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| Ortho-McNeil Neurologics® has the following prescription pharmaceutical products in the United States. This information is intended for use by our customers, patients and healthcare professionals in the United States only. |
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RAZADYNE®/RAZADYNE® ER (galantamine hydrobromide)
For the treatment of the symptoms of mild to moderate dementia of the Alzheimer's type
>> RAZADYNE® ER Full US Prescribing Information
>> www.RazadyneER.com
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TOPAMAX® (topiramate) - Epilepsy
TOPAMAX® is approved as initial monotherapy in patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures.
Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than two seizures in the three months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.
TOPAMAX® is approved as add-on therapy for people 2 years of age and older with primary generalized tonic-clonic seizures, partial-onset seizures, or seizures associated with Lennox-Gastaut syndrome.
>> TOPAMAX® Full US Prescribing Information
>> www.TOPAMAX-epilepsy.com
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TOPAMAX® (topiramate) - Migraine
TOPAMAX® is approved for migraine prevention in adults only.
TOPAMAX® is not used to stop a migraine after it starts.
>> TOPAMAX® Full US Prescribing Information
>> www.TOPAMAX.com
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AXERT® (almotriptan malate) Tablets
AXERT® is approved for the acute treatment of migraine with or without aura in adults and should be used only when a clear diagnosis of migraine has been established. AXERT® is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of AXERT® have not been established for cluster headache, which is present in an older, predominantly male population.
>> AXERT® Full US Prescribing Information
>> www.Axert.com
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Healthcare Information
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Ortho-McNeil Neurologics® is proud to make the following healthcare information sites available to the public:
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www.expressionsofcourage.com - stories of people overcoming the challenges of living with epilepsy
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www.migrainesolutions.com - prevention, treatment and support information for people with migraine
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www.mindovermigraine.com - an educational initiative designed to empower people with migraine to manage their migraine attacks and gain more control over their migraine experience.
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www.rxforsafety.com - this Web site sponsored by Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. contains information about safe medication use for both patients and healthcare professionals. |
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Didn't find a product you were looking for?
For more information about products for schizophrenia and bipolar mania, please visit
Janssen.com
For more information about products for Acid Reflux Disease, Infectious Diseases, and Pain Management, please visit
PriCara.com
For more information about contraceptive and urology products, please visit
Ortho-McNeil Pharmaceutical.com
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IMPORTANT SAFETY INFORMATION ABOUT RAZADYNE® ER (galantamine HBr)
In clinical trials, the most frequent adverse events with RAZADYNE® ER were similar to the twice-daily formulation
of galantamine HBr. With the twice-daily formulation of galantamine HBr, the most common side effects were nausea,
vomiting, diarrhea, loss of appetite, and weight loss. Typically these side effects were mild and temporary.
RAZADYNE® ER may not be for everyone. Some people experience a slowed heart rate, which may lead
to fainting. Serious stomach problems can occur in people taking medications such as nonsteroidal
anti-inflammatory drugs (NSAIDs) or those at risk for stomach ulcers.
Please see full US Prescribing Information.
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IMPORTANT SAFETY INFORMATION ABOUT TOPAMAX® Epilepsy
Serious risks associated with TOPAMAX® include lowered bicarbonate levels in the blood resulting in an increase in the acidity of the blood (metabolic acidosis). Symptoms could include hyperventilation (rapid, deep breathing), tiredness, loss of appetite, irregular heartbeat or changes in the level of alertness. Call your doctor immediately if you get these symptoms. Your doctor may want to do simple blood tests. Chronic, untreated metabolic acidosis may increase the risk for kidney stones or bone disease.
Other serious risks include decreased sweating, increased body temperature, kidney stones, sleepiness, dizziness, confusion, difficulty concentrating, and increased eye pressure (glaucoma). Call your doctor immediately if you have any decrease in vision or eye pain. These problems can lead to blindness if not treated right away.
More common side effects are tingling in arms and legs, loss of appetite, tiredness, nausea, diarrhea, taste change and weight loss.
