Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB)
Medsource Pharmaceuticals
SERTRALINE HYDROCHLORIDE
SERTRALINE 50 mg
ORAL
PRESCRIPTION DRUG
Major Depressive Disorder – 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 sertr
Sertraline hydrochloride modified oval biconvex tablets, containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline, are packaged in bottles. Sertraline hydrochloride 25 mg Tablets: Light Green film coated, Modified oval biconvex tablets de-bossed with I on the left side of bisect and G on the right side of bisect on one side and “212” on other. Sertraline hydrochloride 50 mg Tablets: Light Blue film coated, Modified oval biconvex tablets de-bossed with I on the left side of bisect and G on the right side of bisect on one side and “213” on other. Sertraline hydrochloride 100 mg Tablets: Light Yellow film coated, Modified oval biconvex tablets debossed with I on the left side of bisect and G on the right side of bisect on one side and “214” on other. Store at 25°C (77°F); excursions permitted to 15° - 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET Medsource Pharmaceuticals ---------- MEDICATION GUIDE Sertraline hydrochloride Tablets Read the Medication Guide that comes with Sertraline hydrochloride before you start taking it 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 Sertraline hydrochloride? Sertraline hydrochloride and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Sertraline hydrochloride 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 Sertraline hydrochloride is 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 be Lue koko asiakirja
SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET MEDSOURCE PHARMACEUTICALS ---------- SERTRALINE HYDROCHLORIDE TABLETS 25 MG, 50 MG AND 100 MG 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 TABLETS ARE NOT APPROVED FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER IN PEDIATRIC PATIENTS. (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 NC •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 ethanol. Sertraline hydrochloride Lue koko asiakirja