Sertraline Hydrochloride Tablets, Rx Only, Rev. 09/11

/Sertraline Hydrochloride Tablets, Rx Only, Rev. 09/11
Sertraline Hydrochloride Tablets, Rx Only, Rev. 09/112018-09-06T09:12:40+00:00

Prescription Drug Name:

Sertraline Hydrochloride Tablets, Rx Only, Rev. 09/11

ID:

48e301c4-33b2-4544-970c-1d30a22172a6

Code:

34391-3

DESCRIPTION


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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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 C17H17NCl2∙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 is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg & 50 mg tablets), magnesium stearate, microcrystalline cellulose, polyethylene glycolS, polyvinyl alcohol, povidone K30, sodium starch glycolate, talc, titanium dioxide & yellow iron oxide.

CONTRAINDICATIONS


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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

All Dosage Forms of Sertraline Hydrochloride:
Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (see WARNINGS). Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS). Sertraline hydrochloride is contraindicated in patients with a hypersensitivity to sertraline or any of the inactive ingredients in sertraline hydrochloride tablets.

ADVERSE REACTIONS


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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

During its premarketing assessment, multiple doses of sertraline hydrochloride were administered to over 4000 adult subjects as of February 18, 2000. The conditions and duration of exposure to sertraline hydrochloride varied greatly, and included (in overlapping categories) clinical pharmacology studies, open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies, and studies for multiple indications, including major depressive disorder and PMDD. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories. In the tabulations that follow, a World Health Organization dictionary of terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the over 4000 adult individuals exposed to multiple doses of sertraline hydrochloride who experienced a treatment-emergent adverse event of the type cited on at least one occasion while receiving sertraline hydrochloride. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. It is important to emphasize that events reported during therapy were not necessarily caused by it. The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the side effect incidence rate in the population studied.

HOW SUPPLIED


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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

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 debossed with 5 on the left side of bisect and 8 on the right side of bisect on one side and “W” on other. NDC 51138-585-30    Bottles of 30 Sertraline hydrochloride 50 mg Tablets: Light Blue film coated, Modified oval biconvex tablets debossed with 5 on the left side of bisect and 7 on the right side of bisect on one side and “W” on other. NDC 51138-586-30    Bottles of 30 Sertraline hydrochloride 100 mg Tablets: Light Yellow film coated, Modified oval biconvex tablets debossed with 5 on the left side of bisect and 6 on the right side of bisect on one side and “W” on other. NDC 51138-587-30    Bottles of 30 New Tablet ID Store at 20ºC to 25ºC (68ºF to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

MEDICATION GUIDE


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displayName: SPL MEDGUIDE SECTION
FDA Article Code: 42231-1

Antidepressant Medicines, Depression and other Serious Mental Illnesses,
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 when the medicine is first started.
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?

·    Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings. This is very important  when an antidepressant medicine is first started or when the dose is changed.
·    Call the healthcare provider right away to report new or sudden changes in mood, behaviors, thoughts, or feelings.This is very important when an antidepressant medicine is first started or when the dose is changed.
·    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, 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 effects. You may report side effects to FDA at 1-800-FDA-1088.      What else do I need to know about antidepressant medicines?

·    Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant  medicine suddenly can cause other symptoms.
·    Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks  of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all  treatment choices with the healthcare provider, not just the use of antidepressants.
·    Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
·    Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
·    Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child”s  healthcare provider for more information. This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. Rev. September 2011

PRINCIPAL DISPLAY PANEL


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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL


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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL


id: a6866148-a54a-49c8-b09a-c823c2638ae6
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4