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Healthcare
Professionals
Get important information
and facts about LUVOX CR.
How Do I Take LUVOX CR?
If your doctor has given you a prescription, make sure you have a pharmacy fill it right away so you can begin your treatment. After the first few weeks, your doctor may ask to see you again to check on how you are doing. Depending on how you feel, your doctor may change your medicine or leave it the same.
If your doctor does increase your dosage of LUVOX CR, below is a chart that explains how
LUVOX CR may be taken when given at different dose strengths. Please remember to take your medicine only as your doctor instructs you to.
Helpful tip
Your doctor will determine a schedule that's right for you. If you are not sure about how to take your medicine, please ask your doctor to write down his or her instructions.
Is LUVOX CR habit forming?
No. Research has shown that LUVOX CR is not habit forming.
Can I take LUVOX CR with other medicines?
Always talk with your doctor and pharmacist about any medicines you are taking, including herbal remedies and over-the-counter medicines, for example, aspirin and ibuprofen.
LUVOX CR should not be taken while you are taking any of the following: Lotronex®* (alosetron hydrochloride — a medicine for irritable bowel syndrome), tizanidine (used for muscle spasms and cramps), thioridazine (for schizophrenia and psychosis), pimozide (an antipsychotic drug), or monoamine oxidase inhibitors (MAOIs — a type of antidepressant). In addition, if you should stop taking LUVOX CR, you should wait at least 14 days before you begin treatment with MAOIs. You should also not take LUVOX CR if you have a history of hypersensitivity to fluvoxamine maleate (SSRI antidepressants) or any other ingredients. Talk to your doctor if you have any questions.
What else should I know about taking LUVOX CR?
- Take LUVOX CR only as your doctor instructs you to
- As with all medicines, keep LUVOX CR away from children
- Avoid drinking alcohol while taking LUVOX CR
- LUVOX CR Capsules should be protected from high humidity and stored at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature]. Avoid exposure to temperatures above 30°C (86°F).
- Let your doctor know if you are pregnant, breast-feeding, or plan on becoming pregnant
- Capsules should not be crushed or chewed
*Lotronex® is a registered trademark of GlaxoSmithKline.
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.
