Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. Our heritage is generics, and since 1919, we’ve formulated and manufactured specialty generics for a wide array of customers, backed by our attentive level of service, our strong industry relationships, and our dedication to uninterrupted supply.
As we celebrate our 100th year in business, we enter a new ambitious era that has been accelerated by our 2017 acquisition by Sawai Pharmaceutical Co., Ltd. With our new owner, we look to leverage each other for growth worldwide and embark on an exciting new chapter. Together, we seek to deliver the best value for our stakeholders, and most importantly, to do more good for the patients we serve.
WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW?
Qudexy XR can cause serious side effects, including:
- Serious eye problems, which may include blurred or sudden decrease in vision, eye pain and redness or a blockage of fluid that may cause increased pressure in the eye (secondary angle closure glaucoma). If left untreated, this can lead to permanent vision loss.
- Decreased sweating and fever. People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition.
- Increased acid level in the blood (metabolic acidosis). ). This may or may not cause symptoms. Symptoms may include feeling tired, decreased appetite, change in heartbeat, or trouble thinking clearly. If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm the unborn child of pregnant patients.
- High blood ammonia levels. High ammonia in the blood can affect mental activities, slow alertness and cause tiredness or vomiting. This can also happen when Qudexy XR is taken with a medicine called valproic acid (e.g., Depakene® and Depakote®).
- Kidney stones. Drink plenty of fluids when taking Qudexy XR to decrease your chances of getting kidney stones.
- Low body temperature. Taking Qudexy XR when you are also taking valproic acid may cause a drop in body temperature to less than 95°F, tiredness, confusion, or coma.
- Effects on thinking and alertness. Qudexy XR may affect how you think, and can cause confusion, problems with concentration, attention, memory, or speech. Qudexy XR may cause depression or mood problems, tiredness, and sleepiness.
- Dizziness or loss of muscle coordination.
Call your healthcare provider right away if you have any of the above symptoms.
Like other antiepileptic drugs, Qudexy XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Before taking Qudexy XR, tell your healthcare provider if you have or have had depression, mood problems, or suicidal thoughts or behavior. Call a healthcare provider right away if you have: thoughts about suicide or dying; attempt to commit suicide; have new or worsening depression or anxiety; feel agitated or restless; experience panic attacks, have trouble sleeping (insomnia); have new or worsening irritability; feel or act aggressive, angry, or violent; act on dangerous impulses; experience an extreme increase in activity and talking (mania); or other unusual changes in your behavior or mood.
Qudexy XR can harm your unborn baby. All women of childbearing age should talk to their healthcare provider about possible alternative treatments. If you take Qudexy XR during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. Also, if you take Qudexy XR during pregnancy, your baby may be smaller than expected at birth; the long-term effects of this are not known. If the decision is made to use Qudexy XR, you should use effective birth control (contraception). Tell your healthcare provider right away if you become, or plan to become pregnant while taking Qudexy XR.
The most common side effects of Qudexy XR include: tingling of the arms and legs (paresthesia), not feeling hungry, weight loss, nervousness, nausea, speech problems, tiredness, dizziness, sleepiness/drowsiness, a change in the way foods taste, upper respiratory tract infection, decreased feeling or sensitivity especially in the skin, slow reactions, difficulty with memory, fever, abnormal vision, diarrhea, and pain in the abdomen. These are not all the possible side effects of Qudexy XR. For more information, ask your healthcare provider or pharmacist.
Before taking Qudexy XR, tell your healthcare provider about all of your medical conditions, including if you: have had depression, mood problems, or suicidal thoughts or behavior; have kidney problems, kidney stones, or are getting kidney dialysis; have a history of metabolic acidosis (too much acid in the blood); have liver problems; have weak, brittle or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density); have lung or breathing problems; have eye problems, especially glaucoma; have diarrhea; have a growth problem; are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet; are having surgery; are pregnant or planning to become pregnant; or if you are breastfeeding. The medicine in Qudexy XR (topiramate) passes into your breast milk. It is not known if the medicine, topiramate, that passes into breast milk can harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take Qudexy XR.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take metformin (e.g., Glucophage); valproic acid (e.g., Depakene or Depakote); any medicines that impair or decrease your thinking, concentration, or muscle coordination; birth control pills (Qudexy XR may make birth control pills less effective); medicines used to prevent seizures; or any other carbonic anhydrase inhibitors (e.g., zonisamide or acetazolamide).
Do not stop Qudexy XR without first talking to a healthcare provider. If you have epilepsy and you stop taking Qudexy XR suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking Qudexy XR slowly.
Do not drink alcohol while taking Qudexy XR. Qudexy XR and alcohol can cause side effects such as sleepiness and dizziness.
Do not drive a car, swim, climb, or operate heavy machinery until you know how Qudexy XR affects you. Qudexy XR can slow your thinking and motor skills, and may affect vision. Even when taking Qudexy XR, some patients with epilepsy will continue to have unpredictable seizures.
WHAT IS QUDEXY XR?
Qudexy® XR (topiramate) Extended-Release Capsules is a prescription medicine used:
- To prevent migraine headaches in adults and adolescents 12 years and older.
- To treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years and older.
- With other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older.
