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Drugs reference index «sertraline»

sertraline


sertraline (Oral route)

SER-tra-leen

Oral routeSolutionTablet
  • Suicidality and Antidepressant Drugs
  • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of sertraline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Sertraline hydrochloride is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD) .

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD) .

Commonly used brand name(s):

In the U.S.

  • Zoloft

Available Dosage Forms:

  • Tablet
  • Solution
  • Capsule

Therapeutic Class: Antidepressant

Pharmacologic Class: Serotonin Reuptake Inhibitor

Uses For sertraline

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

Sertraline belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of the chemical called serotonin in the brain.

sertraline is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, sertraline is used in certain patients with the following medical conditions:

  • Premature ejaculation.

Before Using sertraline

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sertraline, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sertraline or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sertraline for the treatment of depression in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sertraline for the treatment of obsessive-compulsive disorder in children above 6 years of age. However, safety and efficacy have not been established in children below 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sertraline in the elderly. However, elderly patients may be more sensitive to the effects of sertraline than younger adults, and are more likely to have hyponatremia (low sodium in the blood) and age-related liver problems, which may require caution and an adjustment in the dose for patients receiving sertraline.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Using sertraline with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Clorgyline
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Levomethadyl
  • Linezolid
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Pimozide
  • Procarbazine
  • Selegiline
  • Toloxatone
  • Tranylcypromine

Using sertraline with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abciximab
  • Acenocoumarol
  • Almotriptan
  • Amitriptyline
  • Amoxapine
  • Ancrod
  • Anisindione
  • Antithrombin III Human
  • Ardeparin
  • Aspirin
  • Astemizole
  • Bivalirudin
  • Certoparin
  • Cilostazol
  • Clomipramine
  • Clopidogrel
  • Dalteparin
  • Danaparoid
  • Defibrotide
  • Dermatan Sulfate
  • Desipramine
  • Desirudin
  • Desvenlafaxine
  • Dexfenfluramine
  • Dicumarol
  • Dipyridamole
  • Dothiepin
  • Doxepin
  • Droperidol
  • Duloxetine
  • Eletriptan
  • Enoxaparin
  • Eptifibatide
  • Erythromycin
  • Fenfluramine
  • Flecainide
  • Fondaparinux
  • Frovatriptan
  • Heparin
  • Imipramine
  • Lofepramine
  • Milnacipran
  • Nadroparin
  • Naratriptan
  • Nortriptyline
  • Oxycodone
  • Parnaparin
  • Pentosan Polysulfate Sodium
  • Phenindione
  • Phenprocoumon
  • Prasugrel
  • Protriptyline
  • Rasagiline
  • Reviparin
  • Rizatriptan
  • Sibutramine
  • St John's Wort
  • Sumatriptan
  • Tapentadol
  • Terfenadine
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tramadol
  • Trimipramine
  • Warfarin
  • Zolmitriptan

Using sertraline with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Alclofenac
  • Alprazolam
  • Benoxaprofen
  • Bromfenac
  • Bufexamac
  • Bupropion
  • Carbamazepine
  • Carprofen
  • Celecoxib
  • Cimetidine
  • Clonixin
  • Clozapine
  • Darunavir
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Droxicam
  • Efavirenz
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenbufen
  • Fenoprofen
  • Fentiazac
  • Floctafenine
  • Flufenamic Acid
  • Fluphenazine
  • Flurbiprofen
  • Fosphenytoin
  • Ginkgo
  • Ibuprofen
  • Indomethacin
  • Indoprofen
  • Isoxicam
  • Ketoprofen
  • Ketorolac
  • Lamotrigine
  • Lithium
  • Lornoxicam
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Metoclopramide
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Niflumic Acid
  • Nimesulide
  • Oxaprozin
  • Parecoxib
  • Phenylbutazone
  • Phenytoin
  • Pirazolac
  • Piroxicam
  • Pirprofen
  • Propafenone
  • Propranolol
  • Propyphenazone
  • Proquazone
  • Rifampin
  • Rofecoxib
  • Sulindac
  • Suprofen
  • Tenidap
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolmetin
  • Valdecoxib
  • Zolpidem
  • Zomepirac

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using sertraline with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use sertraline, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of sertraline. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or
  • Bleeding problems or
  • Hyponatremia (low sodium in the blood) or
  • Purpura (purplish or brownish-red discoloration of the skin), history of or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Diseases affecting metabolism or diseases involving blood circulation—Caution should be used in patients with these medical problems.
  • Heart disease, unstable or
  • Heart attack, recent history of—The effects of sertraline in patients with these conditions are not known.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Mania or hypomania, history of—Use of sertraline may activate these conditions.

