Description
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.
This product is available in the following dosage forms:
- Tablet
- Solution
- Capsule
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of sertraline in children with depression, panic disorder, premenstrual dysphoric disorder (PMDD), posttraumatic stress disorder (PTSD), and social anxiety disorder (SAD), and in children younger than 6 years of age with obsessive-compulsive disorder. Safety and efficacy have not been established.
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 are more likely to have hyponatremia (low sodium in the blood), age-related kidney, liver, or heart problems which may require caution and an adjustment in the dose for patients receiving sertraline.
Breastfeeding
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Drug Interactions
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.
- Bepridil
- Bromopride
- Cisapride
- Dronedarone
- Furazolidone
- Iproniazid
- Isocarboxazid
- Levoketoconazole
- Linezolid
- Mesoridazine
- Methylene Blue
- Metoclopramide
- Ozanimod
- Phenelzine
- Pimozide
- Piperaquine
- Procarbazine
- Rasagiline
- Safinamide
- Saquinavir
- Selegiline
- Sparfloxacin
- Terfenadine
- Thioridazine
- Toloxatone
- Tranylcypromine
- Ziprasidone
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
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Adagrasib
- Alfentanil
- Alfuzosin
- Almotriptan
- Amineptine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Amtolmetin Guacil
- Anagrelide
- Anileridine
- Apixaban
- Apomorphine
- Ardeparin
- Argatroban
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Aspirin
- Astemizole
- Atazanavir
- Atomoxetine
- Avacopan
- Azithromycin
- Bedaquiline
- Bemiparin
- Benzhydrocodone
- Benzphetamine
- Betrixaban
- Bivalirudin
- Bromfenac
- Brompheniramine
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
- Cimetidine
- Fluphenazine
- Ginkgo
- Lamotrigine
- Rifampin
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
- Heart rhythm problems (eg, QT prolongation) 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
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. Follow the instructions carefully. Ask your doctor if you have any questions.
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.
- For depression:
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
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. Blood tests may be needed to check for unwanted 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 14 days after you stop a MAO inhibitor and wait 14 days after stopping sertraline before you start taking a MAO inhibitor. If you take them together or do not wait 14 days, 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, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Frova®, Imitrex®, Maxalt®, Methadose®, 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, including 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, including NSAIDs (eg, aspirin, 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.
Check with your doctor right away if you have chest pain or discomfort, fainting, irregular or slow heart rate, or trouble breathing. These may be symptoms of heart rhythm problems, including QT prolongation and torsades de pointes.
Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have and orgasm in women, inability to have or keep an erection in men, or loss in sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.
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 including 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
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 interest in sexual intercourse
- failure to discharge semen (in men)
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
Less common or rare
- Aggressive reaction
- breast tenderness or enlargement
- confusion
- 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
- seizures
- 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
- 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, discomfort, or tightness
- chills
- clay-colored stools
- cough or hoarseness
- darkened urine
- decreased urine output
- decreased vision
- delayed or inability to have an orgasm
- 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
- stomach pain
- sweating
- swelling of the face, ankles, or hands
- swollen or painful glands
- talking or acting with excitement you cannot control
- trouble 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 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
- Decrease in smell
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased urination
- loss of sense of smell
- 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.
CON-XXXXXXXX
