Sertraline (Page 7 of 8)
16 HOW SUPPLIED/STORAGE AND HANDLING
Sertraline Hydrochloride Tablets USP, 25 mg
Green colored, capsule shaped, biconvex, film-coated tablets, debossed with ‘L’ and ‘U’ on either side of the breakline on one side and ‘D01’ on the other side.
NDC 68180-351-06 Bottles of 30
NDC 68180-351-08 Bottles of 50
NDC 68180-351-09 Bottles of 90
NDC 68180-351-01 Bottles of 100
NDC 68180-351-03 Bottles of 1000
Sertraline Hydrochloride Tablets USP, 50 mg
Blue colored, capsule shaped, biconvex, film-coated tablets, debossed with ‘L’ and ‘U’ on either side of the breakline on one side and ‘D02’ on the other side.
NDC 68180-352-06 Bottles of 30
NDC 68180-352-09 Bottles of 90
NDC 68180-352-01 Bottles of 100
NDC 68180-352-02 Bottles of 500
NDC 68180-352-03 Bottles of 1000
NDC 68180-352-05 Bottles of 5000
NDC 68180-352-11 Box containing 10 x 10’s unit dose blisters
Sertraline Hydrochloride Tablets USP, 100 mg
Yellow colored, capsule shaped, biconvex, film-coated tablets, debossed with ‘L’ and ‘U’ on either side of the breakline on one side and ‘D03’ on the other side.
NDC 68180-353-06 Bottles of 30
NDC 68180-353-09 Bottles of 90
NDC 68180-353-01 Bottles of 100
NDC 68180-353-02 Bottles of 500
NDC 68180-353-03 Bottles of 1000
NDC 68180-353-05 Bottles of 5000
NDC 68180-353-11 Box containing 10 x 10’s unit dose blisters
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Suicidal Thoughts and Behaviors
Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [See Boxed Warning and Warnings and Precautions (5.1)].
Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of sertraline hydrochloride tablets with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [See Warnings and Precautions (5.2), Drug Interactions (7.1)].
Increased Risk of Bleeding
Inform patients about the concomitant use of sertraline hydrochloride tablets with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [See Warnings and Precautions (5.3)].
Activation of Mania/Hypomania
Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [See Warnings and Precautions (5.4)].
Advise patients not to abruptly discontinue sertraline hydrochloride tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when sertraline hydrochloride tablets are discontinued [See Warnings and Precautions (5.5)].
Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [See Adverse Reactions (6.2)].
Inform pregnant women that sertraline hydrochloride tablets may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [See Use in Specific Populations (8.1)].
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
MADE IN INDIA
Revised: February 2017 ID#: 241363
Sertraline Hydrochloride (ser’ tra leen hye” droe klor’ ide) Tablets
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. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency.
Suicidal thoughts or actions:
Sertraline hydrochloride tablets and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within thefirst 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 aggressive or violent
new or worse depression
feeling agitated, restless, angry or irritable
an increase in activity or talking more than what is normal for you
acting on dangerous impulses
thoughts about suicide or dying
new or worse anxiety or panic attacks
other unusual changes in behavior or mood
Serotonin Syndrome. This condition can be life-threatening and symptoms may include:
agitation, hallucinations, coma, or other changes in mental status
racing heartbeat, high or low blood pressure
coordination problems or muscle twitching (overactive reflexes)
nausea, vomiting, or diarrhea
sweating or fever
Increased chance of bleeding: Sertraline hydrochloride tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.
Manic episodes. Symptoms may include:
greatly increased energy
unusually grand ideas
severe trouble sleeping
talking more or faster
Seizures or convulsions.
Glaucoma (angle-closure glaucoma). Many antidepressant medicines including sertraline hydrochloride tablets may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
weakness or feeling unsteady
confusion, problems concentrating or thinking, or memory problems
Do not stop sertraline hydrochloride tablets without first talking to your healthcare provider. Stopping sertraline hydrochloride tablets too quickly may cause serious symptoms including:
anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
headache, sweating, nausea, dizziness
electric shock-like sensations, shaking, confusion
What are sertraline hydrochloride tablets?
Sertraline hydrochloride tablet is a prescription medicine used to:
Major Depressive Disorder (MDD)
Social Anxiety Disorder
Obsessive Compulsive Disorder (OCD)
Posttraumatic Stress Disorder (PTSD)
Premenstrual Dysphoric Disorder (PMDD)
It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
Sertraline hydrochloride tablets are safe and effective in treating children with OCD age 6 to 17 years.
