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Healthcare
Professionals
Get important information
and facts about LUVOX CR.
What Is LUVOX CR?
LUVOX CR is a once-a-day medicine that is taken at bedtime. It has been proven safe and effective to treat
- Social anxiety disorder (SAD) — people with SAD, also known as social phobia, have an ongoing intense fear of social situations
- Obsessive compulsive disorder (OCD) — people with OCD have 2 key symptoms: obsessions and compulsions
- Obsessions are unwanted, recurring, anxiety-causing thoughts
- Compulsions are repetitive behaviors that people do to help relieve the anxiety caused by obsessions
How does Once-A-Day LUVOX CR work?
LUVOX CR is a medicine known as an SSRI. That stands for Selective Serotonin Reuptake Inhibitor. The exact mechanism by which SSRIs work is unknown. SSRIs are thought to help restore the chemical balance of serotonin in the body. This is believed to help people by allowing the brain to send and receive messages better. In turn, this may reduce the symptoms that you experience.
What does serotonin do?
Serotonin helps the nerve cells in your brain send messages. It also helps them communicate with each other. For some people, changes in serotonin levels can affect how their brain sends and receives messages. It can also affect how they feel.
For example, you may feel the need to avoid certain social situations. Or you may spend a long time going over the same issue in your head. LUVOX CR helps to increase the amount of serotonin in the area between your brain's nerve cells. This may help reduce your symptoms. It may also help the way you feel.
This chart shows how LUVOX CR is thought to work
Once-A-Day LUVOX® CR (fluvoxamine maleate) Extended-Release Capsules are indicated for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD).
Important Safety Information
CONTRAINDICATIONS
The use of alosetron, tizanidine, thioridazine, or pimozide with LUVOX CR Capsules is contraindicated. The use of MAO inhibitors in combination with LUVOX CR Capsules, or within 14 days of discontinuing treatment with LUVOX CR Capsules, is contraindicated (see WARNINGS and PRECAUTIONS). LUVOX CR Capsules are also contraindicated in patients with a history of hypersensitivity to fluvoxamine maleate or any of its excipients.
ADVERSE EVENTS
In clinical trials, the most commonly observed adverse events with an incidence of ≥5% and at least twice that of placebo were nausea, somnolence, asthenia, diarrhea, anorexia, tremor, and sweating. Overall, these side effects were mild to moderate in severity and transient in nature. Other common adverse events (≥5% and at least twice that of placebo) included abnormal ejaculation and anorgasmia.
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 (fluvoxamine maleate) 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. LUVOX CR Capsules are not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)
Please see full prescribing information, including boxed warning, for LUVOX CR.
LUVOX is a registered trademark of Solvay Pharmaceuticals, Inc.
© 2008 Jazz Pharmaceuticals, Inc.
