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Get important information
and facts about LUVOX CR.
Common Side Effects
As with any prescription medicine, LUVOX CR may cause side effects. In studies, common side effects seen in at least 5% of patients on LUVOX CR and reported twice as often with LUVOX CR as with a sugar pill were upset stomach, feeling sleepy, feeling weak, diarrhea, anorexia, tremor, and sweating. Overall, these side effects were mild to moderate and often temporary. Other common side effects (seen in at least 5% of patients and reported twice as often as with sugar pill) included some sexual side effects such as abnormal ejaculation and the inability to reach orgasm.
Helpful tip
As treatment continues, some side effects may disappear altogether. Remember, it is still important to let your doctor know about any side effects you are having.
How does LUVOX CR affect weight?
LUVOX CR has been shown in three 12 week studies to cause no major weight gain or loss.
How much of a problem are sexual side effects with
LUVOX CR?
LUVOX CR has been shown over a period of 12 weeks to have a low incidence of sexual side effects. Less than 1% of patients on LUVOX CR discontinued therapy in clinical trials due to any individual sexual side effect.
What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?
Although LUVOX CR is not approved to treat depression, it is in the same family of antidepressant medicines.
Antidepressant medicines may increase suicidal thoughts and actions in some children, teenagers, and young adults within the first few months of treatment.
Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts and actions.
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed
- Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings
- Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms
Call the healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
Thoughts about suicide or dying; attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping (insomnia); new or worse irritability; acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); and any other unusual changes in behavior or mood.
What else do I need to know about antidepressant medicines?
- Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms
- Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants
- Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member
- Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider
- Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information
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 CR is a registered trademark of Solvay Pharmaceuticals, Inc.
© 2008 Jazz Pharmaceuticals, Inc.
