Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB)
MedVantx, Inc.
SERTRALINE HYDROCHLORIDE
SERTRALINE 100 mg
ORAL
PRESCRIPTION DRUG
Major Depressive Disorder Sertraline hydrochloride tablets USP are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride tablets USP 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
Sertraline hydrochloride tablets USP, contains sertraline hydrochloride USP equivalent to 25 mg, 50 mg and 100 mg of sertraline. Sertraline hydrochloride tablets USP are supplied as : 25 mg Tablets: Green colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘6’ on the other side. NDC 16714-611-01 Bottles of 30 NDC 16714-611-02 Bottles of 60 NDC 16714-611-03 Bottles of 90 NDC 16714-611-04 Bottles of 100 NDC 16714-611-05 Bottles of 500 NDC 16714-611-06 Bottles of 1000 50 mg Tablets: Blue colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘7’ on the other side. NDC 16714-612-01 Bottles of 30 NDC 16714-612-02 Bottles of 60 NDC 16714-612-03 Bottles of 90 NDC 16714-612-04 Bottles of 100 NDC 16714-612-05 Bottles of 500 NDC 16714-612-06 Bottles of 1000 100 mg Tablets: Yellow colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘8’ on the other side. NDC 16714-613-01 Bottles of 30 NDC 16714-613-02 Bottles of 60 NDC 16714-613-03 Bottles of 90 NDC 16714-613-04 Bottles of 100 NDC 16714-613-05 Bottles of 500 NDC 16714-613-06 Bottles of 1000 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for: Northstar Rx LLC Memphis, TN 38141 Toll Free: 1-800-206-7821 Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahaboob Nagar (Dt) AP-509302, INDIA M.L.No.: 22/MN/AP/2009/F/G Revised: 01/2013
Abbreviated New Drug Application
SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED MedVantx, Inc. ---------- MEDICATION GUIDE Sertraline Hydrochloride Tablets USP Read the Medication Guide that comes with sertraline hydrochloride 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 sertraline hydrochloride tablets? Sertraline hydrochloride tablets and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Sertraline hydrochloride 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. ∘ New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. ∘ Pay particular attention to such changes when sertraline hydrochloride 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 healthcare pro Lue koko asiakirja
SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED MEDVANTX, INC. ---------- SERTRALINE 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 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 tablets USP are 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 molecular formula C H NCl •HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertrali Lue koko asiakirja