Description
Paroxetine is used to treat depression, obsessive-compulsive disorder (OCD), panic disorder, generalized anxiety disorder (GAD), social anxiety disorder (also known as social phobia), premenstrual dysphoric disorder (PMDD), and posttraumatic stress disorder (PTSD). Brisdelle® is used only to treat moderate to severe hot flashes caused by menopause.
Paroxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of the 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:
- Capsule
- Tablet
- Suspension
- 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 paroxetine in the pediatric population. Safety and efficacy have not been established.
Use of Brisdelle® is not indicated in the pediatric population.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of paroxetine 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 paroxetine.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
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
- Isocarboxazid
- Levoketoconazole
- Linezolid
- Mavorixafor
- Mesoridazine
- Methylene Blue
- Ozanimod
- Phenelzine
- Pimozide
- Piperaquine
- Potassium Citrate
- Procarbazine
- Rasagiline
- Safinamide
- Saquinavir
- Selegiline
- Sparfloxacin
- Terfenadine
- Thioridazine
- 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
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Adagrasib
- Alfentanil
- Alfuzosin
- Almotriptan
- Amantadine
- 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
- Azithromycin
- Bedaquiline
- Bemiparin
- Benzhydrocodone
- Benzphetamine
- Betrixaban
- Bivalirudin
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.
- Amprenavir
- Cimetidine
- Cyproheptadine
- Fluphenazine
- Fosamprenavir
- Ginkgo
- Metoprolol
- Phenytoin
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.
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
- Bone problems or
- Glaucoma, angle-closure or
- Hyponatremia (low sodium in the blood) or
- Mania, history of or
- Seizures, history of—Use with caution. May make these conditions worse.
- Kidney disease, severe or
- Liver disease, severe—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.
Paroxetine may be taken with or without food.
You may have to take paroxetine for a month or longer before you begin to feel better.
If you are taking the oral suspension, shake the bottle well before measuring each dose. Use a small measuring cup or a measuring spoon to measure each dose. The teaspoons and tablespoons that are used for serving and eating food do not measure exact amounts.
Swallow the tablet or extended-release tablet whole. Do not crush, break, or chew it.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
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 (capsules):
- For moderate to severe hot flashes caused by menopause:
- Adults—7.5 milligrams (mg) once a day, at bedtime.
- Children—Use is not recommended.
- For moderate to severe hot flashes caused by menopause:
- For oral dosage form (suspension):
- For depression:
- Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg (25 mL) per day.
- Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.
- Children—Use and dose must be determined by your doctor.
- For generalized anxiety disorder:
- Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg (25 mL) per day.
- Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.
- Children—Use and dose must be determined by your doctor.
- For obsessive-compulsive disorder:
- Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg (30 mL) per day.
- Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.
- Children—Use and dose must be determined by your doctor.
- For panic disorder:
- Adults—At first, 10 milligrams (mg) (5 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg (30 mL) per day.
- Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.
- Children—Use and dose must be determined by your doctor.
- For posttraumatic stress disorder:
- Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg (25 mL) per day.
- Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 40 mg (20 mL) per day.
- Children—Use and dose must be determined by your doctor.
- For social anxiety disorder:
- Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning.
- Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 20 mg (10 mL) per day.
- Children—Use and dose must be determined by your doctor.
- For depression:
- For oral dosage form (tablets):
- For depression:
- Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.
- Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.
- Children—Use and dose must be determined by your doctor.
- For generalized anxiety disorder:
- Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.
- Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 40 mg per day.
- Children—Use and dose must be determined by your doctor.
- For obsessive-compulsive disorder:
- Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 60 mg per day.
- Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.
- Children—Use and dose must be determined by your doctor.
- For panic disorder:
- Adults—At first, 10 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
- Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.
- Children—Use and dose must be determined by your doctor.
- For posttraumatic stress disorder:
- Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 50 mg per day.
- Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.
- Children—Use and dose must be determined by your doctor.
- For social anxiety disorder:
- Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning.
- Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.
- Children—Use and dose must be determined by your doctor.
- For depression:
- For oral dosage form (extended-release tablets):
- For depression:
- Adults—At first, 25 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 62.5 mg per day.
- Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.
- Children—Use and dose must be determined by your doctor.
- For panic disorder:
- Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 75 mg per day.
- Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.
- Children—Use and dose must be determined by your doctor.
- For premenstrual dysphoric disorder:
- Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 25 mg per day.
