MEDICATION GUIDE
Paroxetine (pa rox’ e teen)
Oral Suspension
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What is the most important information I should know about paroxetine oral suspension?
Paroxetine oral suspension can cause serious side effects, including:
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Increased risk of suicidal thoughts or actions. Paroxetine oral suspension and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Paroxetine oral suspension is not for use in children.
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Depression or other mental illnesses are the most important causes of suicidal thoughts and actions.
How can I watch for and try to prevent suicidal thoughts and actions?
- Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.
- Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
- attempts to commit suicide
- acting aggressive or violent
- onew or worse depression
- feeling agitated, restless, angry, or irritable
- an increase in activity and talking more than what is normal for you
- acting on dangerous impulses
- thoughts about suicide or dying
- onew or worse anxiety or panic attacks
- trouble sleeping
- other unusual changes in behavior or mood
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What is paroxetine oral suspension?
Paroxetine oral suspension is a prescription medicine used in adults to treat:
- A certain type of depression called Major Depressive Disorder (MDD)
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder (PD)
- Social Anxiety Disorder (SAD)
- Generalized Anxiety Disorder (GAD)
- Posttraumatic Stress Disorder (PTSD)
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Do not take paroxetine oral suspension if you:
- take a monoamine oxidase inhibitor (MAOI)
- have stopped taking an MAOI in the last 14 days
- are being treated with the antibiotic linezolid or the intravenous methylene blue
- are taking pimozide
- are taking thioridazine
- are allergic to paroxetine or any of the ingredients in paroxetine oral suspension. See the end of this Medication Guide for a complete list of ingredients in paroxetine oral suspension.
Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue.
Do not start taking an MAOI for at least 14 days after you stop treatment with paroxetine oral suspension.
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Before taking paroxetine oral suspension, tell your healthcare provider about all your medical conditions, including if you:
- have heart problems
- have or had bleeding problems
- have, or have a family history of, bipolar disorder, mania or hypomania
- have or had seizures or convulsions
- have glaucoma (high pressure in the eye)
- have low sodium levels in your blood
- have bone problems
- have kidney or liver problems
- are pregnant or plan to become pregnant. Paroxetine may harm your unborn baby. Talk to your healthcare provider about the risks to your unborn baby if you take paroxetine during pregnancy. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with paroxetine oral suspension.
- are breastfeeding or plan to breastfeed. Paroxetine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with paroxetine oral suspension.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Paroxetine oral suspension and some other medicines may affect each other causing possible serious side effects. Paroxetine oral suspension may affect the way other medicines work and other medicines may affect the way paroxetine oral suspension works.
Especially tell your healthcare provider if you take:
- medicines used to treat migraine headaches called triptans
- tricyclic antidepressants
- lithium
- tramadol, fentanyl, meperidine, methadone, or other opioids
- tryptophan
- buspirone
- amphetamines
- St. John’s Wort
- medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin
- diuretics
- tamoxifen
- medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serontonin reuptake (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)
Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take paroxetine oral suspension with your other medicines.
Do not start or stop any other medicines during treatment with paroxetine oral suspension without talking to your healthcare provider first. Stopping paroxetine oral suspension suddenly may cause you to have serious side effects. See, “What are the possible side effects of paroxetine oral suspension?”.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
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How should I take paroxetine oral suspension?
- Take paroxetine oral suspension exactly as prescribed. Your healthcare provider may need to change the dose of paroxetine oral suspension until it is the right dose for you.
- Take paroxetine oral suspension 1 time each day in the morning.
- Paroxetine oral suspension may be taken with or without food.
- If you are taking paroxetine oral suspension, shake the suspension well before taking.
- If you take too much paroxetine oral suspension, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.
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What are possible side effects of paroxetine oral suspension?
Paroxetine oral suspension can cause serious side effects, including:
- See, “What is the most important information I should know about paroxetine oral suspension?”
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Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take paroxetine oral suspension with certain other medicines. See, “Who should not take paroxetine oral suspension?” Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:
- seeing or hearing things that are not real (hallucinations)
- high body temperature (hyperthermia)
- shaking (tremors), stiff muscles, or muscle twitching
- changes in blood pressure
- nausea, vomiting, diarrhea
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Eye problems (angle-closure glaucoma). Paroxetine oral suspension may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.
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Medicine interactions. Taking paroxetine oral suspension with certain other medicines including thioridazine and pimozide may increase the risk of developing a serious heart problem called QT prolongation.
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Seizures (convulsions).
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Manic episodes. Manic episodes may happen in people with bipolar disorder who take paroxetine oral suspension. Symptoms may include:
- excessive happiness or irritability
- talking more or faster than usual
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Discontinuation syndrome. Suddenly stopping paroxetine oral suspension may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:
- electric shock feeling (paresthesia)
- irritability and agitation
- ringing in your ears (tinnitus)
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Low sodium levels in your blood (hyponatremia). Low sodium levels in your blood that may be serious and may cause death, can happen during treatment with paroxetine oral suspension. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in your blood. Signs and symptoms may include:
- weakness and unsteadiness on your feet which can lead to falls
In more severe or more sudden cases, signs and symptoms include:
- seeing or hearing things that are not real (hallucinations)
- stopping breathing (respiratory arrest)
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Abnormal bleeding. Taking paroxetine oral suspension with aspirin, NSAIDs, or blood thinners may increase this risk. Tell your healthcare provider about any unusual bleeding or bruising.
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Bonefractures.
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Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including paroxetine oral suspension, may cause sexual problems.
Symptoms in males may include:
o Delayed ejaculation or inability to have an ejaculation
o Decreased sex drive
o Problems getting or keeping an erection
Symptoms in females may include:
o Decreased sex drive
o Delayed orgasm or inability to have an orgasm
Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with paroxetine. There may be treatments your healthcare provider can suggest.
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The most common side effects of paroxetine oral suspension include:
- male and female sexual function problems
- weakness (asthenia)
- constipation
- decreased appetite
- diarrhea
- dizziness
- dry mouth
- infection
- problems sleeping
- nausea
- nervousness
- sleepiness
- sweating
- shaking (tremor)
- yawning
These are not all the possible side effects of paroxetine oral suspension.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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How should I store paroxetine oral suspension?
- Store paroxetine oral suspension at 68° to 77ºF (20° to 25ºC).
Keep paroxetine and all medicines out of the reach of children.
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General information about the safe and effective use of paroxetine oral suspension.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take paroxetine oral suspension for a condition for which it was not prescribed. Do not give paroxetine oral suspension to other people, even if they have the same symptoms that you have. It may harm them. You may ask your healthcare provider or pharmacist for information about paroxetine oral suspension that is written for healthcare professionals.
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What are the ingredients in paroxetine oral suspension?
Active ingredient: Paroxetine hydrochloride
Inactive ingredients:
Oral suspension: polacrilin potassium, microcrystalline cellulose, carboxymethyl cellulose sodium, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, orange flavor (triacetin, propylene glycol, natural and artificial flavor), FD&C Yellow No. 6, simethicone emulsion and purified water.
All trademarks are the property of their respective owners.
Manufactured by:
Novitium Pharma LLC
70 Lake Drive, East Windsor
New Jersey 08520
Issued: 10/2023
LB4256-04
For more information about paroxetine oral suspension, call 1-855-204-1431.
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