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US Brand Names

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Description

Paroxetine is used to treat mental depression, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder (also known as social phobia), premenstrual dysphoric disorder (PMDD), and posttraumatic stress disorder (PTSD).

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 serotonin 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
• Suspension

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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

Appropriate studies performed to date have not demonstrated any benefit to using paroxetine in children with depression. Studies have shown that some children, teenagers, and young adults think about suicide or attempt suicide when taking the medicine. Because of this toxicity, use in children is not recommended .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of paroxetine in the elderly. However, paroxetine may be removed from the body more slowly in elderly people, which may require an adjustment of dosage in patients receiving paroxetine .

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
• Linezolid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Pimozide
• Procarbazine
• Selegiline
• Thioridazine
• 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 (mood disorder with alternating episodes of mania and depression) or risk of—May make condition worse. Your doctor will check you for this condition.

• Brain disease or damage or
• Epilepsy or seizures (history of) or
• Mental retardation—The risk of seizures may be increased.

• Glaucoma, narrow angle—Patients with this condition should use paroxetine with caution.

• Heart attack, recent or
• Heart disease—Use must be determined by your doctor.

• Kidney disease, severe, or
• Liver disease, severe—Higher blood levels of paroxetine may occur, increasing the chance of side effects.

• Mania or hypomania (history of)—Use of paroxetine may activate these conditions ..

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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.

Paroxetine may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

You may have to take paroxetine for several weeks before you begin to feel better. Your doctor should check your progress at regular visits during this time. Also, if you are taking paroxetine for depression, you will probably need to continue taking it for at least 6 months to help prevent the depression from returning.

If you are taking the oral suspension form of paroxetine, 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.

If you are taking the extended-release tablet form of this medicine, swallow the tablet whole. Do not crush, break, or chew before swallowing.

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 suspension dosage form:
  • For treatment of depression:
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg (25 mL) a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of generalized anxiety disorder:
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg (25 mL) a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of obsessive-compulsive disorder:
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg (30 mL) a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of panic disorder:
    • Adults—At first, 10 milligrams (mg) (5 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg (30 mL) a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of posttraumatic stress disorder:
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg (25 mL) a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of social anxiety disorder:
    • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning .
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 20 mg (10 mL) a day .

• For oral tablet dosage form:
  • For treatment of depression:
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of generalized anxiety disorder:
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of obsessive-compulsive disorder:
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of panic disorder:
    • Adults—At first, 10 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of posttraumatic stress disorder:
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of social anxiety disorder:
    • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning .
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 20 mg a day .

• For oral extended-release tablet dosage form:
  • For treatment of depression:
    • Adults—At first, 25 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 62.5 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
  • For treatment of panic disorder:
    • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 75 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
  • For treatment of social anxiety disorder:
    • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 37.5 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 37.5 mg a day.
  • For treatment of premenstrual dysphoric disorder:
    • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 25 mg a day.
    • Children—Use and dose must be determined by your doctor.
    • Older adults—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.

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 .

Tell your doctor right away if you develop any allergic reactions, such as skin rash or hives, while taking paroxetine.

Paroxetine 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 suddenly stop taking your paroxetine. If you have been instructed to stop taking paroxetine, ask your doctor how to slowly decrease the dose. This is to decrease the chance of having discontinuation symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or light-headedness, 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.

Do not take paroxetine if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [e.g., Marplan®], phenelzine [e.g., Nardil®], selegiline [e.g., Eldepryl®], tranylcypromine [e.g., Parnate®], or linezolid [e.g., Zyvox®]) in the past 2 weeks. Do not start taking an MAO inhibitor within 2 weeks of stopping paroxetine. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions .

Make sure your doctor knows about all the other medicines you are using. Paroxetine may cause a serious condition called Serotonin Syndrome when taken with certain medicines such as linezolid (e.g., Zyvox®), lithium, tryptophan, St. John's Wort, or some pain medicines (e.g., tramadol [e.g., Ultram®], sumatriptan [e.g., Imitrex®], zolmitriptan [e.g., Zomig®], or rizatriptan [e.g., Maxalt®]). Check with your doctor first before taking any other medicines, including thioridazine (Mellaril®) or pimozide (Orap®) .

Paroxetine has not been shown to add to the effects of alcohol. However, 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.

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Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. One rare but serious unwanted effect that may occur with paroxetine use is the serotonin syndrome. This syndrome (group of symptoms) is more likely to occur shortly after the dose of paroxetine is increased.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Agitation
• Chest congestion
• Chest pain
• Chills
• Cold sweats
• Confusion
• Difficulty 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

• Absence of or decrease in body movements
• Bigger, dilated, or enlarged pupils (black part of eye)
• Difficulty in speaking
• Inability to move eyes
• Incomplete, sudden, or unusual body or facial movements
• Increased sensitivity of eyes to light
• Low blood sodium (confusion, convulsions [seizures], drowsiness, dryness of mouth, increased thirst, lack of energy)
• Red or purple patches on skin
• Serotonin syndrome (confusion, diarrhea, fever, poor coordination, restlessness, shivering, sweating, talking and acting with excitement you cannot control, trembling or shaking, twitching)
• Talking, feeling, and acting with excitement and activity you cannot control

