SERTRALINE HYDROCHLORIDE tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB)

Prieinama:

Quality Care Products LLC

INN (Tarptautinis Pavadinimas):

SERTRALINE HYDROCHLORIDE

Sudėtis:

SERTRALINE 100 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 action of sertraline hydrochloride tablets USP in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride tablets USP in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride tablets USP for extended periods should be reevaluated periodically (see Clinical Trials  under CLINICAL PHARMACOLOGY ). Obsessive-Compulsive Disorder Sertraline hydrochloride tablets USP are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of sertraline hydrochloride tablets USP  was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials  under CLINICAL PHARMACOLOGY ). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.  The efficacy of sertraline hydrochloride tablets USP in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking sertraline hydrochloride tablets USP and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY ). Nevertheless, the physician who elects to use sertraline hydrochloride tablets USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Panic Disorder Sertraline hydrochloride tablets USP are indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.  The efficacy of sertraline hydrochloride tablets USP were established in three 10 to 12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials  under CLINICAL PHARMACOLOGY ). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of sertraline hydrochloride tablets USP in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking sertraline hydrochloride tablets USP and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials  under CLINICAL PHARMACOLOGY ). Nevertheless, the physician who elects to use sertraline hydrochloride tablets USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Posttraumatic Stress Disorder (PTSD) Sertraline hydrochloride tablets USP areindicated for the treatment of posttraumatic stress disorder in adults. The efficacy of sertraline hydrochloride tablets USP in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY ). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of sertraline hydrochloride tablets USP in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use sertraline hydrochloride tablets USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Premenstrual Dysphoric Disorder (PMDD) Sertraline hydrochloride tablets USP are indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults.  The efficacy of sertraline hydrochloride tablets USP in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-III­-R/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY ).  The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control.  Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride tablets USP in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials.  Therefore, the physician who elects to use sertraline hydrochloride tablets USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ).  Social Anxiety Disorder Sertraline hydrochloride tablets USP are indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of sertraline hydrochloride tablets USP in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials  under CLINICAL PHARMACOLOGY ).  Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress.  The efficacy of sertraline hydrochloride tablets USP in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of sertraline hydrochloride tablets USP treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe sertraline hydrochloride tablets USP for extended periods should periodically re-­evaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY ). The use of MAOIs intended to treat psychiatric disorders with sertraline hydrochloride tablets or within 14 days of stopping treatment with sertraline hydrochloride tablets is contraindicated because of an increased risk of serotonin syndrome. The use of sertraline hydrochloride tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS  and DOSAGE AND ADMINISTRATION ). Starting sertraline hydrochloride tablets in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS  and DOSAGE AND ADMINISTRATION ). Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS ). Sertraline hydrochloride tablets are contraindicated in patients with a hypersensitivity to sertraline or any of the inactive ingredients in sertraline hydrochloride tablets. Sertraline hydrochloride is not a controlled substance. In a placebo-controlled, double-blind, randomized study of the comparative abuse liability of sertraline hydrochloride, alprazolam, and d-amphetamine in humans, sertraline hydrochloride did not produce the positive subjective effects indicative of abuse potential, such as euphoria or drug liking, that were observed with the other two drugs. Premarketing clinical experience with sertraline hydrochloride did not reveal any tendency for a withdrawal syndrome or any drug-seeking behavior. In animal studies sertraline hydrochloride does not demonstrate stimulant or barbiturate-like (depressant) abuse potential. As with any CNS active drug, however, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of sertraline hydrochloride misuse or abuse (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

Produkto santrauka:

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. 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. 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. 55700-362-30 55700-362-60 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahaboob Nagar (Dt)-509302 India Revised: 12/2015

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
Quality Care Products LLC
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MEDICATION GUIDE
Sertraline Hydrochloride Tablets USP
(ser' tra leen hye'' droe klor' ide)
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.
•
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
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

Prekės savybės

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
QUALITY CARE PRODUCTS LLC
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SERTRALINE 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 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