Paxil CR

Paxil CR is a prescription medication used to treat depression, panic disorder, social anxiety disorder, and Premenstrual Dysphoric Disorder. Paxil CR belongs to a group of drugs called selective serotonin-reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin in the brain, a natural substance that helps maintain mental balance and elevate mood.

This medication comes as an extended-release tablet. It is usually taken once daily, with or without food.

If you are being treated for Premenstrual Dysphoric Disorder, Paxil CR can be taken daily, either daily throughout the menstrual cycle or on certain days of the cycle.

Swallow Paxil CR tablets whole. Do not chew or crush Paxil CR tablets.

Common side effects of Paxil CR include nausea and weakness. Paxil CR can cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how Paxil CR.

Paxil CR is a prescription medicine is used to treat:

• Major depressive disorder (MDD)
• Panic disorder
• Social anxiety disorder
• Premenstrual Dysphoric Disorder

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Apotex Inc.

Common side effects include:

• nausea
• headache
• sleepiness
• weakness
• dizziness
• drowsiness
• trouble falling asleep or staying asleep (insomnia)
• diarrhea and/or constipation
• sexual problems
• sweating
• shaking
• not feeling hungry
• dry mouth
• infection
• yawning

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Paxil CR. For more information, ask your healthcare provider or pharmacist. Paxil CR and other antidepressant medicines may cause serious side effects, see "Drug Precautions".

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Eldepryl, Zelapar) and tranylcypromine (Parnate)
• Mellaril (thioridazine)
• Orap (pimozide)
• triptans used to treat migraine headache
• other antidepressants (SSRIs, SNRIs, tricyclics, or lithium) or antipsychotics
• drugs that affect serotonin, such as lithium, tramadol, tryptophan, St. John’s wort
• certain drugs used to treat irregular heart beats
• certain drugs used to treat schizophrenia
• certain drugs used to treat HIV infection
• certain drugs that affect the blood, such as warfarin, aspirin, and ibuprofen
• certain drugs used to treat epilepsy
• atomoxetine
• cimetidine
• fentanyl
• metoprolol
• certain medicines used to treat seizures (like phenobarbital and phenytoin)
• procyclidine
• tamoxifen

Ask your healthcare provider if you are not sure if you are taking any of these medications.

Paxil CR and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

• Paxil CR and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
• Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
• Watch for these changes and call your healthcare provider right away if you notice:
  • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
  • Pay particular attention to such changes when Paxil CR is started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

• attempts to commit suicide
• acting on dangerous impulses
• acting aggressive or violent
• thoughts about suicide or dying
• new or worse depression
• new or worse anxiety or panic attacks
• feeling agitated, restless, angry, or irritable
• trouble sleeping
• an increase in activity or talking more than what is normal for you
• other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Paxil CR may be associated with these serious side effects:

2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. This condition can be life-threatening and may include:

• agitation, hallucinations, coma, or other changes in mental status
• coordination problems or muscle twitching (overactive reflexes)
• racing heartbeat, high or low blood pressure
• sweating or fever
• nausea, vomiting, or diarrhea
• muscle rigidity

3. Abnormal bleeding: Paxil CR and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin, Jantoven), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

4. Seizures or convulsions

5. Manic episodes:

• greatly increased energy
• severe trouble sleeping
• racing thoughts
• reckless behavior
• unusually grand ideas
• excessive happiness or irritability
• talking more or faster than usual

6. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

• headache
• weakness or feeling unsteady
• confusion, problems concentrating or thinking, or memory problems

7. Akathisia which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. Tell your doctor if you notice a sense of restlessness and an inability to sit or stand still.

Do not stop Paxil CR without first talking to your healthcare provider. Stopping Paxil CR too quickly may cause serious symptoms including:

• anxiety, irritability, high or low mood, feeling restless, or changes in sleep habits
• headache, sweating, nausea, dizziness
• electric shock-like sensations, shaking, confusion

Do not take Paxil CR if you:

• are allergic to Paxil CR or any of the ingredients in Paxil CR. 
• take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
• Do not take an MAOI within 2 weeks of stopping Paxil CR unless directed to do so by your physician.
• Do not start Paxil CR if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
• People who take Paxil CR close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
  • high fever
  • uncontrolled muscle spasms
  • stiff muscles
  • rapid changes in heart rate or blood pressure
  • confusion
  • loss of consciousness (pass out)
• take Mellaril (thioridazine). Do not take Mellaril together with Paxil CR because this can cause serious heart rhythm problems or sudden death.
• take the antipsychotic medicine pimozide (Orap) because this can cause serious heart problems.

