Description
Quetiapine is used alone or together with other medicines to treat bipolar disorder (depressive and manic episodes) and schizophrenia. Quetiapine extended-release tablet is also used together with other antidepressants to treat major depressive disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer disease. Quetiapine is an antipsychotic medicine that works in the brain.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Tablet, Extended Release
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 quetiapine extended-release tablets and tablets in children with schizophrenia younger than 13 years of age, in children with bipolar mania younger than 10 years of age, and in children with bipolar depression. Safety and efficacy have not been established in these age groups.
Appropriate studies have not been performed on the relationship of age to the effects of quetiapine extended-release tablets to treat major depressive disorder in the pediatric population. 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 quetiapine in the elderly. However, elderly patients are more likely to have dementia or age-related heart, liver, or kidney problems, which may require caution and an adjustment in the dose for patients receiving quetiapine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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
- Fluconazole
- Isocarboxazid
- Ketoconazole
- Lefamulin
- Levoketoconazole
- Mesoridazine
- Metoclopramide
- Piperaquine
- Posaconazole
- Potassium Chloride
- Potassium Citrate
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- 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.
- Aclidinium
- Adagrasib
- Alfentanil
- Alfuzosin
- Alprazolam
- Amantadine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Apalutamide
- Apomorphine
- Aripiprazole
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atropine
- Avacopan
- Azithromycin
- Bedaquiline
- Belladonna
- Benzhydrocodone
- Benztropine
- Biperiden
- Boceprevir
- Bromazepam
- Brompheniramine
- Buprenorphine
- Bupropion
- Buserelin
- Butalbital
- Butorphanol
- Cabergoline
- Calcium Oxybate
- Cannabidiol
- Cannabis
- Carbamazepine
- Carbidopa
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.
- Aprepitant
- Fosaprepitant
- Warfarin
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 is usually not recommended, 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
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.
- Ethanol
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:
- Blood vessel or circulation problems or
- Dehydration or
- Heart attack or stroke, history of or
- Heart disease (eg, heart hypertrophy) or
- Heart failure or
- Heart rhythm problems (eg, QT prolongation), or
- Hypotension (low blood pressure) or
- Hypovolemia (low blood volume)—May cause side effects to become worse.
- Bradycardia (slow heartbeat), history of or
- Constipation or
- Diabetes, or family history of or
- Enlarged prostate or
- Heart rhythm problem (eg, congenital long QT interval) or
- Hyperglycemia (high blood sugar) or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Increased pressure in the eye or
- Trouble urinating, or history of—May increase risk for more serious side effects.
- Breast cancer, prolactin dependent or
- Cataracts or
- Hyperlipidemia (high blood cholesterol or fats) or
- Hyperprolactinemia (high prolactin in the blood) or
- Hypertension (high blood pressure) or
- Hypothyroidism (underactive thyroid) or
- Liver disease or
- Seizures, history of or
- Trouble swallowing—Use with caution. May make these conditions worse.
Proper Use
Take this medicine exactly 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. Read and follow the instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.
Quetiapine tablets may be taken with or without food on a full or empty stomach. However, if your doctor tells you to take it a certain way, take it as directed.
Swallow the extended-release tablets whole. Do not break, crush, or chew it. It is best to take this medicine without food or with a light meal (approximately 300 calories).
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 (extended-release tablets):
- For treatment of depression with bipolar disorder:
- Adults—At first, 50 milligrams (mg) once a day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day.
- Children—Use and dose must be determined by the doctor.
- For treatment of mania with bipolar disorder:
- Adults—At first, 300 milligrams (mg) once a day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.
- Children 10 to 17 years of age—At first, 50 mg once a day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 600 mg per day.
- Children younger than 10 years of age—Use and dose must be determined by the doctor.
- For treatment of major depressive disorder (MDD):
- Adults—At first, 50 milligrams (mg) once a day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day.
- Children—Use and dose must be determined by the doctor.
- For treatment of schizophrenia:
- Adults—At first, 300 milligrams (mg) once a day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.
- Children 13 to 17 years of age—At first, 50 mg once a day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.
- Children younger than 13 years of age—Use and dose must be determined by the doctor.
- For treatment of depression with bipolar disorder:
- For oral dosage form (tablets):
- For treatment of depression with bipolar disorder:
- Adults—At first, 50 milligrams (mg) once a day at bedtime. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day.
