What is the most important information I should know about Luvox?

• You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, especially if you are under 18 years old. Talk with your doctor about this risk. While you are taking Luvox you will need to be monitored for worsening symptoms of depression and/ or suicidal thoughts during the first weeks of treatment, or whenever your dose is changed. In addition to you watching for changes in your own symptoms, your family or other caregivers should be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
• Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/ or physical hyperactivity), thoughts of suicide or hurting yourself.
• Do not take Luvox together with thioridazine (Mellaril), terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), pimozide (Orap), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take Luvox. You must wait 5 weeks after stopping Luvox before you can take thioridazine (Mellaril).

What is Luvox?

• Luvox is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors. Luvox affects chemicals in the brain that may become unbalanced and cause obsessive-compulsive symptoms.
• Luvox is used to treat obsessive-compulsive disorders involving recurring thoughts or actions.
• Luvox may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Luvox?

• You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, especially if you are under 18 years old. Talk with your doctor about this risk. While you are taking Luvox you will need to be monitored for worsening symptoms of depression and/ or suicidal thoughts during the first weeks of treatment, or whenever your dose is changed. In addition to you watching for changes in your own symptoms, your family or other caregivers should be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
• Do not use Luvox if you are using any of the following drugs:
  • thioridazine (Mellaril);
  • terfenadine (Seldane);
  • astemizole (Hismanal);
  • cisapride (Propulsid); or
  • pimozide (Orap); or
  • an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam).
• Serious and sometimes fatal reactions can occur when these medicines are taken with Luvox. You must wait at least 14 days after stopping an MAO inhibitor before you can take Luvox. You must wait 5 weeks after stopping Luvox before you can take thioridazine (Mellaril).
• Before taking Luvox, tell your doctor if you have:
  • liver disease;
  • seizures or epilepsy;
  • bipolar disorder (manic depression); or
  • a history of drug abuse or suicidal thoughts.
• You may not be able to take Luvox, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
• Luvox can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Luvox?

• Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from the medication.
• Take each dose with water.
• Try to take the medicine at the same time each day.
• It may take 4 weeks or more for you to start feeling better. Do not stop using Luvox without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.
• Store Luvox at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

• Seek emergency medical attention if you think you have taken too much of this medication. Symptoms of a Luvox overdose may include nausea, vomiting, blurred vision, rapid heartbeat, lack of coordination, trouble breathing, drowsiness, fainting, and coma.

What should I avoid while taking Luvox?

• Do not take Luvox together with thioridazine (Mellaril), terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), pimozide (Orap), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).
• Avoid drinking alcohol, which can increase some of the side effects of Luvox.
• Avoid using other medicines that make you sleepy (such as cold medicine, other pain medication, muscle relaxants). They can add to sleepiness caused by Luvox.
• Luvox can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What are the possible side effects of Luvox?

• Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
• Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/ or physical hyperactivity), thoughts of suicide or hurting yourself.
• Call your doctor at once if you have any of these serious side effects:
  • tremors, shivering, muscle stiffness or twitching;
  • seizure (convulsions);
  • problems with balance or coordination;
  • unusual thoughts or behavior; or
  • agitation, confusion, sweating, fast heartbeat.
• Other less serious side effects are more likely to occur, such as:
  • feeling nervous, restless, or unable to sit still;
  • sleep problems (insomnia);
  • drowsiness, weakness;
  • urinating more than usual;
  • loss of appetite, weight gain or loss;
  • nausea, vomiting, diarrhea, gas, constipation, or upset stomach;
  • decreased sex drive, impotence, or difficulty having an orgasm; or
  • dry mouth, unpleasant taste in your mouth.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
• You may have some side effects after you stop using Luvox, including headache, nausea, vomiting, sleepiness or insomnia, nervousness, or agitation.

What other drugs will affect Luvox?

• Before taking Luvox, tell your doctor if you are using any of the following medicines:
  • clozapine (Clozaril);
  • lithium (Lithobid, Eskalith);
  • propranolol (Inderal, Inderal LA) or metoprolol (Lopressor, Toprol XL);
  • carbamazepine (Tegretol);
  • warfarin (Coumadin);
  • tryptophan (also called L-tryptophan);
  • mexiletine (Mexitil);
  • theophylline (Aerolate, Bronkodyl, Slo-Bid, Theo-Dur);
  • methadone (Dolophine, Methadose);
  • tacrine (Cognex);
  • almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig);
  • a benzodiazepine such as diazepam (Valium), alprazolam (Xanax), midazolam (Versed), or triazolam (Halcion); or
  • any other antidepressants such as amitriptyline (Elavil), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), or sertraline (Zoloft).
• If you are using any of these drugs, you may not be able to use Luvox, or you may need dosage adjustments or special tests during treatment.
• There may be other drugs not listed that can affect Luvox. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.