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US Brand Names

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Description

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 .

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

This product is available in the following dosage forms:

• Capsule
• Tablet
• Solution

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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

Sertraline has been tested in children 6 to 17 years of age with obsessive-compulsive disorder. In effective doses, this medicine 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 this medicine 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 this medicine. 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

Breastfeeding

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

Drug Interactions

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.

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

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 (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 this medicine 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 .

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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 .

Sertraline tablets may be taken with or without food on a full or empty stomach. This medicine 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 this medicine, 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 this medicine 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 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 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 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.

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Precautions

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 liquid form of sertraline if you are also using disulfiram (Antabuse®) .

Avoid drinking alcoholic beverages while 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 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 this medicine 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 .

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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:

• Decreased sexual desire or ability
• Failure to discharge semen (in men)

• 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)

• 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:

• 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:

• 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

• 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

• 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 this medicine, 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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