Razadyne ER (Oral)

Galantamine is used to treat mild to moderate dementia (memory loss and mental changes) that is a sign of Alzheimer's disease. Galantamine will not cure Alzheimer's disease, and it will not stop the disease from getting worse. However, galantamine can improve thinking ability in some patients with Alzheimer's disease.

In Alzheimer's disease, many chemical changes happen in the brain. One of the earliest and biggest changes is that there is less of a chemical called acetylcholine (ACh). ACh helps the brain to function properly. Galantamine slows down the breakdown of ACh, allowing it to build up and have a stronger effect. However, as Alzheimer's disease progresses, there will be less ACh, so galantamine may not work as effectively.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Galantamine may cause stomach or bowel problems. Check with your doctor right away if you have nausea, vomiting, diarrhea, stomach pain, loss of appetite, or weight loss.

If you think you or someone else may have taken an overdose of galantamine, get emergency help at once. Taking an overdose of galantamine may lead to convulsions (seizures) or shock. Some signs of shock are large pupils, irregular breathing, and fast weak pulse. Other signs of an overdose are severe nausea and vomiting, increasing muscle weakness, greatly increased sweating, and greatly increased watering of the mouth.

Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of galantamine in children. Safety and effectiveness have not been established.

Geriatric

Appropriate studies performed to date have not shown geriatric-specific problems that would limit the usefulness of galantamine in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Amiodarone
• Amisulpride
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Atazanavir
• Buprenorphine
• Bupropion
• Buserelin
• Ceritinib
• Chloroquine
• Citalopram
• Clarithromycin
• Clofazimine
• Clothiapine
• Clozapine
• Crizotinib
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Domperidone
• Donepezil
• Efavirenz
• Encorafenib
• Entrectinib
• Escitalopram
• Etrasimod
• Fexinidazole
• Fingolimod
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fostemsavir
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Macimorelin
• Methadone
• Metronidazole
• Mirtazapine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nilotinib
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Phenobarbital
• Pimavanserin
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Quetiapine
• Quizartinib
• Relugolix
• Ribociclib
• Selpercatinib
• Sertraline
• Sevoflurane
• Siponimod
• Solifenacin
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Trazodone
• Triclabendazole
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Vilanterol
• Vinflunine
• Voclosporin
• Zuclopenthixol

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Fluvoxamine
• Ketoconazole
• Oxybutynin
• Quinidine
• Tolterodine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food since interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Asthma (severe), history of or
• Lung disease (e.g., obstructive pulmonary disease) or
• Seizures or
• Stomach bleeding or ulcers, or history of or
• Urinary bladder blockage—Use with caution. May worsen these conditions.

• Heart rhythm problems—May increase the risk of more serious side effects.

• Kidney disease, moderate or
• Liver disease, moderate—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

• Kidney disease, severe or
• Liver disease, severe—Use is not recommended in patients with these conditions.

• Stomach blockage or
• Recent stomach or bowel surgery—Use is not recommended in patients with these conditions.

Along with its intended effects, a medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects occur:

Less common

• Chest pain or discomfort
• lightheadedness, dizziness, or fainting
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• slow or irregular heartbeat
• unusual tiredness

Rare

• Blurred vision
• confusion
• decreased urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• rapid breathing
• redness of the face, neck, arms, and sometimes, upper chest
• sunken eyes
• sweating
• thirst
• troubled breathing
• unusual tiredness or weakness
• wrinkled skin

Incidence not known

• Blistering, peeling, or loosening of the skin
• chills
• cough
• dark urine
• fever
• general tiredness and weakness
• headache
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• light-colored stools
• nausea and vomiting
• nervousness
• pounding in the ears
• rash, hives, or itchy skin
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled swallowing
• upper right abdominal or stomach pain
• yellow eyes and skin

Get emergency help right away if any of the following symptoms of overdose occur:

Symptoms of overdose

• Confusion
• convulsions
• irregular, fast or slow, or shallow breathing
• muscle weakness
• pale or blue lips, fingernails, or skin
• severe nausea
• stomach cramps
• sweating
• tearing of the eyes
• twitches of the muscle visible under the skin
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Decreased appetite
• weight loss

Less common

• Acid or sour stomach
• belching
• discouragement
• feeling sad or empty
• general feeling of discomfort or illness
• heartburn
• increased sweating
• indigestion
• irritability
• lack of appetite
• lack or loss of strength
• loss of interest or pleasure
• muscle spasms
• stomach discomfort, upset, or pain
• trouble concentrating
• trouble sleeping
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Rare

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• dry heaves
• loss of taste
• unusually deep sleep
• unusually long duration of sleep

Incidence not known

• Continuing ringing or buzzing or other unexplained noise in the ears
• hearing loss
• seeing, hearing, or feeling things that are not there

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Razadyne
• Razadyne ER
• Razadyne IR

Available Dosage Forms:

• Solution
• Capsule, Extended Release
• Tablet

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: Cholinesterase Inhibitor, Centrally/Peripherally Acting

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

If you are taking the extended-release capsules:

• Take it with your morning meal.
• Swallow the extended-release capsule whole. Do not crush, break, or chew it.

If you are taking the oral liquid:

• Follow the instruction sheet for the proper dosing of the oral liquid. Ask your doctor or pharmacist if you have any questions.
• Measure your dose with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Take the oral liquid or tablets with morning or evening meals.

Drink extra fluids so you will pass more urine while you are using this medicine. This may help prevent kidney problems.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of Alzheimer's disease: For oral dosage form (extended-release capsules): Adults—At first, 8 milligrams (mg) once a day with food. Your doctor may increase your dose to 16 mg per day after at least 4 weeks, and then to 24 mg per day after at least another 4 weeks. Children—Use and dose must be determined by your doctor. For oral dosage forms (oral solution or tablets): Adults—At first, 4 milligrams (mg) two times a day. Your doctor may increase your dose to 8 mg two times a day after at least of 4 weeks, and then to 12 mg two times a day after at least 4 weeks. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you missed your dose for more than 3 days, call your doctor right away. You may need to go back to a lower dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Is Razadyne (galantamine) used to treat Alzheimer’s?
• What drugs can help improve or slow down memory loss?