Proper Use of sertraline

Take sertraline only as directed by your doctor, to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. .

sertraline should come with a medication guide. Read and follow these instructions carefully. Talk with your doctor if you have any questions.

Sertraline tablets may be taken with or without food on a full or empty stomach. sertraline should be taken once a day in the morning or at night. If your doctor tells you to take it a certain way, follow your doctor's instructions. .

If you are taking the oral liquid form of sertraline, use the dropper to get your dose and mix it with 4 ounces (one-half cup) of water, ginger ale, lemon-lime soda, lemonade, or orange juice. Take it right away after mixing.

You may have to take sertraline for 4 weeks or longer before you begin to feel better. Your doctor should check your progress at regular visits during this time. Also, if you are taking sertraline for depression, you may need to keep taking it for 6 months or longer to help prevent the return of the depression.

Dosing

The dose of sertraline will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of sertraline. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (solution or tablets):
    • For mental depression:
      • Adults—At first, 50 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may gradually increase your dose as needed. However, the dose is usually not more than 200 mg a day.
      • Children—Use and dose must be determined by your doctor.
    • For obsessive-compulsive disorder:
      • Adults and teenagers—At first, 50 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may gradually increase your dose as needed. However, the dose is usually not more than 200 mg a day.
      • Children 6 to 12 years of age—At first, 25 mg once a day, taken either in the morning or evening. Your doctor may gradually increase your dose as needed. However, the dose is usually not more than 200 mg a day.
      • Children below 6 years of age—Use and dose must be determined by your doctor.
    • For panic disorder, posttraumatic stress disorder, or social anxiety disorder:
      • Adults—At first, 25 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may gradually increase your dose as needed. However, the dose is usually not more than 200 mg a day.
      • Children—Use and dose must be determined by your doctor.
    • For premenstrual dysphoric disorder:
      • Adults—At first, 50 milligrams (mg) once a day throughout your menstrual cycle or just during the premenstrual time. Your doctor may increase your dose as needed. However, the dose is usually not more than 150 mg a day throughout your menstrual cycle or 100 mg a day if you are only taking it during your premenstrual time.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of sertraline, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using sertraline

It is very important that your doctor check your or your child's progress at regular visits, to allow for changes in your dose and to help reduce any side effects.

Make sure your doctor knows about all the other medicines you or your child are using. Sertraline may cause a serious condition called serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions when taken with some medicines. Do not use sertraline with linezolid (Zyvox®), lithium, tryptophan, St. John's Wort, or some pain or migraine medicines (e.g., tramadol [Ultram®], sumatriptan [Imitrex®], zolmitriptan [Zomig®], or rizatriptan [Maxalt®]). Check with your doctor first before taking any other medicines.

Sertraline has not been shown to add to the effects of alcohol. However, use of alcohol is not recommended in patients who are taking sertraline. .

sertraline may cause some people to become drowsy, to have trouble thinking, or to have problems with movement. Make sure you know how you react to sertraline before you drive, use machines, or do anything else that could be dangerous if you are not alert or well-coordinated.

Sertraline may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

The dropper dispenser contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child has a latex allergy before you start using sertraline.

Do not stop taking sertraline without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to decrease the chance of having side effects such as agitation, anxiety, dizziness, a feeling of constant movement of self or surroundings, headache, increased sweating, nausea, trembling or shaking, trouble with sleeping or walking, or unusual tiredness when you stop the medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

