Paroxetine 10mg/5ml Oral Suspension

Paroxetine is a potent and highly selective inhibitor of serotonin (5-hydroxytryptamine; 5-HT) reuptake in the central nervous system (CNS). This inhibition leads to an increase in the concentration of serotonin in the synaptic cleft, enhancing serotonergic neurotransmission. It has weak effects on norepinephrine and dopamine neuronal reuptake. It also has weak anticholinergic effects.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Difficulty focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Signs of infection, such as:
+ Fever or chills
+ Severe sore throat, ear or sinus pain, or cough
+ Increased sputum production or a change in sputum color
+ Pain while urinating or mouth sores
+ A wound that will not heal
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Severe dizziness or fainting
Bone pain
Seizures
Significant weight loss
Abnormal burning, numbness, or tingling sensations
Painful or prolonged erections (lasting more than 4 hours)
Sexual problems, including decreased interest in sex, difficulty having an orgasm, ejaculation problems, or trouble getting or maintaining an erection

Serotonin Syndrome: A Rare but Serious Condition

There is a risk of developing serotonin syndrome, a potentially life-threatening condition, especially when taking certain other medications. Seek medical help immediately if you experience:

Agitation
Changes in balance or coordination
Confusion
Hallucinations
Fever
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache

Other Possible Side Effects

While many people may not experience any side effects or only mild ones, it is essential to be aware of the following potential side effects:

Dizziness, drowsiness, fatigue, or weakness
Nervousness or excitability
Headache
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Gas
Dry mouth
Sleep disturbances
Shakiness
Yawning
Back pain
* Sweating

If you are concerned about any side effects or if they persist or worsen, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have been diagnosed with narrow-angle glaucoma.
If you are currently taking or have recently taken any of the following medications: Linezolid, methylene blue, pimozide, or thioridazine.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, be cautious and avoid driving or engaging in activities that require alertness until you understand how it affects you.

To minimize the risk of side effects, do not abruptly stop taking this medication without consulting your doctor. If you need to discontinue use, your doctor will guide you on how to gradually stop taking it.

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, before using marijuana, other forms of cannabis, or prescription and over-the-counter drugs that may cause drowsiness, consult with your doctor.

It may take several weeks to experience the full effects of this medication.

There are potential risks associated with this medication, including an increased chance of fractures. Discuss this risk with your doctor.

This medication may also increase the risk of bleeding, which can be life-threatening in some cases. Consult with your doctor about this risk.

Some individuals may have a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk. If you experience eye pain, changes in vision, or swelling and redness around the eye, contact your doctor immediately.

Low sodium levels, which can be life-threatening and lead to seizures, loss of consciousness, breathing difficulties, or death, are a possible side effect of this medication.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

In children and teenagers, this medication may affect growth. Regular growth checks may be necessary, so discuss this with your doctor.

There is a potential impact on fertility, and it is unclear if this effect is reversible.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. Taking this medication during the first trimester may increase the risk of birth defects, particularly heart defects, in the unborn baby. Use during the third trimester may increase the risk of postpartum bleeding and potentially cause health problems in the newborn. If you are breastfeeding, discuss the potential risks to your baby with your doctor.

• Monoamine Oxidase Inhibitors (MAOIs) (risk of serotonin syndrome)
• Pimozide (risk of QT prolongation)
• Thioridazine (risk of QT prolongation and ventricular arrhythmias)
• Linezolid (MAOI activity)
• Methylene blue (MAOI activity)

• Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome.
• Drugs metabolized by CYP2D6 (e.g., flecainide, propafenone, metoprolol, atomoxetine, risperidone, tamoxifen) - increased plasma concentrations of these drugs.
• Warfarin and other anticoagulants/antiplatelets (e.g., NSAIDs, aspirin) - increased risk of bleeding.
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics) - theoretical increased risk of QT prolongation.
• Phenytoin, Phenobarbital, Carbamazepine - decreased paroxetine levels; paroxetine may increase phenytoin/carbamazepine levels.

• Cimetidine - increases paroxetine levels.
• Fosamprenavir/Ritonavir - decreases paroxetine levels.
• Theophylline - paroxetine may increase theophylline levels.
• Digoxin - paroxetine may increase digoxin levels.
• Alcohol - concurrent use not recommended due to potential for increased CNS depression.

• Not specifically categorized as minor, but caution with any CNS depressants.

• Worsening depression
• Emergence of suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity)
• New or worsening anxiety
• Panic attacks
• Insomnia
• Restlessness
• Mania or hypomania
• Serotonin syndrome symptoms (e.g., agitation, hallucinations, rapid heart beat, fever, sweating, shivering, muscle rigidity, twitching, incoordination, nausea, vomiting, diarrhea)
• Abnormal bleeding or bruising
• Symptoms of hyponatremia (e.g., headache, confusion, weakness, seizures)

Category D. Use during pregnancy, especially the first trimester, has been associated with an increased risk of cardiovascular malformations (e.g., atrial and ventricular septal defects). Third-trimester exposure has been associated with persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome. Use only if the potential benefit justifies the potential risk to the fetus.

L3 (Moderate Concern). Paroxetine is excreted into breast milk. While levels in breast milk are generally low, some infants may experience adverse effects (e.g., sedation, poor feeding, weight loss). Monitor breastfed infants for adverse effects. Consider alternative agents with lower infant exposure or risk, or weigh benefits vs. risks.

Generally not recommended for children and adolescents due to the Black Box Warning regarding increased risk of suicidal thoughts and behaviors. Limited use in specific conditions like OCD where benefits may outweigh risks, with close monitoring.

Use with caution. Elderly patients may be more sensitive to the effects of paroxetine, including hyponatremia and CNS effects (e.g., dizziness, falls). Lower initial doses and slower titration are recommended. Max dose typically 40 mg/day.

• Paroxetine has a relatively short half-life among SSRIs, making it more prone to withdrawal symptoms if discontinued abruptly. Tapering is crucial.
• It is a potent inhibitor of CYP2D6, which is important for drug-drug interaction assessment, especially with drugs like tamoxifen, metoprolol, and tricyclic antidepressants.
• Paroxetine has mild anticholinergic effects, which can contribute to side effects like constipation or dry mouth, and may be a consideration in elderly patients.
• Consider the controlled-release (CR) formulation for patients experiencing significant nausea or other GI side effects with the immediate-release (IR) form.
• Sexual dysfunction (e.g., decreased libido, anorgasmia) is a common and often bothersome side effect that can impact adherence. Discuss this with patients proactively.
• Weight gain can occur with long-term use of paroxetine.

• Other SSRIs (e.g., Fluoxetine, Sertraline, Citalopram, Escitalopram, Fluvoxamine)
• SNRIs (e.g., Venlafaxine, Duloxetine, Desvenlafaxine)
• Atypical antidepressants (e.g., Bupropion, Mirtazapine, Trazodone, Vortioxetine, Vilazodone)
• Tricyclic Antidepressants (TCAs)
• Monoamine Oxidase Inhibitors (MAOIs)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
• Electroconvulsive Therapy (ECT) for severe depression

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.