Generic Name: sertraline (SER-tra-leen)
Brand Name: Zoloft
Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using sertraline concentrate outweigh the risks.
Family and caregivers must closely watch patients who take sertraline concentrate. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.
Sertraline concentrate is not approved for use in CHILDREN except for patients with obsessive-compulsive disorder (OCD).
Sertraline concentrate is used for:
Treating depression or OCD. It may be used to treat panic disorder or posttraumatic stress disorder (PTSD). It may also be used to treat premenstrual dysphoric disorder (PMDD) (a severe form of premenstrual syndrome) or social anxiety disorder. It may also be used for other conditions as determined by your doctor.
Sertraline concentrate is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve certain mood problems.
Do NOT use sertraline concentrate if:
- you are allergic to any ingredient in sertraline concentrate
- you are taking or have taken linezolid, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline), or St. John's wort within the last 14 days
- you are taking disulfiram, a fenfluramine derivative (eg, dexfenfluramine), nefazodone, pimozide, serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine, venlafaxine), sibutramine, other SSRIs (eg, citalopram, fluoxetine), or tryptophan
- you are taking another medicine that contains sertraline
Contact your doctor or health care provider right away if any of these apply to you.
Before using sertraline concentrate:
Some medical conditions may interact with sertraline concentrate. 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 are allergic to latex
- if you or a family member has a history of bipolar disorder (manic depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
- if you have a history of seizures, heart problems (eg, slow heartbeat, a heart attack), high blood pressure, stroke, liver or kidney problems, stomach or bowel bleeding, other bleeding problems, glaucoma, or metabolism problems
- if you are dehydrated, have low blood volume or low blood sodium levels, or drink alcohol
- if you will be having electroconvulsive therapy (ECT)
- if you are taking a medicine that contains methylene blue
Some MEDICINES MAY INTERACT with sertraline concentrate. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anorexiants (eg, phentermine), bupropion, fenfluramine derivatives (eg, dexfenfluramine), fentanyl, linezolid, lorcaserin, MAOIs (eg, phenelzine, selegiline, rasagiline), meperidine, metoclopramide, nefazodone, sibutramine, SNRIs (eg, duloxetine, venlafaxine), other SSRIs (eg, citalopram, fluoxetine), St. John's wort, trazodone, triptans (eg, sumatriptan), or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma, may occur
- Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, ketorolac) because the risk of bleeding, including stomach bleeding, may be increased
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
- Tramadol because the risk of seizures may be increased
- Cimetidine because it may increase the risk of sertraline concentrate's side effects
- Phenothiazines (eg, chlorpromazine, thioridazine) because severe heart problems, including irregular heartbeat, may occur
- Carbamazepine or cyproheptadine because they may decrease sertraline concentrate's effectiveness
- Aripiprazole, beta-blockers (eg, propranolol), clozapine, diazepam, digoxin, flecainide, lithium, phenytoin, pimozide, propafenone, risperidone, tolbutamide, tricyclic antidepressants (eg, amitriptyline), or valproate (eg, valproic acid) because the risk of their side effects may be increased by sertraline concentrate
- Tamoxifen because its effectiveness may be decreased by sertraline concentrate
This may not be a complete list of all interactions that may occur. Ask your health care provider if sertraline concentrate 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 sertraline concentrate:
Use sertraline concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Sertraline concentrate comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get sertraline concentrate refilled.
- Take sertraline concentrate by mouth with or without food.
- Use the dropper that comes with sertraline concentrate to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Sertraline concentrate must be diluted before you take it. Mix the prescribed amount with 4 oz (120 mL) of water, ginger ale, lemon/lime soda, lemonade, or orange juice. Do not mix it with any other kind of liquid.
- This mixture may become slightly hazy. This is normal.
- Drink the dose immediately after mixing. Do not store mixed medicine for use at a later time.
- Taking sertraline concentrate at the same time each day will help you remember to take it.
- Continue to take sertraline concentrate even if you feel well. Do not miss any doses.
- Do not suddenly stop taking sertraline concentrate without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. If you need to stop sertraline concentrate, your doctor may need to gradually lower your dose.
- If you miss a dose of sertraline concentrate, take it as soon as possible. If it almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use sertraline concentrate.
Important safety information:
- Sertraline concentrate may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use sertraline concentrate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are taking sertraline concentrate.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking sertraline concentrate; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or use sertraline concentrate for longer than prescribed without checking with your doctor.
- Children and teenagers who take sertraline concentrate may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take sertraline concentrate closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- If your doctor tells you to stop taking sertraline concentrate, you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor when you should start to take your new medicines after you have stopped taking sertraline concentrate.
- The dropper that comes with sertraline concentrate contains natural dry rubber. Check with your health care provider if you are allergic to latex.
- Sertraline concentrate may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by sertraline concentrate. Your risk may be greater if you take sertraline concentrate with certain other medicines (eg, triptans, MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by sertraline concentrate. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
- Sertraline concentrate may interfere with certain lab tests, including certain urine tests for benzodiazepines. Be sure your doctor and lab personnel know you are taking sertraline concentrate.
- Caution is advised when using sertraline concentrate in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
- Sertraline concentrate should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
- Sertraline concentrate may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take sertraline concentrate.
- CHILDREN and TEENAGERS who take sertraline concentrate may be more likely to experience abnormal muscle movement, agitation, aggression, nosebleeds, heavy menstrual periods, increased urination, or decreased bladder control while taking sertraline concentrate.
- PREGNANCY and BREAST-FEEDING: Sertraline concentrate may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using sertraline concentrate while you are pregnant. It is not known if sertraline concentrate is found in breast milk. If you are or will be breast-feeding while you use sertraline concentrate, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of sertraline concentrate:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; increased sweating; loss of appetite; nausea; tiredness; trouble sleeping; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness; joint pain); bizarre behavior; black or bloody stools; chest pain; confusion; decreased bladder control; decreased concentration; decreased coordination; exaggerated reflexes; fainting; fast or irregular heartbeat; fever; hallucinations; memory loss or other memory problems; new or worsening agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache; severe or persistent trouble sleeping; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness or unsteadiness; vision changes; worsening of depression; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; decreased sexual desire or ability; fainting; fast, slow, or irregular heartbeat; hair loss; hallucinations; seizures; severe or persistent diarrhea, dizziness, drowsiness, nausea, or vomiting; tremor; unusual mental or mood changes.Proper storage of sertraline concentrate:
Store sertraline concentrate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep sertraline concentrate out of the reach of children and away from pets.
- If you have any questions about sertraline concentrate, please talk with your doctor, pharmacist, or other health care provider.
- Sertraline concentrate 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take sertraline concentrate or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about sertraline concentrate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sertraline concentrate. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using sertraline concentrate.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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