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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:

  • Capsule
  • Tablet
  • Solution

Therapeutic Class: Antidepressant

Pharmacologic Class: Serotonin Reuptake Inhibitor

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Uses For sertraline

Sertraline is used to treat mental depression, obsessive-compulsive disorder, panic disorder, premenstrual dysphoric disorder, posttraumatic stress disorder, 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 serotonin, which is a chemical 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

Sertraline has been tested in children 6 to 17 years of age with obsessive-compulsive disorder. In effective doses, sertraline has not been shown to cause different side effects or problems than it does in adults. However, sertraline can cause a decrease in appetite and children who take sertraline for a long time should have their growth and body weight measured by the doctor at regular visits .

Sertraline must be used with caution in children, teenagers, and young adults with depression. Studies have shown occurrences of children, teenagers, and young adults thinking about suicide or attempting suicide in clinical trials for sertraline. More study is needed to be sure sertraline is safe and effective in children .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of sertraline in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require an adjustment in the dose for patients receiving sertraline .

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal 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
  • Anagrelide
  • 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
  • Epoprostenol
  • Eptifibatide
  • Erythromycin
  • Fenfluramine
  • Flecainide
  • Fondaparinux
  • Frovatriptan
  • Heparin
  • Iloprost
  • Imipramine
  • Lamifiban
  • Lexipafant
  • Lofepramine
  • Milnacipran
  • Nadroparin
  • Naratriptan
  • Nortriptyline
  • Oxycodone
  • Parnaparin
  • Pentosan Polysulfate Sodium
  • Phenindione
  • Phenprocoumon
  • Protriptyline
  • Rasagiline
  • Reviparin
  • Rizatriptan
  • Sibrafiban
  • Sibutramine
  • St John's Wort
  • Sulfinpyrazone
  • Sulodexide
  • Sumatriptan
  • Tapentadol
  • Terfenadine
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tramadol
  • Trimipramine
  • Warfarin
  • Xemilofiban
  • 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 (mental disease with cycles of elation and depression), history of, or
  • Bleeding problems or
  • Hyponatremia (low sodium in the blood) or
  • Purpura (purplish or brownish-red discoloration of skin), history of —May make these conditions worse .
  • Latex allergy—Use with caution. The oral liquid form of sertraline has a latex rubber dropper .
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .
  • Seizure disorder, history of—The risk of seizures may be increased .


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 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, you must 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 form (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 increase your dose gradually if needed. However, the dose usually is not more than 200 mg a day.
      • Children—Use and dose must be determined by your doctor .
    • For obsessive-compulsive disorder:
      • Adults and adolescents—At first, 50 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may increase your dose gradually if needed. However, the dose usually is 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 increase your dose gradually if needed. However, the dose usually is 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 increase your dose gradually if needed. However, the dose usually is 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 if needed. However, the dose usually is 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 important that your doctor check your progress at regular visits, to allow for changes in your dose and to help reduce any side effects .

Do not take sertraline with or within 14 days of taking an MAO inhibitor (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not take an MAO inhibitor within 14 days of taking sertraline. If you do, you may have extremely high blood pressure or convulsions (seizures) .

Make sure your doctor knows about all the other medicines you are using. Sertraline may cause a serious condition called serotonin syndrome when taken with some medicines. Do not use sertraline with linezolid (e.g., 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, including pimozide (e.g., Orap®). Do not use the form of sertraline if you are also using disulfiram (Antabuse®) .

Avoid drinking alcoholic beverages while 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 .

Do not stop taking sertraline without first checking 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 .

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 mouth, increased thirst, lack of energy)
  • muscle spasm or jerking of all extremities
  • nose bleeds
  • red or purple spots on 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 skin
  • bloating
  • blood in 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 in breathing
  • difficulty in speaking
  • difficulty 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 coagulation times
  • indigestion
  • inflammation of joints
  • irritability
  • joint or muscle pain
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, and 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 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 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 mouth or on lips
  • sores, welting or blisters
  • stiffness of limbs
  • stupor
  • sweating
  • swelling of face, ankles, or hands
  • swollen lymph glands
  • swollen or painful glands
  • talking or acting with excitement you cannot control
  • tightness in chest
  • troubled breathing
  • twisting movements of body
  • twitching
  • uncontrolled movements, especially of face, neck, and back
  • unexplained bleeding or bruising
  • unpleasant breath odor
  • unusual behavior
  • unusual tiredness or weakness
  • upper right abdominal pain
  • 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
  • bloating
  • blurred vision
  • change in consciousness
  • chest pain or discomfort
  • chills
  • coma
  • confusion
  • confusion as to time or place or person holding false beliefs that cannot be changed by fact
  • constipation
  • convulsions (seizures)
  • darkened urine
  • decreased awareness or responsiveness
  • dizziness or fainting
  • drowsiness
  • fever
  • hallucinations
  • headache
  • indigestion
  • irritability
  • lightheadedness
  • loss of appetite
  • loss of consciousness
  • nausea
  • nervousness
  • pains in stomach, side, or abdomen, possibly radiating to the back
  • pounding in ears
  • seeing, hearing, or feeling things that are not there
  • serotonin syndrome (diarrhea, fever, increased sweating, mood or behavior changes, overactive reflexes, racing heartbeat, restlessness, shivering or shaking)
  • severe sleepiness
  • shakiness in legs, arms, hands, or feet
  • shortness of breath
  • slow or irregular heartbeat
  • sweating
  • trembling or shaking of hands or feet
  • unusual excitement, or restlessness
  • unusual tiredness or weakness
  • unusually fast heartbeat
  • unusually large pupils
  • vomiting
  • yellow eyes or skin

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
  • dizziness
  • drowsiness
  • dryness of mouth
  • headache
  • heartburn
  • increased sweating
  • nausea
  • sleepiness or unusual drowsiness
  • stomach or abdominal cramps, gas, or pain
  • trembling or shaking
  • trouble in sleeping
Less common
  • Agitation, anxiety, or nervousness
  • bladder pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • changes in vision, including blurred vision
  • cloudy urine
  • constipation
  • difficult, burning, or painful urination
  • flushing or redness of skin, with feeling of warmth or heat
  • frequent urge to urinate
  • increased appetite
  • pain or tenderness around eyes and cheekbones
  • stuffy or runny nose
  • vomiting
Incidence not known
  • Flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • redness or other discoloration of skin
  • severe sunburn
  • swelling of 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
  • agitation
  • anxiety
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • dizziness
  • electric shock sensations
  • failure to discharge semen (in men)
  • feeling of constant movement of self or surroundings
  • headache
  • increased sweating
  • nausea
  • sleepiness or unusual drowsiness
  • trembling or shaking
  • trouble in sleeping
  • trouble in walking
  • unusual tiredness

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

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