This is the most important information to know about Qudexy XR, but is not comprehensive. For more information, talk to your healthcare provider and read the Medication Guide for Qudexy XR. You can also visit www.upsher-smith.com or call 1-888-650-3789.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Qudexy is a registered trademark of Upsher-Smith Laboratories, LLC. All other marks are the property of their respective owners.
IMPORTANT SAFETY INFORMATION
WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW ABOUT VIGADRONE?
- Because VIGADRONE might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain the details of this Program to you.
- VIGADRONE can damage the vision of anyone who takes it. People who take VIGADRONE do not lose all of their vision, but some people can have severe loss, particularly to their ability to see to the side when looking straight ahead (peripheral vision). With severe vision loss, you may only be able to see things straight in front of you (sometimes called “tunnel vision”). You may also have blurry vision. If this happens, it will not get better.
- Tell your healthcare provider right away if you (or your child): might not be seeing as well as before starting VIGADRONE; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things in front of you that seem to come out of nowhere; or if your baby is acting differently than normal. These changes can mean that vision damage has occurred.
- Regular vision testing is recommended. It is recommended that your healthcare provider test your (or your child’s) vision before or within 4 weeks after starting VIGADRONE, and at least every 3 months during treatment until VIGADRONE is stopped. It is also recommended that vision be tested about 3 to 6 months after VIGADRONE is stopped. It is difficult to test vision in babies, but to the extent possible, all babies should have their vision tested. Your healthcare provider will determine if testing can be done. Regular vision testing is important because damage can happen before any changes are noticed.
- Vision tests cannot prevent the vision damage that can happen with VIGADRONE, but they do allow VIGADRONE to be stopped if vision has gotten worse, which usually will lessen further damage. Even these regular vision tests may not show vision damage before it is serious and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in babies, until it is severe.
- If you do not have these vision tests regularly, your healthcare provider may stop prescribing VIGADRONE for you (or your child). Some people are not able to complete vision testing. If vision testing cannot be done, your healthcare provider may continue prescribing VIGADRONE, but will not be able to watch for any vision loss.
- Magnetic resonance imaging (MRI) changes in babies with IS. Brain pictures taken by MRI show changes in some babies after they are given VIGADRONE. It is not known if these changes are harmful.
- Risk of suicidal thoughts or actions. Like other antiepileptic drugs, VIGADRONE may cause suicidal thoughts and actions in some people (about 1 in 500 people). Call a healthcare provider right away if you (or your child) have any symptoms, especially sudden changes in mood, behaviors, thoughts or feelings, and especially if they are new, worse, or worry you.
- Do not stop VIGADRONE without first talking to a healthcare provider. Stopping VIGADRONE suddenly can cause seizures that will not stop.
VIGADRONE can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, nerve problems, weight gain, and swelling. Because VIGADRONE causes sleepiness and tiredness, do not drive, operate machinery, or perform any hazardous task, unless it is decided that these things can be done safely. VIGADRONE may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.
Before starting VIGADRONE, tell your doctor about all of your (or your child’s) medical conditions including depression, mood problems, suicidal thoughts or behavior, any allergic reaction to VIGADRONE, vision problems, kidney problems, low red blood cell counts (anemia), and any nervous or mental illnesses. Tell your doctor about all the medicines you (or your child) take.
If you are breastfeeding or plan to breastfeed, VIGADRONE can pass into breast milk and may harm your baby.
If you are pregnant or plan to become pregnant, it is not known if VIGADRONE will harm your unborn baby. You and your healthcare provider will have to decide if you should take VIGADRONE while you are pregnant.
The most common side effects of VIGADRONE in adults include: problems walking or feeling uncoordinated, feeling dizzy, shaking (tremor), joint pain, memory problems and not thinking clearly, and eye problems like blurry vision, double vision, and eye movements that cannot be controlled.
The most common side effects of VIGADRONE in children 10 to 16 years of age include weight gain, upper respiratory tract infection, tiredness, and aggression. Also expect side effects like those seen in adults.
The most common side effects of VIGADRONE in babies include: sleepiness—some babies may have a harder time suckling and feeding or may be irritable, swelling in the bronchial tubes (bronchitis), ear infection, and irritability.
Tell your healthcare provider if you or your child have any side effect that bothers you or that does not go away.
WHAT IS VIGADRONE?
VIGADRONE (vigabatrin) for Oral Solution is a prescription medicine used for the treatment of:
Infantile Spasms (IS) in babies 1 month to 2 years of age, if you and your healthcare provider decide the possible benefits of taking vigabatrin are more important than the possible risk of vision loss.
Refractory Complex Partial Seizures (CPS) used along with other treatments to treat adults and children 10 years and older if: (1) The CPS does not respond well enough to several other treatments, and (2) You and your healthcare provider decide the possible benefit of taking vigabatrin is more important than the risk of vision loss.
VIGADRONE should not be the first medicine used to treat CPS.
This is the most important information to know about VIGADRONE, but not all of the possible side effects of VIGADRONE. For more information, ask your healthcare provider or pharmacist, or please see VIGADRONE Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use. You can also visit www.VIGADRONE.com, www.upsher-smith.com or call 1-888-650-3789.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088.
VIGADRONE is a trademark of Upsher-Smith Laboratories, LLC.