sertraline Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Decreased sexual desire or ability
  • failure to discharge semen (in men)
Less common or rare
  • Aggressive reaction
  • breast tenderness or enlargement
  • fast talking and excited feelings or actions that are out of control
  • fast, pounding, irregular, or slow heartbeat
  • fever
  • inability to sit still
  • increase in body movements
  • loss of bladder control
  • low blood sodium (confusion, convulsions [seizures], drowsiness, dryness of the mouth, increased thirst, lack of energy)
  • muscle spasm or jerking of all extremities
  • nose bleeds
  • red or purple spots on the skin
  • restlessness
  • serotonin syndrome (diarrhea, fever, increased sweating, mood or behavior changes, overactive reflexes, racing heartbeat, restlessness, shivering, or shaking)
  • skin rash, hives, or itching
  • sudden loss of consciousness
  • unusual or sudden body or facial movements or postures
  • unusual secretion of milk (in females)
Incidence not known
  • Abdominal or stomach pain
  • bleeding gums
  • blindness
  • blistering, peeling, or loosening of the skin
  • bloating
  • blood in the urine
  • bloody, black, or tarry stools
  • blue-yellow color blindness
  • blurred vision
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • coma
  • cough or hoarseness
  • darkened urine
  • decreased urine output
  • decreased vision
  • depressed mood
  • difficulty with breathing
  • difficulty with speaking
  • difficulty with swallowing
  • drooling
  • dry skin and hair
  • eye pain
  • fainting
  • feeling cold
  • feeling of discomfort
  • feeling that others are watching you or controlling your behavior
  • feeling that others can hear your thoughts
  • feeling, seeing, or hearing things that are not there
  • fixed position of the eye
  • general feeling of discomfort, illness, tiredness, or weakness
  • hair loss
  • high fever
  • high or low blood pressure
  • hoarseness or husky voice
  • hostility
  • increased clotting times
  • indigestion
  • inflammation of the joints
  • irritability
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lethargy
  • light-colored stools
  • lightheadedness
  • loss of appetite
  • loss of balance control
  • loss of bladder control
  • lower back or side pain
  • muscle aches
  • muscle cramps and stiffness
  • muscle trembling, jerking, or stiffness
  • muscle twitching
  • painful or difficult urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • palpitations
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • rash
  • red skin lesions often with a purple center
  • red, irritated eyes
  • redness, soreness, or itching skin
  • right upper abdominal or stomach pain and fullness
  • seizures
  • severe mood or mental changes
  • severe muscle stiffness
  • shortness of breath
  • shuffling walk
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • sores, welting, or blisters
  • stiffness of the limbs
  • stupor
  • sweating
  • swelling of the face, ankles, or hands
  • swollen lymph glands
  • swollen or painful glands
  • talking or acting with excitement you cannot control
  • tightness in the chest
  • troubled breathing
  • twisting movements of the body
  • twitching
  • uncontrolled movements, especially of the face, neck, and back
  • unexplained bleeding or bruising
  • unpleasant breath odor
  • unusual behavior
  • unusual tiredness or weakness
  • vomiting of blood
  • weight gain
  • wheezing
  • yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose - May be more severe than side effects occurring at regular doses or several may occur together.
  • Actions that are out of control
  • agitation
  • anxiety
  • change in consciousness
  • confusion
  • confusion as to time or place or person
  • constipation
  • convulsions (seizures)
  • darkened urine
  • decreased awareness or responsiveness
  • dizziness or fainting
  • drowsiness
  • headache
  • holding false beliefs that cannot be changed by fact
  • loss of consciousness
  • nausea
  • pounding in the ears
  • severe sleepiness
  • shakiness in the legs, arms, hands, or feet
  • sweating
  • trembling or shaking of the hands or feet
  • unusual excitement or restlessness
  • unusual tiredness or weakness
  • unusually fast heartbeat
  • unusually large pupils

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • decreased appetite or weight loss
  • diarrhea or loose stools
  • heartburn
  • increased sweating
  • sleepiness or unusual drowsiness
  • stomach or abdominal cramps, gas, or pain
  • trouble with sleeping
Less common
  • Agitation, anxiety, or nervousness
  • bladder pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • changes in vision
  • cloudy urine
  • constipation
  • difficult, burning, or painful urination
  • flushing or redness of the skin, with feeling of warmth or heat
  • frequent urge to urinate
  • increased appetite
  • pain or tenderness around the eyes and cheekbones
  • stuffy or runny nose
Incidence not known
  • Flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • redness or other discoloration of the skin
  • severe sunburn
  • swelling of the breasts (in women)
  • unexplained weight loss
  • unusual secretion of milk (in women)

After you stop using sertraline, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Abnormal dreams
  • electric shock sensations
  • failure to discharge semen (in men)
  • feeling of constant movement of self or surroundings
  • trouble with walking

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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  • Sertraline Prescribing Information (FDA)
  • Sertraline Detailed Consumer Information (PDR)
  • Sertraline MedFacts Consumer Leaflet (Wolters Kluwer)
  • Zoloft Prescribing Information (FDA)
  • Zoloft Consumer Overview

See Also...