Paxil CR

The active ingredient in Paxil CR is paroxetine hydrochloride.

Paroxetine works by blocking the reabsorption (reuptake) of serotonin in the brain. Serotonin is a neurotransmitter that affects mood, emotion, and sleep. By preventing its reuptake, Paxil CR increases the amount of serotonin available in the brain, which helps stabilize mood and reduce symptoms of depression and anxiety.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Paxil CR. However, the following is a synopsis of the general guidelines for the use of Paxil CR:

• Take Paxil CR once daily, usually in the morning, with or without food.
• Swallow the tablet whole. Do not crush, chew, or break it, as this will affect the extended-release mechanism.
• Take the medication at the same time each day to maintain even levels in your body.
• If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose. Do not double up.
• Do not stop taking Paxil CR abruptly. Your healthcare provider will help you taper the dose gradually to avoid withdrawal symptoms such as dizziness, anxiety, nausea, and electric shock sensations.

Some mild or common side effects of Paxil CR include:

• Nausea.
• Dry mouth.
• Drowsiness
• Trouble sleeping.
• Constipation
• Diarrhea.
• Dizziness.
• Sweating.
• Weight gain or loss of appetite.
• Sexual problems (delayed ejaculation, reduced libido).
• Blurred vision.
• Tremors or shaking.

Some individuals may experience serious side effects while using Paxil CR. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of serotonin syndrome (agitation, hallucinations, fever, rapid heart rate, stiff muscles, or loss of coordination).
• Suicidal thoughts or worsening depression, especially in children, teens, or young adults.
• Severe, life-threatening allergic reactions (hives, swelling, difficulty breathing).
• Eye pain, vision changes, or glaucoma symptoms.
• Severe dizziness or fainting due to low blood pressure.
• Confusion, headache, weakness, or unsteadiness (possible low sodium levels, or hyponatremia).
• Abnormal bleeding or easy bruising (especially if combined with NSAIDs, aspirin, or blood thinners).
• Signs of mania in patients with bipolar disorder (racing thoughts, elevated mood, impulsive behavior).

These are not all of the possible side effects of Paxil CR. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Paxil CR, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Bipolar disorder or a family history of mania.
• Seizures or a seizure disorder.
• Liver or kidney disease.
• Glaucoma (narrow-angle type).
• Bleeding disorders or use of anticoagulants.
• Heart disease or irregular heartbeat.
• Low sodium or dehydration.
• A history of suicidal thoughts or mental health conditions.
• A history of drug or alcohol abuse.

Boxed Warning

Antidepressants, including Paxil CR, increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults, especially during the early stages of treatment or dose changes. Patients of all ages should be closely monitored for worsening depression, suicidal thoughts, or unusual mood changes.

Paxil CR should not be used in individuals who:

• Are taking or have recently taken a monoamine oxidase inhibitor (MAOI) such as phenelzine, tranylcypromine, or linezolid (within 14 days).
• Are you taking thioridazine or pimozide, as dangerous heart rhythm changes can occur.
• Have had a known hypersensitivity or allergic reaction to paroxetine or any inactive ingredients in the formulation.

It can take 2 to 4 weeks before you notice improvements in mood, sleep, and appetite, and up to 6 to 8 weeks for full benefits in anxiety-related disorders like panic disorder or OCD.

When Paxil CR is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue).
• NSAIDs (ibuprofen, naproxen, aspirin) and anticoagulants (warfarin) may increase the risk of bleeding.
• Tryptophan, St. John’s Wort, tramadol, fentanyl, SNRIs, or other serotonergics because of the risk of serotonin syndrome.
• Lithium, buspirone, or amphetamines can increase serotonin effects.
• Tamoxifen, like paroxetine, can reduce its effectiveness.
• Thioridazine, pimozide, or atomoxetine, as there is a risk of heart rhythm problems.
• Diuretics may increase the risk of low sodium.
• Beta blockers or blood pressure medications may cause dizziness or fainting.
• Alcohol or sedatives can worsen drowsiness.

Paxil CR (controlled-release) is available in the following dosage forms and strengths: 12.5 mg, 25 mg, and 37.5 mg tablets.

The dose depends on your condition and how you respond to treatment. For most adults, treatment begins with a low dose that may be gradually increased under medical supervision. Never adjust your dose without your doctor’s advice.

Store at room temperature and keep out of reach of children.

Paxil CR is manufactured by GlaxoSmithKline (GSK), a global healthcare company that develops and distributes prescription medicines and vaccines.

Yes, generic paroxetine controlled-release tablets are available. These contain the same active ingredient and have been approved by the FDA as therapeutically equivalent to the brand-name product.

Do not stop taking Paxil CR suddenly without consulting your healthcare provider. Stopping abruptly can cause symptoms such as anxiety, dizziness, irritability, electric shock sensations, headache, or trouble sleeping.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. Paxil CR may cause harm to an unborn baby, especially if used during the first trimester. Some studies suggest an increased risk of heart defects. Your healthcare provider will weigh the potential benefits and risks and may recommend an alternative antidepressant if needed.

Paroxetine passes into breast milk in small amounts. While it is sometimes used by breastfeeding women, your doctor will decide if the benefits outweigh any potential risks to your baby. Monitor your infant for signs of drowsiness, irritability, or feeding difficulties.