- Older adults and children—Use and dose must be determined by your doctor.
- For social anxiety disorder:
- Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 37.5 mg per day.
- Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 37.5 mg per day.
- 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 progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not take paroxetine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking paroxetine during the 2 weeks after you stop a MAO inhibitor and wait 2 weeks after stopping paroxetine 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 take pimozide (Orap®) or thioridazine (Mellaril®) while you are taking this medicine. Using these medicines together can cause very serious heart problems.
Paroxetine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use paroxetine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, 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 paroxetine.
This medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
Paroxetine may cause some teenagers and young adults 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. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
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 agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.
Check with your doctor right away if you develop the following symptoms during the first few weeks of treatment with paroxetine: inability to sit still, need to keep moving, or restlessness.
The use of alcohol is not recommended in patients who are taking paroxetine.
Paroxetine may cause some people to become drowsy or have blurred vision. 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 able to see clearly.
Hyponatremia (low sodium in the blood) may occur with this medicine. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.
This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, including NSAIDs (eg, aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).
This medicine may increase the risk of bone fractures. Tell your doctor if you have unexplained bone pain, tenderness, swelling, or bruising. Also, ask your doctor about ways to keep your bones strong to help prevent fractures.
Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have an 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.
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:
Less common
- Agitation
- chest pain or tightness
- chills
- cold sweats
- confusion
- difficulty with breathing
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- muscle pain or weakness
- skin rash
Rare
- Absence of or decrease in body movements
- bigger, dilated, or enlarged pupils (black part of the eye)
- difficulty with speaking
- dry mouth
- fever
- inability to move the eyes
- incomplete, sudden, or unusual body or facial movements
- increased sensitivity of the eyes to light
- poor coordination
- red or purple patches on the skin
- restlessness
- seizures
- shivering
- sweating
- talking, feeling, and acting with excitement and activity you cannot control
- trembling or shaking, or twitching
Incidence not known
- Back, leg, or stomach pains
- blindness
- blistering, peeling, or loosening of the skin
- blue-yellow color blindness
- blurred vision
- constipation
- cough or hoarseness
- dark urine
- decreased frequency or amount of urine
- decreased vision
- difficulty with swallowing
- electric shock sensations
- eye pain
- fainting
- general body swelling
- headache
- high fever
- hives or itching skin
- inability to move the arms and legs
- inability to sit still
- increased thirst
- incremental or ratchet-like movement of the muscle
- joint pain
- light-colored stools
- lockjaw
- loss of appetite
- loss of bladder control
- lower back or side pain
- muscle spasm, especially of the neck and back
- muscle tension or tightness
- need to keep moving
- painful or difficult urination
- painful or prolonged erection of the penis
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- raised red swellings on the skin, the buttocks, legs, or ankles
- red, irritated eyes
- sensitivity to the sun
- skin redness or soreness
- slow heart rate
- sores, ulcers, or white spots on the lips or in the mouth
- spasms of the throat
- stiff muscles
- stomach pain
- sudden numbness and weakness in the arms and legs
- swelling of the breasts
- swelling of the face, fingers, or lower legs
- swollen or painful glands
- tightness in the chest
- unexpected or excess milk flow from the breasts
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- weight gain
- yellowing of the eyes or skin
Incidence not known
- Decreased interest in sexual intercourse
- delayed or inability to have an orgasm
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
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
- heartburn
- pain or tenderness around the eyes and cheekbones
- passing gas
- problems with urinating
- runny or stuffy nose
- sleepiness or unusual drowsiness
- stomach discomfort or upset
- trouble sleeping
Less common
- Abnormal dreams
- change in sense of taste
- congestion
- discouragement, feeling sad, or empty
- drugged feeling
- fast or irregular breathing
- feeling of unreality
- headache, severe and throbbing
- increased appetite
- itching of the vagina or genital area
- itching, pain, redness, or swelling of the eye or eyelid
- lack of emotion
- loss of interest or pleasure
- lump in the throat
- menstrual changes
- pain during sexual intercourse
- problems with memory
- sense of detachment from self or body
- sneezing
- thick, white vaginal discharge with no odor or with a mild odor
- tightness in the throat
- tingling, burning, or prickling sensations
- trouble concentrating
- voice changes
- watering of the eyes
- weight loss
- yawn
Incidence not known
- Decrease in smell
- loss of sense of smell
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.
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