Luvox CR

Luvox CR is a prescription medication used to treat obsessive compulsive disorder (OCD). Luvox CR belongs to a group of drugs called selective serotonin reuptake inhibitors (SSRIs). These work by increasing the amount of serotonin in the brain, which helps maintain mental balance.

This medication comes extended-release capsule form. It is taken once daily, at bedtime. Do not chew or crush the extended-release Luvox CR capsule.

Common side effects include nausea, insomnia, and headache. Luvox CR can also cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how Luvox CR affects you.

Luvox CR is a prescription medication used to treat obsessive compulsive disorder (OCD).

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

• Jazz Pharmaceuticals, Inc.

Serious side effects have been reported with Luvox CR. See the "Luvox CR Precautions" section.

Common side effects include:

• nausea
• insomnia
• drowsiness
• headache
• lack of energy
• vomiting
• nervousness
• agitation
• dizziness

This is not a complete list of Luvox CR side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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:

• alprazolam (Xanax)
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• aspirin or aspirin-containing products and other nonsteroidal anti-inflammatory drugs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• beta-blockers such as metoprolol (Lopressor, Toprol) and propranolol (Inderal, in Inderide); buspirone (BuSpar)
• carbamazepine (Tegretol)
• clopidogrel (Plavix), clozapine (Clozaril)
• cyclosporine (Neoral, Sandimmune)
• dextromethorphan (in cough medications)
• diazepam (Valium)
• diltiazem (Cardizem)
• diuretics ('water pills')
• fentanyl (Abstral, Actiq, Fentora, Onsolis, others)
• haloperidol (Haldol)
• ketoconazole (Nizoral)
• lithium
• medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig)
• methadone (Dolophine, Methadose)
• mexiletine (Mexitil)
• metoclopramide
• midazolam (Versed)
• omeprazole (Prilosec, Zegerid)
• other medications for anxiety, depression, or mental illness
• phenytoin (Dilantin)
• sibutramine (Meridia)
• tacrine (Cognex)
• theophylline (Theo-Dur)
• tramadol (Ultram, in Ultracet)
• triazolam (Halcion)
• quinidine

This is not a complete list of Luvox CR drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Luvox CR, including the following:

• chest pain
• problems with coordination
• dizziness
• hallucination (seeing things or hearing voices that do not exist)
• fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness
• pain, burning, numbness, or tingling in the hands or feet
• shaking of a part of the body that you cannot control
• rash
• hives
• slowed or difficult breathing
• seizures
• loss of consciousness
• unusual bleeding or bruising
• bloody nose
• vomiting blood or a material that looks like coffee grounds
• red blood in stool or black and tarry stools

Luvox CR can also cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how Luvox CR affects you.

Do not take Luvox CR if you:

• are allergic to Luvox CR or to any of its ingredients
• are taking thioridazine, astemizole, cisapride (Propulsid), pimozide (Orap), alosetron (Lotronex), tizanidine (Zanaflex)

Medications 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 Luvox CR, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Luvox CR, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Luvox CR or to any of its ingredients
• consume large amounts of alcohol
• have or ever have used or overused illegal drugs or prescription medications
• have had seizures
• have heart disease
• have liver disease
• have adrenal disease
• have liver disease
• are pregnant or breastfeeding

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 St. John's Wort or supplements containing tryptophan.

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.

Luvox CR falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

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

Luvox CR has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Luvox CR, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Luvox CR exactly as prescribed.

This medication comes extended-release capsule form. It is taken once daily, at bedtime. Do not chew or crush the extended-release Luvox CR capsule.

If you miss a dose, 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 2 doses of Luvox CR at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended starting dose of Luvox CR in adults is 100 mg once daily at bedtime. The dose may be increased slowly based on patient response. The maximum recommended dose is 300 mg.

If you take too much Luvox CR, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Luvox CR is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Luvox CR at room temperature. Protect from heat, light, and humidity.
• Keep this and all medications 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 LUVOX CR Extended-Release Capsules 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.