Sertraline Hydrochloride (SER-tra-leen hye-droe-KLOR-ide)

Treats depression, obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), social anxiety disorder (SAD), and panic disorder. This medicine is an antidepressant called selective serotonin reuptake inhibitor (SSRI).

Brand Name(s):

Zoloft

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. The oral liquid medicine must be mixed with another liquid before you can use it. Mix the medicine with 1/2 cup (4 ounces) of water, ginger ale, lemon-lime soda, lemonade, or orange juice. Do not mix this medicine with any other liquid. Drink the mixture right away. Do not mix the medicine with the liquid until you are ready to take your dose. It is okay if the mixture looks hazy.
• You may need to take this medicine for 4 weeks or longer before you begin to feel better. Keep using this medicine for the full treatment time. If you feel that the medicine is not working well, do not take more than your prescribed dose. Call your doctor for instructions.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take tryptophan while you are using this medicine, unless your doctor says it is okay.
• Make sure your doctor knows if you are also using St. John's wort, cimetidine (Tagamet®), cisapride (Propulsid®), diazepam (Valium®), digitoxin, fenfluramine (Ponderax®, Pondimin®), fentanyl (Sublimaze®), linezolid (Zyvox®), lithium (Eskalith®, Lithobid®), phenytoin (Dilantin®), tramadol (Ultram®), or valproate (Depacon®). Tell your doctor if you are using a blood thinner (such as warfarin, Coumadin®), medicine for depression (such as amitriptyline, nortriptyline, Elavil®, Pamelor®, or Sinequan®), medicine to treat headaches (such as eletriptan, sumatriptan, Imitrex®, or Relpax®), or a phenothiazine medicine (such as prochlorperazine, Compazine®, Phenergan®, Thorazine®, or Trilafon®). Your doctor will need to know if you are using a diuretic or "water pill" (such as hydrochlorothiazide [HCTZ], furosemide, or Lasix®) or medicine for heart rhythm problems (such as flecainide, propafenone, Rythmol®, or Tambocor®).
• Make sure your doctor knows if you are using a pain or arthritis medicine (sometimes called "NSAIDs") such as aspirin, celecoxib, ibuprofen, naproxen, rofecoxib, valdecoxib, Advil®, Aleve®, Bextra®, Celebrex®, Ecotrin®, Motrin®, or Vioxx®.
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, bleeding problems, diabetes, low sodium in the blood, seizures, or a history of mania or drug abuse.
• For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor or your child's doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourselves. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or get worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you, your child, or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
• This medicine may cause hyponatremia (low sodium in the blood). This is more common in elderly patients, those who are taking diuretic medicines for high blood pressure, or those who have decreased amounts of fluid in the body due to severe diarrhea or vomiting. Stop taking this medicine and check with your doctor right away if you or your child have headache, trouble concentrating, memory problems, confusion, weakness, or unsteadiness.
• Tell your doctor if you or your child are allergic to latex rubber. The oral liquid form of this medicine has a latex rubber dropper.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• This medicine may cause serious conditions called serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions when taken with certain medicines. Check with your doctor first before taking any other medicines.
• This medicine may affect blood sugar levels, which is especially important if you or your child has diabetes. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Aggression, anxiety, anger, or hostility.
• Blistering, peeling, or red skin rash.
• Change in how much or how often you urinate.
• Chest pain.
• Fast or pounding heartbeat.
• Headache, trouble concentrating, memory problems, weakness, or unsteadiness.
• Muscle stiffness, twitching, shaking, or uncontrolled muscle movements.
• Painful, prolonged erection of your penis, or trouble having sex.
• Severe confusion, sweating, diarrhea, or fever.
• Unusual behavior, or thoughts about hurting yourself.
• Unusual bleeding or bruising.

If you notice these less serious side effects, talk with your doctor:

• Decreased interest in sex.
• Dizziness.
• Dry mouth.
• Increased sweating.
• Loss of appetite.
• Mild diarrhea, constipation, nausea, vomiting, upset stomach, or stomach pain.
• Sleepiness or unusual drowsiness.
• Tiredness.
• Trouble sleeping.
• Weight loss.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088