- Children—Use and dose must be determined by the doctor.
- For treatment of mania with bipolar disorder:
- Adults—At first, 50 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.
- Children 10 to 17 years of age—At first, 25 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 600 mg per day.
- Children younger than 10 years of age—Use and dose must be determined by the doctor.
- For treatment of schizophrenia:
- Adults—At first, 25 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 750 mg per day.
- Children 13 to 17 years of age—At first, 25 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.
- Children younger than 13 years of age—Use and dose must be determined by the doctor.
- For treatment of depression with bipolar disorder:
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 to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects. You may also need to have your eyes tested on a regular basis.
This medicine may add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using quetiapine.
For some patients, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or are getting worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive illness) or has tried to commit suicide.
Quetiapine may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision (especially during the first week of use), which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or urination. If you have diabetes, the results of your urine or blood sugar tests may change. Check your blood sugar closely and talk with your doctor if you have any questions.
Check with your doctor right away if you have convulsions (seizures), difficulty breathing, a fast heartbeat, high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.
Quetiapine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
Quetiapine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you medicine to lower the cholesterol and fats in the blood.
This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.
You will need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any changes to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.
This medicine can cause changes in your heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects. Contact your doctor right away if you have symptoms of heart rhythm problems, such as a fast, pounding, or uneven heartbeat.
Quetiapine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down.
Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This will decrease the chance of having withdrawal symptoms such as nausea, vomiting, insomnia, dizziness, irritability, or headache.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests (eg, urine drug screens) 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 (eg, St. John's wort) 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
- Chills
- cold sweats
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- sleepiness or unusual drowsiness
Less common
- Black, tarry stools
- blurred vision
- changes in patterns and rhythms of speech
- chest pain
- cough
- drooling
- fever
- inability to move the eyes
- inability to sit still
- increased blinking or spasms of the eyelid
- lip smacking or puckering
- loss of balance control
- mask-like face
- muscle aches
- need to keep moving
- painful or difficult urination
- puffing of the cheeks
- rapid or worm-like movements of the tongue
- restlessness
- shakiness in the legs, arms, hands, or feet
- shuffling walk
- slowed movements
- slurred speech
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sticking out of the tongue
- stiffness of the arms or legs
- sweating
- swelling of the face, arms, hands, feet, or lower legs
- swollen glands
- trembling and shaking of the hands and fingers
- trouble with breathing, speaking, or swallowing
- uncontrolled chewing movements
- uncontrolled movements of the arms and legs
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual bleeding or bruising
- unusual facial expressions
- unusual tiredness or weakness
Rare
- Dry, puffy skin
- fast, pounding, or irregular heartbeat
- loss of appetite
- menstrual changes
- unusual secretion of milk (in females)
- weight gain
Incidence not known
- Aching or discomfort in the lower legs or sensation of crawling in the legs
- agitation
- bed-wetting
- blistering, peeling, or loosening of the skin
- bloating
- bluish lips or skin
- chest discomfort
- constipation
- dark urine
- decreased awareness or responsiveness
- decreased urine output
- depression
- diarrhea
- difficulty breathing
- difficulty in passing urine (dribbling)
- difficulty swallowing
- dizziness
- faintness
- general feeling of tiredness or weakness
- headache
- hives, itching, skin rash
- hoarseness
- increased thirst
- indigestion
- irritability
- joint or muscle pain
- light-colored stools
- loss of consciousness
- lower back or side pain
- muscle cramps, spasms, stiffness, or twitching
- nausea
- painful or prolonged erection of the penis
- painful urination
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- seizures
- severe constipation
- severe sleepiness
- severe vomiting
- sore throat
- stomach pain, continuing
- tightness in the chest
- tingling of the hands or feet
- unusual bleeding or bruising unusual drowsiness, dullness, or feeling of sluggishness
- unusual weight gain or loss
- upper right abdominal pain
- 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:
Less common
- Abnormal vision
- belching
- decreased appetite
- decreased strength and energy
- heartburn
- increased appetite
- increased muscle tone
- increased sweating
- indigestion
- sneezing
- stomach discomfort or upset
- stuffy or runny nose
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.
DRG-20066912