As monotherapy, the most common side effects of TOPAMAX® (in the 400 mg/day group and at a rate higher than the 50 mg/day group) in adults were tingling in arms and legs, weight decrease, sleepiness, loss of appetite, dizziness, and difficulty with memory; and in children, weight decrease, upper respiratory tract infection, tingling in arms and legs, loss of appetite, diarrhea, and mood problems.
In combination with other antiepileptic drugs (AEDs), the most common side effects of TOPAMAX® in adults (200 to 400 mg/day) were sleepiness, dizziness, nervousness, loss of muscle coordination, fatigue, speech disorders and related problems, psychomotor slowing, abnormal vision, difficulty with memory, tingling in arms and legs, and double vision; and in children (5 to 9 mg/kg/day), fatigue, sleepiness, loss of appetite, nervousness, difficulty with concentration/attention, difficulty with memory, aggressive reaction, and weight decrease.
Tell your doctor about other medications you take.
Please see full US Prescribing Information.
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IMPORTANT SAFETY INFORMATION ABOUT TOPAMAX® Migraine
Serious risks associated with TOPAMAX® include lowered bicarbonate levels in the blood resulting in an increase in the acidity of the blood (metabolic acidosis). Symptoms could include hyperventilation (rapid, deep breathing), tiredness, loss of appetite, irregular heartbeat or changes in the level of alertness. Call your doctor immediately if you get these symptoms. Your doctor may want to do simple blood tests. Chronic, untreated metabolic acidosis may increase the risk for kidney stones or bone disease.
Other serious risks include decreased sweating, increased body temperature, kidney stones, sleepiness, dizziness, confusion, difficulty concentrating, and increased eye pressure (glaucoma). Call your doctor immediately if you have any decrease in vision or eye pain. These problems can lead to blindness if not treated right away.
More common side effects are tingling in arms and legs, loss of appetite, tiredness, nausea, diarrhea, taste change and weight loss.
Tell your doctor about other medications you take.
Please see full US Prescribing Information.
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IMPORTANT SAFETY INFORMATION ABOUT AXERT®
AXERT® (almotriptan malate) is a prescription medication for the acute treatment of migraine with or without aura in adults. You should not take AXERT® if you have heart disease, uncontrolled high blood pressure or have ever had heart disease. If you have risk factors for heart disease (high blood pressure, high cholesterol, diabetes, obesity, smoking, family history of heart attack, menopause, or are a male over 40 years of age), or if you are pregnant, nursing, or thinking about becoming pregnant, talk with your doctor before taking AXERT®. Tell your doctor about all prescription and over-the-counter medications you are taking.
AXERT®, like other triptans, may be associated with a potentially life-threatening condition mainly when taken together with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), two classes of drugs for depression or other disorders. Common SSRIs are Celexa® (citalopram HBr), Lexapro® (escitalopram oxalate), Paxil® (paroxetine), Prozac®/Sarafem® (fluoxetine), Symbyax® (olanzapine/fluoxetine), Zoloft® (sertraline), and Luvox® (fluvoxamine). Common SNRIs are Cymbalta® (duloxetine) and Effexor® (venlafaxine). If you experience symptoms such as confusion, sweating, flushing, rapid heartbeat, diarrhea, muscle weakness, poor balance, or worsening headache, contact your doctor immediately.
The most common AXERT® side effects are nausea, sleepiness, tingling sensation, headache, and dry mouth. Ask your doctor about side effects, possible drug interactions, and any other important questions you may have before taking AXERT®.
Celexa and Lexapro are registered trademarks of Forest Laboratories. Paxil is a registered trademark of GlaxoSmithKline. Symbyax, Prozac/Sarafem and Cymbalta are registered trademarks of Eli Lilly. Zoloft is a registered trademark of Pfizer. Luvox is a registered trademark of Solvay. Effexor is a registered trademark of Wyeth.
Please see full US Prescribing Information.
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