ACTAPAROXETINE (PAROXETINE) INDICATIONS
Actaparoxetine is used for treating depression or obsessive-compulsive disorder (OCD). It may be used to treat panic disorder or posttraumatic stress disorder (PTSD). It may also be used to treat generalized anxiety disorder or social anxiety disorder. Actaparoxetine is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve certain mood problems.
ACTAPAROXETINE (PAROXETINE) INSTRUCTIONS
Use Actaparoxetine as directed by your doctor.
- Take Actaparoxetine by mouth with or without food.
- Swallow Actaparoxetine whole. Do not break, crush, or chew before swallowing.
- Taking Actaparoxetine at the same time each day will help you remember to take it.
- Continue to take Actaparoxetine even if you feel well. Do not miss any dose.
- Do not suddenly stop taking Actaparoxetine without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Actaparoxetine and whenever a change in dose is made.
- If you miss a dose of Actaparoxetine, take it as soon as possible. If it almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Actaparoxetine.
ACTAPAROXETINE (PAROXETINE) STORAGE
Store Actaparoxetine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Actaparoxetine out of the reach of children and away from pets.
Do NOT use Actaparoxetine if:
- you are allergic to any ingredient in Actaparoxetine
- you are taking or have taken linezolid, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), selegiline, or St. John's wort within the last 14 days
- you are taking a fenfluramine derivative (eg, dexfenfluramine), nefazodone, pimozide, a serotonin norepinephrine reuptake inhibitor (SNRI) (eg, venlafaxine), another SSRI (eg, fluoxetine), sibutramine, thioridazine, or tryptophan.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Actaparoxetine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
- if you have a history of seizures, heart problems, liver problems, severe kidney problems, stomach or bowel bleeding, narrow-angle glaucoma, diabetes, or metabolism problems
- if you are dehydrated, have low blood sodium levels, or drink alcohol
- if you will be having electroconvulsive therapy (ECT).
Some medicines may interact with Actaparoxetine. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anorexiants (eg, phentermine), cimetidine, fenfluramine derivatives (eg, dexfenfluramine), linezolid, lithium, MAOIs (eg, phenelzine), metoclopramide, nefazodone, selegiline, serotonin 5-HT1
- Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
- Antiarrhythmics (eg, flecainide, propafenone, quinidine), H1
- Cyproheptadine, HIV protease inhibitors (eg, ritonavir), phenobarbital, or phenytoin because they may decrease Actaparoxetine's effectiveness
- Aripiprazole, atomoxetine, clozapine, fluoxetine, pimozide, procyclidine, risperidone, theophylline, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Actaparoxetine
- Digoxin or tamoxifen because their effectiveness may be decreased by Actaparoxetine.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Actaparoxetine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Important safety information:
- Actaparoxetine may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Actaparoxetine with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are taking Actaparoxetine.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Actaparoxetine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or use Actaparoxetine for longer than prescribed without checking with your doctor.
- Children, teenagers, and young adults who take Actaparoxetine may be at increased risk for suicidal thoughts or actions. Closely watch all patients who take Actaparoxetine. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- If your doctor tells you to stop taking Actaparoxetine, you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor when you should start to take your new medicines after you have stopped taking Actaparoxetine.
- Actaparoxetine may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Actaparoxetine. Your risk may be greater if you take Actaparoxetine with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Actaparoxetine. Your risk may be greater if Actaparoxetine is used with certain other medicines called antipsychotics (eg, aripiprazole, risperidone). Symptoms may be similar to serotonin syndrome and may include fever, rigid muscles, blood pressure changes, and mental changes. Contact your doctor at once if you have any of these symptoms.
- Use Actaparoxetine with caution in the elderly; they may be more sensitive to its effects, especially low blood sodium levels.
- Caution is advised when using Actaparoxetine in children; they may be more sensitive to its effects, especially increased risk of suicidal thoughts and actions.
- Actaparoxetine may cause weight changes. Children and teenagers may need regular weight and growth checks while they take Actaparoxetine.
- Pregnancy and breast-feeding: Actaparoxetine may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Actaparoxetine while you are pregnant. Actaparoxetine is found in breast milk. If you are or will be breast-feeding while you use Actaparoxetine, check with your doctor. Discuss any possible risks to your baby.
All medicines may cause side effects, but many people have no, or minor, side effects.
Check with your doctor if any of these most common side effects persist or become bothersome:
Anxiety; blurred vision; constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; gas; increased sweating; increased urination; loss of appetite; nausea; nervousness; numbness or tingling of the skin; stomach upset; trouble concentrating; trouble sleeping; weakness; yawning.
Seek medical attention right away if any of these severe side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; exaggerated reflexes; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; memory loss; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; severe or persistent headache or dizziness; significant weight loss; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; vision changes; worsening of depression.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.