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Sertraline (Oral route)

Pronunciation:

SER-tra-leen

Brand Names:

  • Zoloft

Dosage Forms:

  • Tablet
  • Solution
  • Capsule

Warnings:

Oral route(Solution;Tablet)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders in short-term studies. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults older than 24 years, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 or 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. Sertraline hydrochloride is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD) .

Classifications:

Therapeutic—

Antidepressant

Pharmacologic—

Serotonin Reuptake Inhibitor

Uses of This Medicine:

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

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

This medicine 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 This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of sertraline 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. However, safety and efficacy have not been established in children younger than 6 years of age.

Older adults—

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 this medicine than younger adults, and are more likely to have hyponatremia (low sodium in the blood), 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.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine 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.

  • Amifampridine
  • Clorgyline
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Linezolid
  • Methylene Blue
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Pimozide
  • Piperaquine
  • Procarbazine
  • Rasagiline
  • Selegiline
  • Toloxatone
  • Tranylcypromine

Using this medicine 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
  • Acrivastine
  • Almotriptan
  • Amitriptyline
  • Amoxapine
  • Ancrod
  • Anisindione
  • Antithrombin III Human
  • Apixaban
  • Ardeparin
  • Aripiprazole
  • Aspirin
  • Astemizole
  • Bivalirudin
  • Bupropion
  • Buserelin
  • Certoparin
  • Cilostazol
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clopidogrel
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dalteparin
  • Danaparoid
  • Defibrotide
  • Delamanid
  • Dermatan Sulfate
  • Desipramine
  • Desirudin
  • Deslorelin
  • Desvenlafaxine
  • Dexfenfluramine
  • Dextromethorphan
  • Diclofenac
  • Dicumarol
  • Dipyridamole
  • Dolasetron
  • Dothiepin
  • Doxepin
  • Droperidol
  • Duloxetine
  • Eletriptan
  • Enoxaparin
  • Eptifibatide
  • Escitalopram
  • Fenfluramine
  • Fentanyl
  • Flecainide
  • Fluoxetine
  • Fluvoxamine
  • Fondaparinux
  • Fosphenytoin
  • Frovatriptan
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Haloperidol
  • Heparin
  • Histrelin
  • Hydroxytryptophan
  • Imipramine
  • Iobenguane I 123
  • Ivabradine
  • Ketoconazole
  • Leuprolide
  • Levomilnacipran
  • Lofepramine
  • Lorcaserin
  • Meperidine
  • Methadone
  • Milnacipran
  • Mirtazapine
  • Nadroparin
  • Nafarelin
  • Naratriptan
  • Nortriptyline
  • Ondansetron
  • Oxcarbazepine
  • Oxycodone
  • Palonosetron
  • Parnaparin
  • Paroxetine
  • Pazopanib
  • Pentosan Polysulfate Sodium
  • Phenindione
  • Phenprocoumon
  • Phenytoin
  • Prasugrel
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Reviparin
  • Risperidone
  • Ritonavir
  • Rizatriptan
  • Sevoflurane
  • Sibutramine
  • St John's Wort
  • Sumatriptan
  • Tamoxifen
  • Tapentadol
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tramadol
  • Trazodone
  • Trimipramine
  • Triptorelin
  • Tryptophan
  • Vandetanib
  • Vemurafenib
  • Venlafaxine
  • Vilazodone
  • Vinflunine
  • Vortioxetine
  • Warfarin
  • Zolmitriptan

Using this medicine 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.

  • Alprazolam
  • Carbamazepine
  • Cimetidine
  • Darunavir
  • Efavirenz
  • Fluphenazine
  • Ginkgo
  • Lamotrigine
  • Lithium
  • Metoclopramide
  • Propranolol
  • Rifampin
  • Thiotepa
  • Zolpidem

Other interactions—

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine 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 this medicine, 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bipolar disorder (mood disorder with mania and depression), or risk of or
  • Bleeding problems or
  • Diabetes or
  • Glaucoma, angle-closure, or history of or
  • Hyponatremia (low sodium in the blood) or
  • Mania or hypomania, history of or
  • Purpura (purplish or brownish-red discoloration of the skin), history of or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine 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.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

The tablets may be taken with or without food.

If you are taking the oral liquid, use the dropper provided to measure your dose and mix it 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 it right away after mixing. 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 have to take this medicine for several months before you begin to feel better.

Dosing—

The dose of this medicine 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 this medicine. 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 depression:
      • Adults—At first, 50 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per 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 adjust your dose as needed. However, the dose is usually not more than 200 mg per 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 adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
      • Children younger than 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 adjust your dose as needed. However, the dose is usually not more than 200 mg per 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 adjust your dose as needed. However, the dose is usually not more than 150 mg per day throughout your menstrual cycle or 100 mg per 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 this medicine, 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 This Medicine:

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

Do not take sertraline with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking sertraline during the 2 weeks after you stop a MAO inhibitor and wait 2 weeks after stopping sertraline before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Do not use pimozide (Orap®) while you are taking this medicine. Do not use the oral liquid form of sertraline if you are also using disulfiram (Antabuse®). Using these medicines together can cause serious problems.

Sertraline may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use sertraline with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), linezolid (Zyvox®), lithium (Eskalith®, Lithobid®), methylene blue injection, tryptophan, St. John's wort, or some pain or migraine medicines (eg, rizatriptan, sumatriptan, tramadol, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with sertraline.

For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your 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.

Sertraline may increase your risk for bleeding problems. Make sure your doctor knows if you or your child are also using other medicines that thin the blood, such as aspirin, NSAID pain or arthritis medicines (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

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. Check with your doctor right away if you or your child have headache, trouble concentrating, memory problems, confusion, weakness, or unsteadiness.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, talk with your doctor.

The use of alcohol is not recommended in patients who are taking sertraline. .

This medicine 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 this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or well-coordinated.

The dropper dispenser for the oral liquid contains dry natural rubber (a derivative of latex). This may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you start using this medicine.

Do not stop taking this medicine 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.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this 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.

Side Effects of This Medicine:

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
confusion
convulsions
diarrhea
drowsiness
dryness of the mouth
fast talking and excited feelings or actions that are out of control
fever
inability to sit still
increase in body movements
increased sweating
increased thirst
lack of energy
loss of bladder control
mood or behavior changes
muscle spasm or jerking of all extremities
nosebleeds
overactive reflexes
racing heartbeat
red or purple spots on the skin
restlessness
shivering
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
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, seeing, or hearing things that are not there
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
inflamed joints
irritability
joint or muscle pain
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
lethargy
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
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid weight gain
rash
red, irritated eyes
red, sore, or itching skin
right upper stomach pain and fullness
severe mood or mental changes
severe muscle stiffness
shuffling walk
sore throat
sores, ulcers, or white spots in the mouth or on the lips
sores, welting, or blisters
stiffness of the limbs
sweating
swelling of the face, ankles, or hands
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
yellow eyes and 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
heartburn
sleepiness or unusual drowsiness
stomach or abdominal cramps, gas, or pain
trouble 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 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)

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.


Last Updated: 11/4/2014

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