Paroxetine 30mg Tablets

Paroxetine is a potent and highly selective inhibitor of serotonin (5-HT) reuptake in the central nervous system (CNS). It binds to the serotonin transporter (SERT), blocking the reabsorption of serotonin into the presynaptic neuron, thereby increasing the concentration of serotonin in the synaptic cleft and enhancing serotonergic neurotransmission. It has weak effects on norepinephrine and dopamine neuronal reuptake. It also has some anticholinergic activity.

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 immediate medical attention:

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 sensations, such as burning, numbness, or tingling
Painful or prolonged erections (lasting more than 4 hours)
Sexual problems, including decreased libido, difficulty achieving orgasm, ejaculation issues, or erectile dysfunction

Serotonin Syndrome: A Rare but Serious Condition

There is a risk of developing serotonin syndrome, a potentially life-threatening condition, especially when taking certain medications in combination with this drug. If you experience any of the following symptoms, seek medical help immediately:

Agitation or changes in balance
Confusion or hallucinations
Fever or abnormal heartbeat
Flushing or muscle twitching/stiffness
Seizures or shivering/shaking
Excessive sweating or severe diarrhea, stomach upset, or vomiting
Severe headache

Other Possible Side Effects

While many people may not experience side effects or may only have mild symptoms, 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 or bloating
Dry mouth
Sleep disturbances
Shakiness or tremors
Yawning
Back pain
* Sweating

If you are concerned about any side effects or if they persist or worsen, consult your doctor for guidance. 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 discuss all of your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. 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. This will help ensure your safety and prevent any potential interactions with other treatments.

Until you know how this medication affects you, avoid driving and other activities that require alertness. If you need to stop taking this medication, do not do so abruptly without consulting your doctor, as this may increase your risk of side effects. Instead, your doctor will guide you on how to gradually stop taking the medication.

To minimize potential risks, avoid consuming alcohol while taking this medication. Additionally, discuss the use of marijuana, cannabis, or other prescription or over-the-counter medications that may cause drowsiness with your doctor before taking them.

It may take several weeks to experience the full effects of this medication. Be aware that it may increase your risk of fractures, and your doctor may want to discuss this with you. Furthermore, this medication may raise your risk of bleeding, which can be life-threatening in some cases. Therefore, it is crucial to talk to your doctor about this potential 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 in or around the eye, contact your doctor immediately.

This medication can cause low sodium levels, which can be life-threatening and lead to seizures, loss of consciousness, breathing difficulties, or even death. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary, and your doctor will discuss this with you. Additionally, this medication may impact fertility in males, although it is unclear if this effect is reversible.

If you are pregnant or become pregnant while taking this medication, contact your doctor right away. This medication may harm the unborn baby, particularly if taken during the first trimester, which may increase the risk of birth defects, mainly heart defects. Taking this medication during the third trimester may increase your risk of bleeding after delivery and lead to health problems in the newborn. Your doctor will discuss the benefits and risks of taking this medication during pregnancy.

If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.

• Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome
• Thioridazine - risk of QT prolongation and ventricular arrhythmias
• Pimozide - risk of QT prolongation and ventricular arrhythmias

• Other serotonergic drugs (e.g., triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort, other SSRIs/SNRIs) - increased risk of serotonin syndrome
• Drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants, phenothiazines, Type 1C antiarrhythmics like propafenone and flecainide, atomoxetine, metoprolol) - increased plasma concentrations of these drugs
• Warfarin and other oral anticoagulants - increased risk of bleeding
• NSAIDs, aspirin, other antiplatelet agents - increased risk of bleeding
• Linezolid - risk of serotonin syndrome
• Methylene blue - risk of serotonin syndrome

• Cimetidine - increases paroxetine levels
• Phenobarbital, phenytoin - may decrease paroxetine levels
• Fosamprenavir/ritonavir - may decrease paroxetine levels
• Tamoxifen - paroxetine may reduce tamoxifen efficacy (due to CYP2D6 inhibition)
• Digoxin - paroxetine may increase digoxin levels
• Theophylline - paroxetine may increase theophylline levels
• Alcohol - avoid concomitant use due to CNS depressant effects

• Not available

• Worsening depression
• Emergence of suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity)
• New or worsening anxiety or panic attacks
• Insomnia
• Akathisia (restlessness)
• Hypomania or mania
• Signs of serotonin syndrome (e.g., agitation, hallucinations, rapid heart beat, fever, sweating, muscle rigidity, tremor, incoordination, nausea, vomiting, diarrhea)
• Signs of bleeding (e.g., bruising, petechiae, GI bleeding)

Paroxetine is Pregnancy Category D. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is an increased risk of congenital malformations, particularly cardiovascular defects (e.g., ventricular septal defects), with first-trimester exposure. Third-trimester exposure may lead to neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding (e.g., persistent pulmonary hypertension of the newborn, withdrawal symptoms).

Paroxetine is excreted into breast milk. While levels in breast milk are generally low, potential for adverse effects in the infant exists. The American Academy of Pediatrics considers paroxetine to be a drug for which the effect on the nursing infant is unknown but may be of concern. Monitor infants for drowsiness, poor feeding, and weight gain.

Not recommended for Major Depressive Disorder (MDD) in children and adolescents due to increased risk of suicidal thoughts and behavior. Use for Obsessive-Compulsive Disorder (OCD) in pediatric patients (ages 7-17) is limited and requires careful monitoring for suicidality and other adverse effects. Long-term safety and efficacy in pediatric populations are not fully established.

Lower starting doses (e.g., 10 mg/day) and slower titration are recommended due to decreased clearance and increased risk of adverse effects, particularly hyponatremia (SIADH), falls, and CNS effects (e.g., dizziness, sedation). Monitor closely for adverse reactions and drug interactions.

• Paroxetine is a potent CYP2D6 inhibitor, which can lead to significant drug interactions with other medications metabolized by this enzyme (e.g., tamoxifen, TCAs, antiarrhythmics).
• It has a relatively short half-life compared to other SSRIs, making withdrawal symptoms (discontinuation syndrome) more pronounced and common if discontinued abruptly. Tapering is crucial.
• Paroxetine has some anticholinergic properties, which may contribute to side effects like constipation, dry mouth, and blurred vision, and can be problematic in elderly patients.
• It is often associated with weight gain and sexual dysfunction (e.g., anorgasmia, decreased libido) more frequently than some other SSRIs.
• The controlled-release (CR) formulation may reduce the incidence of nausea and improve tolerability for some patients.
• Due to its pregnancy category D, it is generally avoided in women of childbearing potential unless other options are not suitable and the benefits clearly outweigh the risks.

• Other Selective Serotonin Reuptake Inhibitors (SSRIs): Sertraline, Fluoxetine, Citalopram, Escitalopram, Fluvoxamine
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine, Duloxetine, Desvenlafaxine, Levomilnacipran
• Atypical Antidepressants: Bupropion, Mirtazapine, Trazodone, Vilazodone, Vortioxetine
• Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline, Imipramine
• Monoamine Oxidase Inhibitors (MAOIs): Phenelzine, Tranylcypromine, Selegiline (rarely used due to interaction profile)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please 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 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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.