• Back, leg, or stomach pains
• Bleeding gums
• Blindness
• Blistering, peeling, loosening of skin
• Bloated, full feeling
• Bloody or black, tarry stools
• Bloody urine
• Blue-yellow color blindness
• Blurred vision
• Coma
• Constipation
• Cough or hoarseness
• Dark urine
• Decreased frequency or amount of urine
• Decreased vision
• Depression
• Difficulty opening the mouth
• Difficulty swallowing
• Electric shock sensations
• Epileptic seizure that will not stop
• Excessive muscle tone
• Eye pain
• Fainting
• Fixed position of eye
• Fluid-filled skin blisters
• General body swelling
• General feeling of tiredness or weakness
• Headache
• High fever
• Hives
• Inability to move arms and legs
• Inability to sit still
• Increased blood pressure
• Increased sweating
• Increased thirst
• Incremental or ratchet-like movement of muscle
• Indigestion
• Itching skin
• Joint pain
• Lab results that show problems with liver
• Light-colored stools
• Lockjaw
• Loss of appetite
• Loss of bladder control
• Low blood pressure
• Lower back or side pain
• Muscle spasm, especially of neck and back
• Muscle tension or tightness
• Nausea
• Need to keep moving
• Nosebleeds
• Painful knees and ankles
• 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
• Rigid muscles
• Seizure or coma late in pregnancy
• Sensitivity to the sun
• Skin redness or soreness
• Skin sores, welts, or blisters
• Skin thinness
• Sore throat
• Sores, ulcers, or white spots on lips or in mouth
• Swelling of breasts
• Swollen or painful glands
• Shortness of breath
• Slow heart rate
• Slow movement
• Slow reflexes
• Spasms of throat
• Stiff muscles
• Stomach pain
• Sudden numbness and weakness in the arms and legs
• Swelling of the face, fingers, or lower legs
• Tightness in chest
• Unexpected or excess milk flow from breasts
• Unusual bleeding or bruising
• Unusual or decreased blood cell production
• Unusual tiredness or weakness
• Vomiting
• Weight gain
• Wheezing
• Yellowing of the eyes or skin

• Dizziness
• Drowsiness
• Dryness of mouth
• Flushing of face
• Irritability
• Large pupils
• Nausea
• Racing heartbeat
• Trembling or shaking
• Vomiting

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
• Decreased sexual ability or desire
• Excess air or gas in stomach or intestines
• Heartburn
• Nervousness
• Pain or tenderness around eyes and cheekbones
• Passing gas
• Problems in urinating
• Runny or stuffy nose
• Sexual problems, especially ejaculatory disturbances
• Sleepiness or unusual drowsiness
• Stomach discomfort, upset, or pain
• Sweating
• Trauma
• Trembling or shaking
• Trouble in sleeping

• Abnormal dreams
• Anxiety
• Bladder pain
• Body aches or pain
• Change in sense of taste
• Changes in vision
• Cloudy urine
• Confusion
• Congestion
• Difficulty in focusing eyes
• Difficulty in moving
• Discouragement, feeling sad or empty
• Drugged feeling
• Dryness of throat
• Excessive muscle tone
• Fainting or loss of consciousness
• Fast or irregular breathing
• Feeling of unreality
• Feeling of warmth or heat
• Flushing or redness of skin, especially on face and neck
• Frequent urge to urinate
• Headache, severe and throbbing
• Heavy bleeding
• Increase in body movements
• Increased appetite
• Irritability
• Itching of the vagina or genital area
• Itching, pain, redness, or swelling of eye or eyelid
• Lack of emotion
• Loss of interest or pleasure
• Loss of memory
• Lump in throat
• Menstrual changes
• Menstrual pain or cramps
• Muscle twitching or jerking
• Pain during sexual intercourse
• Problems with memory
• Problems with tooth
• Rhythmic movement of muscles
• Sense of detachment from self or body
• Severe sunburn
• Slow heartbeat
• Sneezing
• Thick, white vaginal discharge with no odor or with a mild odor
• Tightness in throat
• Tingling, burning, or prickling sensations
• Trouble concentrating
• Voice changes
• Watering of eyes
• Weight loss
• Yawn

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
• Actions that are out of control
• Agitation, confusion, or restlessness
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Crying
• Depersonalization
• Diarrhea
• Dizziness or light-headedness
• Dysphoria
• Electric shock sensations
• Euphoria
• Fear
• Feeling unwell or unhappy
• Headache
• Increased sweating
• Irritability
• Mental depression
• Muscle pain
• Nausea or vomiting
• Nervousness
• Paranoia
• Quick to react or overreact emotionally
• Rapidly changing moods
• Runny nose
• Talking, feeling, and acting with excitement
• Trembling or shaking
• Trouble in sleeping
• Unusual drowsiness, dullness or feeling of sluggishness
• Unusual tiredness or weakness
• Vision changes

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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