Pronunciation:

ga-LAN-ta-meen

Brand Names:

• Razadyne
• Razadyne ER
• Razadyne IR

Dosage Forms:

• Solution
• Capsule, Extended Release
• Tablet

Classifications:

Therapeutic—

Central Nervous System Agent

Pharmacologic—

Cholinesterase Inhibitor, Centrally/Peripherally Acting

Uses of This Medicine:

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 the thinking ability in some patients with Alzheimer's disease.

In Alzheimer's disease, many chemical changes take place 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 work properly. Galantamine slows the breakdown of ACh, so it can build up and have a greater effect. However, as Alzheimer's disease gets worse, there will be less and less ACh, so galantamine may not work as well.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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 tell 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of galantamine in the pediatric population. Safety and efficacy have not been established.

Older adults—

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

Breast-feeding—

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

Other medicines—

Although certain 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 cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 required 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
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased 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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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 you tell your doctor if you have any other medical problems, especially:

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

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

• Kidney disease, moderate or
• Liver disease, moderate—Use with caution. The effects may be increased because of 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
• Stomach or bowel surgery, recent—Use is not recommended in patients with these conditions.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately 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 occasionally, 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 itching 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 immediately 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. Also, your health care professional may 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.