Paxil CR can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Paxil CR affects you. Do not drink alcohol while using Paxil CR.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Paxil CR there are no specific foods that you must exclude from your diet when receiving Paxil CR.

Before starting Paxil CR, tell your healthcare provider if you:

• are pregnant or breastfeeding
• have liver problems
• have kidney problems
• have heart problems
• have or had seizures or convulsions
• have bipolar disorder or mania
• have low sodium levels in your blood
• have a history of a stroke
• have high blood pressure
• have or had bleeding problems
• have glaucoma (high pressure in the eye)

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Paxil CR falls under Pregnancy Category D. It has been shown that women taking Paxil CR during pregnancy may have babies with problems. This medication is not recommended to be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Paxil CR has been detected in human breast milk. Because of the possibility for side effects in nursing infants from Paxil CR, a choice should be made whether to stop nursing or to stop using Paxil CR. You should discuss the importance of Paxil CR to your health before any decision to stop or continue using Paxil CR.

• Paxil CR comes as an extended release tablet and is to be taken by mouth.
• It is usually taken once daily in the morning, with or without food.
• If you are being treated for Premenstrual Dysphoric Disorder, Paxil CR can be taken daily, either daily throughout the menstrual cycle or on certain days of the cycle.
• You may want to take Paxil CR with food to prevent stomach upset. Take Paxil CR at around the same time every day.
• Follow the directions on your prescription label carefully.
• Take Paxil CR exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
• Swallow Paxil CR tablets whole; do not chew or crush the tablets.
• If you miss a dose of Paxil CR, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Paxil CR at the same time.
• If you take too much Paxil CR call your healthcare provider or poison control center right away, or get emergency treatment.

Paxil CR controls your condition but does not cure it. It may take several weeks or longer before you feel the full benefit of Paxil CR. Continue to take Paxil CR even if you feel well. Do not stop taking Paxil CR without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking Paxil CR, you may experience withdrawal symptoms such as depression; mood changes; frenzied or abnormally excited mood; irritability; anxiety; confusion; dizziness; headache; tiredness; numbness or tingling in the arms, legs, hands, or feet; unusual dreams; difficulty falling asleep or staying asleep; nausea; or sweating. Tell your doctor if you experience any of these symptoms when your dose of Paxil CR is decreased.

Take Paxil CR exactly as prescribed. Follow the directions on your prescription label carefully. Your healthcare provider will determine the best dose for you based on the medical condition being treated, as well as your age, other medical conditions you have, and other medications you are taking.

Major Depressive Disorder

The recommended starting dose of Paxil CR for Major Depressive Disorder is 25 mg daily.

Panic Disorder

The recommended starting dose of Paxil CR for Panic Disorder is 12.5 mg daily. The maximum daily dose is 75 mg/day.

Social Anxiety Disorder

The recommended starting dose of Paxil CR for Social Anxiety Disorder is 12.5 mg daily. The maximum daily dose is 37.5 mg/day.

Premenstrual Dysphoric Disorder

The recommended starting dose for Paxil CR of Premenstrual Dysphoric Disorder is 12.5 mg/day. PAXIL CR can be taken daily, either daily throughout the menstrual cycle or on certain days of the cycle.

If you take too much Paxil CR, call your healthcare provider or poison control center right away or get emergency treatment.

• Store Paxil CR at or below 25°C (77°F).
• Keep Paxil CR away from light.
• Keep bottle of Paxil CR closed tightly.
• Keep Paxil CR tablets dry.
• Keep Paxil CR and all medicines out of the reach of children.

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of PAXIL CR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PAXIL CR is not approved for use in pediatric patients.