ZOLOFT

Generic Name: sertraline (SER tra leen)
Brand Names: Zoloft

What is the most important information I should know about sertraline?

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While you are taking sertraline you may need to be monitored for worsening symptoms of depression and/ or suicidal thoughts especially at the start of therapy or when doses are changed. Your doctor may want you to monitor for the following symptoms: anxiety, panic attacks, difficulty sleeping, irritability, hostility, impulsivity, severe restlessness, and mania (mental and/ or physical hyperactivity). These symptoms may be associated with development of worsening symptoms of depression and/ or suicidal thoughts or actions. Contact your healthcare provider if you develop any new or worsening mental health symptoms during treatment with sertraline. Do not stop taking sertraline without first talking to your healthcare provider.

ï	Do not stop taking sertraline without first talking to your doctor. It may take 4 weeks or more for you to start feeling better and you may experience unpleasant side effects if you stop taking sertraline suddenly.

What is sertraline?

ï	Sertraline is in a class of drugs called selective serotonin reuptake inhibitors. Sertraline affects chemicals in the brain that may become unbalanced and cause depression, panic or anxiety, obsessive or compulsive symptoms, or other psychiatric symptoms.

ï	Sertraline is used to treat depression, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), and social anxiety disorder, also known as social phobia.

ï	Sertraline may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking sertraline?

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While you are taking sertraline you may need to be monitored for worsening symptoms of depression and/ or suicidal thoughts especially at the start of therapy or when doses are changed. Your doctor may want you to monitor for the following symptoms: anxiety, panic attacks, difficulty sleeping, irritability, hostility, impulsivity, severe restlessness, and mania (mental and/ or physical hyperactivity). These symptoms may be associated with development of worsening symptoms of depression and/ or suicidal thoughts or actions. Contact your healthcare provider if you develop any new or worsening mental health symptoms during treatment with sertraline. Do not stop taking sertraline without first talking to your healthcare provider.

ï	Do not take sertraline if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) during the last 2 weeks. Serious, and sometimes fatal, reactions have occurred when these medicines have been used together.

ï	Do not take sertraline if you are taking pimozide (Orap). A dangerous drug interaction could result.

ï	Before taking sertraline, tell your doctor if you

…	have liver disease;

…	have kidney disease;

…	suffer from seizures; or

…	suffer from mania or have suicidal thoughts.

ï	You may not be able to take sertraline, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

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Sertraline is in the FDA pregnancy category C. Babies exposed to sertraline and/ or other drugs of the same class during the third trimester of pregnancy may develop medical complications. Discuss the risks with your doctor. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.

ï	It is not known whether sertraline passes into breast milk. Do not take sertraline without first talking to your doctor if you are breast-feeding a baby.

How should I take sertraline?

ï	Take sertraline exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

ï	Take each tablet with water.

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The Zoloft Oral Concentrate must be diluted before taking a dose. Use the dropper provided to measure a dose of the liquid. Mix the prescribed amount with 4 oz (one-half cup) of water, ginger ale, lemon/ lime soda, lemonade, or orange juice only. Do not use any liquids other than those listed to dilute the concentrate. A slight haze may appear after mixing, this is normal. Drink this mixture immediately after mixing. Do not save any diluted concentrate for later use.

ï	Try to take sertraline at the same time each day.

ï	Sertraline may be taken with or without food.

ï	Do not stop taking sertraline without first talking to your doctor. It may take 4 weeks or more for you to start feeling better and you may experience unpleasant side effects if you stop taking sertraline suddenly.

ï	Store sertraline at room temperature away from moisture and heat.

What happens if I miss a dose?

ï	Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

ï	Seek emergency medical attention if an overdose is suspected.

ï	Symptoms of a sertraline overdose include nausea, vomiting, tremor, seizures, agitation, drowsiness, hyperactivity, and enlarged pupils.

What should I avoid while taking sertraline?

ï	Use caution when driving, operating machinery, or performing other hazardous activities. Sertraline may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

ï	Use alcohol cautiously. Alcohol may increase drowsiness or dizziness while taking sertraline.

What are the possible side effects of sertraline?

ï	If you experience any of the following serious side effects, stop taking sertraline and contact your doctor immediately or seek emergency medical treatment:

…	an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

…	an irregular heartbeat or pulse;

…	low blood pressure (dizziness, weakness);

…	high blood pressure (severe headache, blurred vision); or

…	chills or fever.

ï	If you experience any of the following less serious side effects, continue taking sertraline and talk to your doctor:

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headache;

…	tremor, nervousness, or anxiety;

…	nausea, diarrhea, dry mouth, or changes in appetite or weight;

…	sleepiness or insomnia; or

…	decreased sex drive, impotence, or difficulty having an orgasm.

ï	Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect sertraline?

ï	Do not take sertraline if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) during the last 2 weeks. Serious, and sometimes fatal, reactions have occurred when these medicines have been used together.

ï	Do not take sertraline if you are taking pimozide (Orap). A dangerous drug interaction could result.

ï	Before taking sertraline, tell your doctor if you are taking any of the following medicines:

…	a benzodiazepine such as diazepam (Valium), alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), temazepam (Restoril), triazolam (Halcion), and others;

…	a tricyclic antidepressant such as amitriptyline (Elavil), imipramine (Tofranil), doxepin (Sinequan), nortriptyline (Pamelor), and others;

…	a phenothiazine including chlorpromazine (Thorazine), thioridazine (Mellaril), fluphenazine (Prolixin), mesoridazine (Serentil), perphenazine (Trilafon), prochlorperazine (Compazine), and others;

…	lithium (Lithobid, Eskalith, others) or clozapine (Clozaril);

…	almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig);

…	carbamazepine (Tegretol) or phenytoin (Dilantin);

…	warfarin (Coumadin);

…	digoxin (Lanoxin);

…	cimetidine (Tagamet, Tagamet HB); or

…	bupropion (Wellbutrin, Zyban).

ï	You may not be able to take sertraline, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

ï	Do not take the Zoloft Oral Concentrate without first talking to your doctor if you are taking disulfiram (Antabuse). The oral solution contains alcohol, which may interact with disulfiram.

ï	Drugs other than those listed here may also interact with sertraline. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

ï	Your pharmacist has additional information about sertraline written for health professionals that you may read.

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ï	Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/ or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.