Razadyne ER

Razadyne ER is a prescription medication used to treat the symptoms of Alzheimer's disease. Razadyne ER belongs to a group of drugs called acetylcholinesterase inhibitors. These work by stopping a specific enzyme from breaking down acetylcholine in the brain.

This medication comes as an extended-release (long-acting) capsule and is taken once a day in the morning, with food.

Common side effects of Razadyne ER include nausea, vomiting, and diarrhea.

Razadyne ER can also cause dizziness. Do not drive or operate heavy machinery until you know how Razadyne ER affects you.

Razadyne ER is a prescription medication used to treat mild to moderate Alzheimer's disease, a disease that impairs memory and the ability to think and perform daily activities. 

Razadyne ER may improve the ability to think and remember or slow the loss of these abilities in people who have Alzheimer's disease. However, Razadyne ER will not cure Alzheimer's disease or prevent the loss of mental abilities at some time in the future.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Janssen Pharmaceuticals, Inc.

Serious side effects have been reported with Razadyne ER. See the "Razadyne ER Drug Precautions" section.

Common side effects of Razadyne ER include the following:

• Nausea
• Vomiting
• Dizziness
• Diarrhea
• Loss of appetite
• Weight loss
• Tiredness
• Headache
• Stomach upset
• Decreased heart rate
• Uncontrollable shaking in a part of your body
• Depression

This is not a complete list of Razadyne ER side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticholinergics such as glycopyrrolate (Cuvposa, Robinul), trospium (Sanctura), oxybutynin (Anturol, Gelnique, Oxytrol, Ditropan), solifenacin (Vesicare), dicyclomine (Bentyl), propantheline (Pro-Banthine), and atropine (Atropen, Sal-Tropine)
• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil, Amitril), and paroxetine (Paxil)
• Cimetidine
• Cholinergics such as bethanechol (Urecholine), cevimeline (Evoxac), pilocarpine (Salagen)

This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Razadyne ER including the following: 

• Bradycardia (slowing of the heart rate) and AV block (changes in heart rhythm. This can cause your body and your brain to not get enough oxygen. Tell your healthcare provider right away if you have some or all of the following symptoms of bradycardia and AV block:
  • Fainting, or nearly fainting
  • Shortness of breath
  • Weakness
  • Getting tired quickly or easily
  • Chest pain
• Increase in the amount of stomach acid produced. Tell your healthcare provider right away if you have some or all of the following symptoms of having more stomach acid:
  • Nausea
  • Vomiting
  • Stomach pain or burning
  • Bloody or tarry stools
  • Acid reflux or heart burn
  • Indigestion
• Bladder outflow obstruction. Tell your healthcare provider right away if you have some or all of the following symptoms of bladder obstruction:
  • pain in the stomach or abdomen
  • pain while urinating
  • Feeling that the bladder is always full
  • Not being able to urinate or pee completely 
  • Urinating or peeing often
  • Urinating slowly
• Seizures
• Worsening of asthma or Chronic Obstructive Pulmonary Disease (COPD). Tell your healthcare provider right away if you have some or all of the following symptoms of asthma or COPD
  • Difficulty breathing
  • Shortness of breath
  • Difficulty catching breath
  • Using inhalers more often

Razadyne ER can cause dizziness. Do not drive or operate heavy machinery until you know how Razadyne ER affects you.

Do not take Razadyne ER if you are allergic to Razadyne ER or any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Razadyne ER, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Razadyne ER, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Razadyne ER or to any of its ingredients
• have, or have had, seizures
• have heart problems, or heart rhythm problems
• have liver problems
• have kidney problems
• will be having surgery that requires anesthesia
• only have mild cognitive impairment, and not Alzheimer's Disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Razadyne ER falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Razadyne ER crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Razadyne ER.

Take Razadyne ER exactly as prescribed.

This medication comes as an extended-release (long-acting) capsule and is taken once a day in the morning, with food.

Do not chew, divide, or break Razadyne ER capsules. Be sure to swallow extended-release capsules whole.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Razadyne ER at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended starting dose for Razadyne ER (galantamine) extended-release capsules is 8 mg once daily in the morning. The maximum recommended dose for Razadyne ER (galantamine) extended-release capsules is 24 mg once daily.

If you take too much Razadyne ER, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Razadyne ER is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Razadyne ER at room temperature.
• Keep this and all medicines out of the reach of children.