertraline hydrochloride capsular-shaped scored tablets, equivalent to 25, 50 and 100 mg of sertraline, are packaged in bottles. Sertraline hydrochloride 25 mg Tablets: light green capsular-shaped scored tablets engraved on one side with G 4960 and on the other side engraved with 25 mg. NDC 59762-4960-1 Bottles of 30 Sertraline hydrochloride 50 mg Tablets: light blue capsular-shaped scored tablets engraved on one side with G 4900 and on the other side engraved with 50 mg. NDC 59762-4900-1 Bottles of 30 NDC 59762-4900-4 Bottles of 100 NDC 59762-4900-5 Bottles of 500 NDC 59762-4900-2 Bottles of 5000 NDC 59762-4900-3 Unit Dose Packages of 100 Sertraline hydrochloride 100 mg Tablets: light yellow capsular-shaped scored tablets engraved on one side with G 4910 and on the side engraved with 100 mg. NDC 59762-4910-1 Bottles of 30 NDC 59762-4910-4 Bottles of 100 NDC 59762-4910-5 Bottles of 500 NDC 59762-4910-2 Bottles of 5000 NDC 59762-4910-3 Unit Dose Packages of 100 Store at 25°C (77°F); excursions permitted to 15° – 30°C (59° – 86°F)[see USP Controlled Room Temperature]. Sertraline hydrochloride Oral Concentrate: sertraline hydrochloride Oral Concentrate is a clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol. It is supplied as a 60 mL bottle with an accompanying calibrated dropper. NDC 59762-4940-1 Bottles of 60 mL Store at 25°C (77°F); excursions permitted to 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature].
New Drug Application
SERTRALINE HYDROCHLORIDE - SERTRALINE HYDROCHLORIDE TABLET, FILM COATED Life Line Home Care Services ---------- MEDICATION GUIDE ANTIDEPRESSANT MEDICINES, DEPRESSION AND OTHER SERIOUS MENTAL ILLNESS, 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? 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: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling very agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood Call your doctor for medical advice about side Llegiu el document complet
SERTRALINE HYDROCHLORIDE - SERTRALINE HYDROCHLORIDE TABLET, FILM COATED LIFE LINE HOME CARE SERVICES ---------- SERTRALINE HYDROCHLORIDE TABLETS AND ORAL CONCENTRATE 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 SERTRALINE HYDROCHLORIDE 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. SERTRALINE HYDROCHLORIDE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS EXCEPT FOR PATIENTS WITH OBSESSIVE COMPULSIVE DISORDER (OCD). (SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC USE) DESCRIPTION Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4- (3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C H NCl •HCl is represented by the following structural formula: Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in et Llegiu el document complet