Sertraline Hydrochloride (Page 9 of 9)

Discontinuation of Treatment with Sertraline

Symptoms associated with discontinuation of sertraline and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

HOW SUPPLIED

Sertraline Hydrochloride Tablets capsular-shaped tablets, containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline, are packaged in bottles and unit dose cartons.

Sertraline Hydrochloride Tablets 25 mg: white to off-white film-coated, capsule-shaped, biconvex tablet with “SL” scoreline “25” on one side and “>” on the other side.

NDC 68533-055-12 Bottles of 30

NDC 68533-055-25 Bottles of 1000

NDC 68533-055-40 Unit Dose Packages of 100

Sertraline Hydrochloride Tablets 50 mg: white to off-white film-coated, capsule-shaped, biconvex tablet with “SL” scoreline “50” on one side and “>” on the other side.

NDC 68533-056-12 Bottles of 30

NDC 68533-056-25 Bottles of 1000

NDC 68533-056-40 Unit Dose Packages of 100

Sertraline Hydrochloride Tablets 100 mg: white to off-white, film-coated, capsule-shaped, biconvex tablet with “SL” scoreline “100” on one side and “>” on the other side.

NDC 68533-057-12 Bottles of 30

NDC 68533-057-25 Bottles of 1000

NDC 68533-057-40 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].

MEDICATION GUIDE

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, behaviors, 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, behavior, thoughts, or feelings.
  • 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

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.

Cobalt Pharmaceuticals

6500 Kitimat Road

Mississauga, Canada

L5N 2B8

Item Number:

Revision:

Date: May 2007

SERTRALINE HYDROCHLORIDE
sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68533-055
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sertraline hydrochloride (sertraline) sertraline 25 mg
Inactive Ingredients
Ingredient Name Strength
dibasic calcium phosphate (anhydrous)
macrogol
magnesium stearate
microcrystalline cellulose
polyvinyl alcohol
sodium starch glycolate
talc
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule shaped) Size 8mm
Flavor Imprint Code SL;25;>
Contains
Coating true Symbol true
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68533-055-12 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE None
2 NDC:68533-055-25 1000 TABLET, FILM COATED (1000 TABLET) in 1 BOTTLE None
3 NDC:68533-055-40 100 TABLET, FILM COATED (100 TABLET) in 1 BOX, UNIT-DOSE None
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68533-056
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sertraline hydrochloride (sertraline) sertraline 50 mg
Inactive Ingredients
Ingredient Name Strength
dibasic calcium phosphate (anhydrous)
macrogol
magnesium stearate
microcrystalline cellulose
polyvinyl alcohol
sodium starch glycolate
talc
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule shaped) Size 10mm
Flavor Imprint Code SL;50;>
Contains
Coating true Symbol true
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68533-056-12 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE None
2 NDC:68533-056-25 1000 TABLET, FILM COATED (1000 TABLET) in 1 BOTTLE None
3 NDC:68533-056-40 100 TABLET, FILM COATED (100 TABLET) in 1 BOX, UNIT-DOSE None
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68533-057
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sertraline hydrochloride (sertraline) sertraline 100 mg
Inactive Ingredients
Ingredient Name Strength
dibasic calcium phosphate (anhydrous)
macrogol
magnesium stearate
microcrystalline cellulose
polyvinyl alcohol
sodium starch glycolate
talc
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule shaped) Size 13mm
Flavor Imprint Code SL;100;>
Contains
Coating true Symbol true
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68533-057-12 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE None
2 NDC:68533-057-25 1000 TABLET, FILM COATED (1000 TABLET) in 1 BOTTLE None
3 NDC:68533-057-40 100 TABLET, FILM COATED (100 TABLET) in 1 BOX, UNIT-DOSE None
Labeler — Cobalt Pharmaceuticals

Revised: 08/2007 Cobalt Pharmaceuticals

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