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Generic Name: Sertraline Tablets (SER-tra-leen)
Brand Name: Zoloft

The RISK OF SUICIDAL THINKING AND BEHAVIOR was increased by antidepressants in short-term studies in children and adolescents with certain psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be watched closely for worsening of symptoms, suicidal thoughts and behavior, or unusual behavior changes. Families and caregivers should be aware of the need for close observation and communication with the prescriber. Results from several studies in children and adolescents with certain psychiatric disorders have revealed a greater risk of side effects related to suicidal thinking and behavior during the first few months of treatment with antidepressants.

Zoloft is used for:

Treating depression, obsessive-compulsive disorder (OCD), panic disorder, posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD; a severe form of premenstrual syndrome), and social anxiety disorder.

Zoloft is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of certain natural substances in the brain, which help to elevate moods.

Do NOT use Zoloft if:

  • you are allergic to any ingredient in Zoloft
  • you are taking or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days
  • you are taking anorexiants (eg, fenfluramine, phentermine), dextromethorphan, H1 antagonists (eg, astemizole, terfenadine), nefazodone, pimozide, selegiline, sibutramine, St. John"s wort, thioridazine, tramadol, or tryptophan

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zoloft :

Some medical conditions may interact with Zoloft . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of seizures, bipolar disorder (manic depression), thoughts of suicide, have attempted suicide, or have a history of substance abuse
  • if you have impaired liver function, a history of stomach or intestinal bleeding, are allergic to latex, or consume alcoholic beverages
  • if you are dehydrated

Some MEDICINES MAY INTERACT with Zoloft . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Carbamazepine or cyproheptadine because the effectiveness of Zoloft may be decreased
  • Anorexiants (eg, fenfluramine, phentermine), dextromethorphan, linezolid, MAO inhibitors (eg, phenelzine), metoclopramide, nefazodone, selegiline, sibutramine, trazodone, or tryptophan because side effects such as sedation, confusion, or serotonin syndrome (restlessness, fever, excessive sweating, confusion, twitching, and seizures; which can rarely be life-threatening) may occur
  • Aspirin, anticoagulants (eg, warfarin), aripiprazole, clozapine, digitoxin, diuretics (eg, furosemide), flecainide, H1 antagonists (eg, astemizole, terfenadine), lithium, nonsteroidal anti-inflammatory agents (NSAIDs) (eg, ibuprofen), phenothiazines (eg, thioridazine), pimozide, propafenone, risperidone, St. John"s wort, sumatriptan, tramadol, or tricyclic antidepressants (eg, amitriptyline) because the side effects of these medicines may be increased by Zoloft

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zoloft may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zoloft :

Use Zoloft as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Zoloft comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Zoloft refilled.
  • Zoloft may be taken on an empty stomach or with food.
  • This medication should be taken once daily.
  • Before taking Zoloft , use the dropper provided to measure the prescribed amount of medicine and mix it with 4 ounces (one-half cup) of water, ginger ale, lemon/lime soda, lemonade, or orange juice. Do not mix the concentrate with any other kind of liquid.
  • This mixture may become slightly cloudy. This is normal.
  • Drink the dose immediately after mixing. Do not mix and store the medicine.
  • Take Zoloft at the same time each day.
  • Do not eat grapefruit or drink grapefruit juice while on Zoloft .
  • Several weeks may pass before Zoloft reaches its full effect.
  • If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your doctor. If more than one dose is missed, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Zoloft .

Important safety information:

  • Zoloft may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Zoloft . Using Zoloft alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
  • Do not drink alcohol while you are using Zoloft .
  • Zoloft will add to the drowsiness effects of other medicines. Check all labels of your medicines for drowsiness causing ingredients. Ask your pharmacist if you are unsure which products may cause drowsiness. Do NOT start any new medicines without checking with your doctor or pharmacist.
  • Antidepressants can increase suicidal thoughts and actions in some children and teenagers. Adults taking Zoloft may also be affected. This risk may be higher in individuals with bipolar illness (also called manic-depressive illness), a family history of bipolar illness, or a history of attempting suicide. Pay close attention to changes in moods or actions, especially if changes occur suddenly. Contact your health care provider right away if any of the following effects occur or worsen: depression, anxiety, restlessness or irritability, panic attacks, thoughts or attempts of suicide, or other unusual changes in behavior or mood.
  • The dropper dispenser contains natural dry rubber. Notify your health care provider if you are allergic to latex.
  • Additional monitoring of your condition is recommended at the start of treatment with Zoloft and whenever a change in dose is made. Do not suddenly stop taking Zoloft without first contacting your doctor. Suddenly stopping Zoloft may cause symptoms such as mental or mood changes, numbness or tingling of the skin, confusion, headache, sleeplessness, or unusual tiredness.
  • If you will be stopping Zoloft and starting nefazodone, a period of time should pass before beginning this new medicine. Discuss this situation with your doctor.
  • LAB TESTS, including liver function, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and laboratory appointments while taking Zoloft .
  • Caution is advised when using Zoloft in the ELDERLY since they may be more sensitive to the effects of Zoloft , including a decrease in sodium levels in the blood. This is especially important if they are also taking "water pills" or diuretics.
  • Caution is advised when using Zoloft in CHILDREN because they may be more sensitive to the effects of Zoloft , especially increased risk of suicidal thoughts or actions. It is important to monitor weight and growth in CHILDREN who are taking Zoloft .
  • In the unlikely event you experience a painful and prolonged erection, seek medical attention immediately or permanent problems could occur.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Zoloft during pregnancy, especially during the third trimester. It is unknown if Zoloft is excreted in breast milk. If you are or will be breast-feeding while you are using Zoloft , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Zoloft :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensation; agitation; anxiety; changes in vision; constipation; decreased sex drive; decreased sexual ability; diarrhea/loose stools; dizziness; drowsiness; dry mouth; failure to ejaculate; gas; headache; hot flushes; increased sweating; indigestion; loss of appetite; nausea; nervousness; pain; rash; sleeplessness; sore throat; stomach pain; tiredness; tremor; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; fever; inability to control bladder; muscle disorder; new or worsening agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, sleeplessness, exaggerated feeling of well being, or inability to sit still; persistent, painful erection; pounding in the chest; seizures; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or rapid weight gain; unusual or severe mental or mood changes; vision changes; worsening of depression.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include hallucinations; fast, slow, or irregular heartbeat; prolonged vomiting; seizures; severe dizziness; severe drowsiness; tremor.

Proper storage of Zoloft :

Store at controlled room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Keep Zoloft out of the reach of children and away from pets.

General information:

  • If you have any questions about Zoloft , please talk with your doctor, pharmacist, or other healthcare provider.
  • Zoloft is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is summary only. It does not contain all information about Zoloft . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other healthcare provider.

Issue Date: November 1, 2006
Database Edition
Copyright © 2006 Wolters Kluwer Health, Inc.

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