It is not known if sertraline hydrochloride tablets are safe and effective for use in children under 6 years of age with OCD or children with other behavior health conditions.
Talk to your healthcare provider if you do not think that your condition is getting better with sertraline hydrochloride tablets treatment.
Who should not take sertraline hydrochloride tablets?
Do not take sertraline hydrochloride tablets if you:
take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
have taken an MAOI within 2 weeks of stopping sertraline hydrochloride tablets unless directed to do so by your healthcare provider.
have stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.
take any other medicines that contain sertraline (such as sertraline HCl or sertraline hydrochloride).
take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems.
are allergic to sertraline or any of the ingredients in sertraline hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in sertraline hydrochloride tablets.
take Antabuse®(disulfiram) (if you are taking the liquid form of sertraline hydrochloride tablets) due to the alcohol content.
People who take sertraline hydrochloride tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
rapid changes in heart rate or blood pressure
uncontrolled muscle spasms
loss of consciousness (pass out)
What should I tell my healthcare provider before taking sertraline hydrochloride tablets?
Before starting sertraline hydrochloride tablets, tell your healthcare provider:
if you have:
bipolar disorder or mania
or have had seizures or convulsions
low sodium levels in your blood
a history of a stroke
high blood pressure
or have had bleeding problems
are pregnant or plan to become pregnant . Your baby may have withdrawal symptoms after birth or may be at increased risk for a serious lung problem at birth. Talk to your healthcare provider about the benefits and risks of taking sertraline hydrochloride tablets during pregnancy.
are breastfeeding or plan to breastfeed . A small amount of sertraline hydrochloride may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking sertraline hydrochloride tablets.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Sertraline hydrochloride tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects.
Your healthcare provider or pharmacist can tell you if it is safe to take sertraline hydrochloride tablets with your other medicines. Do not start or stop any medicine while taking sertraline hydrochloride tablets without talking to your healthcare provider first.
How should I take sertraline hydrochloride tablets?
Take sertraline hydrochloride tablets exactly as prescribed. Your healthcare provider may need to change the dose of sertraline hydrochloride tablets until it is the right dose for you.
Sertraline hydrochloride tablets may be taken with or without food.
If you miss a dose of sertraline hydrochloride tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of sertraline hydrochloride tablets at the same time.
If you take too much sertraline hydrochloride tablets, call your healthcare provider or poison control center right away, or go to the nearest hospital emergency room right away.
What should I avoid while taking sertraline hydrochloride tablets?
Sertraline hydrochloride tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how sertraline hydrochloride tablets affect you. Do not drink alcohol while you take sertraline hydrochloride tablets.
What are the possible side effects of sertraline hydrochloride tablets?
Sertraline hydrochloride tablets may cause serious side effects, including:
See “What is the most important information I should know about sertraline hydrochloride tablets?”
The most common side effects in adults who take sertraline hydrochloride tablets include:
nausea, loss of appetite, diarrhea, or indigestion
tremor or shaking
change in sleep habits including increased sleepiness or insomnia
sexual problems including decreased libido and ejaculation failure
feeling tired or fatigued
The most common side effects in children and adolescents who take include abnormal increase in muscle movement or agitation, nose bleeds, urinary incontinence, aggressive reaction, possible slowed growth rate, and weight change. Your child’s height and weight should be monitored during treatment with sertraline hydrochloride tablets.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of sertraline hydrochloride tablets. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store sertraline hydrochloride tablets?
Store sertraline hydrochloride tablets at room temperature, 68°F to 77°F (20°C to 25°C). Keep sertraline hydrochloride tablets bottle closed tightly.
Keep sertraline hydrochloride tablets and all medicines out of the reach of children.
General information about the safe and effective use of sertraline hydrochloride tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sertraline hydrochloride tablets for a condition for which it was not prescribed. Do not give sertraline hydrochloride tablets to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about sertraline hydrochloride tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about sertraline hydrochloride tablets that is written for healthcare professionals.
For more information about sertraline hydrochloride tablets call Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or visit at www.lupinpharmaceuticals.com.
What are the ingredients in sertraline hydrochloride tablets?
Active ingredient: sertraline hydrochloride
D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration
The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
MADE IN INDIA
Revised: February 2017 ID#: 241364
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.